(287 days)
The Y. JACOBS YOUNG'S THREAD is intended for use in soft tissue approximation where use of an absorbable suture is appropriate.
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 provided text describes a 510(k) premarket notification for the "Y. JACOBS YOUNG'S THREAD," an absorbable polydioxanone surgical suture. The document attests to the substantial equivalence of the device to legally marketed predicate devices, rather than detailing a study against specific acceptance criteria for performance in a clinical setting in the way one might for an AI/ML device.
Here's an analysis based on the information provided, focusing on how a medical device's "acceptance criteria" are typically met in a 510(k) submission, particularly for an absorbable suture:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission of a surgical suture, "acceptance criteria" are generally tied to demonstrating equivalence to predicate devices across various material and mechanical properties, as well as biocompability and sterilization. The document lists the types of performance tests conducted.
| Acceptance Criteria Category | Specific Tests Conducted | Reported Performance (Summary from Document) |
|---|---|---|
| Biocompatibility | Biocompatibility testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
| Sterilization | Sterilization testing | Sterile after ethylene oxide (EO) gas sterilization (stated) |
| Shelf-Life | Shelf-life testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
| Physical/Mechanical Properties | Characterization testing of the suture design, tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile | Demonstrated to be "as substantially equivalent... as the legally marketed predicate devices." The subject and predicate devices have "nearly identical technological characteristics" and "minor differences do not affect substantial equivalence." Specific results (e.g., actual tensile strength values) are not provided in this summary but would have been part of the full 510(k) submission. |
| Material Composition | - | Same material composition (PDO and dye) as predicate K080985 and K130191. |
| Design | - | Similar design with respect to the barbs for fixating to tissue as all predicates. |
| Endotoxin Content | LAL (endotoxin) testing | Confirmed (implied by "Performance Data" and "Summary of Substantial Equivalence") |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the exact sample sizes for each of the performance tests (e.g., number of sutures tested for tensile strength). It mentions "characterization testing of the suture design," "tensile strength," "strength retention (biodegradability)," "straight-pull," "barb holding force," "degradation profile," "biocompatibility," and "LAL (endotoxin)."
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that this is a 510(k) for a physical medical device (suture), the performance data would typically be derived from in vitro (laboratory) and in vivo (animal, if applicable, or simulation) testing conducted under controlled conditions, often by the manufacturer or authorized testing labs.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not relevant for the technical performance testing of a surgical suture in a 510(k) submission. The "ground truth" for suture performance is established by standardized testing methods and international standards (e.g., ASTM, ISO standards for surgical sutures).
- For Biocompatibility: The "ground truth" is adherence to ISO 10993 series standards, assessed by toxicologists and other experts in the field.
- For Mechanical Testing: The "ground truth" is defined by the test method and equipment calibration, with results analyzed by engineers and materials scientists.
4. Adjudication Method for the Test Set
Not applicable in the context of physical and material performance testing for a suture. Test results are objectively measured and compared against predefined specifications or predicate device data, not subject to expert adjudication in the same way clinical image interpretation might be.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies are typically used to evaluate the diagnostic or prognostic performance of imaging devices, AI algorithms, or other tools where human interpretation plays a significant role. This submission pertains to a physical surgical suture.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a physical surgical suture, not an algorithm. Its performance is inherent in its material properties and design, used by a surgeon (human-in-the-loop, but not assisted by this specific device in a way that requires AI/ML evaluation).
7. Type of Ground Truth Used
The ground truth used for the performance evaluation of this surgical suture would be based on:
- Standardized Test Methods and Specifications: Adherence to established industry standards (e.g., for tensile strength, degradation rates, barb holding force).
- Predicate Device Data: The performance of the predicate devices (Quill™ Self-Retaining System and MINT™) serves as the benchmark for demonstrating substantial equivalence.
- Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices.
- Sterility Assurance Levels (SAL): Defined by sterilization standards.
8. Sample Size for the Training Set
Not applicable. The Y. JACOBS YOUNG'S THREAD is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on a design and tested to ensure it meets specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" for an AI/ML algorithm, this question is irrelevant to this device submission. The "ground truth" for manufacturing a suture is the design specification and quality control processes.
Summary of the Study that Proves the Device Meets Acceptance Criteria for a 510(k) Submission:
The provided document describes the basis for a 510(k) clearance, which is demonstrating substantial equivalence to existing legally marketed predicate devices. The "study" here is a series of in vitro and potentially in vivo (non-human) engineering and material science tests.
- Device: Y. JACOBS YOUNG'S THREAD (absorbable polydioxanone surgical suture with barbs).
- Predicate Devices:
- Design: Monofilament PDO suture with uni-directional barbs, dyed with D&C Violet No.2, sterilized by ethylene oxide.
- Intended Use: Soft tissue approximation where an absorbable suture is appropriate.
- Performance Tests Conducted: Biocompatibility, sterilization, shelf-life, characterization testing of suture design, tensile strength, strength retention (biodegradability), straight-pull, barb holding force, degradation profile, and LAL (endotoxin).
- Conclusion of the Study (as stated in the document): "Based on the comparison, as well as the information provided in the SE Comparison Table... 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."
The entire submission package to the FDA, including the detailed reports of these tests (Sections 11, 14, 15, and 18, which are not provided here), constitutes the "study" demonstrating that the device meets the criteria for substantial equivalence, and thus, "acceptance." The acceptance criteria are, in essence, meeting or exceeding the performance characteristics of the identified predicate devices in relevant tests.
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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, Cindy.Chowdhury@fda.hhs.gov.
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 (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/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)
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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: | 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-ClosureDevice (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).
§ 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.