REXMONO 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.

PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

Device Description

REXMONO: Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle (REXMONO) are produced and provided by SM ENG Co., Ltd. REXMONO 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. Suture of REXMONO manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOFAST. SM Eng is receiving bulk MONOFAST from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes REXMONO suture. REXMONO is a sterilized medical device composed with absorbable monofilament suture, poly (glycolide-co-caprolactone), with needle, stainless steel SUS 304. REXMONO Suture is a synthetic absorbable, monofilament, suture composed of poly (qlycolide-co-caprolactone). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 68~78% of tensile strength remain after 1 week. Complete absorption in tissues takes around 90 to 110 days.

PDREX: Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle (PDREX) are produced and provided by SM ENG Co., Ltd. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue. Suture of PDREX manufactured by SAMYANG Biopharmaceuticals Corporation, which is called MONOSORB. SM Eng is receiving bulk MONOSORB from Samyang, and then go through cutting, adhesion of need and thread, winding and sterilization process according to SM Eng procedure, which becomes PDREX suture. PDREX is a sterilized medical device composed with polydioxanone surgical suture, with needle, stainless steel SUS 304. PDREX Suture is a synthetic absorbable, monofilament, suture composed of a Poly (p-dioxanone). The suture is available dyed (D&C Violet No.2). Approximately 50~60% of tensile strength remain after 6 week. Complete absorption in tissues takes around 180 to 210 days.

AI/ML Overview

This looks like a 510(k) premarket notification for surgical sutures (REXMONO and PDREX). The document indicates that the devices are substantially equivalent to predicate devices, and the "study" mostly consists of non-clinical bench tests and biocompatibility testing against established standards.

Here's an analysis of the acceptance criteria and the "study" information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a formal "acceptance criteria" table with specific quantitative thresholds for each parameter alongside the device's performance results in the way a clinical study report might. However, it states that the proposed devices comply with various USP and ISO standards.

Here's a table based on the implicit acceptance criteria (compliance with standards) and the reported performance (that the device met these standards):

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Suture Diameter	USP <861> SUTURES - DIAMETER	Complies with USP <861> (with specified oversizes)
Needle Attachment	USP <871> SUTURES - NEEDLE ATTACHMENT	Complies with USP <871>
Tensile Strength	USP <881> TENSILE STRENGTH	Complies with USP <881>
Absorption Rate	USP monograph of absorbable surgical suture requirements & FDA Class II Special Controls Guidance Document	Studies demonstrated in accordance with requirements
Sterility Packaging	ISO 11607-1, ISO 11607-2, ASTM F 88, ASTM F 1929	Complies with these standards
Shelf Life (Sterility)	ASTM F 1980 for accelerated aging	Accelerated aging stability testing performed
Biocompatibility	ISO 10993-1, 10993-2, 10993-3, 10993-4, 10993-5, 10993-6, 10993-10, 10993-11, 10993-12	Complies with specified ISO 10993 standards (for suture and needle)

It's important to note that the document generally states "complies" or "demonstrated in accordance with requirements" rather than providing specific numerical results for each test. The listed "MAXIMUM SUTURE OVERSIZE IN DIAMETER (mm) FROM U.S.P." for REXMONO and PDREX, and the remaining tensile strength percentages (68-78% for REXMONO after 1 week, 50-60% for PDREX after 6 weeks), are the most quantitative pieces of performance information provided for the sutures themselves.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the sample sizes used for the non-clinical bench tests (e.g., how many sutures were tested for tensile strength or diameter). It refers to the tests performed to "verify that the proposed device...met all design specifications."
Data Provenance: The tests are described as "Bench tests" conducted by the manufacturer/sponsor (SM ENG CO., LTD) or its design partner (Samyang Biopharmaceuticals Corporation). The origin (country) of the raw data for these tests is not explicitly stated beyond the companies being based in Korea. These are typically simulated or laboratory tests rather than trials with human subjects. The data is retrospective in the sense that the tests were completed before this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for surgical sutures in a 510(k) context is typically established by recognized standards (e.g., USP monographs, ISO standards) and regulatory guidance documents, not by expert consensus on individual cases. The FDA's review process itself involves subject matter experts (e.g., engineers, scientists) who evaluate the compliance of the submitted data with these standards.

