ORLON NONABSORABLE SURGICAL SUTURE USP

K030177 · Sri Orion Pharmaceuticals & Sutures · GAR · Jul 21, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K030177
• Device Name: ORLON NONABSORABLE SURGICAL SUTURE USP
• Applicant: Sri Orion Pharmaceuticals & Sutures
• Product Code: GAR · General, Plastic Surgery
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORLON® Polyamide Nonabsorbable Needle Suture USP (Polyamide filament) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

ORLON® is a sterile, nonabsorbable, monofilament surgical suture composed of long-chain aliphatic polymers (Nylon 6 and Nylon 6,6). It is provided uncoated, with or without an attached needle. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device functions as a mechanical support to hold tissue edges together during healing. It meets USP requirements for nonabsorbable sutures.

Clinical Evidence

Bench testing only. Sutures undergo physical testing for diameter, tensile strength, needle attachment, and sterility post-sterilization to ensure conformance with United States Pharmacopoeia standards.

Technological Characteristics

Material: Polyamide (Nylon 6 and Nylon 6,6). Form: Monofilament, nonabsorbable, sterile, flexible thread. Meets USP standards. Provided with or without needle.

Indications for Use

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

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, 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

• NYLON Polyamide Surgical Suture (K993998)
• Surgilon Nonabsorbable Surgical Suture

Submission Summary (Full Text)

{0}------------------------------------------------

# SRI ORION PHARMACEUTICALS & SUTURES

21/22, 1st Cross, Ganesh Block, Nandini Layout, BANGALORE 560096 ① : 349 8093 Fax : [phone] E mail : [e-mail]

Ko30177

### JUL 2 1 2003

## 3.0 SUMMARY OF SAFETY AND EFFECTIVENESS

#### SPONSOR IDENTIFICATION 3.1

S. Gururajarao Sri Orion Pharmaceuticals & Sutures 21/22, 2nd Floor, 1st Cross, Ganesh Block Nandini Layout Bangalore-560096 India Telephone: [phone] Fax: [phone] Orion [e-mail]

#### ESTABLISMENT REGISTRATION NUMBER: PENDING 3.2

#### OFFICIAL CONTACT PERSON AND AGENT 3.3

Norman F. Estrin, Ph.D., RAC President Estrin Consulting Group Inc. 9109 Copenhaver Drive Potomac, MD 20854 Tel: [phone] FAX: [phone] [e-mail]

#### DATE OF PREPARATION: January 14, 2003 3.4

#### DEVICE NAMES 3.5

- Trade Name: ORLON® 3.5.1
- Common or Usual Name: Polyamide Surgical Suture 3.5.2
- Classification Name: Nonabsorbable Polyamide Surgical Suture 3.5.3 (21CFR 978.5020)

. .

- PROPOSED REGULATORY CLASS: Class II 3.6
- DEVICE PRODUCT CODE: 3.7 GAR
- CFR REFERENCE: 21CFR 878.5020 3.8

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#### 3.9 PANEL : General & Plastic Surgery

#### DEVICE DESCRIPTION 3.10

The ORLON® NONABSORBABLE SURGICAL SUTURE USP is a polyamide suture. It is a nonabsorbable, sterile, flexible thread that is prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6. It meets all the requirements established by the United States Pharmacopoeia for nonabsorbable sutures. It is offered in the monofilament form and is dyed with an appropriate FDA listed color additive. The suture is provided uncoated and with or without a standard needle attached.

### INDICATIONS FOR USE 3.11

The ORLON® Polyamide Nonabsorbable Needle Suture USP (Polyamide filament) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

#### PREDICATE DEVICE COMPARISON 3.12

The ORLON® Polyamide Nonabsorbable Needle Suture USP is substantially equivalent to the NYLON Polyamide Surgical Suture (K993998) submitted by Trading Consultants and Distributors International Inc., 157

(ર) Wind Dance Drive, Chicago, IL 60046-6681 and the Surgilon Nonbsorbable Surgical Suture submitted by Sherwood-Davis & Geck.

Both the ORLON® Polyamide Nonabsorbable Needle Suture USP and the predicate devices are nonabsorbable polyamide sutures and are sold in the monofilament form and have the same indications for use. Both the

ORLON® product and the NYLON product meet the requirements of the United States Pharmacopoeia.

#### SUMMARY OF STUDIES 3.13

All the testing and the manufacturing process conform to the standards of the United States Pharmacopoeia. After sterilization, the sutures are subjected to physical tests of diameter, tensile strength, needle attachment and sterility. Once all these tests are conducted and the sutures pass these tests, they are released for distribution.

105

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

Sri Orion Pharmaceuticals & Sutures c/o Norman F. Estrin, Ph.D., RAC Estrin Consulting Group, Inc. 9109 Copenhaver Drive Potomac, Maryland 20854

Re: K030177

Trade/Device Name: The ORLON® Polyamide Nonabsorbable Needle Suture USP Regulation Number: 21 CFR 878.5020 Regulation Name: Suture, nonabsorbable, synthetic, polyamide Regulatory Class: II Product Code: GAR Dated: June 15, 2003 Received: June 16, 2003

Dear Dr. Estrin:

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 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.

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Page 2 - Norman F. Estrin, Ph.D., RAC

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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030177

Page 1 of 1

510(k) Number (if known):

The ORLON® Polyamide Nonabsorbable Needle Suture USP Device Name:

Indications for Use:

The ORLON® Polyamide Nonabsorbable Needle Suture USP (Polyamide filament) is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

OR

Over-the-Counter Use

(Optional Format 1-2-96)

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Muriam C. Provost
(Division Sign Off)

ral, Restorative d Neurological Devi

510(k) Number