FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

Device Description

The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture.

Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.

The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device (Assut FilBloc Permanent Sutures) and focuses on demonstrating substantial equivalence to a predicate device rather than setting and proving new acceptance criteria for a novel AI/software-based medical device.

Therefore, many of the requested sections (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, effect sizes, standalone performance, ground truth establishment) are not applicable to this type of regulatory submission and the information provided. This document is for a physical medical product, not an AI/software device.

However, I can extract information related to performance testing that serves a similar purpose to "acceptance criteria" for a physical device, and indicate which of your requested points are not applicable.

Acceptance Criteria for Assut FilBloc Permanent Sutures and Supporting Study

Note: This document pertains to a physical medical device (surgical sutures) and its 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device. The concepts of "AI/software acceptance criteria," "training/test sets," "expert ground truth for AI," "MRMC studies," and "effect sizes" for human readers are not applicable to this type of device and submission. The performance data provided are for the physical properties and biocompatibility of the sutures.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (based on USP 29 and ISO standards)	Reported Device Performance (Implied as Met)
Physical Performance: - Suture Diameter (<861>) - Suture Attachment (<871>) - Tensile Strength (<881>) - Sterility - Shelf Life - Packaging Integrity - Compliance with applicable USP monographs	Performed and established compliance with USP 29. Available sterile (ethylene oxide, with SAL 10⁻⁶). Tests undertaken to establish shelf life and packaging integrity. Yes (stated in comparison table).
Biocompatibility (based on ISO 10993-1, 5, 6, 10, 11, 3): - Cytotoxicity - Sensitization - Irritation or Intracutaneous Reactivity - Acute Systemic Toxicity - Subchronic Toxicity - Genotoxicity - Implantation - Material Mediated Pyrogenicity - Bacterial endotoxin testing (LAL test)	All listed tests were carried out to establish biocompatibility, indicating successful completion and acceptance. Bacterial endotoxin testing (LAL test) is carried out on every batch.

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

The document does not specify the exact sample sizes for each physical or biocompatibility test. It broadly states that "Physical testing was performed" and "Tests were also undertaken" and "the following tests were carried out to establish the biocompatibility." For physical medical devices like sutures, these tests are typically conducted on representative batches per established test standards (e.g., USP monographs).

Data Provenance: The tests were performed by Assut Europe S.p.A. (manufacturer in Italy). The data is generated prospectively as part of the device's development and manufacturing compliance.

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

Not Applicable. For a physical device like a suture, "ground truth" is established by laboratory measurements according to validated standards (e.g., USP monographs, ISO standards) rather than expert human interpretation of data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing performance in subjective tasks or when reaching consensus on ground truth from human experts, particularly in image interpretation or clinical diagnosis. This is not relevant for the objective physical and biocompatibility 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

Not Applicable. This is a physical medical device, not an AI or imaging diagnostic device. MRMC studies are used to evaluate diagnostic performance of imaging modalities or AI systems.

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

Not Applicable. This is a physical medical device. The concept of "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

The ground truth for the performance of the sutures is based on objective, standardized laboratory measurements and biological assay results as defined by:

United States Pharmacopeia (USP) monographs, e.g., USP 29 for suture diameter (<861>), suture attachment (<871>), and tensile strength (<881>).
International Organization for Standardization (ISO) standards for biocompatibility (e.g., ISO 10993 series).

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/machine learning device. There is no concept of a "training set" for the type of data presented (physical properties and biocompatibility).

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

Not Applicable. As there is no training set mentioned, this question is not relevant. The ground truth for the device's performance relies on adherence to established, internationally recognized medical device standards and regulations.

