Classification of Surgical Sutures used for Cardiovascular Surgery

C

Cinti

#1
Hi,

I understood that all blood contacting devices are classified as Class III in FDA. What is the classification of surgical sutures being used for Cardiovascular surgery? Kindly help me.

Cinti
 
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Jim Wynne

Staff member
Admin
#3
Hi,

I understood that all blood contacting devices are classified as Class III in FDA. What is the classification of surgical sutures being used for Cardiovascular surgery? Kindly help me.

Cinti
Apparently Class II (I'm not an expert in this area). See the relevant federal regulations for sutures here.
 

bio_subbu

Super Moderator
#4
Hi,

I understood that all blood contacting devices are classified as Class III in FDA. What is the classification of surgical sutures being used for Cardiovascular surgery? Kindly help me.

Cinti

Dear Cinti

Surgical sutures are classified under 21 CFR 878 (class II), refer below FDA definition

SUBCHAPTER H--MEDICAL DEVICES

PART 878 -- GENERAL AND PLASTIC SURGERY DEVICES

Subpart E--Surgical Devices

Sec. 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percentl-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. "Monograph for Absorbable Surgical Sutures;" it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.

(b)Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA." See 878.1(e) for the availability of this guidance document.

[56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003]

Attached is Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA

Regards
S. Subramaniam
 

bio_subbu

Super Moderator
#5
In addition to my above post please find below different types of surgical sutures used for cardiovascular surgery.

1. Absorbable Polydioxanone Surgical (PDS) Suture (21 CFR §878.4840) Product code NEW.

2. Absorbable Poly(glycolide/L-lactide) Surgical Suture (21 CFR §878.4493) Product code GAM

3. Absorbable Gut Suture (21 CFR §878.4830) Product code GAL

4. Nonabsorbable Poly(Ethylene Terephthalate) Suture (21 CFR §878.5000) Product code GAT

5. Nonabsorbable Polypropylene Surgical Suture (21 CFR §878.5010) Product code GAW

6. Nonabsorbable Polyamide Surgical Suture (21 CFR §878.5020) Product code GAR

7. Natural Nonabsorbable Silk Surgical Suture (21 CFR §878.5030) Product code GAP

8. Stainless Steel Surgical Suture (21 CFR §878.4495) Product code GAQ

9. Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture (21 CFR §878.5035) Product code NBY

Regards
S. Subramaniam
 
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