K Number

Device Name

REXMONO, PDREX

Manufacturer

SM ENG CO., LTD

Date Cleared

2018-03-12

(90 days)

Product Code

GAM NEW

Regulation Number

878.4493

Intended 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. 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K142810, K073614

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes surgical sutures and their physical properties and testing, with no mention of AI or ML.

Therapeutic

Yes.
The device is a surgical suture used for soft tissue approximation and/or ligation, which is a therapeutic intervention to repair or support tissues.

Diagnostic

The device, REXMONO and PDREX, are surgical sutures used for soft tissue approximation and ligation, which are therapeutic and restorative functions, not diagnostic ones.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical medical device composed of absorbable monofilament suture and a stainless steel needle. It also describes manufacturing processes involving cutting, adhesion of needle and thread, winding, and sterilization.

IVD (In Vitro Diagnostic)

Based on the provided text, these devices (REXMONO and PDREX) are not In Vitro Diagnostic (IVD) devices.

Here's why:

Intended Use: The intended use of both REXMONO and PDREX is for soft tissue approximation and/or ligation during surgical procedures. This is a direct intervention on the body, not a test performed on samples taken from the body to diagnose a condition.
Device Description: The description details the materials and manufacturing process of surgical sutures, which are used to physically close wounds or tie off blood vessels. This aligns with surgical tools, not diagnostic tests.
Lack of Diagnostic Function: There is no mention of these devices being used to analyze biological samples (like blood, urine, tissue) or to provide information for the diagnosis of a disease or condition.
Performance Studies: The performance studies described are bench tests evaluating physical properties of the sutures (diameter, tensile strength, needle attachment, absorption rate) and biocompatibility, which are relevant for surgical implants/devices, not diagnostic tests.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. REXMONO and PDREX are clearly intended for in vivo (within the body) use during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes

GAM, NEW

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 SIZE DESIGNATION	MAXIMUM OVERSIZE (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.

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.

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 SIZE DESIGNATION	MAXIMUM OVERSIZE (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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

general soft tissue, ophthalmic procedures, cardiovascular tissue, neural tissue, adult cardiovascular tissue, microsurgery

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 SUTURES - DIAMETER
USP SUTURES - NEEDLE ATTACHMENT
USP 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K142810, K073614

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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);

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

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)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

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

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

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.

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

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 SIZE
DESIGNATION | MAXIMUM
OVERSIZE
(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.

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

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 SIZE
DESIGNATION | MAXIMUM
OVERSIZE
(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 |

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)

USP SUTURES - DIAMETER USP SUTURES - NEEDLE ATTACHMENT USP 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

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	Proposed
device:
REXMONO	Predicate
device:
WEGO-PGCL
Absorbable
Surgical
Monofilament
Suture	Property	Proposed
device:
PDREX	Predicate
device:
WG-Surgical
Sutures with
Needle
510(k)
Number	K173779	K142810	510(k)
Number	K173779	K073614
Product
Code	GAM	Same	Product
Code	NEW	Same
Indications
for use
statements	REXMONO is
indicated for
use in general
soft tissue
approximation
and/or
ligation,
including use
in ophthalmic
procedures,
but not for use
in
cardiovascula
r or neural
tissue	Same. The
WEGO-PGCL
Absorbable
Surgical
Monofilament
Suture is
indicated for
use in general
soft tissue
approximation
and/or, but not
for use in
cardiovascula
r or
neurological
procedure	indications
for use
statements	PDREX is
indicated for
use in general
soft tissue
approximation
and/or
ligation,
including use
in ophthalmic
procedures,
but not for use
in
cardiovascula
r or neural
tissue	Absorbable
Polydioxanon
e Suture with
Needle is
indicated for
use in all
types of soft
tissue
approximation
, including
use in
cardiovascula
r tissue where
growth is
expected to
occur, PDO
suture is not
indicated in
adult
cardiovascula
r tissue,
					microsurgery,
ophthalmic
and neural
tissue.
Class	II	Same	Class	II	Same
Sterile	Yes	Same	Sterile	Yes	Same
Single Use	Yes	Same	Single Use	Yes	Same
Configuratio
n	PGA-PCL
Suture and
Needle	Same	Configuratio
n	Polydioxanon
e Suture and
Needle	Same
Suture
Material	Poly(glycolide
-co-
caprolactone))
copolymer	Same	Material	Poly (p-
dioxanone)	Same
Coating
material	None	Same	Coating
material	None	None
Color	Undyed
(natural) and
dyed (D&C
Violet No.2)	Same	Color	Dyed (D&C
Violet No.2).	Violet or
Undyed
Absorbable/
Nonabsorba
ble	Absorbable	Same	Absorbable/
Nonabsorba
ble	Absorbable	Absorbable
Braided/Mon
ofilament	Monofilament	Same	Braided/Mon
ofilament	Monofilament	Monofilament
Barbed/Not
Barbed	Not Barbed	Same	Barbed/Not
Barbed	Not Barbed	Same
Suture Size	The proposed
device is
available in 6-
0, 5-0, 4-0,3-
0,2-0, 0, 1
and 2, which
are the sizes
identified in
the currently
recognized
United States
Pharmacopoe
ia.
Sutures are
U.S.P. except
for diameters.
All suture
sizes are
oversized	Similar. The
proposed
device is
available in 6-
0, 5-0, 4-0,3-
0,2-0, 0, and
1, which are
the sizes
identified in
the currently
recognized
United States
Pharmacopoe
ia.
Sutures are
U.S.P. except
for diameters.
All suture
sizes are over
sized	Suture Size	The proposed
device is
available in 7-
0, 6-0,5-0, 4-
0,3-0,2-0, 0, 1
and 2, which
are the sizes
identified in
the currently
recognized
United States
Pharmacopoe
ia.
Sutures are
U.S.P. except
for diameters.
All suture
sizes are
oversized	Same
Length of
Suture	30, 45, 50, 60,
70, 75, 90,
150, 250cm	30cm, 45cm,
60cm, 75cm,
90cm, 100cm,
120cm,
150cm,
180cm,
200cm,
250cm,
280cm,
300cm,
320cm.
360cm and
390cm	Length of
Suture	20, 23, 30, 35,
45, 60, 70, 75,
90, 150cm	Not known
Diameter of
Suture	Oversize	Oversize	Diameter of
Suture	Oversize	Same
Tensile
strength	The tensile
strengths of
proposed
device comply	Same	Tensile
strength	The tensile
strengths of
proposed
device comply	Same
	with the
tensile
requirement
listed in USP
Tensile
Strength			with the
tensile
requirement
listed in USP
Tensile
Strength
Needle
Attachment	The bond
between
suture and
needle of the
applicant
device meet
the
requirements
defined in
USP .	Same	Needle
Attachment	The bond
between
suture and
needle of the
applicant
device meet
the
requirements
defined in
USP .	Same
Needle
Material	Stainless
Steel	Same	Material	Stainless
Steel	Same
Needle type	Taper point,
Reverse
Cutting,
Conventional
cutting, Taper
cutting,
Spatula, Blunt
point	Similar. Taper,
Cutting, Blunt	Needle type	Taper point,
Reverse
Cutting,
Conventional
cutting, Taper
cutting,
Spatula, Blunt
point	Similar. Not
known
Biocompatibi
lity	Comply with
ISO 10993-5
and ISO
10993-10	Same	Biocompatibi
lity	Comply with
ISO 10993-5
and ISO
10993-10	Same

Table. Comparison of Technology Characteristics

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.

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

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.