PD SYNTH IS SYNTHETIC ABSORBABLE (MONOFILAMENT POLYDIOXANONE) SURGICAL SUTURE, STERILE AND FLEXIBLE STRAND, PREPARED FROM THE POLYMER, POLYDIOXANONE, (HOMO POLYMER OF DI OXANONE 100%) AND IS INDICATED FOR USE IN SOFT TISSUE APPROXIMATION, INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIO VASCULAR AND NEUROLOGICAL TISSUES

Device Description

PD Synth is a synthetic absorbable surgical suture, (Monofilament Polydioxanone). PD Synth is a sterile flexible monofilament thread, composed of the polymer, Polydioxanone. The sutures are inert, non collageneous and non antigenic. PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated

AI/ML Overview

The document provided describes a 510(k) premarket notification for a new absorbable surgical suture, "PD SYNTH," by Sutures India Pvt. Ltd. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and supporting study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance (PD SYNTH)
Physical/Material Characteristics:
Absorbable (Polydioxanone) suture is synthetic, absorbable, monofilament	Same (comprised of Polydioxanone polymer)
Sterile, flexible monofilament thread	Same
Inert, non-collagenous, non-antigenic	Same
Dyed with D&C Violet #2 and uncoated (being monofilament)	Same
Supplied for single use only	Same
Sterilized by E.O. gas method	Same
Packaged in same or equivalent manner, with equivalent labeling claims	Same
Meets official monograph of USP 29 for extractable color	Meets USP 29 specifications
Meets performance requirements defined in USP 29 for Tensile strength (<881>)	Meets USP 29 specifications
Meets performance requirements defined in USP 29 for Needle attachment (<871>)	Meets USP 29 specifications
Meets performance requirements defined in USP 29 for Length requirement (95% of length stated on label)	Meets USP 29 specifications
Meets performance requirements defined in USP 29 for Sterility	Meets USP 29 specifications
Biocompatibility:
Biologically compatible when tested as per ISO-10993	Biologically compatible (tested as per ISO-10993)
Non-toxic when tested as per ISO-10993 for toxicity	Non-toxic (tested as per ISO-10993)
Clinical/Indications:
Indicated for use in soft tissue approximation	Same
Indicated for use in ophthalmic procedures	Same
Not for use in cardiovascular and neurological procedures	Same

Note: The document explicitly states "Same" across numerous comparison parameters, indicating that "PD SYNTH" performance matches that of the predicate devices, which are assumed to meet the established acceptance criteria (e.g., USP standards).
One point mentions "Finished suture material does not meet the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter<861>". However, this is listed as "Same" for all three devices in the comparison table, suggesting it's either an accepted deviation for this type of suture or a characteristic shared by the predicates that doesn't preclude substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). The testing appears to be primarily laboratory-based to conform to USP standards and ISO-10993.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of device (surgical suture) relies on objective physical, chemical, and biological testing against established standards (USP, ISO) rather than expert consensus on subjective interpretations. Ground truth is derived from these standardized tests.

4. Adjudication Method for the Test Set

Not applicable. The testing involves objective measurements against predefined specifications from USP and ISO standards. There is no mention of an adjudication process by human experts for the test results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for an absorbable surgical suture, which is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance is irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. As mentioned, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for evaluating the "PD SYNTH" device is based on:

Established Industry Standards: United States Pharmacopeia (USP) 29 specifications for various suture properties (tensile strength, diameter, length, needle attachment, sterility, extractable color).
International Standards: ISO-10993 for biocompatibility and toxicity.
Regulatory Compliance: Conformance to Title 21 CFR § 74.3602 for colorant concentration.
Comparison to Predicate Devices: Demonstrating equivalence to existing legally marketed absorbable polydioxanone sutures (PDS II and Unicryl M) across numerous characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device where a 'training set' would be used. The manufacturing process of the suture does not involve such a concept.

9. How the Ground Truth for the Training Set was Established

Not applicable, for the same reason as point 8.

Summary

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JUN - 9 2008

SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE POLYDIOXANONE SUTURE

PAGE No: 17.0-1 SECTION No: 17.0

510k SUMMARY as required by: 21CFR 807.92

A. APPLICANT INFORMATION

Name

: SUTURÈS INDIA PVT. LTD

Address

PHONE NO.

FAX NÓ.

E mail

Web Address

B. Contact Person

C. Date Prepared

D. DEVICE NAME

Trade Name

Common name
SUTURES INDUSTRY P. LTD

: 472 D 13 th Cross, 4 th Phase, Peenya Industrial Area, Bangalore-560058. India

: 91-80-41868000 (30 lines)

: 91-80-41171056

: sutures(@vsnl.com

: www.suturesin com

: L.G.Chandrasekhar MANAGING DIRECTOR

: 1.4.2008

: PD SYNTH

: Absorbable Surgical Suture, Synthetic (Monofilament Polydioxanone)

Classification Name

: Suture, absorbable, synthetic, Polydioxanone.

