MonoTex PTFE surgical suture is indicated for use In general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues.

MonoTex PTFE suture is provided sterile as a single use device.

Device Description

MonoTex Polytetrafluoroethylene (PTFE) nonabsorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. MonoTex PTFE sutures are monofilament, and are composed of expanded polytetrafluoroethylene material attached to a standard medical grade suture needle as applicable (sutures can be provided without needles as well). Available Suture sizes will be standard according to USP requirements (6/0 through 5).

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Riverpoint Medical MonoTex PTFE Suture. This is a medical device, not an AI/ML algorithm, and as such, the acceptance criteria and study detailed in the document are for a traditional medical device's safety and effectiveness, primarily through demonstrating "substantial equivalence" to a predicate device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set sample size, how ground truth for training set was established) are not applicable to this type of device submission based on the provided text, as they pertain specifically to the evaluation of AI/ML algorithms.

Here's a breakdown of the information that is available or can be inferred, along with an explanation for the inapplicable sections:

Acceptance Criteria and Device Performance for MonoTex PTFE Suture

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Description & Standard	Reported Device Performance
Mechanical Performance	Meets USP requirements for "diameter, tensile strength, and needle attachment strength" for nonabsorbable sutures.	"MonoTex PTFE sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified per USP unless stated otherwise on labeling." "All testing performed has demonstrated that MonoTex PTFE sutures are as safe and effective as the predicate, will meet current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling..."
Material Biocompatibility	Biocompatibility testing in accordance to ISO 10993-1.	"biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed..." "Materials used were selected based on known biocompatibility and established histories of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed."
Substantial Equivalence	The device must be deemed "substantially equivalent" to a legally marketed predicate device (K072076 - Cytoplast PTFE Suture).	"MonoTex PTFE nonabsorbable sutures have been designed and manufactured to be substantially equivalent to the prodicate device listed for safety and effectiveness." "MonoTex PTFE sutures within this submission have substantially equivalent technological characteristics as the predicate device listed." "Riverpoint Medical concludes that the proposed MonoTex PTFE sutures are substantially equivalent to the predicate devices listed according to the requirements of the Federal Food, Drug, and Cosmetic Act."
Sterility	Provided sterile as a single-use device.	"MonoTex PTFE suture is provided sterile as a single use device." "MonoTex PTFE sutures are provided sterile for one-time use only..."
Intended Use Compatibility	Indicated for general soft tissue approximation and/or ligation (cardiovascular, dental, general surgery, dura mater repair). Not for microsurgery, ophthalmic, or peripheral neural tissues.	The stated Indications for Use match the intended use the device was tested against and found "substantially equivalent" for.

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

Not Applicable / Not Provided for an AI/ML algorithm. The document describes performance testing for a physical medical device (suture) against established standards (USP, ISO). It does not involve a "test set" in the context of an AI/ML algorithm's evaluation with patient data. The testing would involve a sufficient number of suture samples to demonstrate compliance with the mechanical and biocompatibility standards. The specific number of samples for each test (e.g., tensile strength, needle attachment) is not provided in this summary. Data provenance is not relevant in the context of material and mechanical testing of a manufactured product.

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

Not Applicable / Not Provided for an AI/ML algorithm. Ground truth, in the AI/ML sense (e.g., expert annotation of medical images), is not relevant here. The "ground truth" for this device is established by international standards (USP for mechanical properties, ISO for biocompatibility) and the performance of the predicate device.

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

Not Applicable / Not Provided for an AI/ML algorithm. Adjudication methods are used in AI/ML studies to resolve discrepancies among expert annotators. This is not pertinent to the mechanical and biocompatibility testing of a physical medical device.

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. An MRMC study is relevant for evaluating the clinical impact of an AI algorithm on human reader performance, typically in diagnostic imaging. This document describes a physical surgical suture, not an AI/ML system.

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

Not Applicable. This question relates to the independent performance of an AI algorithm. The MonoTex PTFE Suture is a physical medical device.

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

Standards and Predicate Device Performance: The "ground truth" for this device's performance is compliance with established industry standards (e.g., USP monographs for surgical sutures, ISO 10993-1 for biocompatibility) and demonstrated equivalence to a legally marketed predicate device (K072076 Cytoplast PTFE Suture) which has already proven its safety and effectiveness.

8. The sample size for the training set

Not Applicable / Not Provided for an AI/ML algorithm. The concept of a "training set" applies to AI/ML algorithms. For this physical device, raw materials are sourced, and manufacturing processes are controlled to produce the final suture. The "training" for such a device is the robust design and manufacturing process itself, based on established scientific principles and existing standards.

