TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE

K041511 · Sutures India Private Limited · GAW · Jun 3, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K041511
• Device Name: TRULENE NON-ABSORBABLE POLYPROPYLENE SURGICAL SUTURE
• Applicant: Sutures India Private Limited
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Jun 3, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Sutures India TRULENE Polypropylene Nonabsorbable Surgical Suture is indicated for use in soft tissue approximation and / or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

TRULENE is a sterile, monofilament, nonabsorbable surgical suture manufactured from long-chain polyolefin polymer (polypropylene). It is dyed with Phthalocyaninato (2-) copper and may be supplied with an attached needle. The device is intended for use by surgeons in clinical settings for soft tissue approximation and ligation. It functions as a mechanical support for tissue healing. The device is provided for single use only and is sterilized via ethylene oxide (EO).

Clinical Evidence

Bench testing only. Testing performed per USP 26 standards including suture diameter, length, knot pull tensile strength, extractable color, needle attachment strength, and sterility. Results demonstrate the device meets or exceeds USP specifications.

Technological Characteristics

Material: Polypropylene (long-chain polyolefin polymer). Dye: Phthalocyaninato (2-) copper. Form: Monofilament, nonabsorbable, sterile thread with optional attached needle. Sterilization: Ethylene oxide (EO). Standards: Meets USP 26 requirements for diameter, tensile strength, needle attachment, and extractable color.

Indications for Use

Indicated for soft tissue approximation and/or ligation in cardiovascular, ophthalmic, and neurological procedures. For prescription use.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

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

• Polypropylene Nonabsorbable surgical suture (K001185)
• Polypropylene Nonabsorbable surgical suture (K961389)

Submission Summary (Full Text)

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JUN 3 - 2005

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. | : 91-80-28395150 / 28370367 / 28377856 |
| FAX NO | : 91-80-28392280. |
| E mail | : [e-mail] |
| Web address | : www.suturesin.com |
| B. Contact Person | : L.G.Chandrasekhar<br>: MANAGING DIRECTOR |
| C. Date Prepared | : May 07,2004 |

#### D. DEVICE TRADE NAME

- Trade Name . : TRULENE Common name : Nonabsorbable Surgical Suture, U.S.P. . (Monofilament Polypropylene)
- . Classification Name : Nonabsorbable Polypropylene Surgical Suture

## E. PREDICATE DEVICES

- . Polypropylene Nonabsorbable surgical suture, 210(K) Number K001185, C.P.Medical, Portland, OR 97232.
- Nonabsorbable surgical ● Polypropylene suture, 510(k) Number K961389. R.K.Medical L.L.C. Danbury, CT 06810

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K041311

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| SECTION NO:16 | PAGE NO: -16-2 |
|---------------|----------------|
|---------------|----------------|

#### F. DESCRIPTION OF THE DEVICE

TRULENE Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene.

The polypropylene surgical suture meets united states pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it is dyed with an FDA approved color additive (Phthalocyaninato (2-) copper); and the suture is provided with a standard needle attached.

#### G. INTENDED USE OF THE DEVICE

Sutures India TRULENE Polypropylene Nonabsorbable Surgical 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 Pvt.<br>Ltd | CP Medical | R.K.Medical |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------|-------------|
| Nonabsorbable polypropylene surgical suture<br>is a monofilament, nonabsorbable, sterile,<br>flexible thread prepared from long-chain<br>polyolefin polymer known as polypropylene. | Same | Same | Same |
| The sutures are inert, noncollageneous and<br>nonantigenic. | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical<br>Suture is available undyed or dyed with<br>(Phthalocyaninato (2-) copper) | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical<br>Suture may be provided with or without a<br>standard needle attached. | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical<br>Suture is indicated for use in soft tissue<br>approximation and / or ligation, including use<br>in cardiovascular, ophthalmic and<br>neurological procedures. | Same | Same | Same |
| Comparison items | Sutures<br>India Pvt.<br>Ltd | C.P. Medical | R.K.Medical |
| Polypropylene Nonabsorbable Surgical<br>Suture is supplied for single use only. | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical<br>Suture is sterilized by EO method | Same | Same | Same |
| Polypropylene Nonabsorbable Surgical<br>Suture is packaged in the same or equivalent<br>manner, and has the same or equivalent<br>labeling claims as the predicate devices<br>including indications, warnings, cautions and<br>precautions | 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 |
| Polypropylene Nonabsorbable Surgical<br>Suture meets the Official Monograph of the<br>United States Pharmacopeia current edition<br>USP26 for 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 finish suture Length Requirement<br>(95% of stated label length) | 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 |
| Polypropylene Nonabsorbable Surgical<br>Suture is biologically compatible when tested | Same | Same | Same |

#### COMPARISON TABLE SUTURES INDIA "TRULENE" NONABSORBABLE SURGICAL SUTURE (POLYPROPYLENE) TO PREDICATE DEVICES

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K041511

## SECTION NO:16

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

#### CONCLUSION

Sutures India "TRULENE" Polypropylene nonabsorbable surgical suture is 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 (Phthalocyaninato (2-) copper) at a concentration that conforms to the requirements of Title 21 CFR § 73.8045, as are of the predicate devices.

Testing of suture diameter, suture length, knot pull tensile strength, extractable color, needle attachment strength and sterility to methods outlined in USP 26 demonstrates Sutures India "TRULENE" Polypropylene nonabsorbable surgical suture meets or exceeds USP specifications and are equivalent in terms of the above mentioned predicate devices.

\$\rightarrow\$ - \$\vdash\$ \$\vdash\$

L.G.Chandrasekhar Managing Director

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the HHS logo, which is a stylized human figure with three arms reaching upwards. The logo is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" in a circular arrangement. The seal is black and white.

Public Health Service

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: K041511

Trade/Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: II Product Code: GAW Dated: May 26, 2005 Received: June 1, 2005

Dear Mr. Chandrasekhar:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclobate) to region) the enactment date of the Medical Device Amendments, or to conimered proc to May 20, 1978, in accordance with the provisions of the Federal Food, Drug, uc vices that have been require approval of a premarket approval application (PMA). and Costlictic 71ct (71ct) that to not requent of the general controls provisions of the Act. The I ou may, mercerere, market the Act include requirements for annual registration, listing of general controls provisions 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 your device is etablineal controls. Existing major regulations affecting your device it may be subject to sach 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 I Teast of advised that I Dris Sussantes over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I caeral statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the Her Frequirements)01); good manufacturing practice requirements as set Of I latt 0077, adoning (21 CFR Part 820); and if applicable, the electronic form in the quality byocally (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) I mis iction will and w you'ls cognifiading of substantial equivalence of your device to a legally prematics notification - The sults 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 If you desire specific durile for your aco) 276-0115 . Also, please note the regulation entitled, eonider and of Crise of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

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): K041511

Device Name: TRULENE™ Non-absorbable Polypropylene Surgical Suture

Indications For Use:

TRULON™ Non-absorbable Polypropylene 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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

f
Neurological Devices
Restorative

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