Non-absorbable Surgical Polyester Suture is indicated for use in general soft tissue approximation and/or ligation, but not for use in ophthalmic, 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

The subject device is a coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate which is supplied sterile. The suture is coated with bees wax and dyed green. The color additive is D&C Green 6. The subject 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.

AI/ML Overview

This document (K231183) is a 510(k) Premarket Notification for a Non-absorbable Surgical Polyester Suture. It seeks to demonstrate substantial equivalence to a predicate device (K172149). The information provided focuses on the physical and biological compatibility of the suture, rather than the performance of a software or AI-driven medical device in a diagnostic context. Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated by compliance with various ISO, USP, and ASTM standards. The "acceptance criteria" are implied by these standards, meaning the device must "Pass" or "Comply" with the requirements of each standard.

Test Category	Specific Test / Standard	Acceptance Criteria (Implied)	Reported Device Performance
Physical Performance	USP <861> Sutures - Diameter	Comply with USP <861>	Comply with USP <861>
	USP <871> Sutures - Needle Attachment	Comply with USP <871>	Comply with USP <871>
	USP <881> Tensile Strength	Comply with USP <881>	Comply with USP <881>
	Length (of suture)	Not less than 95.0% of the length stated on the label	Met the criteria (stated in Analysis 3)
Packaging & Sterility	ASTM F88/F88M-15 Seal Strength of Flexible Barrier Materials	Comply with ASTM F88/F88M-15	Comply with ASTM F88/F88M-15
	ASTM F1929-15 Detecting Seal Leaks by Dye Penetration	Comply with ASTM F1929-15	Comply with ASTM F1929-15
	USP <85> Bacterial Endotoxins Test	Comply with USP <85>	Comply with USP <85>
	ISO 10993-7:2008 Ethylene oxide sterilization residuals	Acceptable Residual Levels	(Not explicitly stated Pass/Fail, but implied by compliance with ISO 10993-1)
Biocompatibility	ISO 10993-5 Cytotoxicity	Pass	Pass
	ISO 10993-10 Sensitization	Pass	Pass
	ISO 10993-10 Intracutaneous Reactivity	Pass	Pass
	ISO 10993-11 Acute systemic toxicity	Pass	Pass
	USP <151> Pyrogen Test	Pass	Pass (also stated as Comply to USP<151>)
	ISO 10993-11 Subacute Systemic Toxicity	Pass	Pass
	ISO 10993-3 Bacterial Reverse Mutation	Pass	Pass
	ISO 10993-3 Chromosome Aberration	Pass	Pass
	ISO 10993-3 Gene Mutation	Pass	Pass
	ISO 10993-6 Implantation	Pass	Pass
	ASTM F756-17 Hemolysis	Pass	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. For non-clinical tests like those listed (USP, ASTM, ISO standards), specific sample sizes and testing methodologies are defined within the respective standards. The document only states that the tests were "conducted" and "complies" or "passed." The data provenance (country of origin, retrospective/prospective) is also not specified, as these are lab-based tests rather than patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. This document describes the testing of a physical medical device (suture) against established performance and biocompatibility standards. "Ground truth" in the context of expert consensus, typical for diagnostic software or AI, is not relevant here. The "ground truth" for physical device performance is defined by the objective measurement criteria within the specified international and national standards (e.g., USP monographs for suture diameter, tensile strength).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As described above, this is not a study involving human interpretation of diagnostic data that would require an adjudication method.

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. An MRMC study is relevant for diagnostic software performance, particularly AI-driven tools. This submission is for a physical surgical suture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" (or more accurately, the reference standard) for this device is based on established objective measurements and criteria defined by validated international and national standards (e.g., USP Monographs for physical properties, ISO 10993 series for biocompatibility). These standards specify methodologies and acceptance limits that the device must meet.

8. The sample size for the training set

Not Applicable. This is not an AI or machine learning device that requires a training set. The device is a physical product.

9. How the ground truth for the training set was established

Not Applicable. As this device does not use a training set, no ground truth needs to be established for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

August 25, 2023

Shandong Haidike Medical Products Co.,Ltd. Yan Wang Registration Manager Tianfu Road, Dongcheng District, Shan County Heze. Shandong 274300 China

Re: K231183

Trade/Device Name: Non absorbable Surgical Polyester Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: July 25, 2023 Received: July 25, 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 (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,

Tek N. Digitally signed by Lamichhane Tek N. Lamichhane -S.
Lamichhane Date: 2023.08.25 -5 10:53:57 -04'00' Tek N. Lamichhane, Ph.D. 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) K231183

Device Name Non-absorbable Surgical Polyester Suture

Indications for Use (Describe)

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.

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."

{3}------------------------------------------------

510(k) Summary-K231183

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

1. Administrative Information

Date of preparation: 07/24/2023

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 2.

Trade Name: Non-absorbable Surgical Polyester Suture Common Name: Nonabsorbable Poly (Ethylene Terephthalate) Suture

Regulatory Information Classification Name: Suture, Nonabsorbable, Synthetic, Polyester Classification: II Product Code: GAT Regulation Number: 21CFR 878.5000 Review Panel: General & Plastic Surgery

3. Identification of Predicate Device

510(k) Number: K172149 Regulation Number: 21CFR 878.5000 Classification: II Product Code: GAT Review Panel: General & Plastic Surgery Product name: MERICRON XL - Non-Absorbable Polyester Surgical Suture

4. Device Description

The subject 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.

