TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE

K041514 · Sutures India Private Limited · GAP · Jun 3, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041514
• Device Name: TRUESILK NON-ABSORBABLE SILK SURGICAL SUTURE
• Applicant: Sutures India Private Limited
• Product Code: GAP · General, Plastic Surgery
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

TRUSILK is a sterile, flexible, multifilament surgical suture composed of natural fibroin protein derived from Bombyx mori silkworms. The device is used by surgeons in clinical settings (e.g., OR) for soft tissue approximation and ligation. It is provided as a braided or twisted thread, either uncoated or with a biocompatible coating, and may be undyed or dyed with FDA-listed color additives (logwood extract). It is available with or without an attached needle. The suture provides mechanical support to hold tissue edges together or ligate vessels, facilitating healing. It is a single-use, non-absorbable device.

Clinical Evidence

Bench testing only. Performance verified against USP 26 requirements for diameter, length, knot pull tensile strength, needle attachment strength, extractable color, and sterility.

Technological Characteristics

Natural nonabsorbable multifilament silk (fibroin protein). Braided or twisted construction. Sterilized via Ethylene Oxide (EO). Meets USP 26 monographs for nonabsorbable surgical sutures. Biocompatible coatings used. Logwood extract colorant per 21 CFR 73.1410.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures. No specific age or gender restrictions provided.

Regulatory Classification

Identification

Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori ) of the family Bombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.

Special Controls

*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.

Predicate Devices

• Silkam Nonabsorbable surgical suture (K990089)
• Silk Nonabsorbable surgical suture (K960328)

Submission Summary (Full Text)

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K0415/4
page 1074

#### 3 2005 JUN

## SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE

SECTION NO: 16 PAGE NO: -16-1

### 510K SUMMARY as required by: 21CFR 807.92

### A. APPLICANT INFORMATION

| Name | : SUTURES INDIA PVT. LTD |
|-----------------------|-------------------------------------------------------------------------------------------------|
| Address | : Sutures India Pvt. Ltd.<br>118, 3rd Phase, Peenya Industrial Area,<br>Bangalore-560058. India |
| PH.NO.<br>FAX NO | : 91-80-28395150 / 28370367 / 28377856<br>:91-80-28392280. |
| E mail<br>Web address | : [e-mail]<br>: www.suturesin.com |
| B. Contact Person | : L.G.Chandrasekhar<br>: MANAGING DIRECTOR |
| C. Date Prepared | : May 15,2004 |

### D. DEVICE TRADE NAME

- . Trade Name : TRUSILK Common name . : Nonabsorbable Surgical Suture, U.S.P.
- (Black Braided Silk)
- Classification Name :Natural Nonabsorbable Silk Surgical Suture. .

# E. PREDICATI: DEVICES

- Silkam Nonabsorbable surgical suture, 510(k) Number K990089, AESCULAP, . South San Fransisco, California.
- Silk Nonabsorbable surgical suture, 510(k) Number K960328. R.K.Medical . L.L.C. Danbury , CT06810

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# SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE

#### PAGE NO: -16-2 SECTION NO: 16

### F. DESCRIPTION OF THE DEVICE

TRUSH.K is a natural nonabsorbable silk surgical suture, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural Nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for "Nonabsorbable Surgical Suture" . Natural Nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive. It will be available with and with out a standard needle attached.

### G. INTENDED USE OF THE DEVICE

Sutures India TRUSH.K Natural nonabsorbable silk suture, is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

