REXMONO, PDREX

K173779 · Sm Eng Co., Ltd. · GAM · Mar 12, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173779
• Device Name: REXMONO, PDREX
• Applicant: Sm Eng Co., Ltd.
• Product Code: GAM · General, Plastic Surgery
• Decision Date: Mar 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

REXMONO and PDREX are synthetic absorbable monofilament surgical sutures provided with or without stainless steel (SUS 304) needles. REXMONO is composed of poly(glycolide-co-caprolactone); PDREX is composed of polydioxanone. Devices are supplied sterile for single use. Sutures are used by surgeons for soft tissue approximation and ligation. The device provides mechanical support to tissue during the healing process until the suture is absorbed by the body. REXMONO retains 68-78% tensile strength after 1 week, with complete absorption in 90-110 days. PDREX retains 50-60% tensile strength after 6 weeks, with complete absorption in 180-210 days. Clinical benefit is the secure approximation of soft tissues during surgical procedures.

Clinical Evidence

Bench testing only. No clinical data. Testing included USP <861> (diameter), USP <871> (needle attachment), USP <881> (tensile strength), and USP monograph requirements for absorbable sutures. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, implantation, blood interaction). Sterile barrier system validated per ISO 11607-1/2 and ASTM F88/F1929. Accelerated aging stability tested per ASTM F1980.

Technological Characteristics

Materials: REXMONO (poly(glycolide-co-caprolactone)), PDREX (polydioxanone), Needle (SUS 304 stainless steel). Monofilament structure. Absorbable. Sterile. Single-use. Dimensions: various USP sizes (oversized). Tensile strength and needle attachment meet USP standards. Biocompatibility per ISO 10993.

Indications for Use

Indicated for general soft tissue approximation/ligation. REXMONO: includes ophthalmic; excludes cardiovascular/neural. PDREX: includes cardiovascular where growth expected; excludes adult cardiovascular, microsurgery, ophthalmic, and neural.

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-PGCL Absorbable Surgical Monofilament Suture (K142810)
• WG-Surgical Sutures with Needle (K073614)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health 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 ([e-mail]) or phone [phone] 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.

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.

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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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: [phone] [e-mail]

# 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: [phone] FAX: [phone] Email: [e-mail]

Establishment Registration Number: 3008912461

### ● 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]

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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: [phone] [e-mail]

### 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

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.

### 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: [phone] [e-mail]

### · 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.<br>SUTURE SIZE<br>DESIGNATION | MAXIMUM<br>OVERSIZE<br>(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: [phone] [e-mail]

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.<br>SUTURE SIZE<br>DESIGNATION | MAXIMUM<br>OVERSIZE<br>(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: [phone] [e-mail]

### ● 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
- 2) 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: [phone] [e-mail]

