The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

Device Description

The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014

AI/ML Overview

This document is primarily a 510(k) premarket notification letter and summary for a surgical suture and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, most of the requested information regarding AI/ML acceptance criteria and study design (e.g., sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the C-PTFE™ Surgical Suture to a predicate device based on non-clinical performance testing and biocompatibility.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information that can be extracted:

1. A table of acceptance criteria and the reported device performance (Non-Clinical Performance Testing):

The document mentions that the C-PTFE™ Surgical Suture was tested against recognized standards to demonstrate substantial equivalence to the predicate device. While specific quantitative "acceptance criteria" and "reported performance" values are not provided in a detailed table format within this summary, the document states that the new device's performance was compared to the predicate device and found to be "substantially equivalent" or "comparable."

Criterion/Test Standard	Acceptance (Implied)	Reported Performance (Implied)
Biocompatibility	Met Standards	Evaluated in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included: Muscle Implantation Study in Rabbits (4 weeks), Maximization Sensitization, Bacterial Reverse Mutation, Systemic Toxicity in Mice, USP Pyrogen Study, Cytotoxicity, Intracutaneous, Chemical Characterization. The device is considered a >30 implantable device (This is a classification based on implantation duration, not a performance metric per se, but part of biocompatibility assessment).
Mechanical/Physical Properties (Non-Clinical Performance Testing)	Met Standards	Tested per recognized standards: - USP-40-NF35:2017, Nonabsorbable Surgical Suture (6-393)- USP-40-NF35:2017, Tensile Strength (<881>) (6-394)- USP-40-NF35:2017, Diameter (<861>) (6-395)- USP-40-NF35:2017, Sutures – Needle Attachment (<871>) (6-396) Conclusion: "Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably [to] the predicate device, MonoTex K140415." "Test report 17-033 confirmed equivalency."
Sterility	Yes	Sterilized via EO in accordance with EN ISO-11135:2014. Confirmed as "Yes" (Sterile) and "EO" (Sterilization method) in comparison table.
Electrical Safety and EMC	Not Applicable	No electrical components, no electrical safety information required.
Software Verification and Validation	Not Applicable	No software in the device, no software required to function.
Mechanical and Acoustical Testing	Not Applicable	This section does not apply to this device.

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: Not explicitly stated as a number of devices or units. The testing refers to conformance with USP standards and biocompatibility tests, where sample sizes are typically defined by the standards themselves, but not detailed here.
Data Provenance: Not specified beyond the general nature of lab-based/bench testing and animal studies (for biocompatibility). No mention of country of origin or retrospective/prospective clinical data for performance assessment, as this is a non-clinical submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This submission is for a medical device (suture) and relies on objective, standardized physical and material testing, and animal biocompatibility studies, not on human expert interpretation of images or clinical outcomes that would require "ground truth" establishment by multiple human experts.

4. Adjudication method for the test set:

Not Applicable. As above, there's no "adjudication" in the context of expert consensus for a test set, as this is not a diagnostic or AI device study.

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 not a study for an AI/ML device.

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

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

Objective Test Standards and Biocompatibility Endpoints: The "ground truth" or reference for this device's performance is established by conformance to recognized industry standards (USP, ISO) for physical properties (e.g., tensile strength, diameter) and biological responses (e.g., tissue reaction in animal models for biocompatibility). There is no "pathology" or "outcomes data" in the typical diagnostic sense.

8. The sample size for the training set:

Not Applicable. This is not a study for an AI/ML device, so there is no concept of a "training set."

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

Not Applicable. As above, no training set.

In summary, this document pertains to the regulatory submission for a surgical suture, demonstrating its substantial equivalence to a predicate device through non-clinical laboratory testing and biocompatibility assessments, rather than an AI/ML or diagnostic device that would require comprehensive clinical performance studies with expert-adjudicated ground truth.

