REXLENE

K173747 · Sm Eng Co., Ltd. · GAW · Dec 21, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173747
• Device Name: REXLENE
• Applicant: Sm Eng Co., Ltd.
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Dec 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REXLENE 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

REXLENE is a sterile, nonabsorbable monofilament surgical suture composed of polypropylene; available with or without stainless steel (STS 304) needles. Sutures are dyed blue for visibility and are uncoated. Used by surgeons in clinical settings for soft tissue approximation and ligation. The device functions as a mechanical fastener to hold tissue edges together during healing. It is provided as a single-use, sterile device. Clinical benefit is derived from its ability to maintain tissue approximation, facilitating wound healing. The device is evaluated against USP standards for diameter, needle attachment, and tensile strength.

Clinical Evidence

Bench testing only. Compliance with USP <861> (diameter), USP <871> (needle attachment), and USP <881> (tensile strength) confirmed. Biocompatibility verified per ISO 10993 standards (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation, and blood interaction). Shelf life supported by real-time and accelerated aging studies.

Technological Characteristics

Material: Polypropylene suture, STS 304 stainless steel needle. Monofilament, uncoated, blue-dyed. Sterilization: Ethylene oxide gas. Standards: USP <861>, <871>, <881>; ISO 10993. Sizes: USP 8-0 to 1. Single-use.

Indications for Use

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

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

• WG-Surgical Sutures with Needle (K080684)

Reference Devices

• PROLENETM Polypropylene Nonabsorbable Suture (K133356)

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 21, 2018

Sm Eng Co., Ltd % Sanglok Lee Manager Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, 08301 Kr

Re: K173747

Trade/Device Name: Rexlene Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: September 1, 2018 Received: September 19, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by David David Krause -S Date: 2018.12.21 12:36:59

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K173747

Device Name REXLENE

Indications for Use (Describe)

REXLENE 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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/4/Picture/1 description: The image shows the text "WISE COMPANY Inc." in a serif font. The text is a light tan color. The words are all capitalized, except for the "c" in "Inc."

#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone]

[e-mail]

Image /page/4/Picture/4 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" shape above the company name. Below the company name, there is text in Korean that says "와이즈컴퍼니(주)".

### 510(k) Summary

#### The assigned 510(k) Number: K173747

#### 01. Date of Submission: December 14, 2017

#### 02. Applicant

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

#### 03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

#### 04. Proposed Device Identification

Proprietary Name: REXLENE Common Name: Synthetic Nonabsorbable Polypropylene Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5010 Product Code: GAW Regulation Description: Nonabsorbable polypropylene surgical suture

#### 05. Indication for use

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

#### 06. Predicate devices

-Primary Predicate Device 510(k) Number: K080684 Device Name: , WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

-Reference Predicate Device

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Image /page/5/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that is formed by a line that resembles a heartbeat. Below the symbol is the text "WISE COMPANY Inc." and below that is the text "와이즈컴퍼니(주)".

#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone]

[e-mail]

#### 510(k) Number: K133356

Device Name: PROLENETM Polypropylene Nonabsorbable Suture Manufacturer: ETHICON, Inc

#### 07. Device Description

REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.

REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1

#### 08. Non-Clinical Test Conclusion

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

USP <861> SUTURES - DIAMETER

USP <871> SUTURES - NEEDLE ATTACHMENT

USP <881> TENSILE STRENGTH

USP Nonabsorbable Surgical Suture

Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.

Real-time and accelerated aging stability testing was performed to support shelf life of REXLENE. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures and are stable over the proposed shelf life.

Raw suture of REXLON were evaluated in accordance with ISO 10993 standards below, they are biocompatible and suitable to use as medical device.

ISO 10993, Biological Evaluation of Medical Devices Including:

- ISO 10993-5: Test for Cytotoxicity
- ISO 10993-10: Test for Irritation and Sensitization
- ISO 10993-11: Test for 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

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Image /page/6/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that resembles a heartbeat line. Below the company name, the Korean translation "와이즈컴퍼니(주)" is written.

