REXLON, REXSIL

K161633 · Sm Eng Co., Ltd. · GAR · Mar 2, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161633
• Device Name: REXLON, REXSIL
• Applicant: Sm Eng Co., Ltd.
• Product Code: GAR · General, Plastic Surgery
• Decision Date: Mar 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5020
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

REXLON 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. REXSIL 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

REXLON and REXSIL are sterile, nonabsorbable surgical sutures used for soft tissue approximation and ligation. REXLON is a monofilament polyamide (Nylon 6 and 6,6); REXSIL is a braided silk suture (fibroin protein from Bombyx mori) coated with silicone. Both are available with or without stainless steel (STS 304) needles. Used by clinicians in surgical settings. Sutures provide mechanical tissue closure; performance verified against USP standards for diameter, tensile strength, and needle attachment. Biocompatibility confirmed per ISO 10993. Sterilized via ethylene oxide. Benefits include secure tissue approximation and visibility (dyed black/blue or natural).

Clinical Evidence

Bench testing only. No clinical data. Testing included USP 35 <861> (diameter), <871> (needle attachment), <881> (tensile strength), <71> (sterility), <85> (bacterial endotoxin), and <151> (pyrogen). Biocompatibility testing performed per ISO 10993-1, -3, -4, -5, -6, -7, -10, and -11. Shelf life supported by real-time and accelerated aging studies.

Technological Characteristics

REXLON: Monofilament polyamide (Nylon 6/6,6). REXSIL: Braided silk (fibroin) with silicone coating. Needles: Stainless steel STS 304. Sterilization: Ethylene oxide (ISO 11135-1). Compliance: USP 35 <861>, <871>, <881>. Biocompatibility: ISO 10993. Packaging: ASTM F88-09 (seal strength), ASTM F1929-98 (leak detection).

Indications for Use

Indicated for general soft tissue approximation and/or ligation, including ophthalmic procedures. Contraindicated for cardiovascular or neural tissue. No specific age or gender restrictions.

Regulatory Classification

Identification

Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide 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 monofilament or multifilament in form; 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

• WG-Surgical Sutures with Needle (K080684)
• Reli (K982646)

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 features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

March 2, 2017

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

Re: K161633

Trade/Device Name: REXLON®, REXSIL® Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR, GAP Dated: January 24, 2017 Received: January 31, 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 (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,

# David Krause -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

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

#### 510(k) Number (if known)

#### K161633

Device Name

REXLON

Indications for Use (Describe)

REXLON' 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 nollection of informating data sources, gather and needed and complete of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

# 510(k) Number (if known)

## K161633

Device Name

REXSIL

Indications for Use (Describe)

REXSIL 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)

2 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)

FORM FDA 3881 (1/14)

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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 institutions, search existing data sources, gather and maintain the data needed and complete and reviouslion of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# 510(k) Summary

# The assigned 510(k) Number: K161633

# Date of Submission: January 24, 2017

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

# Subject Device Information

#### 1. Nylon Monofilament Suture With or Without Needle

#### 1.1 Proposed Device Identification

Proprietary Name: REXLON Common Name: Nonabsorbable Polyamide Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5020 Product Code: GAR Device Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide

#### 1.2 Indication for use

REXLON 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.

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# 1.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD.

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Manufacturer: AILEE CO LTD.

# 1.4 Device Description

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

REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).

REXLON 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 Black (Logwood): USP 11-0 ~ USP 1
- i Dyed suture Blue (FD&C Blue No.2): USP 8-0 ~ USP 2
- Undyed suture (Natural): USP 8-0 ~ USP 1

# 1.5 Non-Clinical Test Conclusion

USP 35 <861> SUTURES - DIAMETER

USP 35 <871> SUTURES - NEEDLE ATTACHMENT

USP 35 <881> TENSILE STRENGTH

USP Nonabsorbable Surgical Suture

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 for development, 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 reproductive toxicity (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)

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

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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)

REXLON were evaluated in accordance with the listed tests above.