Summary

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

August 29, 2017

Assut Europe S.p.A. % Mr. Roger Gray Donawa Lifescience Consulting Srl Piazza Albania, 10 Rome, 00153 Italy

Re: K171039

Trade/Device Name: Assut Filbloc Permanent Sutures Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW Dated: July 18, 2017 Received: July 20, 2017

Dear Mr. Gray:

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 (reporting of medical device

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related 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K171039

Device Name Assut FilBloc Permanent sutures

Indications for Use (Describe)

FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Type of Use (Select one or both, as applicable)

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Summary

Device Name:	Assut FilBloc Permanent Sutures
Type of 510(k) submission:	Abbreviated
Date of submission:	17 July 2017
Manufacturer:	Assut Europe SpAZona Industriale67062 Magliano dei Marsi (AQ)Italy
Phone:Fax:	+39-06-72677348+39-06-72675380
FDA Registration Number:	9617547
510(k) Owner and Submitter:	Assut Europe SpAVia G.Gregoraci, 1200173 RomeItaly
Owner/Operator Number:	9044488
510(k) Application Correspondent:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItaly
Phone:Fax:Email:	+39 06 578 2665+39 06 574 3786rgray@donawa.com
FDA Product Code:	GAW
FDA Regulation Number:	21 CFR 878.5010
FDA Classification Name:	Nonabsorbable Polypropylene Surgical Suture
Classification Panel:	General and Plastic Surgery
Common Name:	Nonabsorbable Polypropylene Surgical Suture
FDA Classification:	Class II
Submission Type:	510(k)
Indication for Use:	FilBloc Permanent sutures are intended for general soft tissueapproximation, excluding closure of the epidermis, where use ofa non-absorbable suture is appropriate.
Predicate Device:	Quill Nonabsorbable Polypropylene barbed suture, K052373.From information on the FDA website, there is no indication thatthis device has been subject to a design-related recall.

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Reference Device:

Assut FilBloc Absorbable Polydioxanone Surqical Suture, K150553. This device has not been subject to a design-related recall.

Device Description:

Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods.

The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.

Technological Characteristics:

The sutures are manufactured in polypropylene monofilament thread, white natural (undyed) or dyed blue colour (phthalocyanine copper - C.I. 74160; 21 CFR§ 74.3045). The suture thread can be smooth or can have unidirectional or bidirectional barbs along the axis of the monofilament surface, either convergent or divergent.

The chemical formula of polypropylene is -(CH(CH3)-CH2)n. The chemical formula of the blue dye is C32H16CuN8. The suture content of the blue dye is below 0.5 wt%.

Assut FilBloc Permanent Sutures are available sterile (ethylene oxide, with SAL 10°) for single use in a wide range of lengths and in sizes from USP 2 to 4/0, (sizes USP 4/0, USP 3/0, USP 2/0, USP 0, USP 1, USP 2), with or without needles (single or double), with or without single-end blocks, and with or without barbs. The barbs can be unidirectional or bidirectional, and if bidirectional, the barbs can be opposing each other or not, at the purchaser's choice.

Performance Data:

Physical testing was performed to establish compliance with USP 29, including <861> suture diameter, <871> suture attachment, <881> tensile strength. Tests were also undertaken to establish sterility, shelf life and packaging integrity.

Biocompatibility:

In accordance with the recommendations of ISO 10993-1 and FDA quidance 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', 16 June 2016, for devices described as implants in contact with tissuelbone for over 30 days, the following tests were carried out to establish the biocompatibility of the FilBloc Permanent Sutures:

. Cytotoxicity (ISO 10993-5)
. Sensitization (ISO 10993-10)
Irritation or Intracutaneous Reactivity (ISO 10993-10) .
Acute Systemic Toxicity (ISO 10993-11) ●
. Subchronic Toxicity (ISO 10993-11)
Genotoxicity (ISO 10993-3) ●
Implantation (ISO 10993-6)
. Material Mediated Pyrogenicity

Bacterial endotoxin testing (LAL test) is carried out on every batch of sutures.

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Substantial Equivalence:

The features and characteristics of predicate device and reference device selected for an evaluation of substantial equivalence with the Filloc Permanent Sutures are provided in Table 1, together with a comparison with the same features and charcteristics of the subject device.