4. Adjudication Method for the Test Set

This information is not applicable as the "test set" refers to physical product samples undergoing laboratory testing against predefined specifications, not clinical cases requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. This submission is for surgical sutures, which are physical medical devices, not AI/CADe (Computer-Aided Detection) or CADx (Computer-Aided Diagnosis) software intended for interpretation by human readers. Therefore, no MRMC study looking at human reader performance with or without AI assistance would be relevant or performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable for the same reason as point 5. The device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for evaluating these sutures is primarily based on established industry standards and regulatory requirements:

USP (United States Pharmacopeia) Monographs and Test Chapters: These define the physical and performance characteristics (e.g., diameter, tensile strength, needle attachment) accepted for surgical sutures.
ISO (International Organization for Standardization) Standards: Specifically ISO 10993 for biocompatibility and ISO 11607 for packaging.
ASTM (American Society for Testing and Materials) Standards: For seal strength and accelerated aging.
FDA Class II Special Controls Guidance Document: Surgical Sutures: This document outlines specific performance testing requirements, including residual strength and absorption rate studies.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of physical medical device testing for substantial equivalence. This concept is relevant to machine learning or AI models.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8.

Summary

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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 and 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 square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 12, 2018

SM ENG CO., LTD % Sanglok Lee Manager Wise COMPANY Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, Seoul, Korea

Re: K173779

Trade/Device Name: REXMONO, PDREX Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW Dated: November 11, 2017 Received: December 12, 2017

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. 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

510(k) Number (if known) K173779

Device Name REXMONO, PDREX

Indications for Use (Describe)

REXMONO 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)

X 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)

FOR FDA USE ONLY
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.

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K173779 page 1 of 9

Image /page/4/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 symbol, the text "WISE COMPANY Inc." is displayed in a simple font. Underneath that, the text "와이즈컴퍼니(주)" is displayed in a smaller font.

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

510(k) Summary

The assigned 510(k) Number: K173779

● Date of Preparation: March 05, 2018

● Sponsor Identification

Company name: SM ENG CO., LTD Address: 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, Korea TEL: +82 51 3058016 FAX: +82 513058021 Email: leesg@sm-eng.net

Establishment Registration Number: 3008912461

● Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

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K173779 page 2 of 9

Image /page/5/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized line graph above the company name. Below the company name, there is text in Korean that says "와이즈컴퍼니(주)".

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.orq

Proposed Device Identification

1. REXMONO

Device Identification and Regulatory information

Proprietary Name: REXMONO

Common Name: Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle

Device Class: Class II Regulation Number: 21 C.F.R. 878.4493 Product Code: GAM

Indications for Use

REXMONO 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. PDREX

Device Identification and Regulatory information

Proprietary Name: PDREX Common Name: Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle Device Class: Class II Product Code: NEW

Indications for Use

Predicate Device Identification

1. REXMONO

-Predicate Device 510(k) Number: K142810 Device Name: WEGO-PGCL Absorbable Surgical Monofilament Suture Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

2. PDREX

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

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K173779 page 3 of 9

Image /page/6/Picture/1 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 is the same name in Korean.

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

· Device Description

1. REXMONO

Synthetic Absorbable PGA-PCL Monofilament Suture With or Without Needle (REXMONO) are produced and provided by SM ENG Co., Ltd. REXMONO 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.

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

REXMONO is a sterilized medical device composed with absorbable monofilament suture, poly (glycolide-co-caprolactone), with needle, stainless steel SUS 304.

REXMONO Suture is a synthetic absorbable, monofilament, suture composed of poly (qlycolide-co-caprolactone). The suture is available undyed (natural) or dyed (D&C Violet No.2). Approximately 68~78% of tensile strength remain after 1 week. Complete absorption in tissues takes around 90 to 110 days.