Real-time and accelerated aging stability testing was performed to support shelf life of REXLON. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures, are biocompatible per ISO 10993-1, and are stable over the proposed shelf life

# 1.6 Substantially Equivalent Conclusion

| | Table 1: Substantial Equivalence Comparison | |
|--|---------------------------------------------|--|
| | | |

| Property | Proposed device<br>REXLON | Predicate device 01<br>WG-Surgical Sutures<br>with Needle | Predicate device 02<br>Reli |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K161633 | K080684 | K982646 |
| Product Code | GAR | GAR | GAR |
| Regulation No, | 21 C.F.R. 878.5020 | 21 C.F.R. 878.5020 | 21 C.F.R. 878.5020 |
| Class | II | II | II |
| Sterile | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Intended use | Indication for use is in<br>general soft tissue<br>approximation and/or<br>ligation, including use in<br>ophthalmic procedures, | Indication for use is in<br>general soft tissue<br>approximation and/or<br>ligation, including use in<br>ophthalmic procedures. | Indication for use as non<br>absorbable sutures is in<br>general soft tissue<br>approximation and/or<br>ligation, including use in |
| | but not for use in<br>cardiovascular or neural<br>tissue. | | cardiovascular,<br>ophthalmic, neural<br>tissue. |
| Configuration | Nonabsorbable<br>Polyamide Suture With<br>Needle | Nonabsorbable<br>Polyamide Suture With<br>Needle | Nonabsorbable<br>Polyamide Suture With<br>Needle |
| | | Suture | |
| Raw Suture Material | polyamide surgical<br>suture from long-chain<br>aliphatic polymers Nylon<br>6 and Nylon 6,6 | polyamide surgical<br>suture from long-chain<br>aliphatic polymers Nylon<br>6 and Nylon 6,6 | polyamide surgical<br>suture from long-chain<br>aliphatic polymers Nylon<br>6 and Nylon 6,6 |
| Suture Manufacturer | Ashaway Line & Twine<br>Mfg. Co. | Pearsalls Limited | Ashaway Line & Twine<br>Mfg. Co. |
| Color (Colorant) | Dyed suture Black<br>(Logwood), Blue<br>(FD&C Blue No.2) and<br>Undyed suture (Natural) | Dyed suture Black<br>(Logwood), Blue &<br>phthalocyanine blue<br>(FD&C Blue No.2) and<br>Undyed suture (Natural) | Dyed suture Black<br>(Logwood), Blue<br>(FD&C Blue No.2) and<br>Undyed suture (Natural) |
| Coating material | Not used | Not used | Not used |
| Absorbable/Nonabsorb<br>able | Nonabsorbable | Nonabsorbable | Nonabsorbable |
| Braided/Monofilament | Monofilament | Monofilament | Monofilament |
| Suture Size | Available suture sizes<br>are standard according<br>to USP requirements<br>Available suture size is<br>as below.<br>#1 Dyed suture Black<br>(Logwood): USP 11-<br>0~USP 1<br>#2 Dyed suture Blue<br>(FD&C Blue No.2): USP<br>8-0~USP 2<br>#3 Undyed suture<br>(Natural): USP 8-0~USP<br>1 | Available suture sizes<br>are standard according<br>to USP requirements | Available suture sizes<br>are standard according<br>to USP requirements |
| | | | |
| Length of Suture | 15cm, 20cm, 30cm,<br>35cm, 40cm, 45cm,<br>50cm 60cm, 70cm,<br>75cm, 80cm, 100cm,<br>150cm, 200cm | Unknown | 15cm, 20cm, 30cm,<br>45cm, 50cm |
| Diameter of Suture | The suture diameters of<br>proposed device comply<br>with the diameter<br>requirement listed in<br>U5P 35 <861> Diameter. | The suture diameters of<br>proposed device comply<br>with the diameter<br>requirement listed in<br>U5P 35 <861> Diameter. | Meet the requirements<br>defined in the USP |
| Tensile strength | The tensile strengths of<br>proposed device comply<br>with the tensile<br>requirement listed in<br>U5P 35 <881> Tensile<br>Strength | The tensile strengths of<br>proposed device comply<br>with the tensile<br>requirement listed in<br>U5P 35 <881> Tensile<br>Strength | Meet the requirements<br>defined in the USP |
| Needle Attachment | The bond between<br>suture and needle of the<br>applicant device meet<br>the requirements defined<br>in USP 35 <871>. | The bond between<br>suture and needle of the<br>applicant device meet<br>the requirements defined<br>in USP 35 <871>. | Meet the requirements<br>defined in the USP |
| Needle | | | |
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle type | Reverse Cutting, Taper<br>point, Spatula | Taper, cutting, spatual,<br>blund ,taper cut,<br>diamond, premimum<br>cutting and square | Spatula, taper point,<br>Blunt point |

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The proposed device, REXLON, is determined to be Substantially Equivalent (SE) to the predicate device, WG-Surgical Sutures with Needle (K080684) and Reli (K982646) in respect of safety and effectiveness.

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# 2. Nonabsorbable Silk Suture With or Without Needle

#### 2.1 Proposed Device Identification

Proprietary Name: REXSIL Common Name: Nonabsorbable Braided Silk Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5030 Product Code: GAP Device Classification Name: Suture, Nonabsorbable, Silk

#### 2.2 Indication for use

REXSIL 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.