Table 1: Predicate device comparison table
Item	Predicate Device	Subject device	Similarity
Device name	Quill Nonabsorbable PolypropyleneBarbed Suture	FilBloc Permanent Sutures	N/A
Device Manufacturer	Angiotech, Reading PA, US	Assut Europe, Italy	N/A
510(k) Reference	K052373	Not yet assigned	N/A
FDA Product Code	GAW	GAW	Same
FDA ClassificationName	Nonabsorbable polypropylene surgicalsuture	Nonabsorbable polypropylene surgicalsuture	Same
FDA RegulationNumber	21 CFR 878.5010	21 CFR 878.5010	Same
Device description	Nonabsorbable polypropylene surgicalsuture in various thread sizes and needleshapes/sizes, with bi-directional threadbarbs	Nonabsorbable polypropylene surgicalsuture in various thread sizes with orwithout unidirectional or bidirectionalbarbs, and with or without variousneedle shapes/sizes	Similar
Indications for Use /Intended use	Quill® Nonabsorbable PolypropyleneBarbed Sutures are indicated for use insoft tissue approximation excludingclosure of the epidermis.	FilBloc Permanent sutures areintended for general soft tissueapproximation, excluding closure ofthe epidermis, where use of a non-absorbable suture is appropriate.	Equivalent topredicate. Verysimilar toreferencedevice
Rx only?	Yes	Yes	Same
Monofilament?	Yes	Yes	Same
USP sizes	4/0 to 2	4/0 to 1	Different
Suture barbs	Bi-directional	NoneBidirectionalUnidirectional	Different frompredicate butsame asreferencedevice
Locking block?	Not available	Optional	Different frompredicate butsame asreferencedevice
Thread color	WhiteBlueCopper	WhiteBlue	Similar
Sterility	Sterile by EO, SAL 10-6	Sterile by EO, SAL 10-6	Same
Single use?	Yes	Yes	Same
Complies withapplicable USPmonographs?	Yes	Yes	Same

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Table 1: Predicate device comparison table
Item	Predicate Device	Subject device	Similarity
Needles attached?	Yes	YesAlso available without needles	Different frompredicate butsame asreferencedevice
Needle shapes	1/2 circle3/8 circle	1/2 circle3/8 circle5/8 circle"ski" needleStraight	Different frompredicate butsame asreferencedevice
Needle cross-section	Unknown	CylindricalTriangularTrapezoidal	Same asreferencedevice
Needle point	TaperDiamond	CylindricalTriangularDiamond (Taper-cut)Blunt pointSpatula	Different frompredicate butsame asreferencedevice
Needle eye	Unknown	OpenClosed	Same asreferencedevice
Needle materials	Surgical stainless steel:AISI 470	Surgical stainless steel:AISI 470AISI 455AISI 301AISI 302AISI 304AISI 304LAISI 316AISI 320AISI 321Cobalt chromium	Similar, sameas referencedevice
Needle coating	Siliconized	Siliconized	Same
Biocompatibility	Biocompatible	Biocompatible	Same

The subject device and the predicate device have many identical or similar properties and features. In summary, the differencesare:

USP sizes available: The subject device has one USP thread size less in its range. .
Suture barb orientation: The predicate device has bidirectional barbs on all versions in the . range, whereas the subject device has options with or without barbs, and when barbs are included, these can be either bidirectional or unidirectional. The reference device has the same options of no barbs, bidirectional barbs and unidirectional barbs.
Locking block: The predicate device does not offer a locking block option, whereas the subject device range does, which is the same as the reference device.
. Needle sizes, shapes, points, etc: The subject device includes a wider variety of needle sizes, shapes, points, etc, than the predicate device. The reference device has a similarly wide range of needle sizes, shapes, points, etc.

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Conclusion:

Based on the information contained within this submission, it is concluded that the FilBloc Permanent Sutures are substantially equivalent to the identified predicate device already in interstate commerce within the USA.

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.