POLYESTER

K994000 · Trading Consultants and Distributors Intl., Inc. · GAT · Feb 4, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K994000
• Device Name: POLYESTER
• Applicant: Trading Consultants and Distributors Intl., Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Device Story

POLYESTER is a nonabsorbable, sterile, surgical suture composed of high-molecular-weight, long-chain, linear poly(ethylene terephthalate) fibers. It is provided as a multifilament thread, either coated or uncoated, and may be undyed or dyed with D&C Green No. 6. The suture is available with or without attached surgical needles. It is intended for use by clinicians in surgical settings for soft tissue approximation and ligation. The device functions as a mechanical support for tissue healing; it is not absorbed by the body and maintains tensile strength in vivo. Safety and effectiveness are established through conformance to U.S.P. standards for nonabsorbable surgical sutures.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing confirming conformance to U.S.P. standards for suture diameter, length, knot pull tensile strength, and needle attachment strength.

Technological Characteristics

Material: Poly(ethylene terephthalate) fibers. Form: Multifilament, coated or uncoated. Sterilization: Gamma irradiation. Standards: U.S.P. monograph for Nonabsorbable Surgical Suture, ISO 9002, EN 46002, EN 552. Packaging: Aluminum foil and polyester tear-open pouch.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including cardiovascular, ophthalmic, and neurological procedures. Prescription use only.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; 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

• Tri-Cron® Non-Absorbable Polyester Surgical Suture (K930591)
• Ethibond® Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.)

Submission Summary (Full Text)

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## SECTION III

# 510(K) Summary of Safety and Effectiveness

This summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and Title 21 CFR 8807.92

- A. Applicant & Submitted By:
Trading Consultants And Distributors International Inc. (T.CAD International) 157 WindDance Dr. Chicago, IL 60046-6681 Telephone: [phone] Fax. : [phone] Contact Person: Main M. Ghazal, President September 28th 1999. Date Prepared:

#### B. Device Name:

- Trade Name: POLYESTER a.
- b. Common or Usual Name: Polyester Surgical Suture
- Classification Name: Nonabsorbable Poly (ethyleme terephthalate) C.
- Surgical Suture (Per 21CFR878.5000)

#### C. Predicate Device:

Tri-Cron® Non-Absorbable Polyester Surgical Suture (Davis & Geck (K930591)) Ethibond@ Nonabsorbable Polyester Surgical Suture (Ethicon, Inc.)

#### D. Device Description:

POLYESTER is a nonabsorbable, sterile, surgical suture composed of Poly (ethylene terephthalate). It is prepared from fibers of high-molecular weight, longchain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. POLYESTER meets all requirements as described in the United States Pharmacopeia (U.S.P.) monograph for Nonabsorbable Surgical Suture. Offered as monofilament in form. POLYESTER could be offered coated or uncoated, undyed or dyed with an FDA listed color additive, D&C Green No. 6. (21CFR74.3206). POLYESTER will be offered with or without standard needles attached.

- E. Intended Use:
POLYESTER is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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| | POLYESTER | Predicate Device |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | General soft tissue approximation<br>and/or ligation, including use in<br>cardiovascular, ophthalmic and<br>neurological procedures. | General soft tissue approximation<br>and /or ligation, including use in<br>cardiovascular, ophthalmic and<br>neurological procedures. |
| Suture Material | Flexible fibers of high-molecular<br>weight, long-chain, linear poly-<br>(ethylene terephthalate) having<br>recurrent aromatic rings as an<br>integral component | Flexible fibers of high-molecular<br>weight, long-chain, linear poly-<br>(ethylene terephthalate) having<br>recurrent aromatic rings as an<br>integral component |
| Suture<br>Characteristics | Not absorbed and no significant<br>change in tensile strength retention<br>known to occur in vivo. | Not absorbed and no significant<br>change in tensile strength retention<br>known to occur in vivo. |
| Sterilization Method | Gamma Irradiation | Same or equivalent process. |
| How Supplied | Multifilament thread, it will be<br>offered coated or uncoated,<br>undyed or dyed with an FDA<br>listed color additive, D&C Green<br>No. 6. (21CFR74.3206). Sterile<br>and offered for Single Use Only.<br>Available with or without surgical<br>needles. | Same or equivalent manner.<br>Offered in a multifilament form,<br>coated or uncoated, undyed and<br>dyed with the same FDA listed<br>colorant. Sterile and for single use<br>only. Available with or without<br>surgical needles. |
| Suture Diameter,<br>Suture Length,<br>Knot Pull Tensile<br>Strength and Needle<br>Attachment<br>Strength | Meet U.S.P. Requirements | Meet U.S.P. Requirements |
| Packaging | Dry packaged in Aluminum Foil<br>and Polyester tear open packaging. | Same or equivalent manner. |
| Labeling | In conformance with CDRH<br>instructions of the "Medical<br>Device Quality Manual" dated<br>December 1996. Package Inserts<br>in accordance with the FDA<br>Guidance documents "Alternate<br>Suture Labeling" Resulting from<br>the January 11th 1993 meeting with<br>HIMA, reformatted on December<br>17th 1997. | Same |

#### Comparison to Predicate Device: F.

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## G. Clinical & Non-Clinical Testing:

Non-Clinical Testing was conducted on the subject device to prove conformance to the requirements of U.S.P. standards and to demonstrate substantial equivalence to the predicate device. Physical properties and functionality testing assured the safety and effectiveness of the subject device within its intended uses. Results of the non-clinical testing demonstrate conformance with the U.S.P. standards and requirements for Absorbable surgical suture.

Clinical Testing: Not available at the present time.

### H. Conclusion:

Based on the technological characteristics and physical properties of the device, the device description, the intended use of the device, and conformance with voluntary performance standards like:

- a. United States Pharmacopeia Standards
- b. ISO 9002, EN 46002 & EN 552 Standards
- c. FDA Guidance documents " Alternate Suture Labeling" Resulting from the January 11th 1993 meeting with HIMA.

T.CAD International believes that the subject device demonstrates a substantial equivalence to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

FEB 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Main M. Ghazal Trading Consultants and Distributors International, Inc. 157 WindDance Drive Chicago, Illinois 60046-6681

Rc: K994000 Trade Name: Polyester Regulatory Class: II Product Code: GAT Dated: November 22, 1999 Received: November 24, 1999

Dear Mr. Ghazal:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Friday, May 31, 1991 (Vol. 56, No. 105, Pages 24684 and 24685). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at [phone] or [phone]. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Ilrug, and Cosmetic Act (Act) and the following limitations:

- 1 . The Polyester Surgical Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procecurrys.
- 2. This device may not be manufactured from any material other than high molecular weight fibers composed of long chain linear polyester having recurrent aromatic rings as an integral component. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacture of the Polyester surgical suture. Any devization of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and Food and Drug Administration (FDA) clearance pror to commercial distribution of the modified device.

The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109.

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Page 2 - Mr. Main M. Ghazal

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, The Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control Provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil K.P. Eglen

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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大9999800

# SECTION II

# Statement of indication for use

Device Name: POLYESTER

510(k) Number:

Indication for use: POLYESTER 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 THE LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21CFR 801.109) OR

Over-the-Counter Use

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