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OK, ladies and gentleman, we've got a range of opinions on this one from our notified body, our distributor, and ourselves ranging from Class I (non-measuring), to Class IIa, and to Class IIb. What say you? Here is the device intended use:
Rule 12 is the default for an Active Device for Diagnosis which does not fit into Rule 10. Page 45 of MedDEV 2.4/1 lists thermography, an active device for diagnosis, as Class I by Rule 12. On page 42, an electronic thermometer is listed as IIa under Rule 10 because it allows "direct diagnosis or monitoring of vital physiological processes".
[FONT="]thermography [/FONT]
[FONT="]a technique wherein an infrared camera photographically portrays the body's surface temperature, based on self-emanating infrared radiations; used as a diagnostic aid in the detection of breast tumors and the assessment of rheumatic joints; also used in the study of pain.
[/FONT]
[FONT="]Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition[/FONT]
Hence, thermography must be not providing *direct* diagnosis, but rather indirect diagnosis (of breast cancer, for instance).
Further, thermography must be not monitoring a "vital physiological process", even though it is looking at patterns in body temperature (Note 1 on page 43 lists "body temperature as a vital physiological process".)
Similar to thermography, heart rate variability analysis is looking at the *patterns of* a vital sign in order to provide a risk assessment of sepsis, but not a direct diagnosis.
Hence, the device is Class I.
The Case for Class IIa:
By rule 10, we've got an Active Device for Diagnosis, but one where the nature of the variations is such that it could NOT result in *immediate* danger to the patient.
In the context of a Neonatal Intensive Care Unit, where babies stop breathing routinely and must be revived before they suffer results of hypoxia, harboring a case of sepsis that brews over days does not require *immediate* intervention.
Hence IIa.
The Case for IIb:
By rule 10, we've got an Active Device for Diagnosis where the nature of the variations DOES result in *immediate* danger to the patient. Sepsis is dangerous and it needs to be treated ASAP.
Hence IIb.
***
Looking forward to your opinions!
DEVICE is intended to acquire, store, analyze, and report on ECG data collected from infants. DEVICE is intended to be used by trained operators under the direct supervision of a licensed health care practitioner in a hospital neonatal or pediatric ICU environment.
DEVICE is intended to be used for the analysis of the variability in RR Intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by DEVICE are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
DEVICE is intended to provide specialized HRV measurements and may detect arrhythmias, that when combined with other risk factors, can be used as an aid in assessing the risk of sepsis in infants. The use of the DEVICE monitoring improves survival in very low birth weight neonates.
DEVICE acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
Installation, training, maintenance and support are to be performed by MANUFACTURER employees or contractors who have been certified by MANUFACTURER as qualified to perform such duties.
This case for Class I:DEVICE is intended to be used for the analysis of the variability in RR Intervals (heart rate) and to report measurements of the variability of heart rate data (HRV). The HRV measurements reported by DEVICE are specialized in nature, and intended to identify periods of transient decelerations and/or reduced baseline variability in the heart rate.
DEVICE is intended to provide specialized HRV measurements and may detect arrhythmias, that when combined with other risk factors, can be used as an aid in assessing the risk of sepsis in infants. The use of the DEVICE monitoring improves survival in very low birth weight neonates.
DEVICE acquires data from a user-supplied ECG monitor, and requires a user-supplied local area network.
Installation, training, maintenance and support are to be performed by MANUFACTURER employees or contractors who have been certified by MANUFACTURER as qualified to perform such duties.
Rule 12 is the default for an Active Device for Diagnosis which does not fit into Rule 10. Page 45 of MedDEV 2.4/1 lists thermography, an active device for diagnosis, as Class I by Rule 12. On page 42, an electronic thermometer is listed as IIa under Rule 10 because it allows "direct diagnosis or monitoring of vital physiological processes".
[FONT="]thermography [/FONT]
[FONT="]a technique wherein an infrared camera photographically portrays the body's surface temperature, based on self-emanating infrared radiations; used as a diagnostic aid in the detection of breast tumors and the assessment of rheumatic joints; also used in the study of pain.
[/FONT]
[FONT="]Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition[/FONT]
Hence, thermography must be not providing *direct* diagnosis, but rather indirect diagnosis (of breast cancer, for instance).
Further, thermography must be not monitoring a "vital physiological process", even though it is looking at patterns in body temperature (Note 1 on page 43 lists "body temperature as a vital physiological process".)
Similar to thermography, heart rate variability analysis is looking at the *patterns of* a vital sign in order to provide a risk assessment of sepsis, but not a direct diagnosis.
Hence, the device is Class I.
The Case for Class IIa:
By rule 10, we've got an Active Device for Diagnosis, but one where the nature of the variations is such that it could NOT result in *immediate* danger to the patient.
In the context of a Neonatal Intensive Care Unit, where babies stop breathing routinely and must be revived before they suffer results of hypoxia, harboring a case of sepsis that brews over days does not require *immediate* intervention.
Hence IIa.
The Case for IIb:
By rule 10, we've got an Active Device for Diagnosis where the nature of the variations DOES result in *immediate* danger to the patient. Sepsis is dangerous and it needs to be treated ASAP.
Hence IIb.
***
Looking forward to your opinions!
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