Non absorbable Surgical Polyester Suture

K231183 · Shandong Haidike Medical Products Co., Ltd. · GAT · Aug 25, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K231183
• Device Name: Non absorbable Surgical Polyester Suture
• Applicant: Shandong Haidike Medical Products Co., Ltd.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Aug 25, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Coated, braided, non-absorbable synthetic surgical suture composed of polyethylene terephthalate; dyed green with D&C Green 6; coated with bees wax. Available in USP sizes 6-0 through 2; lengths 45cm to 150cm; supplied with or without stainless steel needles. Used by clinicians for general soft tissue approximation and ligation. Device provides short-term wound support (7-10 days) and is removed within 10 days. Sterile, single-use device.

Clinical Evidence

No clinical data. Bench testing only. Biocompatibility testing performed per ISO 10993-1:2018, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, genotoxicity, and implantation. Performance testing verified compliance with USP <861> (diameter), USP <871> (needle attachment), and USP <881> (tensile strength).

Technological Characteristics

Material: Polyethylene terephthalate; Coating: Bees wax; Colorant: D&C Green 6; Structure: Braided; Needle: Stainless steel; Sterilization: Ethylene Oxide (EO). Standards: USP <861>, <871>, <881>, <85>; ASTM F88/F88M-15, F1929-15, F756-17; ISO 10993 series.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in patients requiring short-term wound support (7-10 days). Contraindicated for ophthalmic, cardiovascular, and neurological procedures. Maximum duration of use is 10 days.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MERICRON XL - Non-Absorbable Polyester Surgical Suture (K172149)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K231183

Device Name Non-absorbable Surgical Polyester Suture

### Indications for Use (Describe)

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.

| 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-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: [phone] Fax: [phone] 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 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.

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## 5. Indications for Use:

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.

## 6. Summary of Technological Characteristics

| ITEM | Subject Device<br>(K231183) | Predicate Device<br>K172149 | 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 Surgical<br>Polyester Suture is indicated for<br>use in general soft tissue<br>approximation and/or ligation, but<br>not for use in ophthalmic,<br>cardiovascular, and neurological<br>procedures. The device is limited<br>to use where short term wound<br>support (7-10 days) is required<br>and can be left in place for a<br>maximum of 10 days. | MERICRON XL suture is<br>intended for use in general soft<br>tissue approximation and/or<br>ligation including<br>cardiovascular surgery,<br>neurosurgery, and ophthalmic<br>procedures. | Analysis 1 |
| | Configuration | Polyester Suture with or without<br>needle | 1、MERICRON XLTM Suture<br>with or without needle.<br>2、MERICRON XLTM Suture is<br>available with or without<br>PTFE<br>(Polytetrafluoroethylene)<br>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 USP<br>Requirement | |
| Tensile Strength | Comply with USP <881> | | Same |
| Length | Not less than 95.0% of the length<br>stated on the label | Unknown | Analysis 3 |
| Biocompatibility | | | |
| Cytotoxicity (ISO<br>10993-5) | Pass | The Surgical Suture has been<br>Evaluated:<br>a.In Vitro Cytotoxicity Study<br>b. Skin Sensitization Study<br>c.Intracutaneous Reactivity Test<br>d.Acute Systemic Toxicity<br>Study<br>e.Sub Chronic Toxicity Study<br>f. Intramuscular Implantation<br>Test<br>g. Bacterial Reverse Mutation<br>Test<br>h. Mammalian Erythrocyte<br>Micronucleus Test<br>i. In Vitro Hemolysis Test<br>j. Pyrogen Test | |
| Sensitization (ISO<br>10993- 10) | Pass | | |
| Intracutaneous<br>Reactivity (ISO<br>10993- 10) | Pass | | |
| Acute systemic<br>toxicity (ISO<br>10993- 11) | Pass | | |
| Pyrogen (USP 43<br>NF38 <151>) | Pass | | |
| Subacute<br>Systemic Toxicity<br>(ISO 10993- 11) | Pass | | Analysis 4 |
| Bacterial Reverse<br>Mutation (ISO<br>10993-3) | Pass | | |
| Chromosome<br>Aberration (ISO<br>10993-3) | Pass | | |
| Gene Mutation (ISO<br>10993-3) | Pass | | |
| Implantation (ISO<br>10993-6) | Pass | | |
| Hemolysis ( ASTM<br>F756-17) | Pass | | |

Table 1: Comparison of Technological Characteristics

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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,

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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

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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.