CRYLREX

K161629 · Sm Eng Co., Ltd. · GAM · Feb 10, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161629
• Device Name: CRYLREX
• Applicant: Sm Eng Co., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Feb 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

CRYLREX® 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

CRYLREX® is a sterile, braided, coated, synthetic absorbable surgical suture composed of a copolymer of 90% glycolide and 10% L-lactide. It is coated with poly(glycolide-co-lactide) (30/70) and calcium stearate. The suture is available in dyed (D&C Violet No. 2) or undyed (natural) forms, with or without stainless steel (SUS 304) needles. It is intended for use by clinicians for soft tissue approximation and ligation. The device maintains approximately 75% tensile strength after 2 weeks and 50% after 3 weeks, with complete absorption occurring within 56 to 70 days. It is a single-use device.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included USP 35/36 standards for suture diameter, needle attachment, tensile strength, sterility, and pyrogenicity. Biocompatibility testing performed per ISO 10993 (genotoxicity, cytotoxicity, irritation, sensitization, systemic toxicity, and implantation effects). Real-time and accelerated aging studies supported shelf life.

Technological Characteristics

Multifilament braided suture; 90% glycolide/10% L-lactide copolymer; coated with poly(glycolide-co-lactide) (30/70) and calcium stearate. Stainless steel (SUS 304) needles. Sterilized via ethylene oxide (ISO 11135-1). Complies with USP 35 <861>, <871>, <881> and ASTM F88-09, F1929-98.

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

• WEGO-PGLA Absorbable Surgical Suture (K130735)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 three human profiles facing to the right, connected by flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 10, 2017

SM ENG CO., Ltd % Mr. Sanglok Lee Wise Company, Inc. #306, 3 Daerim-ro 27ga-gil Yeongdeungpo-gu, 07413 KR

Re: K161629

Trade/Device Name: CRYLREX® Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: December 28, 2016 Received: January 5, 2017

Dear Mr. 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. 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 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Jennifer R. Stevenson -S

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

510(k) Number (if known)

#### K161629

Device Name CRYLREX®

Indications for Use (Describe)

CRYLREX® 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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

#### 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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# 510(k) Summary

## The assigned 510(k) Number: K161629

#### 01. Date of Submission: 2016.12.28

#### 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. #306, 3 Daerim-ro 27ga-gil,Yeongdeungpo-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

## 04. Proposed Device Identification

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

#### 05. Indication for use

CRYLREX® is indicated for use in general soft tissue approximationand/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

#### 06. Predicate devices

Predicate device 01 510(k) Number:K130735 DeviceName: WEGO-PGLA Absorbable Surgical Suture Classification Name: Suture, Absorbable, Synthetic, Polyglycolic Acid Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

#### 07. Device Description

CRYLREX® is a sterilized medical device composed with multifilament absorbable, braided, coated suture, 90% glycolide and 10% L-lactide, with needle, stainless steel SUS 304.

CRYLREX® Suture is a synthetic absorbable, braided, coated suture composed of a copolymer made from 90% glycolide and 10% L-lactide and is available both dyed and

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undyed. CRYLREX® Suture is coated with poly(glycolideco-lactide)(30/70) and calcium stearate. The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 75% of tensile strength remain after 2 weeks, 50% of tensile strength remain after 3 weeks. Complete absorption in tissues takes around 56 to 70 days.

CRYLREX® Sutures are U.S.P. except for diameters in the following sizes:

| U.S.P.<br>SUTURE SIZE<br>DESIGNATION | MAXIMUM<br>OVERSIZE<br>(mm) |
|--------------------------------------|-----------------------------|
| 8-0 | 0.007 |
| 7-0 | 0.010 |
| 6-0 | 0.021 |
| 5-0 | 0.036 |
| 4-0 | 0.031 |
| 3-0 | 0.036 |
| 2-0 | 0.021 |
| 0 | 0.056 |
| 1 | 0.046 |
| 2 | 0.031 |

MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P.