E. PREDICATE DEVICES

A. PDS II Absorbable Monofilament Polydioxanone Suture, P.M.A. Number : N 18331

B. Unicryl M Absorbable Monofilament Polydioxanone Suture, 510(k) Number K 042285, United Medical Industries Co.Ltd (UNIMED), Riyadh, SA 11553

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SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE POLYDIOXANONE SUTURE

081001

SECTION No: 17.0 PAGE No: 17.0-2

F. DESCRIPTION OF THE DEVICE

PD Synth is dyed with D&C Violet #2 and being monofilament it is uncoated

G. INTENDED USE OF THE DEVICE

PD Synth, Absorbable (Polydioxanone) suture, is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.

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K.081001
page 3 of 5

SUTURES INDIA PVT.LTD

SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE POLYDIOXANONE SUTURE

SECTION No: 17.0 PAGE No: 17.0-3 COMPARISON TABLE OF SUTURES INDIA'S "PD SYNTH" ABSORBABLE POLYDIOXANONE SUTURE TO PREDICATE DEVICES

Comparison parameters	PD Synth	PDS II	Unicryl M
Absorbable (Polydioxanone) suture is a synthetic absorbable surgical suture. (Monofilament). It is a sterile flexible multifilament thread, composed of the homo polymer, Polydioxanone.	Same	Same	Same
The sutures are inert, non collageneous and non antigenic.	Same	Same	Same
Absorbable Polydioxanone suture is dyed with D&C Violet #2 and being monofilament it is uncoated	Same	Same	Same
Absorbable (Polydioxanone) suture is indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.	Same	Same	Same
Absorbable Polydioxanone suture is supplied for single use only.	Same	Same	Same
Absorbable Polydioxanone suture is sterilized by E.O. gas method	Same	Same	Same
Absorbable Polydioxanone suture is packaged in the same or equivalent manner, and has the same or equivalent labeling claims as the predicate devices including indications, warnings, cautions and precautions	Same	Same	Same
Absorbable Polydioxanone suture meets the official monograph of the United States Pharmacopeia current edition U.S.P. 29 for extractable color.	Same	Same	Same
Finished suture material does not meet the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Diameter<861>	Same	Same	Same
Finished suture material meets the performance requirements defined in the United States Pharmacopeia current edition U.S.P. 29 for Tensile strength<881>	Same	Same	Same
Comparison parameters	PD Synth	PDS II	Unicryl M
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionU.S.P. 29 for Needle attachment<871>	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionU.S.P.29 for length requirement (95% oflength stated on the label)	Same	Same	Same
Finished suture material meets theperformance requirements defined in theUnited States Pharmacopeia current editionU.S.P. 29 for sterility	Same	Same	Same
Finished suture material packaged in a sameor equivalent manner with sterile single ordouble packing having labeling conformingto 21CFR and USP 29	Same	Same	Same
Absorbable Polydioxanone suture isbiologically compatible when tested as perISO-10993	Same	Same	Same
Absorbable Polydioxanone suture is testedand proved to be non toxic, when tested asper ISO-10993 for toxicity	Same	Same	Same

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のお気になる。

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K08100
page 5 of 5

SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510k) FOR ABSORBABLE POLYDIOXANONE SUTURE

PAGE No: 17.0-4 SECTION No: 17.0

CONCLUSION

Sutures India's PD Synth Absorbable (Polydioxanone) suture is composed of the same material, as of the predicate devices and has the same design, as that of the predicate devices. The suture is manufactured in a manner typical of the industry and equivalent to that used to produce predicate devices. Further the subject device is offered with the same colorant D&C Violet No.2 at a concentration that conforms to the requirements of Title 21 CFR § 74.3602, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensile strength, needle attachment strength, extractable color and sterility to methods outlined in U.S.P. 29 demonstrates Sutures India's PD Synth (Absorbable Polydioxanone suture) meets or exceeds U.S.P. specifications and are equivalent in terms of the above mentioned predicate devices.

For SUTURES INDIA PVT. LTD.

L. G. CHANDRASEKHAR
MANAGING DIRECTOR
L.G.Chandrasekhar
Managing Director

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 9 2008

Sutures India Private Limited % L.G. Chandrasekhar 472 D 13th Cross, 4th Phase Peenya Industrial Area Bangalore-560058 India

Re: K081001 Trade/Device Name: PD SYNTH Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: II Product Code: NEW Dated: May 22, 2008 Received: May 27, 2008

Dear L.G. Chandrasekhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set

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Page 2 - L.G. Chandrasekhar

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mardi N. Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number K081001

PD SYNTH Device Name:

ABSORBABLE SURGICAL SUTURE (SYNTHETIC) (MONOFIL AMENT POLYDIOXANONE)

Indications For Use:

Neil R. Oslen for nxn

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_KOS 100

Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.