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

Not Applicable / Not Provided for an AI/ML algorithm. As with the "training set" concept, this question is specific to AI/ML. The "ground truth" for the design and manufacturing of the suture is based on known material properties, engineering principles, and the specific requirements outlined in USP standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" in a square on the left, and the words "RIVERPOINT MEDICAL" on the right. The word "MEDICAL" is smaller and located below the word "RIVERPOINT".

K140415

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510(k) Summary

Submitter Information

Submitter's Name:	Riverpoint Medical
Address:	825 NE 25th Ave.Portland, OR 97232
Phone Number:	(503) 517-8001 or 866 445-4923
Fax Number:	(503) 517-8002
Registration Number:	3006981798
Contact Person:	Douglas Rowley(503) 517-8001
Date of Preparation:	February 11th, 2014

Device Name

Trade Name:	MonoTex
Common Name:	PTFE Nonabsorbable Surgical Sutures
Classification Name:	Suture, surgical, nonabsorbable, expandedPolytetrafluoroethylene

Device Classification

FDA Class:	2
Product Classification:	878.5035: Nonabsorbable expanded polytetrafluoroethelenesurgical suture
Code:	NBY
Classification Panel:	Class II (special controls); General and Plastic Surgery

Predicate Devices (applicable 510(k) number ilsted):

K072076 (Cytoplast PTFE Suture, Osteogenics Biomedical, Inc.)

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Special Controls

FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission.

Device Description

Intended Uses

Riverpoint MonoTex PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. MonoTex PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. MonoTex PTFE suture is provided sterile as a single use device.

Substantial Equivalence

MonoTex PTFE nonabsorbable sutures have been designed and manufactured to be substantially equivalent to the prodicate device listed for safety and effectiveness. Materials used were selected based on known biocompatibility and established histories of use in the medical device industry for implantable devices, and are identical or substantially equivalent to the materials used in the predicate devices listed. MonoTex PTFE sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified per USP unless stated otherwise on labeling. Testing is performed on each lot of product to verify that requirements have been met prior to release.

Technological Characteristics

The MonoTex PTFE sutures within this submission have substantially equivalent technological characteristics as the predicate device listed. As with the predicate device, MonoTex PTFE sutures are monofilament, uncoated, synthetic nonabsorbable surgical sutures. MonoTex PTFE sutures are provided sterile for one-time use only, and meet USP requirements unless stated otherwise within labeling.

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Performance Data

Per FDA's Special Control Guidance Document: Surgical Sutures, performance testing, including mechanical testing in accordance to USP for nonabsorbable suture and biocompatibility testing of the suture material in accordance to ISO 10993-1 has been performed to further ensure substantial equivalence with the predicate devices listed. All testing performed has demonstrated that MonoTex PTFE sutures are as safe and effective as the predicate, will meet current performance requirements for nonabsorbable surgical sutures unless stated otherwise in labeling, and that they are substantially equivalent to the applicable predicate devices.

Conclusion

Based on the information provided within this 510(k) submission, Riverpoint Medical concludes that the proposed MonoTex PTFE sutures are substantially equivalent to the predicate devices listed according to the requirements of the Federal Food, Drug, and Cosmetic Act.

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Public Ficalth Service

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

March 26, 2014

Riverpoint Medical Mr. Douglas Rowley 825 Northeast 25" Avenue Portland, Oregon 97232

Re: K140415

Trade/Device Name: MONOTEX PTFE Suture Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetrafluorocthylenc surgical suture Regulatory Class: Class II Product Code: NBY Dated: February 11, 2014 Received: February 18, 2014

Dear Mr. Rowley:

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 warrantics. 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, Paris 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 or any reading 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-rclated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Douglas Rowley

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K140415

Image /page/5/Picture/1 description: The image shows the logo for Riverpoint Medical. The logo consists of the letters "RP" inside of a rounded square on the left. To the right of the square is the word "RIVERPOINT" in all capital letters, with the word "MEDICAL" in smaller letters underneath.

Indications for Use Statement

510(k) Number:	Unknown at this time
Device Name:	Nonabsorbable expanded polytetrafluoroethylene (PTFE) surgical suture
Trade Name:	MonoTex

Indications for Use:

MonoTex PTFE suture is provided sterile as a single use device.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR -

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter L. Hudson -S 2014.03.20 09:36:18 -04'00'

Page 1 of 1

510(k) Indications for Use Statement - PTFE Suture

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.