## 08. Non-Clinical Test Conclusion

Bench 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 proposeddevice complies with the following standards:

USP 35 <861> SUTURES - DIAMETER

USP 35 <871> SUTURES - NEEDLE ATTACHMENT

USP 35 <881> TENSILE STRENGTH

USP Absorbable Surgical Suture

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

ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;

ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

USP, <71> STERILITY TEST

USP 36, <151>; Pyrogen Test

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements fordevelopment, validation and routing control of a sterilization process for medical devices;

USP <85> Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices:

Including:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Biological evaluation of medical devices - Part 3:Tests for genotoxicity, carcinogenicity and reproductivetoxicity (ISO 10993-3:2014)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

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Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

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

#### 09. Substantially Equivalent Conclusion

| Property | Proposed device<br>CRYLREX® | Predicate device 01<br>WEGO-PGLA Absorbable<br>Surgical Suture |
|----------------|-----------------------------|----------------------------------------------------------------|
| 510(k) Number | K161629 | K130735 |
| Product Code | GAM | Same |
| Regulation No, | 2 1 CFR 878.4493 | Same |
| Class | II | Same |
| Sterile | Yes | Same |
| Single Use | Yes | Same |
| Configuration | PGLA Suture and Needle | Same |

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| Suture | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Raw Suture Material | Neosorb | Same | |
| Manufacturer of Raw Suture<br>Material | Samyang Biopharmaceuticals<br>Corporation | Same | |
| Final Material Composition | 90% glycolide and 10% L-<br>lactide (PGLA) | Same | |
| Coating material | Poly(glycolide-co-lactide)<br>(30/70)+ Calcium Stearate | Same | |
| Color (Colorant) | Undyed (natural) or Dyed (D&C<br>Violet No.2) | Same | |
| Absorbable/Nonabsorbable | Absorbable | Same | |
| Braided/Monofilament | Braided | Same | |
| Suture Size | The proposed device is<br>available in 8-0, 7-0, 6-0,5-0, 4-<br>0,3-0,2-0, 0, 1 and 2, which are<br>the sizes identified in the<br>currently recognized United<br>States Pharmacopoeia except<br>for diameter | The proposed device is<br>available in 6-0,5-0, 4-0,3-0,2-0,<br>0 and 1, which are the sizes<br>identified in the currently<br>recognized United States<br>Pharmacopoeia except for<br>diameter | |
| Length of Suture | 20cm, 30cm, 45cm, 60cm,<br>70cm, 75cm, 90cm, 100cm,<br>125cm, 140cm, 150cm, 250cm, | 30cm, 45cm, 60cm, 75cm,<br>90cm, 100cm, 120cm,<br>150cm,180cm, 200cm, 250cm,<br>280cm, 300cm, 320cm,<br>360cmand 390cm | |
| Diameter of Suture | Oversize | Oversize | |
| Tensile strength | The tensile strengths of<br>proposed device comply with<br>thetensile requirement listed in<br>USP 35 <881> TensileStrength | The tensile strengths of<br>proposed device comply with<br>thetensile requirement listed in<br>USP 35 <881> TensileStrength | |
| Needle Attachment | The bond between suture and<br>needle ofthe applicantdevice<br>meet the requirements defined<br>in USP 35 <871>. | The bond between suture and<br>needle ofthe applicantdevice<br>meet the requirements defined<br>in USP 35 <871>. | |
| Needle | | | |
| Material | Stainless Steel | Stainless Steel | |
| Needle type | Taper point, Reverse<br>Cutting, Conventional cutting,<br>Taper cutting, Spatula, Blunt<br>point | Taper, Spatula, Cutting, Blunt | |

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The proposed device, CRYLREX® Suture, is determined to be SubstantiallyEquivalent (SE) to the predicate device, SYNTHETIC ABSORBABLE SUTURE (K130735) in respect of safety and effectiveness.