Y . JACOBS YOUNG'S THREAD synthetic absorbable PDO suture is made of polydioxanone. The pigment for the violet dye is D&C Violet No.2. It degrades and dissolves over time in tissue. Each dyed (violet) suture has uni-directional barbs along the axis of the suture monofilament without needle attachment. The Y. JACOBS YOUNG'S THREAD Synthetic Absorbable PDO suture approximates tissues without the need to tie surgical knots, because of the presence of barbs on the suture surface which imbed in the tissues after precise placement by the surgeon. Y. JACOBS YOUNG'S THREAD consists of absorbable polydioxanone (PDO) suture. Y. JACOBS YOUNG'S THREAD consists of:

absorbable polydioxanone (PDO) suture
absorbable PLGA cone with each suture
disposable polycarbonate hub which has no patient contact

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called "Y. Jacobs Young's Thread," which is an absorbable polydioxanone surgical suture. The document establishes substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study with outcome metrics.

Therefore, the requested information for acceptance criteria and a study proving the device meets them, as typically seen with performance-based devices, is not applicable in this context for the Y. JACOBS YOUNG'S THREAD based on the provided document.

Instead, the document focuses on demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices. This means that it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.

Here's how the provided information relates to your questions, noting where the information is not present or not applicable for this type of submission:

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

Not Applicable in the traditional sense for this 510(k) submission. This document does not present specific quantitative acceptance criteria or performance metrics for the Y. JACOBS YOUNG'S THREAD in the way a clinical study would for efficacy/accuracy. Instead, the "acceptance" is based on demonstrating substantial equivalence to predicate devices.
The document states: "The data presented in this 510(k) encompasses biocompatibility, sterilization, shelf-life, and characterization testing of the suture design." However, no specific performance values or acceptance limits for these tests are provided in the public summary. The conclusion is a general statement of equivalency.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document states that "biocompatibility, sterilization, shelf-life, and characterization testing" was done, but it does not specify sample sizes for these tests or the data provenance.
Given this is a 510(k) for a surgical suture, the "test set" would typically refer to the samples used in these non-clinical tests (e.g., number of sutures tested for tensile strength, degradation profile, etc.).

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)

Not Applicable. This type of information is relevant for studies involving human interpretation or diagnosis, such as imaging or AI algorithms. For a surgical suture, "ground truth" would be established through objective laboratory testing (e.g., material analysis, strength testing) rather than expert consensus on diagnostic images.

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

Not Applicable. See point 3.

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. This is specific to AI-assisted diagnostic devices, which is not the nature of a surgical suture.

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

Not Applicable. This is specific to AI algorithms.

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

Not Applicable in the direct sense of diagnostic ground truth. For a surgical suture, "ground truth" for non-clinical testing would be established through validated laboratory methods and standards for material properties, tensile strength, degradation rate, biocompatibility, and sterility. The document refers to "characterization testing" which implies such objective measurements.

8. The sample size for the training set

Not Applicable. This is an AI-specific term. For a physical device like a suture, there isn't a "training set" in the machine learning sense. The development of the suture would involve materials science and engineering, with "training" referring to iterative design and testing.

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

Not Applicable. See point 8.

Summary for Y. Jacobs Young's Thread based on the provided document:

The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the Y. JACOBS YOUNG'S THREAD to existing predicate devices. This is a regulatory pathway that relies on showing the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. It does so by referencing:

Identical Indications for Use: "The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate." (Page 2 & 3)
Similar Material Composition: Absorbable PDO with D&C Violet No.2 (suture), PLGA (cone), Polycarbonate (hub). These are compared to the predicate devices' materials. (Page 3 & 4)
Similar Design: Knotless design with barbs, similar to the "QuillTM Self-Retaining System (SRS)" and "MINTTM" predators. (Page 4)
Performance Data: The submission includes "biocompatibility, sterilization, shelf-life, and characterization testing of the suture design." (Page 4) However, specific quantitative results from these tests are not detailed in this public summary document. The absence of specific performance metrics and acceptance criteria for these tests means the document does not allow for a table of "reported device performance against acceptance criteria" for the Y. JACOBS YOUNG'S THREAD itself. The substantial equivalence argument implies that these tests were sufficient to show the device performed comparably to, and as safely and effectively as, the predicate devices.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 23, 2016

