MEGASORB Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.

MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular or neurological tissues.

MITSU FST suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.

FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.

FILAPRON dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

Device Description

MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate.

FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone).

FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone).

All sutures are available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.

AI/ML Overview

This document is a 510(k) premarket notification for several types of absorbable surgical sutures (MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON). It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving novel effectiveness through a new clinical effectiveness study.

Therefore, the typical acceptance criteria and study design for new AI/Medical Device effectiveness, as requested in your prompt (which often includes human reader studies, ground truth establishment by experts, and analysis of effect sizes), are not applicable to this type of regulatory submission.

Instead, the "acceptance criteria" here refer to meeting the performance specifications of the predicate devices and relevant USP standards, and the "study" is a series of laboratory and biocompatibility tests designed to show that the new devices perform equivalently to the predicates.

Here's a breakdown based on the provided document, addressing the closest analogues to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" but refers to compliance with USP (United States Pharmacopeia) standards and equivalence to predicate devices. The "reported device performance" is implicitly that the devices met these standards and demonstrated substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Physical Properties	Conformance to USP <861> for Diameter	Met USP <861> requirements (implied by "evaluated for... requirements")
	Conformance to USP <881> for Tensile Strength	Met USP <881> requirements (implied)
	Conformance to USP <871> for Needle Attachment	Met USP <871> requirements (implied)
	Equivalent Resorption Profile to Predicate	Equivalent to predicate (implied)
	Conformance to Suture Length requirements	Met requirements (implied)
Biocompatibility Studies	Non-toxic, non-irritating, non-sensitizing, non-pyrogenic, non-mutagenic, no adverse systemic effects (as per ISO 10993 concepts)	Devices demonstrated biocompatibility, non-pyrogenic properties (implied by listing studies and conclusion of safety)
Material/Design Equivalence	Same materials of construction, design, and intended use as predicate devices	Confirmed ("composed of the same materials... and has the same design, as do the predicate.")

2. Sample Size for Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes used for each individual performance test (e.g., number of sutures tested for tensile strength, number of animals for biocompatibility). It generally states that the "Surgical Suture was subjected to the performance testing as per USP requirements." USP standards often outline minimum sample sizes for specific tests.
Data Provenance: The tests were conducted by the submitter, Meril Endo Surgery Private Limited, based in India. The studies are prospective in the sense that they were conducted specifically to demonstrate the performance of these new devices for the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable: This type of submission (510(k) for surgical sutures) does not involve medical image interpretation or clinical diagnostic tasks that require experts to establish "ground truth" in the way an AI diagnostic device would. Performance is measured against physical and biological standards, not against expert medical consensus on a particular condition.

4. Adjudication Method for Test Set

Not Applicable: There is no "adjudication method" in the sense of resolving conflicting interpretations by multiple human readers. Lab tests follow standardized protocols. Biocompatibility studies involve expert animal pathologists and toxicologists interpreting results, but this is standard scientific interpretation rather than "adjudication" of a ground truth label in an AI context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable: No MRMC study was done. This device is a surgical suture, not a diagnostic imaging device or an AI-assisted tool meant to improve human reader performance.

6. Standalone Performance Study (Algorithm Only)

Not Applicable: This is not an algorithm or AI device. Its performance is measured directly through physical and biological testing.

7. Type of Ground Truth Used

For physical properties (diameter, tensile strength, needle attachment, suture length): The "ground truth" is established by objective measurements against predefined scientific standards (USP specifications).
For resorption profile: The "ground truth" or reference is the resorption profile of the legally marketed predicate device.
For biocompatibility: The "ground truth" is established by standardized laboratory tests and expert interpretation of biological responses, adhering to recognized toxicology and biocompatibility guidelines (e.g., ISO 10993 series, though not explicitly cited in the summary, is standard practice). There isn't a single "ground truth" label; rather, it's a demonstration that the device's biological interactions fall within acceptable safety limits.

8. Sample Size for Training Set

Not Applicable: There is no "training set" as this is not a machine learning or AI device.

9. How Ground Truth for Training Set was Established

Not Applicable: As above, no training set or its associated ground truth.

In summary: The K172659 submission demonstrates substantial equivalence for absorbable surgical sutures by showing that these new devices meet established performance standards (primarily USP) and exhibit similar material compositions, designs, and intended uses to existing predicate devices. The evaluation focuses on laboratory testing and biocompatibility assessments rather than clinical performance studies that would involve human readers or AI algorithms.