| Comparison items | Sutures<br>India<br>Pvt.Ltd | Aesculap | R.K.Medical |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|----------|-------------|
| Natural Nonabsorbable silk surgical suture is<br>a nonabsorbable, sterile,<br>flexible<br>multifilament thread composed of an organic<br>protein called fibroin. This protein is derived<br>from the domesticated species Bombyx mori<br>(B. mori) of the family Bombycidae. | Same | Same | Same |
| The sutures are inert, noncollageneous and<br>nonantigenic. | Same | Same | Same |
| Natural nonabsorbable silk surgical suture is<br>available undyed or dyed with logwood<br>extract | Same | Same | Same |
| Natural nonabsorbable silk surgical suture is<br>offered both uncoated, and treated with<br>biocompatible coatings to enhance its<br>handling properties. | Same | Same | Same |
| Natural Nonabsorbable silk suture is<br>indicated for use in soft tissue approximation<br>and/ or ligation, including use in<br>cardiovascular, ophthalmic and neurological<br>procedures. | Same | Same | Same |
| SECTION NO:16 | PAGE NO: -16-3 | | |
| Comparison items | Sutures<br>India<br>Pvt.ltd | Aesculap | R.K.Medical |
| Natural nonabsorbable sterile silk suture is<br>supplied for single use only. | Same | Same | Same |
| Natural nonabsorbable sterile silk suture is<br>sterilized by EO method | Same | Same | Same |
| Natural nonabsorbable silk suture is<br>packaged in the same or equivalent manner,<br>and has the same or equivalent labeling<br>claims as the predicate devices including<br>indications, warnings, cautions and<br>precautions | Same | Same | Same |
| Natural nonabsorbable silk suture meets the<br>Official Monograph of the United States<br>Pharmacopeia current edition USP26 for<br>extractable color | Same | Same | Same |
| Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Diameter<861> | Same | Same | Same |
| Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Tensile strength<881> | Same | Same | Same |
| Finished suture material meets the<br>performance requirements defined in the<br>United States Pharmacopeia current edition<br>USP26 for Needle attachment<871> | Same | Same | Same |
| Natural nonabsorbable silk suture meets the<br>Official Monograph of the United States<br>Pharmacopcia current edition USP26 for<br>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 26 | Same | Same | Same |
| Nonabsorbable Surgical Suture (Braided<br>Silk Black) is biologically compatible when | Same | Same | Same |

### COMPARISON TABLE SUTURES INDIA `S "TRUSILK" NATURAL SILK NONABSORBABLE SURGICAL SUTURE TO PREDICATE DEVICES

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## SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE

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K041514 page 494

### SUTURES INDIA PVT.LTD SUBMISSION OF PREMARKET NOTIFICATION (510K) FOR NATURAL NONABSORBABLE SILK SURGICAL SUTURE

#### SECTION NO: 16 PAGE NO: - 16-4

### CONCLUSION

Sutures India's TRUSILK is Natural Nonabsorbable silk suture, composed of the same material, as are the predicated devices and has the same design, as do 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 Logwood extract at a concentration that conforms to the requirements of Title 21 CFR § 73.1410, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensile strength and needle attachment strength, extractable color and sterility to methods outlined in USP 26 demonstrates Sutures India's TRUSILK, Natural Nonabsorbable silk suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.

Robert F

L.G.Chandrasekhar Managing Director

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping figures suggesting community or support.

3 2005 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041514

Trade/Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural nonabsorbable silk surgical suture Regulatory Class: II Product Code: GAP Dated: May 3, 2005 Received: May 6, 2005

Dear Mr. Chandrasekhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have teviewed your becalled by (4) personally equivalent (for the indications for use stated in above and nave determined the ad predicate devices marketed in interstate commerce prior to the chelosure) to regary mantowe of the Medical Device Amendments, or to devices that have been May 20, 1770, the chartinent and on the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require upproval or a premails provisions of the Act. The general controls provisions of the device, dolor to the gallery 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 be subject to such additions, 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 I case or advised that 12 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . I DA ilas made a deceminations administered by other Federal agencies. You must comply with all the I caral states and regarding, but not limited to: registration and listing (21 CFR Part 807); labeling / (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Mr. L.G. Chandrasekhar

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 Office of Compliance at [phone] . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Signature

Miriam C. Provost, Ph.D. Acting 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 (if known): K041514

Device Name: TRUSILK™ Non-absorbable Silk Surgical Suture

Indications For Use:

TRUSILK" Non-absorbable Silk Surgical Suture is indicated for use in soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic and neurological procedures.

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)

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