Y. Jacobs Medical, Inc. c/o Ms. Meredith May, M.S., RAC Empirical Consulting 4628 Northpark Drive Colorado Spring, Colorado 80918

Re: K160705

Trade/Device Name: Y Jacobs Young's Synthetic Absorbable Surgical Fixation Suture Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: October 24, 2016 Received: October 26, 2016

Dear Ms. May:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160705

Device Name Y. JACOBS YOUNG'S THREAD

Indications for Use (Describe)

The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.

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)

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Submitter's Name:	Y. JACOBS MEDICAL Inc.
Submitter's Address:	(Nonhyeon-dong) 6F Sangkyung Bldg. 669 Seolleung-ro,Gangnam-gu, Seoul, Korea
Submitter's Telephone:	+82 2-546-0715
Contact Person:	Meredith L. May MS, RACEmpirical Consulting LLC719.337.7579
Date Summary was Prepared:	10-Mar-2016
Trade or Proprietary Name:	Y. JACOBS YOUNG'S THREAD
Common or Usual Name:	Absorbable polydioxanone surgical suture
Classification:	Class II per 21 CFR §878.4840
Product Code:	NEW
Classification Panel:	Division of General and Plastic Surgery.

Description of the Device Subject to Premarket Notification

absorbable polydioxanone (PDO) suture
absorbable PLGA cone with each suture ●
disposable polycarbonate hub which has no patient contact ●

The environment for use of this device is in a medical professional facility, such as a hospital, clinic or specialty treatment center.

Indications for Use

The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.

Technological Characteristics

Y . JACOBS YOUNG'S THREAD is a Synthetic Absorbable Monofilament made from the following materials:

Suture: Absorbable PDO with D&C Violet No.2
Cone: PLGA (82% L-Lactide, 18% Glycolide) ●
HUB: Polycarbonate

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Y.JACOBS MEDICAL The subject and predicate devices have nearly identical technological characteristics and the minor differences do not affect substantial equivalence. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use ●
Materials of manufacture .

Table 5-1 Primary Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer
K080985	QuillTM Self-Retaining System (SRS)	Surgical Specialties Corp.

Table 5-2 Additional Predicate Device

510k Number	Trade or Proprietary or Model Name	Manufacturer
K130191	MINTTM	Hansbiomed Corp.
K031216	MonoPlus Poly-p-dioxanoneabsorbable suture	Aesculap, Inc.
K123877	QuillTM PDO Knotless-Tissue ClosureDevice, Variable Loop	Angiotech

Performance Data

The data presented in this 510(k) encompasses biocompatibility, sterilization, shelf-life, and characterization testing of the suture design.

Summary of Substantial Equivalence

Based on the comparison, as well as the information and data provided in the submission we have demonstrated that the Y. JACOBS YOUNG'S THREAD has been shown to be as substantially equivalent for the proposed Intended and Indications for Use as the legally marketed predicate devices. Therefore, we conclude that the proposed Y. JACOBS YOUNG'S THREAD suture is substantially equivalent to those predicate devices.

Conclusion

The Y. JACOBS YOUNG'S THREAD has the same intended use. material composition (PDO and dye) as the Quill™ Self-Retaining System (SRS) (K080985) and the MINTTM (K130191), MonoPlus Poly-p-dioxanone absorbable suture (K031216), Quill™ PDO Knotless-Tissue Closure Device, Variable Loop (K123877). In addition, K080985 and K130191, K031216 and K123877 are similar design with respect to the barbs and knot or its alternatives for fixation to tissue as the predicates.

Therefore, the Y. JACOBS YOUNG'S THREAD is substantially equivalent to Quill™ Self-Retaining System (SRS) comprised of PDO (K080985) and MINT1M (K130191), MonoPlus Poly-p-dioxanone absorbable suture (K031216), Quill™ PDO Knotless-Tissue Closure Device, Variable Loop (K123877).

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.