Summary

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

September 28, 2017

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, India, Valsad Gujarat, 396191, IN

Re: K172659

Trade/Device Name: MEGASORB - Natural absorbable Polyglycolic Acid Surgical Suture, MITSU - Absorbable Polyglactin 910 Surgical Sutures, MITSU FST -Absorbable Polyglactin 910 Surgical Suture, FILAXYN - Absorbable Polydioxanone Surgical (PDS), FILAPRON - Absorbable poly(glycolide-co-caprolactone) Surgical Suture Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW Dated: August 28, 2017 Received: September 5, 2017

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

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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 (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 (DICE) 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 (DICE) 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.

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) K172659

Device Name MEGASORB, MITSU, MITSU FST, FILAXYN, FILAPRON

Indications for Use (Describe)

MITSU suture is intended for use in general soft tissue approximation including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.

FILAXYN sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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K172659 Page 1 of 7

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: August 26, 2017

II. Device

Sr.No.	Trade / ProprietaryName	CommonName	Regulatory Class	ProductCode	Regulation Number	ReviewPanel
1.	MEGASORBTMabsorbable PolyglycolicAcid Surgical Suture	Braided coatedPolyglycolicAcid Suture	II	GAM	878.4493	General &PlasticSurgery
2.	MITSUTM Absorbablepoly(glycolide/l-lactide)Surgical Sutures	Braided coatedPolyglactinSuture	II	GAM	878.4493	General &PlasticSurgery
3.	MITSU FSTTMAbsorbable poly(glycolide / l-lactide) Surgical Sutures	Braided coatedPolyglactinSuture	II	GAM	878.4493	General &PlasticSurgery
4.	FILAXYNTM Absorbablepoly (p-dioxanone)Surgical Suture	MonofilamentPolydioxanoneSuture	II	NEW	878.4840	General &PlasticSurgery
5.	FILAPRONTMAbsorbable poly(glycolide -co caprolactone) SurgicalSuture	MonofilamentPolyglecaproneSuture	II	GAM	878.4493	General &PlasticSurgery

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III. Predicate Device

Sr. No.	Meril's SutureProprietary Name	Suture Trade /Predicate Device Name	Predicate Device510(k) No.
1.	MEGASORBTMPolyglycolic Acid Surgical Suture	absorbableMEGASORBTM	K150717
2.	MITSUTMpoly(glycolide/l-lactide) SurgicalSutures	AbsorbableMITSUTM	K150717
3.	MITSU FSTTMpoly(glycolide/l-lactide) SurgicalSutures	AbsorbableMITSU FSTTM	K150717
4.	FILAXYNTM Absorbable poly (p-dioxanone) Surgical Suture	FILAPRONTM	K150717
5.	FILAPRONTMpoly(glycolide-co-caprolactone)Surgical Suture	AbsorbableFILAXYNTM	K150717

IV. Device Description

A. MEGASORB™ absorbable Polyglycolic Acid Surgical Suture

MEGASORB™ suture is a synthetic absorbable sterile surgical suture composed of Polyglycolic Acid. Braided MEGASORB™ sutures are coated with polycaprolactone and calcium stearate. Poly Glycolic Acid coated with polycaprolactone and calcium stearate has been found to be non-pyrogenic and eliciting only slight tissue reaction during absorption. The empirical formula of the Polyglycolic Acid, polycaprolactone and calcium stearate is (C2H2O2)n, (C6H10O2)n and C36H70Q4Ca respectively.MEGASORB™ sutures are available either undyed or dyed (D and C Violet No. 2, Colour Index number: 60725) form. MEGASORB™ is available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.

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MEGASORB™ suture is available in U.S.P. size range 8-0 to 2, undyed/dyed form in pack size of 6/12/24/36.

B. MITSUT™ Absorbable poly(glycolide/l-lactide) Surgical Sutures

MITSUTM is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made of glycolide and L-lactide. MITSUTM sutures are coated with a mixture containing equal parts of copolymer of glycolide and lactide and calcium stearate. The empirical formula of the copolymer is (C2H2O2)m (C3HzO2)n and calcium stearate is C36H704Ca. Poly(glycolide/l-lactide) copolymer and poly(glycolide/l-lactide) with calcium stearate exhibit non-pyrogenic properties. MITSU™ sutures are available in undyed and dyed (D and C violet No. 2, Colour Index No. 60725) form. Available in a broad range of suture sizes and lengths, MITSU™ comes with standard stainless steel needles of varying types and sizes.

