FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.
FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.
MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.

Device Description

FILASILK™ silk suture is a non-absorbable, sterile, surgical suture composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. FILASILK™ sutures are processed to remove the natural waxes and gums. FILASILK™ suture is available undyed or dyed black with Logwood extract and coated with bees wax. FILASILK™ suture meets requirements established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.
FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.
MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture. MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes.
FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue. FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Meril Endo Surgery Private Limited sutures, based on the provided document:

This document, a 510(k) Premarket Notification from the FDA, focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of novel performance criteria for a new type of device. Therefore, the "acceptance criteria" discussed are primarily regulatory and harmonized standards (USP requirements) that the device must meet to show it is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Device: Filasilk, Filamide, Mericron XL, Filaprop (All are different types of non-absorbable surgical sutures)

Acceptance Criteria (USP Requirements)	Reported Device Performance (Compliance)	Notes
Diameter USP <861>	Complies	FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes.
Tensile strength USP <881>	Complies	Includes knot pull tensile strength.
Needle attachment USP <871>	Complies	Includes suture-needle attachment.
Suture Length	Complies
Biocompatibility (various tests)	Evaluated (Implied compliance for substantial equivalence)	Tests include: In Vitro Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Sub Chronic Toxicity, Intramuscular Implantation, Bacterial Reverse Mutation, Mammalian Erythrocyte Micronucleus, In Vitro Hemolysis, Pyrogen Test.
Extractable Color	Complies	Colorants used (Logwood extract, D&C Green No. 6, Phthalocyanine blue) are in accordance with 21 CFR sections.
Sterility	Complies
Material Composition	Same as predicate devices	Made from organic protein (Filasilk), polyamide (Filamide), polyester (Mericron XL), polypropylene (Filaprop).
Design	Similar to predicate devices
Intended Use	Similar to predicate devices
Suture Size	Similar to predicate devices
Colorant Used Dye / Un-dyed	Similar to predicate devices
Suture Coating	Similar to predicate devices
Single Use	Similar to predicate devices
Sterilization Method	Similar to predicate devices
Packaging	Similar to predicate devices
Label Claim	Similar to predicate devices
Labeling and Instructions for Use (IFU)	Similar to predicate devices

Conclusion (from document): "Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (number of sutures tested) for the performance criteria. It only states that "The Surgical Suture was subjected to the performance testing as per USP requirements."

The data provenance is not explicitly stated as country of origin, but the submitting company is Meril Endo Surgery Private Limited, located in Vapi, Gujarat, India. The testing was conducted to meet United States Pharmacopoeia (U.S.P.) standards, implying internationally recognized quality and testing protocols for medical devices. The data is retrospective in the sense that it was generated for the 510(k) submission, not as part of a prospective clinical trial.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of submission. This document pertains to physical and chemical performance standards of surgical sutures, not diagnostic or interpretive tasks requiring expert ground truth establishment (like image analysis by radiologists). The "ground truth" here is defined by objective, measurable USP physical and chemical property standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is against objective physical/chemical standards, not interpretive judgments that would require adjudication.

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 device is a surgical suture, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the performance of diagnostic systems, often involving human readers.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation is based on established, objective, and quantitative specifications outlined in the United States Pharmacopoeia (USP) for non-absorbable surgical sutures. This includes:

USP <861> for diameter
USP <881> for tensile strength
USP <871> for needle attachment
General USP requirements for suture length, biocompatibility, sterility, and colorant compliance (e.g., 21 CFR references for dyes).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; there is no training set in the context of algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an algorithm, there is no ground truth established for such a purpose. The "ground truth" for demonstrating substantial equivalence is adherence to recognized industry standards (USP).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or bird with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2016

M/S. Meril Endo Surgery Private Limited Mr. Umesh Sharma Deputy General Manager - Quality Assurance 3fl, E1-e3, Meril Park, Survey No. 135/2/b & 174/2, Muktanand Marg Chala, Vapi, Gujaret 396191 INDIA

Re: K160623

Trade/Device Name: Filasilk - Natural Non-absorbable Silk Surgical Suture, Filamide -Non Absorbable Polyamide Surgical Sutures, Mericron XI - Non Absorbable Polyester Surgical Suture, Filaprop - Non Absorbable Polypropylene Surgical Suture

Regulation Number: 21 CFR 878.5030 Regulation Name: Natural Nonabsorbable Silk Surgical Suture Regulatory Class: Class II Product Code: GAP, GAR, GAT, GAW Dated: March 1, 2016 Received: March 4, 2016

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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -A

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)

K160623

Device Name FILAMIDE

Indications for Use (Describe)

FILAMIDE is intended for use as non-absorbable sutures in general soft tissue approximation including skin tissue closure and/or ligation in cardiac, vascular and ophthalmic procedures.

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

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Indications for Use

510(k) Number (if known)

K160623

Device Name FILAPROP

Indications for Use (Describe)

FILAPROP sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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Indications for Use

510(k) Number (if known)

K160623

Device Name FILASILK

Indications for Use (Describe)

FILASILK is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.

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

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Indications for Use

510(k) Number (if known)

K160623

Device Name MERICRON XL

Indications for Use (Describe)

MERICRON XL suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurosurgery and ophthalmic procedures.

