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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA regarding a Non-absorbable Surgical Silk Suture. This type of device is a physical medical product, not an AI/software device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as it applies to AI/software performance metrics (like sensitivity, specificity, AUC, human reader improvement with AI assistance, etc.) is not applicable here.

Instead, for a physical medical device like a surgical suture, the "acceptance criteria" and "proof" relate to:

Material properties: Does the suture material meet established standards (e.g., USP requirements for diameter, tensile strength)?
Biocompatibility: Is the material safe for use in the human body (e.g., non-toxic, non-irritating, non-hemolytic)?
Sterilization: Is the device effectively sterilized and free from harmful residuals?
Packaging integrity: Is the packaging designed to maintain sterility until use?
Performance: Does the device perform as intended (e.g., needle attachment strength)?

The document details the non-clinical tests performed to demonstrate substantial equivalence to a predicate device, as required for 510(k) clearance.

Here's a breakdown of the relevant information from the document, reinterpreting "acceptance criteria" for a physical device:

Acceptance Criteria and Device Performance for Non-absorbable Surgical Silk Suture (K232355)

The acceptance criteria for this medical device are based on compliance with various established standards and the demonstration of substantial equivalence to a legally marketed predicate device (K161633, REXSIL). The performance is evidenced by non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Standard/Requirement	Reported Device Performance/Conclusion
Material Properties	USP <861> Sutures - Diameter	"Comply with USP <861>"
	USP <881> Tensile Strength	"Comply with USP <881>"
	Suture Length	"Not less than 95.0% of the length stated on the label"
Performance (Device Assembly)	USP <871> Sutures - Needle Attachment	"Comply with USP <871>"
Biocompatibility	ISO 10993-3:2014 (Genotoxicity, carcinogenicity, reproductive toxicity)	"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." (General statement for ISO 10993 tests)
	ISO 10993-5:2009 (In vitro Cytotoxicity)	"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."
	ISO 10993-6:2016 (Local effects after implantation)	"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."
	ISO 10993-10:2010 (Irritation and skin sensitization)	"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."
	ISO 10993-11:2017 (Systemic Toxicity)	"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."
	ASTM F756-17 (Assessment of Hemolytic Properties)	"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."
Sterilization & Endotoxins	ISO 10993-7:2008 (Ethylene oxide sterilization residuals)	Compliance stated in "Non-Clinical Test Conclusion" section.
	USP <151> Pyrogen Test (USP Rabbit Test)	Compliance stated in "Non-Clinical Test Conclusion" section.
	USP <85> Bacterial Endotoxins Test	Compliance stated in "Non-Clinical Test Conclusion" section.
Packaging & Shelf Life	ASTM F88/F88M-15 (Seal Strength of Flexible Barrier Materials)	Compliance stated in "Non-Clinical Test Conclusion" section.
	ASTM F1929-15 (Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration)	Compliance stated in "Non-Clinical Test Conclusion" section.
Overall Substantial Equivalence (Non-Clinical)	Comparison to predicate device (K161633) characteristics and performance based on standards.	"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 following sections (2-9) are not applicable as they relate to AI/software performance studies, which are not relevant for this physical surgical suture device. The information provided in the document confirms that this is a traditional medical device submission for which clinical trials (and thus clinical data for training/testing or expert adjudication for ground truth) were not required.

2. Sample size used for the test set and the data provenance: Not applicable for this physical device. Testing would involve a statistically significant number of physical samples for each test (e.g., tensile strength, diameter, biocompatibility). Data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties and biocompatibility is established by adherence to recognized international and national standards (e.g., ISO, ASTM, USP) and laboratory measurements by qualified technicians.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" is adherence to established engineering specifications, material standards, and biological safety standards (e.g., precise diameter measurements, specific tensile strength values, confirmed absence of cytotoxicity, etc.). These are objectively measured in laboratories according to validated test methods.

8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

{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)

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

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:

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 Sutureis indicated for use in general softtissue approximation and/or ligation,but not for use in ophthalmicprocedures, cardiovascular andneurological procedures. The deviceis limited to use where short termwound support (7-10 days) isrequired and can be left in place fora maximum of 10 days.	REXSIL is indicated for use in generalsoft tissue approximation and/orligation, including use in ophthalmicprocedures, but not for use incardiovascular 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 Undyedsuture (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 2Undyed suture(Natural): USP 7-0~~USP 2
Needle
Material	Stainless Steel	Stainless Steel
Performance Test
Diameter of suture	Comply with USP <861>	All characteristics meet USPRequirement
Needle Attachment	Comply with USP <871>	All characteristics meet USPRequirement
Tensile Strength	Comply with USP <881>	All characteristics meet USPRequirement
Length	Not less than 95.0% of the lengthstated 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<151> Pyrogen Test (USP Rabbit Test)
USP<85>Bacterial Endotoxins Test
USP<861>Sutures - Diameter
USP<871>Sutures - Needle Attachment
USP<881>Tensile 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.

Regulation Number and Section

§ 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.