Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.

Device Description

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device, specifically absorbable polydioxanone surgical sutures. The purpose of this document is to demonstrate that the new device, "Secret Line up / i-Thread," is substantially equivalent to existing legally marketed predicate devices.

1. A table of acceptance criteria and the reported device performance:

The document implicitly uses the performance of the predicate devices as its acceptance criteria and demonstrates that the subject device meets or is similar to these criteria through various tests. Explicit numerical acceptance criteria are not presented in a direct table with reported performance. However, the "Substantially Equivalent (SE) Comparison Chart" (page 6) serves this purpose by comparing various attributes of the subject device to the predicate device. All "SE" remarks indicate that the device meets the implied acceptance criteria.

Key performance tests and their outcomes (reported device performance):

Category	Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Subject Device)	Remark/Outcome
Product Code	NEW	NEW	SE
Regulation Number	21 CFR 878.4840	21 CFR 878.4840	SE
Class	II	II	SE
Sterilization method	E.O. sterilization (SAL: 1.0×10-6)	E.O. sterilization (SAL: 1.0×10-6)	SE
Stability time	2 years	2 years	SE
Suture material	Polydioxanone	Polydioxanone	SE
Configuration	PDO Suture and Needle (pre-loaded, hollow needle, not swaged)	PDO Suture and Needle (pre-loaded, hollow needle, not swaged)	SE
Suture Color	Dyed suture (violet)	Dyed suture (violet)	SE
Suture type	Cog (barb) type	Cog (barb) type	SE
Barb angle	2 - 45 degrees (Predicate)	50 - 80 degrees	Justified by barb holding performance test
Suture composition	Polydioxanone, Dyed with D&C Violet No.2	Polydioxanone, Dyed with D&C Violet No.2	SE
Needle Material	Stainless steel	Stainless steel	SE
Absorbable / Non-Absorbable	Absorbable	Absorbable	SE
Braided / Monofilament	Monofilament	Monofilament	SE
Barb Type	Bi-directional	Bi-directional	SE
Biocompatible	Yes	Yes	SE
Material of components that come into patient contact	Needle: Stainless steel; Suture: Polydioxanone	Needle: Stainless steel; Suture: Polydioxanone	SE
Anatomical Location	Soft tissue (Skin, Dermal or Sub-dermal tissue)	Soft tissue (Skin, Dermal or Sub-dermal tissue)	SE
Intended population	Adults population	Adults, but inappropriate for elderly population	SE
Performance Test conducted	Suture (Length, Diameter, Tensile strength, Barb-Holding, Needle attachment strength); Needle (Length, Outer diameter, Bending(elasticity), Flexural strength, Pulling out)	Same tests conducted	SE
Performance (Animal Testing)	In Vivo Biodegradation in Sprague-Dawley Rat - Barb Holding forces, Absorption and Residual Tensile Strength over time	In Vivo testing in Sprague-Dawley Rat - Absorption, Barb Holding force and Tensile Strength over time	SE
Performance testing result	Pass	Pass	SE
Single use	Yes	Yes	SE

Differences noted and justified:

Suture Size (USP): Predicate: 4-0, 3-0, 2-0, 0. Subject: 2-0, 2, 0. (Similar - predicate has more sizes but subject still equivalent).
Suture Length: Predicate: 90, 110, and 150 mm. Subject: 150, 160 mm. (Similar - predicate has various lengths but subject still equivalent).
Barb Angle: Predicate: 2 - 45 degrees. Subject: 50 - 80 degrees. (Justified by barb holding performance test).

The overall conclusion states: "Despite the differences, the test results submitted in this 510k show that the subject device is substantially equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device." (Page 7)

2. Sample size used for the test set and the data provenance:

The document references several performance tests, but it does not explicitly state the sample sizes used for each test. The tests include:

Bench Tests (Non-clinical):
- Suture measurements (Length, Diameter, Hub)
- Bending test
- Barb Holding strength
- Flexural test
- Pulling out (or) Extraction Test
- USP standards: Sutures Diameter (<861>), Sutures Needle Attachment (<871>), Sutures Tensile Strength (<881>).
- ASTM F1874-98 9 bending test.
Biocompatibility Tests (in vitro and in vivo):
- ISO 10993 series tests for various aspects (cytotoxicity, hemolysis, systemic toxicity, irritation, sensitization, local effects after implantation, genotoxicity).
- Ethylene Oxide Sterilization Results (ISO 10993-7, ISO 11135).
Animal Study (In Vivo):
- Biodegradability evaluation in Sprague-Dawley Rats.
- Comparing "absorption", "Tensile strength test" and "Barb holding strength test" over time.