Summary

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

March 26, 2018

CP Medical Inc. Mr. John Hartigan Director QA/RA 1775 Corporate Dr. Suite 150 Norcross, Georgia 30093

Re: K173922

Trade/Device Name: C-PTFFE™ Surgical Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY Dated: December 21, 2017 Received: December 26, 2017

Dear Mr. Hartigan:

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, 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 (OS) regulation (21 CFR Part 820);

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Page 2 - John Hartigan

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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer R. Stevenson -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) K173922

Device Name C-PTFETM Surgical Suture

Indications for Use (Describe)

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)

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1. 510(k) Summary

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the C-PTFE® Surgical Suture is provided below.

Date SummaryPrepared	December 14, 2017
Manufacturer/Distributor/ Sponsor	CP Medical Inc.1775 Corporate Drive, Ste. 150Norcross, GA 30093
510(k) Contact	CP MedicalJohn Hartigan1775 Corporate DriveNorcross, GA 30093470-273-6005 (phone)hartiganj@cpmedical.com (email)
Trade Name	C-PTFETM Surgical Suture
Common Name	Surgical Suture, Nonabsorbable
Code -Name -Classification	NBY – Surgical Suture Class II: 21 CFR §878.5035
Predicate Devices	MonoTex K140415This predicate has not been subject to a design-related recall(FDA's TPLC website,. no filings from 2000 to date 2017)
Device Description	Device Description: The CP Medical C-PTFETM SurgicalSutures are Nonabsorbable, Polytetraflouroethylene,single use, sterile, disposable, monofilament sutures andare provided with or without needles.Individual sutures are available in a "racetrack"configuration, attached around a HDPE delivery system,and/or in a figure 8 in a Tyvek/film pouch.The CP Medical C-PTFETM Surgical Sutures are sterilizedvia EO in accordance with EN ISO-11135:2014
Intended Use	CP Medical nonabsorbable C-PTFETM Surgical Suture isa removable, nonabsorbable surgical suture intended foruse in general soft tissue approximation and/or ligation,including dental surgical procedures. CP Medical C-
PTFE™ sutures are contra indicated for use inmicrosurgery, ophthalmic procedures, or peripheralneural tissue.
Non-ClinicalPerformance Testing	The CP Medical nonabsorbable C-PTFE™ Surgical Suturewas tested recognized standard 6-393: USP-40-NF35:2017,Nonabsorbable Surgical Suture, 6-394: USP-40-NF35:2017,<881>, Tensile Strength, 6-395: USP-40-NF35:2017 <861>,Diameter, 6-396 USP-40-NF35:2017 <871>, Sutures –Needle Attachment.
SubstantialEquivalenceSummary(Conclusion)	Based on the technological; characteristics and non-clinicalperformance testing the CP Medical C-PTFE™ SurgicalSuture was shown to be substantially equivalent to thepredicate device, the MonoTex K140415.

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Additionally, a comparison between the CP Medical C-PTFETM Surgical Suture and the predicate device is summarized below:

