The MINT™ synthetic absorbable PDO suture is made of polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment for the violet dye is D&C Violet No.2. The MINT™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The MINTM Synthetic Absorbable PDO suture approximate tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues.

While the formation of barbs in the MINT™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the MINT™ can be compared with USP knot strength of non-barbed sutures and the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0.

AI/ML Overview

The provided text for the MINT™ 510(k) submission (K130191) describes the device, its intended use, and its substantial equivalence to predicate devices, but does not include a study proving device performance against acceptance criteria in the way a clinical trial or algorithm performance study would.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Quill™ Self-Retaining System) based on similar materials, design features (bi-directional barbs), and intended use. The "Safety and performance" section mentions types of testing performed but does not provide specific performance data or acceptance criteria for those tests.

Therefore, for many of the requested points, the information is not available in the provided text, as this document is a summary for a 510(k) submission, not a detailed study report.

Here's a breakdown of the available and unavailable information based on your request:

Acceptance Criteria and Device Performance Study (K130191 - MINT™ Suture)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Material Composition	Made of polydioxanone (PDO)	"The MINT™ synthetic absorbable PDO suture is made of polydioxanone"
Bi-directional Barbs	Has bi-directional barbs	"Each dyed (violet) suture has bi-directional barbs..."
Absorption Profile	Degrades or dissolves over time	"degrades or dissolves over time in tissue."
Sterility	Sterile after ethylene oxide (EO) gas sterilization	"The MINT™ is available sterile after ethylene oxide (EO) gas sterilization"
Biocompatibility	Nonantigenic, slight tissue reaction	"has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption."
Tensile Strength	USP size 1, tensile strength equivalent to USP 2-0.	"...the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0."
Intended Use	Soft tissue approximation where absorbable sutures are appropriate.	"The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate."
Safety and Performance Testing	Per FDA's Class II Special Controls Guidance Document: Surgical Sutures, including: - USP monograph for absorbable sutures - In vitro and in vivo resorption testing - Biocompatibility testing per ISO 10993 - Barb holding strength evaluation	Document states these tests were performed but does not provide specific numerical acceptance criteria or performance results. The conclusion is that it is "substantially equivalent" to predicate devices, implying it met the necessary performance standards to demonstrate this equivalence.

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

Not available: The document does not describe a "test set" in the context of a clinical performance study with a distinct sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a series of physical and biological tests for the device itself rather than patient data.

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

Not applicable/Not available: Ground truth is not established in the context of a "test set" for diagnostic performance. The document describes product characteristic testing, not a study requiring expert-derived ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not available: No adjudication method is mentioned as there is no "test set" requiring it.

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

Not applicable/Not available: This device is an absorbable surgical suture, not an AI-powered diagnostic or decision support tool. An MRMC study is not relevant to its type of evaluation.

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

Not applicable/Not available: This is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not available: As this is a medical device (suture) and not an AI/diagnostic tool, the concept of "ground truth" as typically defined for such studies is not directly applicable. The "truth" in this context is adherence to physical, chemical, and biological standards (e.g., USP monographs, ISO 10993).

8. The sample size for the training set

Not applicable/Not available: There is no "training set" as this is not an AI/machine learning device.

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

Not applicable/Not available: No training set exists.

Summary of Study (as described in the 510(k) Summary):

The "study" described in the provided text is primarily a demonstration of substantial equivalence to existing predicate devices (Quill™ Self-Retaining System and Quill™ Synthetic Absorbable Barbed Suture). This is a regulatory pathway for medical devices where a new device can be marketed if it is shown to be as safe and effective as a legally marketed device that does not require premarket approval (PMA).

The evidence for this substantial equivalence included:

Material Comparison: The MINT™ is made of the same material (Polydioxanone, PDO) as the predicate.
Design Comparison: Both the MINT™ and the predicate have bi-directional barbs. The submission notes a difference in barb size and spacing but implies this does not alter substantial equivalence.
Intended Use Comparison: Both devices share the same indication for use: "soft tissue approximation where use of an absorbable suture is appropriate."
Safety and Performance Testing: The submission states that various tests were performed in accordance with FDA guidance and USP monographs, including:
- USP monograph for absorbable sutures (physical properties like tensile strength).
- In vitro and in vivo resorption testing (how it degrades).
- Biocompatibility testing as per ISO 10993 (tissue reaction, toxicity).
- Barb holding strength evaluation.

The conclusion of the submission is that "the MINT™ is substantially equivalent to predicate device as described herein" based on these comparisons and the implied successful completion of the performance tests. The document does not provide the detailed results or specific acceptance criteria for each of these performance tests, as is common in a 510(k) summary which focuses on the overall conclusion of equivalence.

Summary

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K130191 Page 1/2

510(k) Submission

Mint™

510(K) SUMMARY

JUN 1 2 2013

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

Submitter:

Ho Chan Hwang HansBiomed Corporation. 461-37, Jeonmin-dong, Yuseong-gu, Daejeon, 305-811, Korea Phone: 82-2-466-2266 Fax: 82-2-463-1554

Contact /US agent: April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116

Date Prepared: 4/19/2013

Device Name: MINTTM

Trade Name: MINT™ Classification Name: Suture, Surgical, Absorbable, Polydioxanone Common Name: Absorbable polydioxanone surgical suture Classification: Class II Product Code: NEW Regulation number: 21 CFR 878.4840

General description

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510(k) Submission

Intended uses

The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

Predicate device

Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone), Angiotech . (Quill Medical, Inc) (K080985)
. Quill™ Synthetic Absorbable Barbed Suture, Angiotech (Quill Medical, Inc) (K042075)

Safety and performance

Testing was performed per FDA's Class II Special Controls Guidance Document: Surgical Sutures, including testing in accordance with the USP monograph for absorbable sutures, in vitro and in vivo resorption testing, biocompatibility testing in accordance with ISO 10993, and a barb holding strength evaluation.

Substantial equivalence summary

The MINT™ has a substantially equivalent intended use as the identified predicate, Quill™ Self-Retaining System (SRS) comprised of PDO (Polydioxanone) manufactured by Angiotech and is made of polydioxanone intended for soft tissue approximation. The subject and predicate devices are composed of the same material (PDO), have bi-directional barbs, and have the same indications for use. The subject device differs from the predicate with respect to barb size and spacing.

Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification Quill™ Self-Retaining System (SRS) comprised of PDO(Polydioxanone) (K080985) concludes that the MINT™ is substantially equivalent to predicate device as described herein.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing a bird or eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 12, 2013

HansBiomed Corporation % KoDent, Inc. Ms. April Lee 325 N. Puente Street, Unit B Brea, California 92821

Re: K130191

Trade/Device Name: MINT™ Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: May 08, 2013 Received: May 10, 2013

Dear Ms. 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

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Page 2 - Ms. April Lee

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

David Kraiuse -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and "Radiological Health"

Enclosure

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5. INDICATIONS FOR USE

510(k) Number (if known): K130191 Device Name: MINT™

Indications for Use:

The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of an absorbable suture is appropriate.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130191

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.