{4}------------------------------------------------

5. Indications for Use:

6. Summary of Technological Characteristics

ITEM	Subject Device(K231183)	Predicate DeviceK172149	Remark
	Product Code	GAT
Regulation Number	21CFR 878.5000	21CFR 878.5000	Same
Class	II	II	Same
Sterile	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Same
Indication for Use	Non absorbable SurgicalPolyester Suture is indicated foruse in general soft tissueapproximation and/or ligation, butnot for use in ophthalmic,cardiovascular, and neurologicalprocedures. The device is limitedto use where short term woundsupport (7-10 days) is requiredand can be left in place for amaximum of 10 days.	MERICRON XL suture isintended for use in general softtissue approximation and/orligation includingcardiovascular surgery,neurosurgery, and ophthalmicprocedures.	Analysis 1
	Configuration	Polyester Suture with or withoutneedle	1、MERICRON XLTM Suturewith or without needle.2、MERICRON XLTM Suture isavailable with or withoutPTFE(Polytetrafluoroethylene)Pledget
Suture
Material	polyethylene terephthalate	poly (ethylene terephthalate)	Same
Structure	braided	braided	Same
Coating	Bees wax	Bees wax	Same
Dyed. Un-dyed	Dyed	Undyed/Dyed	Same
Colorant	D&C Green 6	D & C Green No.6	same
Length	45cm to 150cm	Unknown
Diameter	6-0 through 2	6-0 through 5	Analysis 3
Needle
Material	Stainless Steel	Stainless Steel	Same
Performance Test
Diameter of suture	Comply with USP <861>
Needle Attachment	Comply with USP <871>	All characteristics meet USPRequirement
Tensile Strength	Comply with USP <881>		Same
Length	Not less than 95.0% of the lengthstated on the label	Unknown	Analysis 3
Biocompatibility
Cytotoxicity (ISO10993-5)	Pass	The Surgical Suture has beenEvaluated:a.In Vitro Cytotoxicity Studyb. Skin Sensitization Studyc.Intracutaneous Reactivity Testd.Acute Systemic ToxicityStudye.Sub Chronic Toxicity Studyf. Intramuscular ImplantationTestg. Bacterial Reverse MutationTesth. Mammalian ErythrocyteMicronucleus Testi. In Vitro Hemolysis Testj. Pyrogen Test
Sensitization (ISO10993- 10)	Pass
IntracutaneousReactivity (ISO10993- 10)	Pass
Acute systemictoxicity (ISO10993- 11)	Pass
Pyrogen (USP 43NF38 <151>)	Pass
SubacuteSystemic Toxicity(ISO 10993- 11)	Pass		Analysis 4
Bacterial ReverseMutation (ISO10993-3)	Pass
ChromosomeAberration (ISO10993-3)	Pass
Gene Mutation (ISO10993-3)	Pass
Implantation (ISO10993-6)	Pass
Hemolysis ( ASTMF756-17)	Pass

Table 1: Comparison of Technological Characteristics

{5}------------------------------------------------

Analysis 1-Indications for Use

The indications for use for the subject device is not exactly the same as the predicate device. The subject device is indicated for general tissue approximation but not for use in ophthalmic, cardiovascular, and neurological procedures. In addition, the longest duration of use for the subject device is up to 10 days,

{6}------------------------------------------------

while the predicate device is a permanent contact device per the contact duration. However, the biocompatibility tests have been conducted on the subject device, and the test results showed that the material and colorant of the subject device will not have any adverse effects when used for up to 10 days.

Analysis 2-Configuration

The configuration of the subject device is different from the predicate device. However, the configuration of Polyester Suture with or without a needle is the same as the predicate device.

Analysis 3-Length & Diameter

The length and diameter of the subject device is different from the predicate device. However, the length and diameter of the proposed device is within the range of that of the predicate device. In addition, the performance test about the length and diameter has been conducted on the subject device and the test result shows that the length and diameter of the subject device met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the subject device.

Analysis 4-Biocompatibility

The subject device is a prolonged contact device, while the predicate device is a permanent contact device. Based on the identified contact duration and indication for use of subject device, the biocompatibility tests were performed in accordance with ISO 10993- 1: 2018 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, and FDA guidance document entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" dated September 4, 2020.

Although the Biocompatibility contact duration is not the biocompatibility test has been conducted on the subject device and the test result showed that the material of the subject device will not have adverse effects.

7. Performance Data

Non-clinical Testing a.

The biocompatibility evaluation for the subject device was conducted in accordance with the ISO 10993-1:2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process".

The tests were conducted following these standards:

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
A after implantation
ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 10993-10 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

{7}------------------------------------------------

Toxicity

USP<151> Pyrogen Test (USP Rabbit Test)
ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials

Non-clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the subject device. The test results demonstrated that the subject device complies with the following standards:

ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
ハ ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
USP<85>Bacterial Endotoxins Test
USP<861>Sutures - Diameter
USP<871>Sutures - Needle Attachment
USP<881>Tensile Strength

c. Animal Study

No animal study is included in this submission.

d. Clinical Test Conclusion

No clinical study is included in this submission.

7. Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device, Non-absorbable Surgical Polyester Suture (K231183), is as safe, as effective, and performs as well as the legally marketed predicate device, K172149.

Regulation Number and Section

§ 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.