#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone]

[e-mail]

## 09. Summary of Technological characteristic of subject and predicate devices.

| Property | Subject device<br>REXLENE | Primary Predicate<br>Device<br>WG-Surgical Sutures<br>with Needle | Reference Predicate<br>Device<br>PROLENETM<br>Polypropylene<br>Nonabsorbable Suture | Suture | | | | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--|--|
| 510(k) Number | K173747 | K080684 | K133356 | Material | Polypropylene | Polypropylene | Polypropylene | | |
| Product Code | GAW | Same | Same | Coating | uncoated | same | same | | |
| Regulation No, | 21 C.F.R. 878.5010 | Same | Same | Color | Blue dyed | same | same | | |
| Class | II | Same | Same | Absorbable/Nonabsor<br>bable | Nonabsorbable | same | same | | |
| Sterile | Yes | Same | Same | Braided/Monofilament | Monofilament | same | same | | |
| Single Use | Yes | Same | Same | Suture Size | The proposed device is<br>available in 8-0 through<br>1, which are the sizes<br>identified in the<br>currently recognized<br>United States<br>Pharmacopoeia. | Available suture sizes<br>(USP 10-0 ~ USP 2) are<br>standard according to<br>USP requirements | Available suture (USP<br>10-0 ~ USP 2) sizes are<br>standard according to<br>USP requirements<br>except for USP size 7-0 | | |
| Indications for use<br>statements | REXLENE is indicated<br>for use in general soft<br>tissue approximation<br>and/or ligation,<br>including use in<br>ophthalmic procedures,<br>but not for use in<br>cardiovascular or neural<br>tissue | Nonabsorbable<br>Polypropylene Suture<br>with Needle is indicated<br>for use in general soft<br>tissue approximation<br>and/or ligation including<br>use in cardiovascular,<br>ophthalmic and<br>neurological<br>procedures. | PROLENETM suture is<br>indicated for use in<br>general soft tissue<br>approximation and/or<br>ligation, including use in<br>cardiovascular,<br>ophthalmic and<br>neurological<br>procedures. | Length of Suture | 13, 15, 45, 50, 60, 70,<br>75, 90, 100, 120, 180<br>cm | Unknown | Unknown | | |
| Configuration | Polypropylene Suture<br>and Needle | Same | Same | Diameter of Suture | The suture diameters of<br>proposed device comply<br>with the diameter<br>requirement listed in<br>USP <861> Diameter. | same | Meet the requirements<br>defined in the USP<br>except for USP size 7-0 | | |
| Tensile strength | The tensile strengths of<br>proposed device comply<br>with the tensile<br>requirement listed in<br>USP <881> Tensile<br>Strength | same | Meet the requirements<br>defined in the USP<br>except for USP size 7-0 | | | | | | |

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Image /page/7/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized line that resembles a heartbeat or a mountain range. Below the line is the text "WISE COMPANY Inc." in a simple sans-serif font. Underneath the English text is the Korean translation, "와이즈컴퍼니(주)".

#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone]

[e-mail]

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Image /page/8/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized "W" shape above the company name. Below the English name is the Korean translation of the company name, "와이즈컴퍼니(주)".

#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: [phone]

[e-mail]

| Needle Attachment | The bond between<br>suture and needle of<br>the applicant device<br>meet the requirements<br>defined in USP <871>. | same | Meet the requirements<br>defined in the USP<br>except for USP size 7-0 |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterilization method | Ethylene oxide gas<br>sterilization | same | same |
| Needle | | | |
| Material | Stainless Steel | Same | same |
| Indication for use | Disposable suturing<br>needle | Same | Same |
| Needle Tip Geometry<br>(Needle type) | Taper point, Tapper cut<br>Spatula, Reverse<br>cutting, | Same.<br>Taper point<br>Tapper cut<br>Conventional cutting<br>Reverse Cutting<br>Extra-Sharp cutting<br>Blunt<br>Spatula | Same.<br>Based on Ethicon's<br>catalog, they provide<br>ATRALOC needles to<br>surgeons. Surgeon<br>select type of needle<br>that, in their experience,<br>is appropriate for the<br>specific procedure and<br>Needle shapes are<br>generally classified<br>according to the degree<br>of curvature of the body<br>and needle type<br>- 1/2, 3/8, 1/4, 5/8,<br>straight<br>- Tapper point, Blunt<br>point, Conventional<br>cutting, Reverse<br>Cutting, Spatula, Micro<br>point |
| Circle (Shape) | 1/2, 3/8, straight | Same.<br>1/2, 3/8, 1/4, 5/8,<br>Straight, Ski Needle,<br>Compound curve | - 1/2, 3/8, 1/4, 5/8,<br>straight<br>- Tapper point, Blunt<br>point, Conventional<br>cutting, Reverse<br>Cutting, Spatula, Micro<br>point |

### 10. Substantially Equivalent Conclusion

The proposed device, REXLENE is determined to be Substantially Equivalent (SE) to the predicate devices in respect of safety and effectiveness.