(378 days)
REXLENE 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.
REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.
REXLENE 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 blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1
The provided text is a 510(k) Premarket Notification from the FDA for a surgical suture device named REXLENE. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of AI or software performance metrics.
Instead, the document focuses on demonstrating that the REXLENE suture is "substantially equivalent" to already legally marketed predicate devices, primarily WG-Surgical Sutures with Needle (K080684) and PROLENE™ Polypropylene Nonabsorbable Suture (K133356). The "acceptance criteria" referred to in this document are compliance with established regulatory standards for surgical sutures.
Here's a breakdown of the information that is available, reframed to address your request as much as possible, and highlighting what is not present:
1. A table of acceptance criteria and the reported device performance:
The document outlines compliance with specific USP (United States Pharmacopoeia) and ISO standards for surgical sutures as the "acceptance criteria" for the REXLENE device, and states that the device meets these.
| Acceptance Criteria (Standard) | Reported Device Performance (REXLENE) |
|---|---|
| USP <861> SUTURES - DIAMETER | Complies with the diameter requirement |
| USP <871> SUTURES - NEEDLE ATTACHMENT | Meet the requirements defined in USP <871> |
| USP <881> TENSILE STRENGTH | Complies with the tensile requirement listed in USP <881> Tensile Strength |
| USP Nonabsorbable Surgical Suture | Conforms to USP requirements for nonabsorbable sutures and are stable over the proposed shelf life. |
| Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA | Complies with the standard. |
| ISO 10993-5: Test for Cytotoxicity | Biocompatible and suitable to use as medical device. |
| ISO 10993-10: Test for Irritation and Sensitization | Biocompatible and suitable to use as medical device. |
| ISO 10993-11: Test for Systemic Toxicity | Biocompatible and suitable to use as medical device. |
| ISO 10993-3: Tests for Genotoxicity | Biocompatible and suitable to use as medical device. |
| ISO 10993-6: Test for Local Effects after Implantation | Biocompatible and suitable to use as medical device. |
| ISO 10993-4: Selection of Tests for Interaction with Blood | Biocompatible and suitable to use as medical device. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Non clinical tests were conducted," but does not detail the sample sizes for these tests, or the specific provenance of any data beyond the manufacturer being in Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and not provided. The device is a surgical suture, not a diagnostic imaging device or AI-driven system that would require expert consensus for ground truth establishment. The "ground truth" here is compliance with scientific and regulatory standards as measured through laboratory testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for AI/CAD devices. This document deals with laboratory testing against physical and biological standards.
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 information is not applicable and not provided. REXLENE is a surgical suture, not an AI or CAD (Computer-Aided Detection) system. MRMC studies are used to evaluate the performance of diagnostic tools (often involving AI) with human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. REXLENE is a physical medical device (suture), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is defined by the specifications and requirements set forth in the US Pharmacopoeia (USP) and ISO 10993 standards. For example, the device must meet specific diameter ranges as defined in USP <861>.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are relevant for AI/machine learning models, which this device is not.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
In summary, the provided document is a regulatory submission for a surgical suture and outlines its compliance with established physical and biological standards. It does not describe an AI or software device and therefore lacks the information requested regarding AI acceptance criteria, study design, expert involvement, or data sets for AI development.
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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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2018
Sm Eng Co., Ltd % Sanglok Lee Manager Wise Company Inc. #1005, 11-19, Gamasan-ro 27a-gil Guro-gu, 08301 Kr
Re: K173747
Trade/Device Name: Rexlene Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: September 1, 2018 Received: September 19, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
Digitally signed by David David Krause -S Date: 2018.12.21 12:36:59
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)
Device Name REXLENE
Indications for Use (Describe)
REXLENE 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/4/Picture/1 description: The image shows the text "WISE COMPANY Inc." in a serif font. The text is a light tan color. The words are all capitalized, except for the "c" in "Inc."
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
Image /page/4/Picture/4 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, there is text in Korean that says "와이즈컴퍼니(주)".
510(k) Summary
The assigned 510(k) Number: K173747
01. Date of Submission: December 14, 2017
02. Applicant
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
03. 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
04. Proposed Device Identification
Proprietary Name: REXLENE Common Name: Synthetic Nonabsorbable Polypropylene Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5010 Product Code: GAW Regulation Description: Nonabsorbable polypropylene surgical suture
05. Indication for use
REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in tophthalmic procedures, but not for use in cardiovascular or neural tissue.
06. Predicate devices
-Primary Predicate Device 510(k) Number: K080684 Device Name: , WG-Surgical Sutures with Needle Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD
-Reference Predicate Device
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Image /page/5/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo features a stylized "W" that is formed by a line that resembles a heartbeat. Below the symbol is the text "WISE COMPANY Inc." and below that is the text "와이즈컴퍼니(주)".
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
510(k) Number: K133356
Device Name: PROLENETM Polypropylene Nonabsorbable Suture Manufacturer: ETHICON, Inc
07. Device Description
REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.
