REXSIN

K200392 · Sm Eng Co., Ltd. · GAM · Jul 7, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200392
• Device Name: REXSIN
• Applicant: Sm Eng Co., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Jul 7, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Device Story

REXSIN is a synthetic, absorbable, braided, coated surgical suture, provided with or without a stainless steel (SUS 304) needle. The suture material is polyglycolic acid (PGA), coated with polycaprolactone and calcium stearate. It is available in various sizes (8-0 to 2) and lengths. The device is used by surgeons in clinical settings for tissue approximation and ligation. It functions by providing temporary wound support during healing; it retains over 65% of tensile strength after 2 weeks and is completely absorbed in tissue within approximately 90 days. The device is supplied sterile for single use.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with USP <861> (diameter), USP <871> (needle attachment), USP <881> (tensile strength), and USP monograph for absorbable surgical sutures. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation, blood interaction). Sterile barrier system validated per ISO 11607 and ASTM standards.

Technological Characteristics

Synthetic, braided, coated PGA suture. Coating: polycaprolactone and calcium stearate. Needle: stainless steel (SUS 304). Sizes: 8-0 to 2. Sterilization: terminally sterilized. Standards: USP <861>, <871>, <881>; ISO 10993 (biocompatibility); ISO 11607 (packaging); ASTM F88, F1929, F1980.

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular or neural 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

• WG-Surgical Sutures with Needle (K073614)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

July 7, 2020

Sm Eng Co., Ltd % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, 08507 Kr

Re: K200392

Trade/Device Name: Rexsin Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: June 4, 2020 Received: June 11, 2020

Dear Sanglok Lee:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Cindy Chowdhurv, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K200392

Device Name REXSIN

Indications for Use (Describe)

REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for SM Eng, which is a company that specializes in engineering. The logo is purple and white, and it features the company's name and website address. The website address is www.sm-eng.net. The logo is simple and modern, and it is likely used on the company's website and marketing materials.

46,Nakdong-daero,1302beon-gil, Sasang-Gu, Busan, Korea TEL.[phone] FAX.[phone]

## 510(k) Summary

### The assigned 510(k) Number: K200392

### Date of Submission: February 12, 2020

### Applicant

Company name: SM ENG CO., LTD Address: 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

### Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

### Subject Device Identification

Proprietary Name: REXSIN Common Name: Synthetic Absorbable PGA Suture With or Without Needle Device Class: Class II Regulation Number:21 C.F.R. 878.4493 Product Code: GAM Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid

### Indication for use

REXSIN is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue

### Predicate devices

510(k) Number: K073614 Device Name: WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

#### De vice Description

Synthetic Absorbable PGA Suture With or Without Needle (REXSIN) are produced and provided by SM ENG Co., Ltd. REXSINis indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue

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SM Eng
www.sm-eng.net

46,Nakdong-daero,1302beon-gil, Sasang-Gu, Busan, Korea

TEL.[phone] FAX.[phone]

Suture of REXSIN is Trisorb manufactured by SAMY ANG Biopharmaceuticals Corporation. SM Eng is receiving bulk Trisorb from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXSIN suture.

REXSIN is a sterilized medical device composed with absorbable, braided, coated suture with needle, stainless steel SUS 304

REXSIN Suture is a synthetic absorbable, braided, coated suture composed of a Polyglycolic acid (PGA). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately over 65% of tensile strength remain after 2week. Complete absorption in tissues takes around 90 days.

REXSIN Sutures meets requirements established by the United States Pharmacopoeia (USP) for Absorbable Surgical Sutures. REXSIN Sutures is available in 8-0, 7-0, 6-0, 5-0, 2-0, 0, 1 and 2, which are the sizes identified in the currently recognized United States.

### Non-Clinical Test Conclusion

Bench tests were conducted to verify that the subject device (REXSIN) met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

USP <861> SUTURES - DIAMETER USP <871> SUTURES - NEEDLE ATTACHMENT

USP <881> TENSILE STRENGTH USP MONOGRAPH OF ABSORBABLE SURGICAL SUTURE

Sterile barrier system testing

ISO 11607-1, Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements For Materials, Sterile Barrier Systems And Packaging Systems ISO 11607-2, Packaging For Terminally Sterilized Medical Devices - Part 2: Validation Requirements For Forming, Sealing And Assembly Processes ASTM F 88, Standard Test Method for Seal Strength of Flexible Barrier Materials ASTM F 1929, Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

