The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

Device Description

APTOS Threads - Polypropylene Surgical Sutures are a dyed, nonabsorbable, sterile surgical strand of polypropylene in USP size 2-0. The base product is an isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin. The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives. The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.

AI/ML Overview

This document describes the premarket notification for APTOS Threads - Polypropylene Surgical Sutures. As a medical device, the acceptance criteria and supporting studies focus on demonstrating its substantial equivalence to a legally marketed predicate device (FilBloc Permanent Sutures, K171039) rather than on specific diagnostic performance metrics of an AI algorithm.

Therefore, the requested information on AI-specific criteria, sample sizes for test/training sets for AI, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable in this context.

The acceptance criteria for this device are based on its physical properties, biocompatibility, and sterility, ensuring it functions similarly and as safely as existing sutures.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (APTOS Threads)
Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance (specifically ISO 10993-5, -10, -11, -6, -4; ASTM F756-17; OECD 471, 487, 476; USP<161>)	Biocompatibility testing was performed in accordance with ANSVAAMI/ISO 10993-1:2009/(R)2013 and FDA's 2016 guidance document. All specific tests (Cytotoxicity, Sensitization, Irritation, Acute systemic Toxicity, Materials Mediated Pyrogenicity, Implantation, Hemocompatibility, Subchronic Toxicity, Genotoxicity, Bacterial Endotoxin Test) were conducted and results demonstrated the device is biocompatible.
Physical Testing	USP<861> Suture Diameter	Compliance with USP<861> suture diameter was established through physical testing.
	USP<871> Suture Attachment	Compliance with USP<871> suture attachment was established through physical testing.
	USP<881> Tensile Strength	Compliance with USP<881> tensile strength was established through physical testing.
Tissue Holding Strength	Adequate tissue holding strength comparable to the predicate device.	Ex-vivo tissue holding strength testing was conducted and compared to the predicate device to demonstrate substantially equivalent tissue holding strength.
Sterility	Ethylene Oxide Sterilization with a Sterility Assurance Level (SAL) of 10⁻⁶	Ethylene Oxide sterility validation testing was conducted in accordance with overkill half-cycle methods per ISO 11135:2014, demonstrating an SAL of 10⁻⁶. Residuals were evaluated in accordance with ANSI/AAMI/ISO 10993-7:2008/(R) 2012.
Shelf Life	Maintenance of package integrity and seal strength after environmental preconditioning and distribution simulation.	Shelf life testing involved package integrity and seal strength testing subsequent to environmental preconditioning and distribution simulation, in accordance with AAMI/ISO 11607-1: 2006 (R) 2010, ASTM D4169-16, ASTMF88/F88M-15, and ASTM F2096-11. (Results are implied to be satisfactory for clearance).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "test sets" in the context of AI performance evaluation. The "testing" refers to laboratory and ex-vivo studies on the material and mechanical properties of the suture.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Ground truth in this context is established through standardized laboratory testing protocols, not expert consensus on diagnostic interpretations.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. Adjudication methods are relevant for subjective interpretations, which are not part of the physical and biological testing of a suture.

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 information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture. This type of study relates to AI-assisted diagnostic tools and human reader performance, not physical medical devices like sutures.

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

This information is not applicable as the device is a physical surgical suture, not an AI algorithm.

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

The "ground truth" for this device, in essence, is established through:

Standardized Material Specifications: Polypropylene material and dye complying with US 21CFR, Parts 70-82.
USP Standards: Compliance with United States Pharmacopeia (USP) standards (<861> suture diameter, <871> suture attachment, <881> tensile strength).
ISO Standards: Compliance with ISO 10993 series for biocompatibility and ISO 11135 for sterilization.
ASTM Standards: Compliance with relevant ASTM standards for hemocompatibility (F756-17) and shelf life testing (D4169-16, F88/F88M-15, F2096-11).
Ex-vivo Comparative Performance: Direct comparison of tissue holding strength to a legally marketed predicate device.

These standards and comparative studies serve as the "ground truth" to demonstrate that the device is safe and effective for its intended use and substantially equivalent to predicate devices.

8. The sample size for the training set

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture, which does not involve "training sets" in the context of AI.