#### 2.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: AILEE CO LTD.

#### 2.4 Device Description

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

REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).

REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture. Available suture size is as below.

- Dyed suture Black (Logwood): USP 8-0 ~ USP 2
- Undyed suture (Natural): USP 7-0 ~ USP 2

### 2.5 Non-Clinical Test Conclusion

USP 35 <861> SUTURES - DIAMETER USP 35 <871> SUTURES - NEEDLE ATTACHMENT USP 35 <881> TENSILE STRENGTH USP Nonabsorbable Surgical Suture ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials; ASTM F1929-98-98 Standard Test Method for Detecting Seal Leaks in Porous Medical

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Package by Dye Penetration

USP <71> STERILITY TEST

USP <151>; Pyrogen Test

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

USP <85> Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices:

Includina:

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 reproductive toxicity (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)

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)

REXSIL were evaluated in accordance with the listed tests above.

Real-time and accelerated aging stability testing was performed to support shelf life of REXSIL. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures, are biocompatible per ISO 10993-1, and are stable over the proposed shelf life

# 2.6 Substantially Equivalent Conclusion

| Property | Proposed device<br>REXSIL | Predicate device 01<br>WG-Surgical Sutures<br>with Needle | Predicate device 02<br>Reli |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| 510(k) Number | K161633 | K080684 | K982646 |
| Product Code | GAP | GAP | GAP |
| Regulation No, | 21 C.F.R. 878.5030 | 21 C.F.R. 878.5030 | 21 C.F.R. 878.5030 |
| Class | II | II | II |
| Sterile | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Configuration | Nonabsorbable Silk<br>Suture and Needle | Nonabsorbable Silk<br>Suture and Needle | Nonabsorbable Silk<br>Suture |
| Suture | | | |
| Raw Suture Material | Silk suture | Silk suture | Silk suture |
| Suture Manufacturer | Ashaway Line & Twine<br>Mfg. Co. | Pearsalls Limited | Ashaway Line & Twine<br>Mfg. Co. |
| Coating material | Silicone coated | Silicone and wax coated | Silicone coated |
| Color (Colorant) | Dyed suture Black<br>(Logwood) and Undyed<br>suture (Natural) | Dyed suture Black<br>(Sulphol or Logwood)<br>and Undyed suture<br>(Natural) | Dyed suture Black<br>(Logwood) and Undyed<br>suture (Natural) |
| Absorbable/Nonabsorb<br>able | Nonabsorbable | Nonabsorbable | Nonabsorbable |
| Braided/Monofilament | Braided | Braided | Braided |
| Suture Size | Available suture sizes<br>are standard according<br>to USP requirements<br>Available suture size is<br>as below.<br>#1 Dyed suture Black<br>(Logwood): USP 8-0 ~ | Available suture sizes<br>are standard according<br>to USP requirements | Available suture sizes<br>are standard according<br>to USP requirements |
| | USP 2<br>#2 Undyed suture<br>(Natural): USP 7-0 ~<br>USP 2 | | |
| Length of Suture | 30cm, 35cm, 40cm,<br>45cm, 50cm, 55cm,<br>60cm, 70cm, 75cm,<br>100cm, 110cm, 150cm,<br>180cm, | Unknown | Unknown |
| Diameter of Suture | The suture diameters of<br>proposed device comply<br>with the diameter<br>requirement listed in<br>USP 35 <861><br>Diameter. | The suture diameters of<br>proposed device comply<br>with the diameter<br>requirement listed in<br>USP 35 <861><br>Diameter. | Meet the requirements<br>defined in the USP |
| Tensile strength | The tensile strengths of<br>proposed device comply<br>with the tensile<br>requirement listed in<br>USP 35 <881> Tensile<br>Strength | The tensile strengths of<br>proposed device comply<br>with the tensile<br>requirement listed in<br>USP 35 <881> Tensile<br>Strength | Meet the requirements<br>defined in the USP |
| Needle Attachment | The bond between<br>suture and needle of the<br>applicant device meet<br>the requirements defined<br>in USP 35 <871>. | The bond between<br>suture and needle of the<br>applicant device meet<br>the requirements defined<br>in USP 35 <871>. | Meet the requirements<br>defined in the USP |
| Needle | | | |
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle type | Reverse Cutting, Taper<br>point, Spatula | Taper point, Reverse<br>Cutting, Conventional<br>cutting, Taper cutting,<br>Spatula, Blunt point | Spatula, taper point |

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The proposed device, REXSIL, is determined to be Substantially Equivalent (SE) to the predicate device, WG-Surgical Sutures with Needle (K080684) and Reli (K982646) in respect of safety and effectiveness.