Data Provenance: The document does not explicitly state the country of origin of the data. The studies and tests appear to be retrospective, conducted in support of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided within the document. The document describes laboratory and animal studies, not studies involving human experts establishing ground truth for a diagnostic interpretation.

4. Adjudication method for the test set:

This information is not applicable as the studies described are laboratory, animal, and biocompatibility tests, not studies requiring expert adjudication of results like image interpretation.

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 as the device is a surgical suture, not an AI-powered diagnostic device, and no MRMC studies are mentioned.

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

This information is not applicable as the device is a surgical suture, not an algorithm.

7. The type of ground truth used:

For the performance and biocompatibility studies, the "ground truth" is established by adherence to recognized international and FDA standards, and comparison to the performance of legally marketed predicate devices.

Bench Test Ground Truth: Defined by the specifications and performance characteristics of the predicate device, as well as established industry standards (USP, ASTM). The goal is to show the subject device performs similarly or within acceptable limits.
Biocompatibility Ground Truth: Defined by the requirements of the ISO 10993 series of standards, which assess the biological safety of medical devices.
Animal Study Ground Truth: The observed biological response in the Sprague-Dawley Rat model (absorption, tensile strength, barb holding strength) is compared against the expected performance based on the predicate device and established knowledge of polydioxanone sutures.

8. The sample size for the training set:

This information is not applicable as the device is a surgical suture, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 27, 2024

HyunDae MediTech Co., Ltd. Ju-In Oh Senior QA staff 80, Cheongjeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do 26347 Korea, South

Re: K240389

Trade/Device Name: Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable Polydioxanone Surgical Suture Regulatory Class: Class II Product Code: NEW Dated: January 30, 2024 Received: February 8, 2024

Dear Ju-In Oh:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Nils Potter Nils Potter -S 2024.03.27 - S 11:59:01 -04'00'

for Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240389

Device Name Secret Line up / i-Thread

Indications for Use (Describe)

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)

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Traditional 510(k) Summary

This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date 510k summary prepared:	February 19, 2024
-----------------------------	-------------------

I. SUBMITTER

Submitter's Name	Hyundae MediTech Co.,Ltd.
Submitter's Address	80, Cheongjeong-ro, Jijeong-myeon,
	Wonju-si, Gangwon-do, Republic of Korea
Submitter's Telephone	+82 (070) 4490-2602
Contact person	Gwang-jun, Park / Quality management dept General Manager
	qa@hyundaemed.co.kr
Telephone	+82-70-4490-2602
Fax:	+82-33-734-3065

II. DEVICE

Trade/proprietary Name	Secret Line up / i-Thread
Common or Usual Name	Absorbable polydioxanone suture with needle
Regulation Name	Absorbable Polydioxanone Suture with Needle
Regulation Number	21 CFR 878.4840 (Product Code: NEW)
Regulatory Class	Class II

III. PREDICATE DEVICE

Primary Manufacturer	Feeltech Co., Ltd.
Device Name	MiracuTM (MiracuTM barbed surgical suture)
510(k) Number	K172602
Regulation Name	Absorbable Polydioxanone Suture with Needle
Regulation Number	21 CFR 878.4840 (Product Code: NEW)
Regulatory Class	Class II

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Absorbable polydioxanone suture with needle

This predicate has not been subject to a design-related recall.

Exceptionally, the Reference Device for the largest needle size is K220549.

Manufacturer	Hans Biomed Corporation
Device Name	MINT TM FINE+ (MINT Product Family)
510(k) Number	K220549
Regulation Name	Polydioxanone absorbable surgical suture
Regulation Number	21 CFR 878.4840 (Product Code: NEW)
Regulatory Class	Class II

IV. DEVICE DESCRIPTION

Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.

V. INDICATIONS FOR USE

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VI. SUBTANTIALLY EQUIVALENT (SE) COMPARISON CHART:

Subject device is substantially equivalent to Miracu™ (K172602) and MINT (K220549). The following comparison table is presented to demonstrate substantial equivalence.