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

This information is not applicable as the document describes a 510(k) submission for a non-AI surgical suture.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

August 27, 2020

Aptos, LLC. Nikolai Pirtskhalaichvili Vice President of Operations 20/4 V. Orbeliani Street Tbilisi, 0105 Ge

Re: K192953

Trade/Device Name: APTOS Threads - Polypropylene Surgical Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable Polypropylene Surgical Suture Regulatory Class: Class II Product Code: GAW Dated: October 18, 2019 Received: October 21, 2019

Dear Nikolai Pirtskhalaichvili:

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 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

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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 mediation-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.

Cindy Chowdhury, Ph.D., M.B.A. 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) K192953

Device Name

APTOS Threads - Polypropylene Surgical Sutures

Indications for Use (Describe)

The APTOS Threads - Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submission Date: October 21, 2019

K192953

SUBMITTER 1.

APTOS, LLC. 20/4 V. Orbeliani Street T'bilisi Georgia, 0105

Contact Person: Tamara Beshidze Phone: +99532 2920371/Ext 533 Email: tamara.beshidze@aptos.ge

DEVICE 2.

Device Trade Name: APTOS Threads - Polypropylene Surgical Sutures Common Name: Nonabsorbable polypropylene surgical suture Classification Regulation: 21 CFR 878.5010 Regulatory Class: II Product Code: GAW Panel: General and Plastic Surgery

PREDICATE DEVICE 3.

Predicate Device: FilBloc Permanent Sutures (K171039)

DEVICE DESCRIPTION 4.

The pigmented suture is dyed blue (with [Phthalocyaninato(2-)] copper, Color Index Number 74160) to enhance visibility; the colorant meets all requirements of US 21CFR, Parts 70-82. There is no coating or any other additives.

The threads incorporate a bidirectional barbed design. The threads are supplied with needles attached to both ends. The thread's upper and lower anchoring sections are barbed in opposite direction with a small unbarbed section between them and two smooth unbarbed sections, each immediately adjacent to needle-thread attachment interfaces. The needles are constructed from 420B stainless steel. The needles are provided sterile via Ethylene Oxide sterilization.

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INDICATIONS FOR USE ട്.

The APTOS Threads – Polypropylene Surgical Sutures are indicated for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 6.

The proposed device is a barbed suture device with very similar physical characteristics to the predicate. Both devices are constructed from polypropylene and possess barbs to achieve the intended use of approximation of tissue.

The FilBloc Permanent Suture device does have some differences, as it has a wider variety of designs and options, such as unidirectional barbs, non-barbed sutures. The proposed device configuration is the same design as one of the predicate configuration, i.e. size 2-0 sutures with bidirectional barbs.

The similarities and differences in technological characteristics between the subject APTOS Threads - Polypropylene Surgical Sutures and the predicate sutures are summarized below.

