SURGISORB

K984374 · Samyang Corp. · GAM · Jun 4, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K984374
• Device Name: SURGISORB
• Applicant: Samyang Corp.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jun 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.

Device Story

Surgisorb is a synthetic, absorbable surgical suture composed of polyglycolic acid (PGA). Available in braided and monofilament types, it is coated with polycaprolate and calcium stearate. The suture is provided in various USP sizes (8.0 through 2) and is available in dyed (D&C Violet #2) or undyed (milk white) forms. It is intended for use by surgeons in clinical settings for soft tissue approximation. The device is terminally sterilized via ethylene oxide (EtO) gas. It functions as a mechanical support for tissue during the healing process, eventually being absorbed by the body. It is a prescription-only device.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of material, design, and functional performance characteristics to the predicate device.

Technological Characteristics

Material: Polyglycolic acid (PGA) coated with polycaprolate and calcium stearate. Form: Braided and monofilament. Sizes: USP 8.0 to 2. Sterilization: Ethylene oxide (EtO) gas. Compliance: Meets USP 23 performance requirements and applicable ASTM/ISO standards for materials and quality systems.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic surgery. Contraindicated for use in cardiovascular and neurological tissue.

Regulatory Classification

Identification

An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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

• Dexon® II polyglycolic acid, synthetic absorbable surgical sutures (Pre-amendment device)

Submission Summary (Full Text)

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Summary of Safety and Effectiveness Information

Premarket Notification, Section 510(k) SANITARY CORPORATION
K963999

Registiation Authority: Safe Madical Devices Act of 1930, 21 CFR 807,92

- 1. Device Name:
Trace Name: S. Agisorb

Containon Alisorbable suture, synthetic absorbable suture, PGA suture Nonex(s):

Clarido and Nન્દાાા(s): Sulture, Absorbable, Synthelic, Polyglycolic Acid

- Establishment Nome & Registration Number: 2.
SAMYANG CCRPORATION N:#:#:3: Num! XIII Pending

#### 3. Classification:

PGA based suture is not specifically categorized or defined in 21CFR, Parts 800-1299. The responsible device provided the following cless, classification panel and product corte for this product.

Device Class: Class II

Class : Micalion Pa. .el: General & Plestic Surgery Devices Panel

Product Co-It(s): 79GAM

- 4. E quivalent Predicate Device:
SAMTANG CORPORATION believes that Surgisorb PGA Absorbable Sulure is substantially equivalent to the following absorbable suture marketed by Davis & Geck:

- Dexon® II polyglycolic acid, synthetic atsorbable surgical sutures with polyceprolute axating ー system.
With respect to substantial equivalison the comparison a virtually identical Malurials, packaging, storilization method, sizes, multi and monofiliment, dyed and device. undyod as well as functional characteristics (absorption rate, strangth, etc.) Equivalericy can also be diawn with respect to the design, material composition, performance and intended use. Surg: sou and Dex: on® II both meet or exceed the performance requirements of USP 23.

#### 5. Device Description:

Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate.

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## K984374

Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). The brief table below illustrates the sizes offered.

| USP Size |
|---------------|
| (Metric Size) |
| 8.0(0.4) |
| 7.0(0.55) |
| 6.0(0.7) |
| 5.0 (1) |
| 4.0(1.5) |
| 3.0 (2) |
| 2.0 (3) |
| 0 (3.5) |
| 1 (4) |
| 2 (5) |

Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.

Indications for Use. "General soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue."

#### 6. Applicant Name & Address:

SANTANG COLPORATIC N 263 Yeonii-dung, Chongno-gu Seoul 110-725, Korea

#### 7. Compsity Contact:

·

Mr. Dong-Kee Yoo SASIYANIS COLLIFORATION 263 Yeonji-dung, Chongrio-gu Seoul 110-725, Korea Tel. [phone] Fax [phone]

#### Submission Contespondent: 8.

Mr. David W. Schlorf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356 2640 - 925.356.2654 - fax

#### ਰੇ. Farformance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Vanous voluntary performance standards are utilized. Voluntary standards uffilized include U.S.P., ASTM, Standard Operating Procedures, veridor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

SANTANG CORPORATION also mests appropriate general controls authurized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

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#### 10. Special Conticts:

The following spe .ial controls apply to the marketing of this device when used as PGA based absolbable suture

- Cony.Cance with specifical laboling requirements. As outlined in the guidance "Altomate ﻬﺎ Suture Labeling Resulting from the January 11, 1993 Mosting with HIMA".
#### Storage, Packaging & Sterilization Information: 11.

Packaying should be inspected on arrival for evidence of shipping damage. Packaging. Dameged packaging may indicate the presence of unsalle product and it should not be used until cansfully inspected. If the parkage or product is damaged, the product should not be used and should be returned. Once of ened, the product should never be resterilized or reused.

Storinge. Product must be handled, stored and opened in such a way that it is protected from inadvartent damage or contamination. Rotate stock and observe shelf life dates. Discard when outdated or damaged. When used, the product must be placed into use following accapted surgical sterile technique.

Sistilization. The suture is torminally EtO ges sterilized.

### 12. Summary Comperison Table:

| FEATURE | Surgisorb | Davis & Geck | SE? |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------|-----|
| Indications for Use: | GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN<br>OPHTHALMIC SURGERY, BUT NOT FOR USE IN<br>CARDIOVASCULAR AND NEUROLOGICAL TISSUE. | SAME | YES |
| Design: | BRAIDED AND MONOFILIMENT | SAME | YES |
| Sterile: | YES - EtO | SAME | YES |
| Sizes: | USP - 8.0 THROUGH 2 | SAME | YES |
| Material: | PGA | SAME | YES |
| Origin: | KOREA | USA | YES |
| Manufacturer: | SAM YANG | DAVIS GECK | YES |
| Product Code: | 79GAM | SAME | YES |
| K - Number: | PENDING | PREAMENDMENT DEVICE | YES |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wing-like shapes, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

SAMYANG Corporation c/o Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K984374 Trade Name: Surgisorb Absorbable Suture Regulatory Class: II Product Code(s): GAM Suture, Absorbable, Synthetic, PolyGlycolic Acid (PGA) Dated: March 20, 1999 Received: April 13, 1999

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) 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 Monday, December 11, 1989 (Vol. 54, No. 236, Pages 50737 and 50738). 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 devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- The Polygolycolic acid (PGA) Surgical Sutures are indicated for use in general soft 1. tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
- 2. The Polygolycolic acid (PGA) Surgical Sutures may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or Llactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be sumitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. 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 manufacturing of the PGA surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and FDA clearance prior to commercial distribution of the modified device.

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Page 2 -- Mr. David W. Schlerf

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

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

Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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,

C. S. M. Witte, Ph.D., M.D.

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

Enclosure

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Page_1 of

# 510(k) Number : K984374

Device Name(s): SurgiSorb® Absorbable PGA Suture

Intended Use(s) of the Device:

GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.

Fresse DO MOT MBITE BETOM THIS LINE - COMITING ON AMOLITIERS BROETE VECESSERY Concurrence of CDRH, Office of Device Evaluation (ODE)

DC Olles

(Division Sign-Off) Division of General Restorative Devices 1942 510(k) Number

Prescription Use
(Per 21 CFR 801.109) X

ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)