(77 days)
Not Found
No
The device description and testing information focus on the physical properties and performance of a surgical suture, with no mention of AI or ML technologies.
No
This device is a surgical suture used for soft tissue approximation and ligation, which are procedural steps, not a therapeutic treatment itself.
No
The device description clearly states "POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation". This indicates a therapeutic or surgical use, not a diagnostic one.
No
The device description clearly states it is a "synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed on the body. IVDs are used to examine specimens from the body (like blood, urine, or tissue samples) to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is described as a "synthetic absorbable sterile surgical suture." This is a physical implant used during surgery, not a reagent, instrument, or system used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, analyzers, or the analysis of biological specimens.
Therefore, this device is a surgical suture, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAM
Device Description
POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue, ophthalmic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
This device may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or L-lactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed change(s). In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the Polyglycolic Acid surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
§ 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 percent l-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.
0
FEB 9 2000
T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID
SECTION III
: 44.4
510(K) Summary of Safety and Effectiveness
This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR 8807.92
A. Applicant & Submitted by:
| Trading Consultants And Distributors International Inc. |
|---|
| (T.CAD International) |
| 157 WindDance Dr. |
| Chicago, IL 60046-6681 |
| Telephone: (847) 265-7676 |
| Fax: (847) 265-7686 |
| Main M. Ghazal |
| September 27th 1999. |
Contact Person: Date Prepared:
B. Device Name:
- Trade Name: POLYGLYCOLIC ACID a.
- Common or Usual Name: Polyglycolic Acid Surgical Suture b.
- Classification Name: Absorbable Poly (glycolide/L-lactide) Surgical C. Suture (Per 21CFR878.4493)
C. Predicate Device:
DEXON II® Polyglycolic Acid Surgical Suture, Davis & Geck (K972566) Ethicon Absorbable Poly (L-lactide/glycolide) Surgical Suture, Undyed. (K964345)
D. Device Description:
POLYGLYCOLIC ACID is a synthetic absorbable sterile surgical suture composed of a synthetic polyglycolic acid polymer and is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures. POLYGLYCOLIC ACID meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Absorbable Surgical Suture. Offered as monofilament or multifilament in form, and it is offered uncoated or coated with polycarpolactone and calcium stearate, it could also be undyed or dyed with an FDA listed color additive, D&C Violet No. 2 (21CFR74.3602). POLYGLYCOLIC ACID will be offered with or without standard needles attached.
- E. Intended Use: POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
1
Ky44001
T.CAD International
990927/MG-510(k)
POLYGLYCOLIC ACID
| F. Comparison to Predicate Device: | POLYESTER | Predicate Device |
|---|---|---|
| Intended Use | General soft tissue approximation | |
| and/or ligation, including use in | ||
| ophthalmic procedures, but not for | ||
| use in cardiovascular and | ||
| neurological procedures. | Same | |
| Suture Material | Composed of glycolide polymer. | Ethicon: Composed of copolymers |
| made of glycolide and L-lactide | ||
| Davis & Geck: composed of | ||
| glycolide polymer. | ||
| Suture | ||
| Characteristics | Retains approximately 65% of its | |
| original tensile strength at two | ||
| weeks post implantation, with | ||
| approximately 40% remaining at | ||
| three weeks. Absorption of the | ||
| suture is essentially complete | ||
| between 60 and 90 days. | Same. | |
| Sterilization Method | Ethylene Oxide Gas | Same or equivalent process. |
| How Supplied | Monofilament or Braided, coated | |
| with polycaprolactone & calcium | ||
| stearate or uncoated, undyed or | ||
| dyed with D&C Violet No. 2. | ||
| Sterile and offered for Single Use | ||
| Only with or without needle. | Same or equivalent manner. Both | |
| Predicate devices are offered | ||
| Braided. Both are coated with | ||
| Polycaprolactone; a copolymer of | ||
| caprolactone and glycolide. Davis | ||
| & Geck is dyed with D&C violet | ||
| No. 2. Ethicon is undyed. | ||
| Suture Diameter, | ||
| Suture Length, | ||
| Knot Pull Tensile | ||
| Strength and Needle | ||
| Attachment Strength | Meet U.S.P. Requirements | Meet U.S.P. Requirements |
| Packaging | Dry packaged in Aluminum Foil | |
| and Polyester tear open packaging. | Same or equivalent manner. | |
| Labeling | In conformance with CDRH | |
| instructions of the "Medical Device | ||
| Quality Manual" dated December |
- Package Inserts in accordance
with the FDA Guidance documents "
Alternate Suture Labeling" Resulting
from the January 11th 1993 meeting
with HIMA, reformatted on
December 17th 1997. | Same |
F. Comparison to Predicate Device:
2
Kaquool
T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID
G. Clinical & Non-Clinical Testing:
Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.
Clinical Testing: Not available at the present time.
H. Conclusion:
Based on the technological characteristics and physical properties of the device, the device description, the intended use of the device, and conformance with voluntary performance standards like:
- a. United States Pharmacopeia Standards
- b. ISO 9002 & EN 46002.
- FDA Guidance documents " Alternate Suture Labeling" Resulting from ﻦ ﺍ the January 11th 1993 meeting with HIMA.
T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, arranged in a row.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
- 9 2000
Mr. Main M. Ghazal Trading Consultants and Distributors International, Inc. 157 WindDance Drive Chicago, Illinois 60046-6681
Re: K994001 Trade Name: Polyglycolic Acid Regulatory Class: II Product Code: GAM Dated: November 22, 1999 Received: November 24, 1999
Dear Mr. Ghazal:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Wednesday, September 18, 1991 (Vol. 56, No. 18, Pages 47150 and 47151). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:
- The Polyglycolic Acid Surgical Suture is indicated for use in general soft tissue 1. approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
-
- This device may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or L-lactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be submitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed change(s). In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the Polyglycolic Acid surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance prior to commercial distribution of the modified device.
4
Page 2 - Mr. Main M. Ghazal
The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.
The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.
Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
Sincerely yours,
Neil R.P. Ogden
SED James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
5
T.CAD International 990927/MG-510(k) POLYGLYCOLIC ACID
SECTION II
Statement of indication for use
Device Name: POLYGLYCOLIC ACID
510(k) Number:
Indication for use:
POLYGLYCOLIC ACID is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
ま
(PLEASE DO NOT WRITE BELOW THE LINE - CONTINUE ON ANOTHER PACE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) √
Over-the-Counter Use OR
Nho fr J2D
IT mision Sign-Off) Division of General Restorative Devices 1994001 510(k) Number __