Category	Subject Device	Predicate Device	Remark
510(k) Number	K240389	K172602	Not applicable
Product Code	NEW	NEW	SE
Regulation Number	21 CFR 878.4840	21 CFR 878.4840	SE
Class	II	II	SE
Device Trade(Brand) Name	Secret Line and i-Thread(Absorbable polydioxanone suturewith needle)	MiracuTM(MiracuTM barbed surgical suture)	Not applicable
Common Name	Absorbable polydioxanone suturewith needle	Absorbable Polydioxanone Suturewith Needle	SE
Manufacturer	Hyundae MediTech Co.,Ltd.	Feeltech Co., Ltd.	Not applicable
Device description	Secret line up, i-Thread (Sterile singleuse absorbable polydioxanone suturewith needle) consist of a cannula typeneedle which is straight and hollow(pre-loaded on the suture), a needle cap,a hub, a sponge and polydioxanone(PDO) suture which is sterilized byethylene oxide (EO) gas. The pigmentfor the violet dye is D&C Violet No.2	MiracuTM synthetic barded surgicalabsorbable polydioxanone (PDO)suture with needle. The needle isstraight, hollow, cannula and is pre-loaded onto the suture. The pigmentfor the violet dye is D&C Violet No.2The MiracuTM is available sterile afterethylene oxide (EO) gas sterilizationand degrades or dissolves over time intissue.	Similar - As thesubject deviceand predicatedevice consist ofthe same suturematerial alongwith the needle
Indication for Use	Secret Line and i-Thread (Sterile singleuse absorbable polydioxanone suture)comprised of dyed polydioxanonesuture with a sterile needle. It isindicated for use in soft tissueapproximation where use of absorbablesuture is appropriate. This device is notintended for body cavity applications orlifting and supporting tissues and isintended for dermatological use only.	The MiracuTM barbed surgical sutureis comprised of dyed polydioxanone,is indicated for soft tissueapproximation where use of anabsorbable suture is appropriate.The anatomical location(s) of use areon the skin for dermatologicalapplications only. The suture is notintended for interior body cavityapplications and the suture is notintended for lifting and supportingtissues.	Similar - As thesubject deviceand predicatedevice have sameindication of usefor soft tissueapproximationand not intendedto be used forinterior bodycavity
Sterilization method	E.O. sterilization (SAL: 1.0×10-6)	E.O. sterilization (SAL: 1.0×10-6)	SE
Stability time	2 years	2 years	SE
Suture material	Polydioxanone	Polydioxanone	SE
Configuration	PDO Suture and Needle. The subjectdevice is pre-loaded with a hollowneedle and is not swaged.	PDO Suture and Needle. The subjectdevice is pre-loaded with a hollowneedle and is not swaged.	SE
Suture Color	Dyed suture (violet)	Dyed suture (violet)	SE
Suture Size (USP)	2-0, 2, 0	4-0, 3-0, 2-0, 0	Similar - As therange of suturesize for predicatedevice is morecompared tosubject device
Suture Length	150, 160 mm	90, 110, and 150 mm	Similar - As thepredicate devicehas variousranges of suturelengths comparedto subject device
Suture type	Cog (barb) type	Cog (barb) type	SE
Barb angle	50 - 80 degrees	2 - 45 degrees	This is justified bythe barb holdingperformance test
Suture composition	Polydioxanone,Dyed with D&C Violet No.2	Polydioxanone,Dyed with D&C Violet No.2	SE
Needle Material	Stainless steel	Stainless steel	SE
Absorbable /Non- Absorbable	Absorbable	Absorbable	SE
Braided /Monofilament	Monofilament	Monofilament	SE
Barb Type	Bi-directional	Bi-directional	SE
Biocompatible	Yes	Yes	SE
Material of componentsthat come into patientcontact	Needle: Stainless steelSuture: Polydioxanone	Needle: Stainless steelSuture: Polydioxanone	SE
Anatomical Location	Soft tissue(Skin, Dermal or Sub- dermal tissue)	Soft tissue(Skin, Dermal or Sub- dermal tissue)	SE
Intended population	Adults, but inappropriatefor elderly population	Adults population	SE
Performance Testconducted	Suture : Length, Diameter, Tensilestrength, Barb-Holding, Needleattachment strengthNeedle : Length, Outer diameter,Bending(elasticity), Flexural strength,Pulling outREFER: IX Bench Test Summary fortest results	Suture : Length, Diameter, Tensilestrength, Barb-Holding, Needleattachment strengthNeedle : Length, Outer diameter,Bending(elasticity), Flexural strength,Pulling outREFER: IX Bench Test Summary fortest results	SE
Performance(Animal Testing)	In Vivo testing in Sprague-Dawley Rat- Absorption, Barb Holding force andTensile Strength over time	In Vivo Biodegradation in Sprague-Dawley Rat - Barb Holding forces,Absorption and Residual TensileStrength over time	SE
Performance testingresult	Pass	Pass	SE
Single use	Yes	Yes	SE
Reusable component	N/A	N/A	SE
Nano technology	N/A	N/A	SE
Clinical test	Not required	Not required	SE

510(k) Summary page 3 / 6

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Absorbable polydioxanone suture with needle

Despite the differences, the test results submitted in this 510k show that the subject device is substantally equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device.