1

### ● 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<br>device:<br>REXMONO | Predicate<br>device:<br>WEGO-PGCL<br>Absorbable<br>Surgical<br>Monofilament<br>Suture | Property | Proposed<br>device:<br>PDREX | Predicate<br>device:<br>WG-Surgical<br>Sutures with<br>Needle |
| 510(k)<br>Number | K173779 | K142810 | 510(k)<br>Number | K173779 | K073614 |
| Product<br>Code | GAM | Same | Product<br>Code | NEW | Same |
| Indications<br>for use<br>statements | REXMONO is<br>indicated for<br>use in general<br>soft tissue<br>approximation<br>and/or<br>ligation,<br>including use<br>in ophthalmic<br>procedures,<br>but not for use<br>in<br>cardiovascula<br>r or neural<br>tissue | Same. The<br>WEGO-PGCL<br>Absorbable<br>Surgical<br>Monofilament<br>Suture is<br>indicated for<br>use in general<br>soft tissue<br>approximation<br>and/or, but not<br>for use in<br>cardiovascula<br>r or<br>neurological<br>procedure | indications<br>for use<br>statements | PDREX is<br>indicated for<br>use in general<br>soft tissue<br>approximation<br>and/or<br>ligation,<br>including use<br>in ophthalmic<br>procedures,<br>but not for use<br>in<br>cardiovascula<br>r or neural<br>tissue | Absorbable<br>Polydioxanon<br>e Suture with<br>Needle is<br>indicated for<br>use in all<br>types of soft<br>tissue<br>approximation<br>, including<br>use in<br>cardiovascula<br>r tissue where<br>growth is<br>expected to<br>occur, PDO<br>suture is not<br>indicated in<br>adult<br>cardiovascula<br>r tissue, |
| | | | | | microsurgery,<br>ophthalmic<br>and neural<br>tissue. |
| Class | II | Same | Class | II | Same |
| Sterile | Yes | Same | Sterile | Yes | Same |
| Single Use | Yes | Same | Single Use | Yes | Same |
| Configuratio<br>n | PGA-PCL<br>Suture and<br>Needle | Same | Configuratio<br>n | Polydioxanon<br>e Suture and<br>Needle | Same |
| Suture | | | | | |
| Material | Poly(glycolide<br>-co-<br>caprolactone))<br>copolymer | Same | Material | Poly (p-<br>dioxanone) | Same |
| Coating<br>material | None | Same | Coating<br>material | None | None |
| Color | Undyed<br>(natural) and<br>dyed (D&C<br>Violet No.2) | Same | Color | Dyed (D&C<br>Violet No.2). | Violet or<br>Undyed |
| Absorbable/<br>Nonabsorba<br>ble | Absorbable | Same | Absorbable/<br>Nonabsorba<br>ble | Absorbable | Absorbable |
| Braided/Mon<br>ofilament | Monofilament | Same | Braided/Mon<br>ofilament | Monofilament | Monofilament |
| Barbed/Not<br>Barbed | Not Barbed | Same | Barbed/Not<br>Barbed | Not Barbed | Same |
| Suture Size | The proposed<br>device is<br>available in 6-<br>0, 5-0, 4-0,3-<br>0,2-0, 0, 1<br>and 2, which<br>are the sizes<br>identified in<br>the currently<br>recognized<br>United States<br>Pharmacopoe<br>ia.<br>Sutures are<br>U.S.P. except<br>for diameters.<br>All suture<br>sizes are<br>oversized | Similar. The<br>proposed<br>device is<br>available in 6-<br>0, 5-0, 4-0,3-<br>0,2-0, 0, and<br>1, which are<br>the sizes<br>identified in<br>the currently<br>recognized<br>United States<br>Pharmacopoe<br>ia.<br>Sutures are<br>U.S.P. except<br>for diameters.<br>All suture<br>sizes are over<br>sized | Suture Size | The proposed<br>device is<br>available in 7-<br>0, 6-0,5-0, 4-<br>0,3-0,2-0, 0, 1<br>and 2, which<br>are the sizes<br>identified in<br>the currently<br>recognized<br>United States<br>Pharmacopoe<br>ia.<br>Sutures are<br>U.S.P. except<br>for diameters.<br>All suture<br>sizes are<br>oversized | Same |
| Length of<br>Suture | 30, 45, 50, 60,<br>70, 75, 90,<br>150, 250cm | 30cm, 45cm,<br>60cm, 75cm,<br>90cm, 100cm,<br>120cm,<br>150cm,<br>180cm,<br>200cm,<br>250cm,<br>280cm,<br>300cm,<br>320cm.<br>360cm and<br>390cm | Length of<br>Suture | 20, 23, 30, 35,<br>45, 60, 70, 75,<br>90, 150cm | Not known |
| Diameter of<br>Suture | Oversize | Oversize | Diameter of<br>Suture | Oversize | Same |
| Tensile<br>strength | The tensile<br>strengths of<br>proposed<br>device comply | Same | Tensile<br>strength | The tensile<br>strengths of<br>proposed<br>device comply | Same |
| | with the<br>tensile<br>requirement<br>listed in USP<br><881> Tensile<br>Strength | | | with the<br>tensile<br>requirement<br>listed in USP<br><881> Tensile<br>Strength | |
| Needle<br>Attachment | The bond<br>between<br>suture and<br>needle of the<br>applicant<br>device meet<br>the<br>requirements<br>defined in<br>USP <871>. | Same | Needle<br>Attachment | The bond<br>between<br>suture and<br>needle of the<br>applicant<br>device meet<br>the<br>requirements<br>defined in<br>USP <871>. | Same |
| Needle | | | | | |
| Material | Stainless<br>Steel | Same | Material | Stainless<br>Steel | Same |
| Needle type | Taper point,<br>Reverse<br>Cutting,<br>Conventional<br>cutting, Taper<br>cutting,<br>Spatula, Blunt<br>point | Similar. Taper,<br>Cutting, Blunt | Needle type | Taper point,<br>Reverse<br>Cutting,<br>Conventional<br>cutting, Taper<br>cutting,<br>Spatula, Blunt<br>point | Similar. Not<br>known |
| Biocompatibi<br>lity | Comply with<br>ISO 10993-5<br>and ISO<br>10993-10 | Same | Biocompatibi<br>lity | Comply with<br>ISO 10993-5<br>and ISO<br>10993-10 | 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: [phone] [e-mail]

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.

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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: [phone] [e-mail]

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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: [phone] [e-mail]

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