J+PRAS YOUNG'S Thread

K143413 · Y. Jacobs Medical, Inc. · NEW · Sep 11, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K143413
• Device Name: J+PRAS YOUNG'S Thread
• Applicant: Y. Jacobs Medical, Inc.
• Product Code: NEW · General, Plastic Surgery
• Decision Date: Sep 11, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4840
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Y. JACOBS YOUNG'S THREAD is a synthetic, absorbable, monofilament polydioxanone (PDO) surgical suture featuring uni-directional barbs along its axis. Designed for use in medical professional facilities (hospitals, clinics, specialty centers) by surgeons, the device facilitates soft tissue approximation without the need for surgical knots. The barbs embed into tissue upon placement, providing fixation. The suture is supplied sterile in single-use packages. By eliminating knot-tying, the device simplifies the closure process, potentially reducing procedure time and improving tissue approximation outcomes.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through bench testing, including biocompatibility, sterilization validation, shelf-life testing, tensile strength, strength retention (biodegradability), straight-pull testing, barb holding force, degradation profile, and LAL (endotoxin) testing.

Technological Characteristics

Synthetic absorbable monofilament suture made of polydioxanone (PDO) with D&C Violet No. 2 dye. Features uni-directional barbs for tissue fixation. Sterile, single-use, ethylene oxide (EO) gas sterilized. No needle attachment.

Indications for Use

Indicated for soft tissue approximation in patients where an absorbable suture is appropriate.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• QuillTM Self-Retaining System (SRS) (K080985)
• MINT™ (K130191)
• Quill™ PDO Knotless Tissue-Closure Device (Polydioxanone) (K120827)

Submission Summary (Full Text)

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July 20, 2021

Y. Jacobs Medical, Inc. % Meredith May Vice-President Empirical Consulting Qserve Group US Inc. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K143413

Trade/Device Name: Y. JACOBS YOUNG'S THREAD Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW

Dear Meredith May:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 11, 2015. Specifically, FDA is updating this SE Letter as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cindy Chowdhury, OHT4: Office of Surgical and Infection Control Devices, 240-402-6647, [e-mail].

Sincerely,

Cindy Chowdhury -S

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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

September 11, 2015

Y. Jacobs Medical, Incorporated % Ms. Meredith May MS, RAC, Vice-President Empirical Consulting Qserve Group US Incorporated 4628 Northpark DriveCharleston, New Hampshire 03603

Re: K143413

Trade/Device Name: Y.JACOBS YOUNG'S THREAD Regulation Number: 21 CFR 878.4840 Regulation Name: Absorbable polydioxanone surgical suture Regulatory Class: Class II Product Code: NEW Dated: September 1, 2015 Received: September 2, 2015

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Binita S. Ashar -S

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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## Indications for Use

510(k) Number (if known) K143413

Device Name Y. JACOBS YOUNGS 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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| Submitter's Name: | Y. Jacobs Medical Inc. |
|----------------------------|----------------------------------------------------------------------------------|
| Submitter's Address: | (Nonhyeon-dong) 6F Sangkyung Bldg. 669 Seolleung-ro,<br>Gangnam-gu, Seoul, Korea |
| Submitter's Telephone: | [phone] |
| Contact Person: | Meredith L. May MS, RAC<br>Empirical Consulting LLC<br>719.337.7579 |
| Date Summary was Prepared: | 25-Nov-14 |
| 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:

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.

The Y. JACOBS YOUNG'S THREAD will be available in single use packages, sterile after ethylene oxide (EO) gas sterilization. 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 ●
## 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 w here 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 ●
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

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## Y.JACOBS YOUNG'S THREAD Traditional 510(k)

Image /page/5/Picture/1 description: The image shows the logo for Y. Jacobs Medical. The logo consists of a circular emblem with the letter "Y" inside, followed by the text "Y. JACOBS" in black and "MEDICAL" in maroon. Above the logo, the text "K143413 Page 2 of 2" is visible.

- 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 | MINT™ | Hansbiomed Corp. |
| K120827 | Quill™ PDO Knotless Tissue-Closure<br>Device (Polydioxanone) | 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 provided in the SE Comparison Table in Section 12.5, supported by data found in Sections 11, 14, 15 and 18, 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. The following performance tests were conducted to determine substantial equivalence: tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile, biocompatibility, and LAL (endotoxin).

## Conclusion

The Y. JACOBS YOUNG'S THREAD has the same Intended Use for soft tissue approximation as all the predicate sutures.

The Y. JACOBS YOUNG'S THREAD has the same material composition (PDO and dye) as the Quill™ Self-Retaining System (SRS) (K080985) and the MINT™ (K130191) and similar design with respect to the barbs for fixating to tissue as all the predicates.

Therefore, the Y. JACOBS YOUNG'S THREAD is substantially equivalent to Quill™ Self-Retaining System (SRS) comprised of PDO (K080985) and MINTTM (K130191).