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VII. DESCRIPTION FOR DIFFERENCE

The Subject device has the same intended use as that of the predicate device. There are minor differences between the two devices where it is indicated "similar", in all other cases it is seen that the subject stays as "Substantial Equivalent" to that of the predicate device characteristics.

Few main differences observed from the above table are with respect to suture length and the performance test results. Despite these difference, it is witnessed from the test results submitted as part of 510(K) that the subject device is substantially equivalent to the predicate device in terms of safety and effectiveness and there is no difference in terms of intended clinical application. Additionally, the subject device is substantially equivalent to the capacity and function of the predicate device.

VIII. Performance Testing

Performance testing was conducted on the subject device to prove that all the design specifications are substantially equivalent to the predicate device. The test results of the subject device are demonstrated in accordance with the following FDA and international standards:

- FDA Guidance on Surgical Sutures Performance Criteria for Safety and Performance Based Pathway"
- Surgical Sutures Class II Special Controls Guidance Document for Industry and FDA Staff
- USP 43-NF38 <861> Sutures Diameter
- USP 43-NF38 <871> Sutures Needle Attachment
- USP 43-NF38 <881> Sutures Tensile Strength
- USP 37-NF 32: 2014 Dimension test
- ASTM F1874-98 9 bending test

ISO 10993-1:2020, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process

- ISO 10993-7:2008, Biological Evaluation of Medical Devices Part 7: Ethylene Oxide Sterlization Results
- ISO 11135:2014, Sterilization of Healthcare Products Ethylene oxide Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
- ISO 10993:2009, Biological Evaluation of medical devices Part 5: Test for in vitro cytotoxicity
- ISO 10993:2017, Biological Evaluation of medical devices Part 4: Selection of Test for Interaction with Blood, Annex D.5 Hemolysis Testing
- ISO 10993:2017, Biological Evaluation of medical devices Part 11: Test for systemic Toxicity, Annex G -Information on material mediated pyrogens
- ISO 10993:2021, Biological Evaluation of medical devices Part 23: Tests for Irritation, 7.3 Animal Irritation test by Intracutaneous (Intradermal) administration
- ISO 10993:2010, Biological Evaluation of medical devices Part 10: Test for Irritation and Skin Sensitization, 7.5 Guinea Pig Maximization Test
- ISO 10993:2021, Biological Evaluation of medical devices Part 12: Sample preparation and reference materials
- ISO 10993:2016, Biological Evaluation of medical devices Part 6: Test for local effects after implantation
- ISO 10993:2014, Biological Evaluation of medical devices Part 3: Test for Genotoxicity, Carcinogenicity and Reproductive toxicity, 5. Genotoxicity test
- ISO 14971:2019, Medical Devices Risk Management for Medical Devices.

Furthermore, the following non-clinical bench tests were performed on the subject device:

- Measurement (Outside diameter, Length, hub)
- Bending test
- Barb Holding strength
- Flexural test
- Pulling out (or) Extraction Test

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IX. Animal Studies

The purpose of the in vivo study is to evaluate the biodegradability of the Sterile Single Use Absorbable Polydioxanone Suture by comparing the two models in "absorption", "Tensile strength test" and "Barb holding strength test" by the time.

Clinical studies X.

As per the Guidance document "Surgical Sutures - Class II Special Controls Guidance Document for Industry and FDA Staff', no Clinical Studies were performed nor required.

XI. Summary

Based on the indications for use and safety and performance testing, the subject device meets the requirements that are considered for its intended use and is substantially equivalent in design materials, sterilization, and indications for use. The conclusions drawn from the non-clinical and biocompatibility test reports to demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the legally marketed device.

Regulation Number and Section

§ 878.4840 Absorbable polydioxanone surgical suture.

(a)
Identification. An absorbable polydioxanone surgical suture is an absorbable, flexible, sterile, monofilament thread prepared from polyester polymer poly (p-dioxanone) and is intended for use in soft tissue approximation, including pediatric cardiovascular tissue where growth is expected to occur, and ophthalmic surgery. It may be coated or uncoated, undyed or dyed, and with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for the 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.