REXLENE 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 blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1
08. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
USP <861> SUTURES - DIAMETER
USP <871> SUTURES - NEEDLE ATTACHMENT
USP <881> TENSILE STRENGTH
USP Nonabsorbable Surgical Suture
Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.
Real-time and accelerated aging stability testing was performed to support shelf life of REXLENE. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures and are stable over the proposed shelf life.
Raw suture of REXLON were evaluated in accordance with ISO 10993 standards below, they are biocompatible and suitable to use as medical device.
ISO 10993, Biological Evaluation of Medical Devices Including:
- 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
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Image /page/6/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 company name, the Korean translation "와이즈컴퍼니(주)" is written.
#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
09. Summary of Technological characteristic of subject and predicate devices.
| Property | Subject deviceREXLENE | Primary PredicateDeviceWG-Surgical Sutureswith Needle | Reference PredicateDevicePROLENETMPolypropyleneNonabsorbable Suture | Suture | |||||
|---|---|---|---|---|---|---|---|---|---|
| 510(k) Number | K173747 | K080684 | K133356 | Material | Polypropylene | Polypropylene | Polypropylene | ||
| Product Code | GAW | Same | Same | Coating | uncoated | same | same | ||
| Regulation No, | 21 C.F.R. 878.5010 | Same | Same | Color | Blue dyed | same | same | ||
| Class | II | Same | Same | Absorbable/Nonabsorbable | Nonabsorbable | same | same | ||
| Sterile | Yes | Same | Same | Braided/Monofilament | Monofilament | same | same | ||
| Single Use | Yes | Same | Same | Suture Size | The proposed device isavailable in 8-0 through1, which are the sizesidentified in thecurrently recognizedUnited StatesPharmacopoeia. | Available suture sizes(USP 10-0 ~ USP 2) arestandard according toUSP requirements | Available suture (USP10-0 ~ USP 2) sizes arestandard according toUSP requirementsexcept for USP size 7-0 | ||
| Indications for usestatements | REXLENE is indicatedfor use in general softtissue approximationand/or ligation,including use inophthalmic procedures,but not for use incardiovascular or neuraltissue | NonabsorbablePolypropylene Suturewith Needle is indicatedfor use in general softtissue approximationand/or ligation includinguse in cardiovascular,ophthalmic andneurologicalprocedures. | PROLENETM suture isindicated for use ingeneral soft tissueapproximation and/orligation, including use incardiovascular,ophthalmic andneurologicalprocedures. | Length of Suture | 13, 15, 45, 50, 60, 70,75, 90, 100, 120, 180cm | Unknown | Unknown | ||
| Configuration | Polypropylene Sutureand Needle | Same | Same | Diameter of Suture | The suture diameters ofproposed device complywith the diameterrequirement listed inUSP <861> Diameter. | same | Meet the requirementsdefined in the USPexcept for USP size 7-0 | ||
| Tensile strength | The tensile strengths ofproposed device complywith the tensilerequirement listed inUSP <881> TensileStrength | same | Meet the requirementsdefined in the USPexcept for USP size 7-0 |
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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 is the text "WISE COMPANY Inc." in a simple sans-serif font. Underneath the English text is the Korean translation, "와이즈컴퍼니(주)".
#1005, 11–19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
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Image /page/8/Picture/1 description: The image shows the logo for WISE COMPANY Inc. The logo consists of a stylized "W" shape above the company name. Below the English name is the Korean translation of the company name, "와이즈컴퍼니(주)".
#1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Republic of Korea Tel: +82 2 831 3615
| Needle Attachment | The bond betweensuture and needle ofthe applicant devicemeet the requirementsdefined in USP <871>. | same | Meet the requirementsdefined in the USPexcept for USP size 7-0 |
|---|---|---|---|
| Sterilization method | Ethylene oxide gassterilization | same | same |
| Needle | |||
| Material | Stainless Steel | Same | same |
| Indication for use | Disposable suturingneedle | Same | Same |
| Needle Tip Geometry(Needle type) | Taper point, Tapper cutSpatula, Reversecutting, | Same.Taper pointTapper cutConventional cuttingReverse CuttingExtra-Sharp cuttingBluntSpatula | Same.Based on Ethicon'scatalog, they provideATRALOC needles tosurgeons. Surgeonselect type of needlethat, in their experience,is appropriate for thespecific procedure andNeedle shapes aregenerally classifiedaccording to the degreeof curvature of the bodyand needle type- 1/2, 3/8, 1/4, 5/8,straight- Tapper point, Bluntpoint, Conventionalcutting, ReverseCutting, Spatula, Micropoint |
| Circle (Shape) | 1/2, 3/8, straight | Same.1/2, 3/8, 1/4, 5/8,Straight, Ski Needle,Compound curve | - 1/2, 3/8, 1/4, 5/8,straight- Tapper point, Bluntpoint, Conventionalcutting, ReverseCutting, Spatula, Micropoint |
10. Substantially Equivalent Conclusion
The proposed device, REXLENE is determined to be Substantially Equivalent (SE) to the predicate devices in respect of safety and effectiveness.
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene 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 undyed or dyed with an FDA approved color additive; and 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.