PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE

K081001 · Sutures India Pvt., Ltd. · NEW · Jun 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081001
• Device Name: PD SYNTH, ABSORBABLE (POLY DIOXANONE) SUTURE
• Applicant: Sutures India Pvt., Ltd.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Jun 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

PD Synth is a sterile, flexible, monofilament absorbable surgical suture composed of polydioxanone polymer. Device is used by surgeons for soft tissue approximation. Suture is dyed with D&C Violet #2 and is uncoated. Device is supplied for single use only. Clinical benefit derived from providing temporary wound support during healing process before being absorbed by body. Healthcare providers use suture during surgical procedures to close incisions or wounds; output is physical closure of tissue. Device is equivalent to existing polydioxanone sutures in material, design, and manufacturing process.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included USP 29 performance requirements (diameter, length, knot pull tensile strength, needle attachment strength, extractable color, sterility) and ISO 10993 biocompatibility/toxicity testing.

Technological Characteristics

Material: Polydioxanone (homopolymer). Form: Sterile, flexible monofilament thread. Colorant: D&C Violet #2 (21 CFR 74.3602). Sterilization: Ethylene Oxide (E.O.) gas. Compliance: USP 29 (tensile strength, needle attachment, diameter, length, sterility). Biocompatibility: ISO 10993.

Indications for Use

Indicated for soft tissue approximation in patients requiring surgical sutures, including ophthalmic procedures. Contraindicated for use in cardiovascular and neurological tissues.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• PDS II Absorbable Monofilament Polydioxanone Suture (N 18331)
• Unicryl M Absorbable Monofilament Polydioxanone Suture (K 042285)

Submission Summary (Full Text)

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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 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

#### 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 the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>U.S.P. 29 for Needle attachment<871> | Same | Same | Same |
| Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>U.S.P.29 for length requirement (95% of<br>length stated on the label) | Same | Same | Same |
| Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>U.S.P. 29 for sterility | Same | Same | Same |
| Finished suture material packaged in a same<br>or equivalent manner with sterile single or<br>double packing having labeling conforming<br>to 21CFR and USP 29 | Same | Same | Same |
| Absorbable Polydioxanone suture is<br>biologically compatible when tested as per<br>ISO-10993 | Same | Same | Same |
| Absorbable Polydioxanone suture is tested<br>and proved to be non toxic, when tested as<br>per ISO-10993 for toxicity | Same | Same | Same |

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K08100
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# 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 [phone]. 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 [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 [phone] or [phone] 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:

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

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