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

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

U.S.P.SUTURE SIZEDESIGNATION	MAXIMUMOVERSIZE(mm)
6-0	0.050
5-0	0.050
4-0	0.050
3-0	0.090
2-0	0.060
0	0.100
1	0.071
2	0.011

2. PDREX

Synthetic Absorbable Monofilament Polydioxanone Suture With or Without Needle (PDREX) are produced and provided by SM ENG Co., Ltd. PDREX is indicated for use in all types of soft tissue approximation, including use in cardiovascular tissue where growth is expected to occur, PDO suture is not indicated in adult cardiovascular tissue, microsurgery, ophthalmic and neural tissue.

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K173779 page 4 of 9

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, the text "WISE COMPANY Inc." is written in a serif font. Underneath the English text, there is Korean text that says "와이즈컴퍼니(주)".

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

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

PDREX is a sterilized medical device composed with polydioxanone surgical suture, with needle, stainless steel SUS 304.

PDREX Suture is a synthetic absorbable, monofilament, suture composed of a Poly (pdioxanone). The suture is available dyed (D&C Violet No.2). Approximately 50~60% of tensile strength remain after 6 week. Complete absorption in tissues takes around 180 to 210 days.

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

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

U.S.P.SUTURE SIZEDESIGNATION	MAXIMUMOVERSIZE(mm)
7-0	0.025
6-0	0.050
5-0	0.050
4-0	0.050
3-0	0.090
2-0	0.060
0	0.100
1	0.071
2	0.011

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K173779 page 5 of 9

Image /page/8/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that also resembles a heartbeat line. Below the "W" is the text "WISE COMPANY Inc." in a simple, sans-serif font. Below that is the text "와이즈컴퍼니(주)".

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

● Non-Clinical Test Conclusion (REXMONO & PDREX)

Bench tests were conducted to verify that the proposed device (REXMONO & PDREX) 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 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
1. Suture
ISO 10993-1: Selection of Tests
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: 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

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

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K173779 page 6 of 9

Image /page/9/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized line that resembles a heartbeat or a mountain range above the company name. Below the English name, the company name is also written in Korean: 와이즈컴퍼니(주).

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

● Substantially Equivalent Conclusion

The following table compares the REXMONO and PDREX to the predicate devices with respect to intended use, technological characteristics and principles of operation, etc.

