Non absorbable Surgical Polypropylene 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

The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.

AI/ML Overview

The provided text describes the 510(k) summary for a Non Absorbable Surgical Polypropylene Suture (K230746). It focuses on demonstrating substantial equivalence to a predicate device (K080684) through non-clinical performance data.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly provide a single table listing "acceptance criteria" alongside "reported device performance" in a quantitative manner for most tests. Instead, it lists the standards the device complies with for various performance aspects and states that the test results met these requirements.

However, some specific acceptance criteria and general performance statements are given:

Criterion Type	Acceptance Criteria	Reported Device Performance
Diameter of suture	Comply with USP <861>	"the test result shows that the length and diameter of the proposed device met the acceptance criteria." (General statement, implies compliance with USP <861>)
Needle Attachment	Comply with USP <871>	Reported as "Same" as predicate, implying compliance with USP <871>
Tensile Strength	Comply with USP <881>	Implied compliance with USP <881>
Length	Not less than 95.0% of the length stated on the label	"the test result shows that the length and diameter of the proposed device met the acceptance criteria." (General statement, implies compliance with this criterion)
Cytotoxicity	The viability is not reduced to less than 70%	The device passed, implying viability was not reduced to less than 70%
Sensitization	The Magnusson and Kligman grades is less than 1.	The device passed, implying grades less than 1.
Intracutaneous Reactivity	The erythema and edema grades is less than 1.0.	The device passed, implying grades less than 1.0.
Acute systemic toxicity	No animal died or abnormal behavior occurred.	The device passed, implying no animal died or abnormal behavior occurred.
Pyrogen	Temperature raise is less than 0.5℃ No behavioral change or sign of toxicity was observed. Clinical pathology parameter within the reference range.	The device passed, implying these conditions were met.
Subacute Systemic Toxicity	No macroscopic changes in the viscera at necropsy. Histopathology within normal histomorphological limits	The device passed, implying these conditions were met.
Bacterial Reverse Mutation	No obviously increase in the mean number of revertant of colonies between the test group and control group.	The device passed, implying no obvious increase.
Chromosome Aberration	No significant difference in the percentage of cells with chromosome aberrations between the test group and control group.	The device passed, implying no significant difference.
Gene Mutation	There was no significant difference in the TFT-resistant mutant frequency between the test article	The device passed, implying no significant difference.
Implantation	No lesion at the implantation site. The irritation score is less than 1.0.	The device passed, implying no lesion and irritation score less than 1.0.
Hemolysis	Hemolytic index is less than 2%	The device passed, implying hemolytic index less than 2%.
Seal Strength	Complies with ASTM F88/F88M-15	"The test results demonstrated that the subject device complies with the following standards" (including ASTM F88/F88M-15).
Detecting Seal Leaks	Complies with ASTM F1929-15	"The test results demonstrated that the subject device complies with the following standards" (including ASTM F1929-15).
Hemolytic Properties	Complies with ASTM F756-17	"The test results demonstrated that the subject device complies with the following standards" (including ASTM F756-17).
EO Sterilization Residuals	Complies with ISO 10993-7:2008	"The test results demonstrated that the subject device complies with the following standards" (including ISO 10993-7:2008).
Penetration Testing of Needles	Complies with ASTM F3014-14	"The test results demonstrated that the subject device complies with the following standards" (including ASTM F3014-14).
Bend Testing of Needles	Complies with ASTM F1874-98	"The test results demonstrated that the subject device complies with the following standards" (including ASTM F1874-98).

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for any of the non-clinical tests mentioned.
The data provenance is also not specified, as these are bench tests and biological evaluations, not human data. It is implied these tests were conducted by the manufacturer or a contracted lab to meet international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to the provided information. The tests conducted are non-clinical (bench testing, biocompatibility). There is no "test set" requiring expert ground truth establishment in the context of diagnostic performance or clinical outcomes. The "ground truth" for these tests comes from adherence to established scientific and regulatory standards (e.g., USP, ISO, ASTM).

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or diagnostic performance evaluations involving human interpretation. The reported tests are non-clinical lab tests and biocompatibility assessments, where results are typically objective measurements or observations against predefined criteria.

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

This question is not applicable. The device is a surgical suture, not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this device.

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

This question is not applicable. The device is a surgical suture, not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is established by adherence to recognized international standards and pharmacopeial monographs. For example:

USP <861>, <871>, <881>: These are pharmacopeial standards defining requirements for suture diameter, needle attachment, and tensile strength.
ISO 10993 series: These are international standards for the biological evaluation of medical devices, covering aspects like cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, and hemolysis.
ASTM standards: These are industrial standards covering material properties and packaging (e.g., seal strength, dye penetration, needle bend/penetration).

The ground truth is based on the objective criteria and methodologies outlined in these standards.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The submission focuses on verifying the physical and biological characteristics of a mechanical device against established standards.

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

This question is not applicable, as there is no training set for this device.

Summary

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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the agency's name, "U.S. Food & Drug Administration."

September 14, 2023

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

Re: K230746

Trade/Device Name: Non absorbable Surgical Polypropylene Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: March 15, 2023 Received: March 17, 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.

