(162 days)
Not Found
No
The description focuses on the material composition and physical properties of a surgical suture, with no mention of AI or ML capabilities.
No.
This device is a surgical suture used for short-term wound support and ligation, which are mechanical functions for wound closure and not inherently therapeutic in the sense of treating a disease or condition actively.
No
Explanation: The device is a surgical suture used for tissue approximation and/or ligation, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a physical surgical suture made of silk and stainless steel needles, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Description: The provided text describes a surgical suture, which is a material used to close wounds and hold tissues together within the body (in vivo).
- Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which is a surgical procedure performed directly on the patient.
The description clearly indicates a device used during surgery on a living patient, not a test performed on a sample in a laboratory.
N/A
Intended Use / Indications for Use
Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
Product codes (comma separated list FDA assigned to the subject device)
GAP
Device Description
Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture.
The device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General soft tissue
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 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
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
- ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
- ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10 :2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- USP Pyrogen Test (USP Rabbit Test)
- USP Bacterial Endotoxins Test
- USP Sutures - Diameter
- USP Sutures - Needle Attachment
- USP Tensile Strength
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
§ 878.5030 Natural nonabsorbable silk surgical suture.
(a)
Identification. Natural nonabsorbable silk surgical suture is a nonabsorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated speciesBombyx mori (B. mori ) of the familyBombycidae. Natural nonabsorbable silk surgical suture is indicated for use in soft tissue approximation. Natural nonabsorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Nonabsorbable Surgical Suture (class I). Natural nonabsorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.(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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
January 16, 2024
Shandong Haidike Medical Product Co., Ltd. Yan Wang Registration Manager Tianfu Road, Dongcheng District, Shan County Heze, Shandong 274300 China
Re: K232355
Trade/Device Name: Non absorbable Surgical Silk Suture Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP Dated: December 14, 2023 Received: December 14, 2023
Dear Yan Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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-regulatory-
assistance/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,
Yu-chieh Chiu -S
for Tek Lamichhane, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232355
Device Name Non absorbable Surgical Silk Suture
Indications for Use (Describe)
Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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: K232355
1. Date of Preparation: Jan. 12, 2024
2. Sponsor Identification
Shandong Haidike Medical Product Co., Ltd.
Tianfu Road, Dongcheng District, Shan County, 274300 Heze City, Shandong Province, China.
Establishment Registration Number: 3016426842
Contact Person: Yan Wang Position: Registration Manager Tel: +86-530-4660062 Fax: +86-530-4660055 Email: registration01@suturescn.com
Identification of Subject Device: 3.
Trade Name: Non absorbable Surgical Silk Suture Common Name: Natural Non absorbable Silk Surgical Suture
Regulatory Information
Classification Name: Suture, Non absorbable, Silk; Classification: II; Product Code: GAP; Regulation Number: 21CFR 878.5030; Review Panel: General & Plastic Surgery
4. Identification of Predicate Device
510(k) Number: K161633 Regulation Number: 21CFR 878.5030 Classification: II; Product Code: GAP; Review Panel: General & Plastic Surgery; Product name: REXSIL
5
5. Device Description
Non absorbable Surgical silk Suture is a nonabsorbable, braided surgical suture which is supplied sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori of the family Bombycidae. Silk for braided material is processed to remove the natural waxes and gums. Silk suture is dyed black(Logwood extract) and coated with silicone. The quantity of color additive is not to exceed 1.00% by weight of the suture.
The device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. Silk suture meets all the requirements of USP for nonabsorbable surgical suture. The suture needle are made from medical stainless steel, the grade of medical stainless steel is SUS 420 J2.
6. Indications for Use:
Non absorbable Surgical Silk Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. The device is limited to use where short term wound support (7-10 days) is required and can be left in place for a maximum of 10 days.
| Table 1 Comparision of Technological Characteristics | ||
|---|---|---|
| ITEM | Proposed Device | Predicate Device K161633 |
| Product Code | GAP | GAP |
| Regulation Number | 21CFR 878.5030 | 21CFR 878.5030 |
| Class | II | II |
| Sterile | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Indication for Use | Non absorbable Surgical Silk Suture | |
| is indicated for use in general soft | ||
| tissue approximation and/or ligation, | ||
| but not for use in ophthalmic | ||
| procedures, cardiovascular and | ||
| neurological procedures. The device | ||
| is limited to use where short term | ||
| wound support (7-10 days) is | ||
| required and can be left in place for | ||
| a maximum of 10 days. | REXSIL is indicated for use in general | |
| soft tissue approximation and/or | ||
| ligation, including use in ophthalmic | ||
| procedures, but not for use in | ||
| cardiovascular or neural tissue. | ||
| Configuration | Silk Suture with or without needle | Silk Suture with or without needle |
| Raw Suture Material | Silk suture | Silk suture |
| Suture Manufacturer | Ashaway Line & Twine Mfg. Co. | Ashaway Line & Twine Mfg. Co. |
7. Technological characteristic comparision
6
| Structure | Braided | Braided |
|---|---|---|
| Dyed, Un-dyed | Dyed suture Black | Dyed suture Black |
| (Logwood) and Undyed | ||
| suture (Natural) | ||
| Colorant | Black (Logwood extract) | Black (Logwood) |
| Length | 45cm to 150cm | 30cm, 35cm, 40cm, |
| 45cm, 50cm, 55cm, | ||
| 60cm, 70cm, 75cm, | ||
| 100cm, 110cm, 150cm, | ||
| 180cm, | ||
| Diameter | 6-0 through 2 | Dyed suture Black |
| (Logwood): USP 8-0 ~USP 2 | ||
| Undyed suture | ||
| (Natural): USP 7-0~USP 2 | ||
| Needle | ||
| Material | Stainless Steel | Stainless Steel |
| Performance Test | ||
| Diameter of suture | Comply with USP | All characteristics meet USP |
| Requirement | ||
| Needle Attachment | Comply with USP | All characteristics meet USP |
| Requirement | ||
| Tensile Strength | Comply with USP | All characteristics meet USP |
| Requirement | ||
| Length | Not less than 95.0% of the length | |
| stated on the label | Unknown |
The Indications for Use (duration of use) is different between the subject and predicate devices. The proposed device is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic procedures, cardiovascular and neurological procedures. In addition, the longest duration of use for the proposed device is up to 10 days, while the predicate device is a permanent contact device per the contact duration. However, the biocompatibility test has been conducted in accordance with ISO 10993 per the contact class on the proposed device and the test result showed that the material and colorant of the proposed device will not have any adverse effects when used for up to 10 days.
Non-Clinical Test Conclusion 8.
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:
-
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
- A ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
- A ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro Cytotoxicity
- A ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects
7
after implantation
-
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- A ISO 10993-10 :2010Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- A ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
- A USP Pyrogen Test (USP Rabbit Test)
-
USPBacterial Endotoxins Test
-
USPSutures - Diameter
-
USPSutures - Needle Attachment
-
USPTensile Strength
Clinical Test Conclusion 9.
No clinical study is included in this submission.
10. Conclusion
The proposed device, Non absorbable Surgical Silk Suture is determined to be Substantially Equivalent to the predicate devices in respect of safety and performance.