MITSUTM suture is available in size range 8-0 to 2, undyed/dyed form, and pack size of 6/12/24/36.

C. MITSU FST™ Absorbable poly(glycolide/l-lactide) Surgical Sutures

MITSU FST™ is a braided coated synthetic absorbable sterile poly(glycolide/llactide) surgical suture. It is composed of a copolymer made from glycolide and L-lactide. MITSU FST™ sutures are coated with a mixture containing equal parts of copolymer of glycolide and calcium stearate. The empirical formula of the copolymer is (C2H2O2)m (C3H4O2)n and calcium stearate is C36H704Ca. The rapid loss of strength is achieved by using polymer material with lower molecular weight than that of regular MITSUTM suture. Poly(glycolide/l-lactide) copolymer and poly(glycolide/l-lactide) with calcium stearate exhibit non-pyrogenic properties and elicit only slight tissue reaction during absorption. MITSU FST™ sutures are available in undyed form. Available in a broad range of suture sizes and lengths, MITSU FST™ comes with standard stainless steel needles of varying types and sizes.

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MITSU FST™ suture is available in U.S.P. size range 6-0 to 1, undyed form in pack size of 6/12/24/36.

D. FILAXYN™ Absorbable poly (p-dioxanone) Surgical Suture

FILAXYN™ is a sterile synthetic absorbable monofilament suture composed of Poly (p-dioxanone). The empirical molecular formula of the polymer is (C4HgO3), Poly (p-dioxanone) polymer has non-pyrogenic properties. FILAXYN™ sutures are available in undyed or dyed (D and C Violet No.2, Color Index number: 60725) form. FILAXYN™ is available in a range of gauge sizes and lengths, attached to standard stainless steel needles of varying types and sizes.

FILAXYN™ suture is available in size range 7-0 to 2, undyed/dyed form in pack size of 6/12/24/36.

E. FILAPRON™ Absorbable poly(glycolide-co-caprolactone) Surgical Suture

FILAPRON™ is a sterile synthetic absorbable monofilament suture is composed of poly(glycolide-co-caprolactone). The empirical molecular formula of the polymer is (C2H2O2)m (C6H10O2)n poly(glycolide-cocaprolactone) has non-pyrogenic properties. FILAPRON™ sutures are available either in undyed or dyed (D and C violet No. 2, Colour Index No. 60725) form. FILAPRON™ is available in a range of gauge sizes and lengths and attached to standard stainless steel needles of varying types and sizes. FILAPRON™ suture is available in size range 6-0 to 2, undyed/dyed form in pack size of 6/12/24/36.

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V. Intended Use

1. MEGASORBTM Absorbable Polyglycolic Acid Surgical Sutures are indicated for use in soft tissue approximation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological procedures.
1. MITSUTM suture is intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological tissues.
1. MITSU FST™ suture is indicated only for use in superficial general soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required. MITSU FST™ suture is not intended for use in ligation, ophthalmic, cardiovascular or neurological procedures.
1. FILAXYN™ sutures are indicated for use in soft tissue approximation, including use in ophthalmic procedures, but not for use in cardio vascular and neurological procedures.
1. FILAPRON™ dyed / undyed sutures are intended for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

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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
1. Suture Coating
1. Single use
1. Sterilisation method
1. Packaging
1. Label Claim
1. Performance
- a. Diameter USP <861>
- b. Tensile strength USP <88|>
- Needle attachment USP <871> ﻥ ﻧ
- d. Resorption profile
- e. Suture Length

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>
1. Tensile strength USP <881>
1. Needle attachment USP <871>
1. Resorption Profile
1. Suture Length
1. Biocompatibility
- a. In Vitro Cytotoxicity Study

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b. Skin Sensitization Study
c. Intracutaneous Reactivity Test
d. Acute Systemic Toxicity Study
e. Sub Chronic Toxicity Study
Intramuscular Implantation Test f.
Bacterial Reverse Mutation Test g.
h. Mammalian Erythrocyte Micronucleus Test
In Vitro Hemolysis Test İ.
j. Pyrogen Test

Conclusion VIII.

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

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.