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

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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: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com E-mail: umesh.sharma@merillife.com

Contact Person: Umesh Sharma Date Prepared: Feb 26, 2016

II. Device

Sr. No.	Trade Proprietary Name	/ Common Name	Classification	Regulatory Class	Product Code	Regulation Number	Review Panel
1.	FILASILKTMNatural Non-absorbable Silk Surgical Suture	Natural Non-absorbable Silk Surgical Suture	Suture, Non absorbable, Silk	II	GAP	878.5030	General & Plastic Surgery
2.	FILAMIDETMNon Absorbable Polyamide Surgical Sutures	Non-absorbable Polyamide Surgical Suture	Suture, Non absorbable, Synthetic, Polyamide	II	GAR	878.5020	General & Plastic Surgery
3.	MERICRON XLTM Non Absorbable Polyester Surgical Suture	Non absorbable Poly (Ethylene Terephthal ate) Suture	Suture, Non absorbable, Synthetic, Poly (Ethylene Terephthalate)	II	GAT	878.5000	General & Plastic Surgery
4.	FILAPROPTMNon Absorbable Polypropylene Surgical Suture	Non-absorbable Polypropyl ene Surgical Suture	Suture, Non absorbable, Synthetic, Polypropylene	II	GAW	878.5010	General & Plastic Surgery

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III. Predicate Device

Sr. No.	Meril's Proprietary Name	Suture Trade / Predicate Device Name	Predicate Device 510(k) No.
1.	FILASILKTM Natural Non-absorbable Silk Surgical Suture	TRUSILK	K041514
2.	FILAMIDETM Non Absorbable Polyamide Surgical Sutures	TRULON	K041510
3.	MERICRON XLTM Non Absorbable Polyester Surgical Suture	TRUBOND	K041512
4.	FILAPROPTM Non Absorbable Polypropylene Surgical Suture	PROLENE	K133356

IV. Device Description

a. FILASILK™ Natural Non-absorbable Silk Surgical Suture

established by the United States Pharmacopoeia (U.S.P.) for non-absorbable surgical suture.

b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures

FILAMIDE™ suture is a non-absorbable, sterile, synthetic, monofilament surgical suture composed of polyamide 6 [(NH-CO-(CH2)s]n and Polyamide 6,6 (NH(CH2)g-NH-CO-(CH2)4-CO)n. FILAMIDE™ sutures are dyed with Logwood extract. Available in a broad range of suture sizes and lengths, FILAMIDE'M is either non-needled or attached to standard stainless steel needles of varying types and sizes.

c. MERICRON XL™ Non Absorbable Polyester Surgical Suture

MERICRON XL™ suture is a coated, braided, non-absorbable sterile surgical suture composed of poly (ethylene terephthalate). The empirical molecular formula of the polymer is (C10HoO4),. The suture is coated with bees wax which acts as a lubricant to mechanically improve the ease of passage through tissue and the overall handling quality of the suture.

MERICRON XL™ is available undyed or dyed green with D & C Green No.6. MERICRON XL™ is available in a range of gauge sizes and lengths, or attached to standard stainless steel needles of various types and sizes

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d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture

FILAPROP™ suture is a monofilament, synthetic non-absorbable, sterile surgical suture composed of an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The molecular formula of polypropylene is (C3Hs)n, FILAPROP™ sutures are dyed with phthalocyanine blue.

FILAPROP™ is available in a range of gauge sizes and lengths attached to standard stainless steel needles of various types and sizes

V. Intended Use

a. FILASILK™ Natural Non-absorbable Silk Surgical Suture

FILASILK'" is intended for use as non-absorbable sutures in general soft tissue approximation and/or ligation including use in cardiac, vascular and ophthalmic procedures.

b. FILAMIDE™ Non Absorbable Polyamide Surgical Sutures

FILAMIDE™ Non-absorbable Polyamide Surgical suture is indicated for use in soft tissue approximation and/ or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

c. MERICRON XL™ Non Absorbable Polyester Surgical Suture

MERICRON XL™ suture is intended for use in general soft tissue approximation and/or ligation including cardiovascular surgery, neurological and ophthalmic procedures.

d. FILAPROP™ Non Absorbable Polypropylene Surgical Suture

FILAPROP™ sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

VI. Substantial Equivalence

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

1. Product description
1. Intended use
1. Suture Size
1. Colorant Used Dye / Un-dyed
1. Suture Coating
1. Single use
1. Sterilisation method

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1. Packaging
1. Label Claim
1. Performance
- a. Diameter USP <861>
- b. Tensile strength USP <88l>
- c. Needle attachment USP <871>
- d. Suture Length
1. Labeling 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>
1. Tensile strength USP <88l>
1. Needle attachment USP <871>
1. Suture Length
1. Biocompatibility
- a. In Vitro Cytotoxicity Study
- b. Skin Sensitization Study
- c. Intracutaneous Reactivity Test
- d. Acute Systemic Toxicity Study
- e. Sub Chronic Toxicity Study
- f. Intramuscular Implantation Test
- Bacterial Reverse Mutation Test g.
- h. Mammalian Erythrocyte Micronucleus Test
- In Vitro Hemolysis Test i.
- Pvrogen Test ....

VIII. Conclusion

Meril's Surgical Sutures are composed of the same materials, as are the predicate devices and has the same design, as do the predicate.

The subject devices are offered with the same colorants as predicate devices i.e. Logwood extract black used in FILASILK™ & FILAMIDE™ is in accordance to 21 CFR 73.1410, D&C Green No. 6 used in MERICRON XL™ is in accordance with 21 CFR 74.3206 & Phthalocyanine blue used in FILAPROP™ is in accordance with 21 CFR 74. 3045).

Performance testing of the Meril sutures complies the USP requirements i.e. suture diameter, suture length, knot pull tensile strength, extractable color, suture-needle

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attachment and sterility. However, FILAMIDE™ & FILAPROP™ may be slightly oversize in diameter to U.S.P. requirement for some suture sizes.

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.