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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) 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.Lamichhane -S	Digitally signed byTek N. Lamichhane -SDate: 2023.09.1409:51:31 -04'00'
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Tek N. Lamichhane, Ph. D. 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

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Indications for Use

510(k) Number (if known) K230746

Device Name

Non Absorbable Surgical Polypropylene 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)

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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: K230746

1. Date of Preparation: 08/12/2023
1. 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: registration(01(@suturescn.com

1. Identification of Subject Device:
  Trade Name: Non Absorbable Surgical Polypropylene Suture Common Name: Nonabsorbable Polypropylene Surgical Suture

Regulatory Information

Classification Name: Suture, Nonabsorbable, Synthetic, Polypropylene Classification: II Product Code: GAW Regulation Number: 21CFR 878.5010 Review Panel: General & Plastic Surgery

1. Identification of Predicate Device 510(k) Number: K080684 Regulation Number: 21CFR 878.5010 Classification: II Product Code: GAW Review Panel: General & Plastic Surgery Product name: WG-Surgical Sutures with Needle

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1. Device description
  The subject device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device is dyed blue. The color additive is [phtalocyaninato(2-)] copper(Color Index Number 74160), and the weight percentage for the color additive is less than 0.1%. The device will be offered in diameters ranging from USP size 6-0 through 2 and is available in length 75cm or 150cm with or without needles attached. Polypropylene suture meets all the requirements of USP for Non-absorbable surgical suture.
1. Indications for Use
  Non absorbable Surgical Polypropylene 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.
1. Technological characteristic comparison

ITEM	Subject Device(K230746)	Predicate Device(K080684)	Remark
Product Code	GAW	GAW	Same
Regulation Number	21CFR 878.5010	21CFR 878.5010	Same
Class	II	II	Same
Sterile	Ethylene Oxide (EO)	Ethylene Oxide (EO)	Same
Indication for Use	Non absorbable SurgicalPolypropylene Suture is indicatedfor use in general soft tissueapproximation and/or ligation, butnot for use in ophthalmicprocedures, cardiovascular andneurological procedures. Thedevice is limited to use whereshort term wound support (7-10days) is required and can be leftin place for a maximum of 10days.	Nonabsorbable PolypropyleneSuture with Needle is indicatedfor use in general soft tissueapproximation and/or ligationincluding use in cardiovascular,ophthalmic and neurologicalprocedures.	Analysis 1
Configuration	Polypropylene Suture with orwithout needle	Polypropylene Suture with needle	Similar
Suture
Material	Polypropylene	Polypropylene	Same

Table 1: Comparison of Technological Characteristics

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Structure	Monofilament	Monofilament	Same
Dyed, Un-dyed	Dyed	Dyed	Same
Colorant	[phtalocyaninato(2-)] copper	Blue	Analysis 2
Length	75cm, 150cm	Unknown	Analysis
Diameter	6-0 through 2	10-0 through 2	3
Needle
Material	Stainless Steel	Stainless Steel	Same
Performance Test
Diameter of suture	Comply with USP <861>	All characteristics meet USPRequirement
Needle Attachment	Comply with USP <871>	Same
Tensile Strength	Comply with USP <881>
Length	Not less than 95.0% of thelength stated on the label	Unknown	Analysis3
Suture Biocompatibility
Cytotoxicity	The viability is not reduced to lessthan 70%
Sensitization	The Magnusson and Kligmangrades is less than 1.
IntracutaneousReactivity	The erythema and edema grades isless than 1.0.	The specific test items areunknown. However, the productshould meet the requirements ofISO10993 series standards.
Acute systemictoxicity	No animal died or abnormalbehavior occurred.
Pyrogen	Temperature raise is less than 0.5℃No behavioral change or sign oftoxicity was observed.Clinical pathology parameterwithin the reference range.
SubacuteSystemic Toxicity	No macroscopic changes in theviscera at necropsy.Histopathology within normalhistomorphological limits
BacterialReverseMutation	No obviously increase in the meannumber of revertant of coloniesbetween the test group and controlgroup.
ChromosomeAberration	No significant difference in thepercentage of cells withchromosome aberrationsbetween the test group andcontrol group.
Gene Mutation	There was no significant differencein the TFT-resistant mutantfrequency between the test article

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Implantation	No lesion at the implantation site.The irritation score is less than 1.0.
Hemolysis	Hemolytic index is less than 2%

Analysis 1-Indication for Use

The indication for use for the subject device is not exactly the same as the predicate device. The proposed device is just indicated for general tissue approximation but not for use in ophthalmic procedures, cardiovascular and neurological procedures and this indication can be covered by the predicate device. 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 on the proposed device and the test result showed that the material and colorant of the proposed device will not have an adverse effect when used for up to 10 days.

Analysis 2- Colorant

The material and colorant of the proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have adverse effects. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Analysis 3- Length & Diameter

The length and diameter of the proposed device is different from the predicate device. However, the length and diameter of the proposed device are 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 proposed device met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

8. Non-Clinical Performance Data

Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate 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 >
A 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
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

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Sensitization

ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic Toxicity
USP<151> Pyrogen Test (USP Rabbit Test) A
USP<85>Bacterial Endotoxins Test
USP<861>Sutures - Diameter
USP<871>Sutures - Needle Attachment
USP<881>Tensile Strength
ASTM F3014-14 Standard Test Method for Penetration Testing of Needles Used in Surgical Sutures
ASTM F1874-98 Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
1. Clinical Test Conclusion

No clinical study is included in this submission.

10. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, effective, and performs as well as the legally marketed predicate device, K080684.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.