(287 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a barbed suture, with no mention of AI or ML.
No
The device is a surgical suture used for soft tissue approximation, which is a medical device, but not typically classified as a therapeutic device, which are devices used to treat or manage a disease or condition.
No
The device is a dissolvable suture used for tissue approximation, not for diagnosing conditions.
No
The device description clearly states it is a physical suture made of polydioxanone with barbs, intended for soft tissue approximation. It is a physical medical device, not software.
Based on the provided information, the Y. JACOBS YOUNG'S THREAD is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in soft tissue approximation where use of an absorbable suture is appropriate." This describes a surgical procedure performed on the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a surgical suture made of polydioxanone with barbs for tissue approximation. This is a physical device used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties and biological compatibility of the suture (tensile strength, degradation, biocompatibility), not on diagnostic accuracy or analytical performance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Y. JACOBS YOUNG'S THREAD does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NEW
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The environment for use of this device is in a medical professional facility, such as a hospital, clinic or specialty treatment center.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The data presented in this 510(k) encompasses biocompatibility, sterilization, shelf-life, and characterization testing of the suture design. 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines connecting them. The profiles are stacked on top of each other, creating a sense of depth and unity.
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
2
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
3
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, |
| Gangnam-gu, Seoul, Korea | |
| Submitter's Telephone: | +82 2-546-0715 |
| Contact Person: | Meredith L. May MS, RAC |
| Empirical Consulting LLC | |
| 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 | |
| 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).