Accelerated aging stability testing

- ASTM F 1980, Standard Guide For Accelerated Aging Of Sterile Barrier Systems For Medical Devices. (Sterility)

Biocompatibility testing

- 1) Suture Needle
- ISO 10993-12: Sample Preparation
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization

2) Suture

- ISO 10993-1: Selection of Tests

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46,Nakdong-daero,1302beon-gil, Sasang-Gu, Busan, Korea

TEL.[phone] FAX.[phone]

- ISO 10993-2: Animal Welfare
- ISO 10993-12: Sample Preparation
- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Testfor Systemic Toxicity
- ISO 10993-3: Tests for Genotoxicity
- ISO 10993-6: Test for Local Effects after Implantation
- ISO 10993-4: Selection of Tests for Interaction with Blood

Real-time and accelerated aging stability testing was performed to support shelf life of REXS IN. Additionally, the residual strength and absorption rate studies were evaluated in accordance with the requirements outlined in FDA's Class II Special Controls Guidance Document: Surgical

Sutures.

#### Substantially Equivalent Conclusion

The following table compares the subject device (REXSIN) to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.

| Property | Subject device:<br>REXSIN | Predicate device:<br>WG-Surgical Sutures with<br>Needle |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)Number | K200392 | K073614 |
| Product Code | GAM | Same |
| Indicationsfor use<br>statements | REXSIN is indicated for use in<br>general soft tissue approximation<br>and/or ligation, including use in<br>ophthalmic procedures, but not<br>for use in cardiovascular or<br>neural tissue. | Same |
| Class | ll | Same |
| Sterile | Yes | Same |
| Single Use | Yes | Same |
| Configuration | PGA Suture and Needle | Same |
| Suture | | |
| Material | Polyglycolic acid | Same |
| Coating material | Polycaprolactone and Calcium<br>stearate | Same |
| Color | Undyed (natural) and dyed (D&C<br>Violet No.2) | Same |
| Absorbable/Nonabsorbable | Absorbable | Same |
| Braided/Monofilament | Braided | Same |
| Barbed/Not Barbed | Not Barbed | Same |
| Suture Size | The subject device is available in<br>8-0, 7-0, 6-0, 5-0, 4-0,3-0,2-0, 0,<br>1 and 2., which are the sizes<br>identified in the currently<br>recognized United States<br>Pharmacopoeia. | Same. The subject device is<br>available in 10-0 through 3 or<br>4, which are the sizes<br>identified in the currently<br>recognized United States<br>Pharmacopoeia. |
| Length of Suture | 15, 30, 45, 50, 60, 75, 90, 100,<br>120, 125, 140, 250cm | Unknown |

Table. Comparison of Technology Characteristics

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Image /page/6/Picture/1 description: The image shows the logo for SM Eng. The logo is in a light gray color and has a stylized design. The website address, www.sm-eng.net, is written in a smaller font below the logo. The logo is simple and modern.

46,Nakdong-daero,1302beon-gil, Sasang-Gu, Busan, Korea TEL.[phone] FAX.[phone]

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Image /page/7/Picture/1 description: The image shows the logo for SM Eng. The logo is in a serif font and is a dark gray color. The website address, www.sm-eng.net, is written in a smaller font below the logo. A purple line underlines the logo and website address. There is a gray swirl to the left of the logo.

46,Nakdong-daero,1302beon-gil, Sasang-Gu, Busan, Korea

TEL.[phone] FAX.[phone]

| Diameter of Suture | The tensile strengths of subject<br>device comply with the tensile<br>requirement listed in USP <861> | Same | | |
|--------------------|-----------------------------------------------------------------------------------------------------------------|---------|--|--|
| Tensile strength | The tensile strengths of subject<br>device comply with the tensile<br>requirement listed in USP <881> | Same | | |
| Needle Attachment | The bond between suture and<br>needle of the applicant device<br>meet the requirements defined in<br>USP <871>. | Same | | |
| Needle | | | | |
| Material | Stainless Steel | Same | | |
| Needle type | Taper point, Reverse Cutting,<br>Conventional cutting, Taper<br>cutting, Spatula, Blunt point | Unknown | | |
| Biocompatibility | Comply with ISO 10993-5,<br>10993-10 | Same | | |

The subject devices, REXSIN are determined to be Substantially Equivalent (SE) to the predicate device, and as safe and effective as the predicate device.