REXMONO		PDREX
Property	Proposeddevice:REXMONO	Predicatedevice:WEGO-PGCLAbsorbableSurgicalMonofilamentSuture	Property	Proposeddevice:PDREX	Predicatedevice:WG-SurgicalSutures withNeedle
510(k)Number	K173779	K142810	510(k)Number	K173779	K073614
ProductCode	GAM	Same	ProductCode	NEW	Same
Indicationsfor usestatements	REXMONO isindicated foruse in generalsoft tissueapproximationand/orligation,including usein ophthalmicprocedures,but not for useincardiovascular or neuraltissue	Same. TheWEGO-PGCLAbsorbableSurgicalMonofilamentSuture isindicated foruse in generalsoft tissueapproximationand/or, but notfor use incardiovascular orneurologicalprocedure	indicationsfor usestatements	PDREX isindicated foruse in generalsoft tissueapproximationand/orligation,including usein ophthalmicprocedures,but not for useincardiovascular or neuraltissue	AbsorbablePolydioxanone Suture withNeedle isindicated foruse in alltypes of softtissueapproximation, includinguse incardiovascular tissue wheregrowth isexpected tooccur, PDOsuture is notindicated inadultcardiovascular tissue,
					microsurgery,ophthalmicand neuraltissue.
Class	II	Same	Class	II	Same
Sterile	Yes	Same	Sterile	Yes	Same
Single Use	Yes	Same	Single Use	Yes	Same
Configuration	PGA-PCLSuture andNeedle	Same	Configuration	Polydioxanone Suture andNeedle	Same
Suture
Material	Poly(glycolide-co-caprolactone))copolymer	Same	Material	Poly (p-dioxanone)	Same
Coatingmaterial	None	Same	Coatingmaterial	None	None
Color	Undyed(natural) anddyed (D&CViolet No.2)	Same	Color	Dyed (D&CViolet No.2).	Violet orUndyed
Absorbable/Nonabsorbable	Absorbable	Same	Absorbable/Nonabsorbable	Absorbable	Absorbable
Braided/Monofilament	Monofilament	Same	Braided/Monofilament	Monofilament	Monofilament
Barbed/NotBarbed	Not Barbed	Same	Barbed/NotBarbed	Not Barbed	Same
Suture Size	The proposeddevice isavailable in 6-0, 5-0, 4-0,3-0,2-0, 0, 1and 2, whichare the sizesidentified inthe currentlyrecognizedUnited StatesPharmacopoeia.Sutures areU.S.P. exceptfor diameters.All suturesizes areoversized	Similar. Theproposeddevice isavailable in 6-0, 5-0, 4-0,3-0,2-0, 0, and1, which arethe sizesidentified inthe currentlyrecognizedUnited StatesPharmacopoeia.Sutures areU.S.P. exceptfor diameters.All suturesizes are oversized	Suture Size	The proposeddevice isavailable in 7-0, 6-0,5-0, 4-0,3-0,2-0, 0, 1and 2, whichare the sizesidentified inthe currentlyrecognizedUnited StatesPharmacopoeia.Sutures areU.S.P. exceptfor diameters.All suturesizes areoversized	Same
Length ofSuture	30, 45, 50, 60,70, 75, 90,150, 250cm	30cm, 45cm,60cm, 75cm,90cm, 100cm,120cm,150cm,180cm,200cm,250cm,280cm,300cm,320cm.360cm and390cm	Length ofSuture	20, 23, 30, 35,45, 60, 70, 75,90, 150cm	Not known
Diameter ofSuture	Oversize	Oversize	Diameter ofSuture	Oversize	Same
Tensilestrength	The tensilestrengths ofproposeddevice comply	Same	Tensilestrength	The tensilestrengths ofproposeddevice comply	Same
	with thetensilerequirementlisted in USP<881> TensileStrength			with thetensilerequirementlisted in USP<881> TensileStrength
NeedleAttachment	The bondbetweensuture andneedle of theapplicantdevice meettherequirementsdefined inUSP <871>.	Same	NeedleAttachment	The bondbetweensuture andneedle of theapplicantdevice meettherequirementsdefined inUSP <871>.	Same
Needle
Material	StainlessSteel	Same	Material	StainlessSteel	Same
Needle type	Taper point,ReverseCutting,Conventionalcutting, Tapercutting,Spatula, Bluntpoint	Similar. Taper,Cutting, Blunt	Needle type	Taper point,ReverseCutting,Conventionalcutting, Tapercutting,Spatula, Bluntpoint	Similar. Notknown
Biocompatibility	Comply withISO 10993-5and ISO10993-10	Same	Biocompatibility	Comply withISO 10993-5and ISO10993-10	Same

Table. Comparison of Technology Characteristics

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K173779 page 7 of 9

Image /page/10/Picture/1 description: The image shows the text "WISE COMPANY Inc." in a light tan color. The text is horizontally aligned and appears to be a company logo or heading. The font is a serif typeface, giving it a professional and classic look.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

Image /page/10/Picture/5 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that resembles a heartbeat line in a gold color. Below the logo, the text "WISE COMPANY Inc." is written in a serif font, and below that, the Korean translation "와이즈컴퍼니(주)" is written in a smaller font.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized line graph above the company name. Below the company name, the Korean translation of the company name, 와이즈컴퍼니(주), is written in Korean characters. The logo is simple and modern.

K173779 page 8 of 9

WISE COMPANY Inc.

#1005, 11–19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

{12}------------------------------------------------

K173779 page 9 of 9

Image /page/12/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized line that resembles a heartbeat or a mountain range. Below the line, the text "WISE COMPANY Inc." is displayed in a simple, sans-serif font, and below that is the Korean translation of the company name, "와이즈컴퍼니(주)".

WISE COMPANY Inc.

#1005, 11-19, Gamasan-ro 27-gil,

Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615 info@wisecompany.org

The proposed devices, REXMONO & PDREX, are determined to be Substantially Equivalent (SE) to the predicate devices.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
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.(b)
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.