MERISTEEL

K172146 · M/s. Meril Endo Surgery Private Limited. · GAQ · Feb 1, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172146
• Device Name: MERISTEEL
• Applicant: M/s. Meril Endo Surgery Private Limited.
• Product Code: GAQ · General, Plastic Surgery
• Decision Date: Feb 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4495
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

Device Story

Meristeel is a monofilament, non-absorbable sterile surgical suture made of stainless steel. It is provided in various gauge sizes and lengths, often attached to stainless steel needles. Used by surgeons in clinical settings (OR) for tissue approximation in abdominal, hernia, sternal, and orthopedic procedures. The device functions as a mechanical fastener to hold tissue edges together during healing. It is a single-use, sterile device. Benefits include high tensile strength and non-absorbable nature, providing long-term support for wound closure.

Clinical Evidence

Bench testing only. Performance evaluated against USP requirements for diameter (USP <861>), tensile strength (USP <881>), needle attachment (USP <871>), and suture length. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Monofilament stainless steel surgical suture. Complies with USP for non-absorbable surgical sutures and European Pharmacopoeia for sterile non-absorbable surgical strands. Available in various gauge sizes and lengths with attached stainless steel needles. Single-use. Sterilization method not specified.

Indications for Use

Indicated for abdominal wound closure, hernia repair, sternal closure, and orthopedic procedures including cerclage and tendon repair in patients requiring non-absorbable surgical sutures.

Regulatory Classification

Identification

A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.

Special Controls

*Classification.* Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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

• Stainless Steel surgical suture (CP Medical) (K030351)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

### February 1, 2018

M/s. Meril Endo Surgery Private Limited Mr. Umesh Sharma Deputy General Manager - Quality Assurance Third Floor, E1-E3. Meril Park Survey No. 135/2/B & 174/2, Muktanand Marg Chala, Vapi District, Valsad, 396191 India

### Re: K172146

Trade/Device Name: Meristeel Regulation Number: 21 CFR 878.4495 Regulation Name: Stainless Steel Suture Regulatory Class: Class II Product Code: GAO Dated: December 29, 2017 Received: January 3, 2018

### Dear Mr. Sharma:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172146

Device Name MERISTEEL

Indications for Use (Describe)

MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary

#### l. Submitter

M/s. Meril Endo Surgery Private Limited Third Floor, E1 – E3, Meril Park, Survey No. 135/2/B & 174/2, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: [phone], Fax: [phone] Web site: www.merillife.com E-mail: [e-mail]

Contact Person: Umesh Sharma Date Prepared: June 21, 2017

# II. Device

| Sr.<br>No. | Trade /<br>Proprietary Name | Common<br>Name | Classification<br>n | Regulatory Class | Product Code | Regulation Number | Review Panel |
|------------|----------------------------------------------------------------|----------------------------------------------------------|----------------------------------------------------------|------------------|--------------|-------------------|-----------------------------------------------------|
| 1. | Meristeel™<br>- Stainless Steel<br>Steel<br>Surgical<br>Suture | Stainless Steel<br>Surgical<br>Suture,<br>Non-Absorbable | Stainless Steel<br>Surgical<br>Suture,<br>Non-Absorbable | II | GAQ | 21 CFR 878.4495 | General &<br>Plastic<br>Surgery<br>Devices<br>Panel |

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## III. Predicate Device

Stainless Steel surgical suture (CP Medical) - (510k : K030351)

# IV. Device Description

MERISTEEL™ Stainless steel suture is a monofilament, non-absorbable sterile surgical suture composed of stainless steel.

This suture is available undyed and uncoated.

MERISTEEL™ suture is available in a range of gauge sizes and lengths, and attached to standard stainless steel needles of various types and sizes.

Stainless steel suture complies with the requirements of the United States Pharmacopoeia for Non Absorbable Surgical suture and European Pharmacopoeia for Sterile Non-Absorbable surgical strands

## V. Intended Use

MERISTEEL™ sutures are intended for use in abdominal wounds closure, hernia repair, sterna closure and orthopaedic procedure including cerclage & tendon repair.

### VI. Substantial Equivalence

The device design, material of construction, performance, packaging and intended uses are substantial equivalence to the predicate device. Substantial equivalence is based on the following parameters:

- 1. Product description
- 2. Intended use
- 3. Suture Size
- 4. Single use
- 5. Sterilisation method

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- 6. Packaging
- 7. Label Claim
- 8. Performance
- a. Diameter USP <861>
- b. Tensile strength USP <881>
- c. Needle attachment USP <871>
- d. Suture Length
- 9. Labelling and Instructions for use (IFU)

# VII. Performance Data

The Surgical Suture was subjected to the performance testing as per USP requirements. The safety and effectiveness of the Surgical Suture has been evaluated for the following performance and safety requirements.

- 1. Diameter USP <861>
- 2. Tensile strength USP <881>
- 3. Needle attachment USP <871>
- 4. Suture Length
- 5. Biocompatibility as per ISO 10993-1

#### Conclusion VIII.

Meristeel™ Stainless Steel Sutures are substantially equivalent to currently marketed devices Stainless Steel surgical suture (CP Medical) - (510k: K030351) and present no substantial differences in design, material, intended use and function to predicate device.