(160 days)
Not Found
No
The device description and performance studies focus on the physical properties and biological compatibility of a surgical suture, with no mention of AI or ML.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues, which are mechanical functions rather than therapeutic in nature.
No
Explanation: The device is a surgical suture used for tissue approximation and ligation, not for diagnosing medical conditions.
No
The device description clearly states it is a physical surgical suture made of synthetic materials, which is a hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures." This describes a surgical device used in vivo (within the body) for physical manipulation of tissues.
- Device Description: The description details a "braided synthetic, non-absorbable surgical suture." This is a physical implant/device used during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for use in vivo during surgical procedures.
N/A
Intended Use / Indications for Use
The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures.
Product codes
GAT
Device Description
The proposed device is a braided synthetic, non-absorbable surgical suture made of ultra-high molecular weight polyethylene and medical adhesive at both ends of the suture. The proposed device is undyed and uncoated. The sutures are available in a range of sizes. The device does not contain needle. And the device is provided in sterile.
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
Not Found
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
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- USP 41-NF 36:2018 Non-absorbable Surgical Suture
- USP 41-NF 36:2018 Tensile Strength
- USP 41-NF 36:2018 Sutures – Diameter
- ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- ISO 10993-7:2008 Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-11:2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- USP 41 NF 36 Pyrogen Test (USP Rabbit Test)
- ISO 10993-3:2014 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
- ISO 10993-6:2016 Biological Evaluation Of Medical Devices -- Part 6: Tests For Local Effects After Implantation
- USP 41 NF 36 Bacterial Endotoxins Test
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 2, 2020
Yunyi (Beijing) Medical Device Co., LTD % Diana Hong General Manager Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai, 200120 Cn
Re: K192637
Trade/Device Name: High Strength Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: September 20, 2019 Received: September 24, 2019
Dear Ms. Hong:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Cindy Chowdhury, Ph.D., M.B.A. Acting 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
Enclosure
2
Indications for Use
510(k) Number (if known) K192637
Device Name High Strength Suture
Indications for Use (Describe)
The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Tab #6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 08/06/2019
-
- Sponsor Identification
Yunyi (Beijing) Medical Device Co., LTD.
Floor 1-4, Building 4, No. 9 Tianfu Street, Biomedical Base, Daxing District, Beijing 102600, People's Republic of China
Establishment Registration Number: Not registered
Contact Person: Xiaowei Liu Position: General Manager Tel: +86-10-57234533 Fax: +86-10-57234533 Email:liuxiaowei@yunyimedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850 Fax: 360-925-3199 Email: info@mid-link.net
4
Identification of Proposed Device 4.
Trade Name: High Strength Suture Common Name: Polyblend Suture, Non-absorbable Surgical Sutures Size: UP-(2-0) W, UP-0W, UP-2W, UP-5W and UP-7W
Regulatory Information
Classification Name: Nonabsorbable Poly (Ethylene Terephthalate) Surgical; Classification: II; Product Code: GAT; Regulation Number: 21 CRFR878.5000 Review Panel: General& Plastic Surgery;
Indication for Use:
The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures.
Device Description
The proposed device is a braided synthetic, non-absorbable surgical suture made of ultra-high molecular weight polyethylene and medical adhesive at both ends of the suture. The proposed device is undyed and uncoated. The sutures are available in a range of sizes. The device does not contain needle. And the device is provided in sterile.
-
ડ. Identification of Predicate Device
510(k) Number: K190817 Product Name: HS Fiber® Suture Manufacturer: Riverpoint Medical -
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
USP 41-NF 36:2018 Non-absorbable Surgical Suture
-
USP 41-NF 36:2018 Tensile Strength
5
-
USP 41-NF 36:2018 Sutures – Diameter
-
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ISO 10993-5:2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
ISO 10993-7:2008 Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-11:2017 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
-
USP 41 NF 36 Pyrogen Test (USP Rabbit Test)
-
ISO 10993-3:2014 Biological Evaluation Of Medical Devices - Part 11: Tests For Systemic Toxicity
-
ISO 10993-6:2016 Biological Evaluation Of Medical Devices -- Part 6: Tests For Local Effects After Implantation
- USP 41 NF 36 Bacterial Endotoxins Test >
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
8. Substantially Equivalent (SE) Comparison
| Table 1 Comparison of Technology Characteristics | ||
|---|---|---|
| Item | Proposed Device | Predicate Device |
| K190817 | ||
| Product Code | GAT | GAT |
| Regulation Number | 21 CRFR878.5000 | 21 CRFR878.5000 |
| Indication for Use | The device is indicated for use in general soft tissue approximation and/or ligation, including use in allograft tissues for orthopedic procedures. | HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures. |
| Material | ultra-high molecular weight polyethylene | ultra-high molecular weight polyethylene |
| Color | Undyed | Dyeing |
| Absorbable / | ||
| Non-absorbable | Non-absorbable | Non-absorbable |
| Braided / | ||
| Monofilament | Braided | Braided |
| Sterile | EO Sterilized | Unknown |
| Suture Size | UP-(2-0) W, UP-0W, UP-2W, UP-5W ,UP-7W | Unknown |
| Single Use | Yes | Yes |
| Performance | Comply with: | |
| USP 41 | ||
| USP 41 | Comply with: | |
| USP | ||
| USP | ||
| Biocompatibility | ||
| Cytotoxicity | No cytotoxicity | Comply with ISO 10993 |
| Intracutaneous Study | No irritation | |
| Sensitization | No sensitization | |
| Pyrogenicity Test | No pyrogenicity | |
| Acute Systemic Toxicity | No systemic toxicity | |
| Bacterial Reverse Mutation | Not induce backward mutation | |
| Gene Mutation Test | Non-mutagenic | |
| Muscle Implantation Test | Non-irritant to the muscle tissue | |
| Subchronic Toxicity Test | No subchronic toxicity |
- Substantially Equivalent (SE) Conclusion
7
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.