	Proposed New Device	Predicate Device
510(k) Number	K192953	K171039
Applicant	AMAP International, Inc.	Assut Europe, Italy
Device Name	APTOS Threads – PolypropyleneSurgical Sutures	FilBloc Permanent Sutures
ClassificationRegulation	21 CFR 878.5010	21 CFR 878.5010
Product Code	GAW	GAW
Indication	Aptos Threads – PolypropyleneSurgical Sutures are indicated forgeneral soft tissue approximation,excluding closure of the epidermis,where use of a non-absorbable sutureis appropriate.	FilBloc Permanent sutures are intendedfor general soft tissue approximation,excluding closure of the epidermis,where use of a non-absorbable sutureis appropriate.
	Proposed New Device	Predicate Device
Design	APTOS Threads – PolypropyleneSurgical Sutures incorporate abidirectional barbed design. Thethreads are supplied with needlesattached to both ends. The thread'supper and lower anchoring sectionsare barbed in opposite direction witha small unbarbed section betweenthem and two smooth unbarbedsections, each immediately adjacentto needle-thread attachmentinterfaces. The needles areconstructed from 420B stainless steel.Standard needle attachment.	Device Description:The Assut FilBloc Permanent Suture rangeof devices comprises a variety of gaugesizes and lengths,supplied with or without stainless steelneedles, which are also available in avariety of different sizes and shapes.The sutures may have a 'block' at one end,which allows surgeons to close woundsquickly and securely without tying knotsor changing suturing techniques. The blockis made from the same material as thesuture, and is used to anchor the suture.The suture thread can be smooth or canhave unidirectional or bidirectional barbsalong the axis of the monofilament surface,either convergent or divergent.
Rx Only?	Yes	Yes
Suture Barbs	Bi-Directional	NoneBidirectionalUnidirectional
Materials	Polypropylene Monofilament	Polypropylene Monofilament
Dyed	phthalocyanine copper - C.I. 74160;21 CFR§ 74.3045	phthalocyanine copper - C.I. 74160; 21CFR§ 74.3045
USP Sizes	USP 2-0	4/0 to 1
Needle Shape	Straight	1/2 circle, 3/8 circle, 5/8 circle, "ski"needle, Straight
Needle CrossSection	Cylindrical	Cylindrical, Triangular, Trapezoidal
Needle Material	420B stainless steel	Surgical stainless steel: AISI 470, AISI455, AISI 301, AISI 302, AISI 304, AISI304L, AISI 31,6 AISI 320, AISI 321,Cobalt chromium
Single Use	Yes	Yes
Sterile	Yes, EO Sterilization, SAL 10-6	Yes, EO Sterilization, SAL 10-6
Complies withUSP<861>,USP<871>,USP<881>	Yes	Yes
Biocompatible	Biocompatible in accordance withISO 10993-1 and FDA Guidance	Biocompatible in accordance with ISO10993-1 and FDA Guidance

Device Comparison Table:

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7. PERFORMANCE DATA

Biocompatibility

Biocompatibility testing was performed in accordance with ANSVAAMI/ISO 10993-1:2009/(R)2013, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within A Risk Management Process, as well as FDA's 2016 guidance document "Use of International Standard ISO 10993-1. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Specific testing included the following:

. Cytotoxicity, ISO 10993-5
Sensitization, ISO 10993-10
Irritation, ISO 10993-10
. Acute systemic Toxicity, ISO 10993-11
Materials Mediated Pyrogenicity, ISO 10993-11
Implantation, ISO 10993-6
Hemocompatibility, ISO 10993-4, ASTM F756-17 ●
Subchronic Toxicity, 90-day Subchronic Intramuscular Implantation, ISO 10993-11
Genotoxicity, Ames Bacterial Reverse Mutation Assay, OECD 471
Genotoxicity: In Vivo Mouse Micronucleus Mutagenicity Assay, OECD 487
Genotoxicity: Mouse Lymphoma Assay, OECD 476
Bacterial Endotoxin Test, USP<161>

Bench Testing

Physical testing was performed to establish compliance with:

. USP<861> suture diameter
USP<871> suture attachment
USP<881> tensile strength

Ex-vivo tissue holding strength testing was conducted compared to the predicate to demonstrate substantially equivalent tissue holding strength.

Ethylene Oxide sterility validation testing was conducted in accordance with overkill half-cycle methods per ISO 11135:2014 to demonstrate SAL 10°. Residuals were evaluated in accordance with ANSI/AAMI/ISO 10993-7:2008/(R) 2012.

Shelf life testing involved package integrity and seal strength testing subsequent to environmental preconditioning and distribution simulation, in accordance with AAMI/ISO 11607-1: 2006 (R) 2010, ASTM D4169-16, ASTMF88/F88M-15, and ASTM F2096-11.

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Animal Study

Not applicable. Animal studies are not necessary to establish the substantial equivalence of this device.

Clinical Study

Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device.

CONCLUSIONS 8.

The technological features of the APTOS Threads – Polypropylene Surgical Sutures are very similar to the predicate device, as both devices are constructed of dyed polypropylene, and may have divergent bi-directional barbs, with smooth sections in the middle and next to the introductory needles. Testing was conducted to demonstrate that the APTOS Threads -Polypropylene Surgical Sutures are substantially equivalent to the predicates. This included testing to demonstrate that, like the predicates, the APTOS Threads are biocompatible, sterile, have adequate shelf life, meet USP physical testing requirements for sutures, and possess tissue holding strength adequate to approximate tissue. The results of this testing demonstrate that the APTOS Threads - Polypropylene Surgical Sutures are substantially equivalent to the predicate devices.

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.