Feature	CP Medical C-PTFETMSurgical Suture	MonoTex K140415	SubstantiallyEquivalent
DeviceClassification	Class II: 21 CFR§878.5035	Class II: 21 CFR§878.5035	Yes
Product Code	NBY – Suture Surgical	NBY – Suture Surgical	Yes
DeviceCommonName asCleared byFDA	Suture, SurgicalNonabsorbable,Polytetraflouroethylene	Suture, SurgicalNonabsorbable,Polytetraflouroethylene	Yes
Indications foruse	CP Medicalnonabsorbable C-PTFETM SurgicalSuture is a removable,nonabsorbable surgicalsuture intended for usein general soft tissueapproximation and/orligation, includingdental surgicalprocedures. CPMedical C-PTFETMsutures are contraindicated for use inmicrosurgery,ophthalmic procedures,or peripheral neuraltissue.	Riverpoint MonoTexsurgical suture isindicated for use ingeneral soft tissueapproximation and/orligation, includingcardiovascular, dental,general surgicalprocedures and repairof dura matter.Riverpoint MonoTexsutures are notindicated for use inmicrosurgery,ophthalmic procedures,or peripheral neuraltissue	Yes
PatientPopulation	Single use only	Single use only	Yes
Environmentof Use	Point of procedure –clinical settings.	Point of procedure –clinical settings.	Yes
Feature	CP Medical C-PTFE™Surgical Suture	MonoTex K140415	SubstantiallyEquivalent
DeviceDescription	CP Medical C-PTFE™Surgical Suture aresterile, nonabsorbable,monofilament suturesavailable with orwithout needles, Thesutures are delivered ina figure 8 or racetrackconfiguration, which iscontained within aTyvek/film package.The sutures aresterilized by EO.	Riverpoint PTFEMonoTex SurgicalSuture are sterile,nonabsorbable,monofilament suturesavailable with orwithout needles, Thesutures are delivered ina figure 8 or racetrackconfiguration, which iscontained within aTyvek/film package.The sutures aresterilized by EO.	Yes
Principles ofOperation	CP Medical C-PTFE™Surgical Suture are foruse in clinical settingsand carry a prescription.The sutures areremoved for devicepacking followingaseptic protocols.	Riverpoint PTFEMonoTex SurgicalSuture are for use inclinical settings andcarry a prescription.The sutures areremoved for devicepacking followingaseptic protocols.	Yes
Sizes	Various diametersbased on USP (unlessstated on labeling),various lengths.	Various diametersbased on USP (unlessstated on labeling),various lengths.	Yes
Needles	Available with orwithout standardneedles attached.	Available with orwithout standardneedles attached.	Yes
Colorsavailable	White/Undyed	White/Undyed	Yes
Feature	CP Medical C-PTFE™ Surgical Suture	MonoTex K140415	Substantially Equivalent
Non-ClinicalTestingSummary	The CP Medicalnonabsorbable C-PTFE™ SurgicalSuture was tested perrecognized standard:6-393: USP-40-NF35:2017,NonabsorbableSurgical Suture, 6-394: USP-40-NF35:2017, <881>,Tensile Strength. 6-395: USP-40-NF35:2017 <861>,Diameter 6-396 USP-40-NF35:2017 <871>,Sutures – NeedleAttachment.	Riverpoint PTFEMonoTex are testedper USP <861>, <871>and <881>.	Yes – Testreport 17-033confirmedequivalency.
Sterile	Yes	Yes	Yes
Sterilizationmethod	EO	EO	Yes
Biocompatiblematerials	Per ISO 10993	Per ISO 10993	Yes
Instructionsfor Use	Yes	Yes	Yes
Materials	MonofilamentPolytetraflouroethylene	MonofilamentPolytetraflouroethylene	Yes
RX	Yes	Yes	Yes

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PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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Biocompatibility testing

The biocompatibility evaluation for CP Medical C-PTFE™ was conducted in accordance with FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk management Process," as recognized by FDA. The battery of testing included the following tests:

. Muscle Implantation Study in Rabbits - 4 weeks
. Maximization Sensitization
. Bacterial Reverse Mutation
Systemic Toxicity in Mice
USP Pyrogen Study .
Cytotoxicity
Intracutaneous .
Chemical Characterization ●

The C-PTFE™ device is considered a >30 implantable device

Electrical safety and electromagnetic compatibility (EMC)

There are no electrical components in the C-PTFE™. No Electrical safety information is required for the safe functioning of this device.

Software Verification and Validation Testing

There is no software in the C-PTFE™ and the C-PTFE™ sutures requires no software to function. This section does not apply to this device.

Mechanical and acoustical testing

This section does not apply to this device.

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Animal study

This section does not apply to this device.

Clinical Studies

This section does not apply to this device.

Summary

Based on the comparative testing between post sterile, aged, C-PTFE™ and MonoTex (predicate) currently in interstate commerce, the C-PTFE™ was found to have a safety and effectiveness profile that is similar to the predicate device.

Conclusions

The non-clinical data support the safety of the device and the sterilization validation demonstrate that the C-PTFE™ device should perform as intended in the specific use conditions. Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably the predicate device, MonoTex K140415, which is currently marketed for the same intended use.

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.