HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.

Device Description

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles. HS SutureTape is a flat braid configuration of the HS Fiber suture.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called HS SutureTape. This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device to the predicate device and establishing substantial equivalence rather than presenting an independent study to prove the device meets specific acceptance criteria in a clinical setting.

Therefore, the document does NOT contain the detailed information typically found in a clinical study report addressing acceptance criteria for device performance as a standalone product. It instead focuses on performance data that demonstrates compliance with recognized standards.

Here's an attempt to answer your questions based on the available information, with clear notes where the information is absent:

A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Compliance with United States Pharmacopeia (USP) requirements for surgical sutures (general standards)	"The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia." The HS SutureTape (the new device) is also "tested per USP performance requirements for tensile strength, needle and attachment." This implies the HS SutureTape also meets these requirements.
USP performance requirements for needle attachment	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for needle attachment." This implies compliance, though specific quantitative results are not provided.
USP performance requirements for tensile strength	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for tensile strength." This implies compliance, though specific quantitative results are not provided.
Biological Evaluation of Medical Devices (ISO 10993-1:2009)	"Materials used were evaluated per ISO 10993-1:2009 - Biological Evaluation of Medical Devices." This indicates that the materials (UHMWPE) used in the suture are biocompatible according to this standard.
Endotoxin quantities (per FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers")	"Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance 'Pryogens and Endotoxins Testing: Questions and Answers.'"
Pyrogenicity (Rabbit pyrogenicity assessments)	"Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations." This implies the device meets pyrogenicity limits, though specific results or quantitative acceptance criteria are not detailed beyond "periodic determinations" and "process-validation basis."
Substantial Equivalence to Predicate Device (K100006 – Riverpoint Medical HS Fiber)	"The HS SutureTape line extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS SutureTape has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device... These differences do not raise new questions of safety or effectiveness, therefore the HS SutureTape line extension is substantially equivalent to the currently marketed predicate device." This is the overarching "acceptance criteria" for a 510(k) submission. Specific performance data demonstrating this equivalence (e.g., side-by-side comparison of tensile strength values for both devices) are not provided in this summary, but would have been part of the full 510(k) submission.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only states that the sutures are "tested per USP performance requirements" and that "LAL endotoxin quantification assessments" and "Rabbit pyrogenicity assessments" were performed. The specific number of samples for these tests is not provided in this summary.
- Data Provenance: Not specified. The tests are general performance tests and not clinical data. The location where these tests were conducted is not mentioned.
- Retrospective or Prospective: Not applicable as these are laboratory and bench testing, not clinical studies in humans.
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)
- Not applicable. This document describes a medical device's technical and safety performance through laboratory and bench testing against recognized standards (USP, ISO, FDA guidance), not a diagnostic device requiring expert interpretation of results or establishing "ground truth" through expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert review in diagnostic assessments, which is not relevant for the type of testing described here.
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
- No. This is a surgical suture, not a diagnostic imaging device involving human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve algorithms or AI. It is a physical medical device.
The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For this type of device, "ground truth" is established by compliance with predefined, objective engineering and material science standards (e.g., a specific tensile strength value, a certain level of biocompatibility, endotoxin limits). The "ground truth" for showing safety and effectiveness is largely based on meeting these established performance criteria from USP, ISO, and FDA guidance documents.
The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The document describes the materials and performance characteristics of a physical suture.
How the ground truth for the training set was established
- Not applicable. See explanation for #8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

February 12, 2016

Riverpoint Medical Mr. Edwin Anderson Director of Quality and Regulatory 825 NE 25th Avenue Portland, Oregon 97232

Re: K153307

Trade/Device Name: HS SutureTape Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable, polyethylene terephthalate surgical suture Regulatory Class: Class II Product Code: GAT Dated: January 13, 2016 Received: January 14, 2016

Dear Mr. Anderson:

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

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device-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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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 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) K153307

Device Name HS SutureTape®

Indications for Use (Describe)

HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image contains the logo for Riverpoint Medical. The logo consists of a green rounded square with the letters "RP" in white inside. To the right of the square is the word "RIVERPOINT" in large, bold, black letters, with the word "MEDICAL" in smaller letters underneath.

510(k) SUMMARY

Riverpoint Medical HS SutureTape® Line Extension

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:	Edwin Anderson(503) 517-8001
Date of Preparation:	November 13th, 2015

Device Name

Trade Name:	HS SutureTape®
Common or Usual Names:	Polyblend Suture, Non-absorbable Surgical Sutures
Classification Name:	Nonabsorbable poly(ethylene terephthalate) Surgical Suture

Device Classification

FDA Class:	II
Product Classification:	878.5000: Suture, nonabsorbable, synthetic, polyethylene
Classification Code:	GAT
Review Panel	General & Plastic Surgery
Premarket Review	Office of Device EvaluationDivision of Surgical Devices, Plastic and ReconstructiveGeneral Surgery Devices Branch

Predicate Device

K100006 – Riverpoint Medical HS Fiber (Polyblend)

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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of the letters RP inside of a green rounded square. To the right of the square is the text "RIVERPOINT" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it.

Device Description

Intended Use / Indications for Use

HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.

Performance Data

The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia. The HS Fiber sutures are tested per USP performance requirements for needle attachment and tensile strength. FDA Guidance "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA" was followed during the preparation of this submission. Materials used were evaluated per ISO 10993-1:2009 - Biological Evaluation of Medical Devices. Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers." Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations.

Substantial Equivalence and Comparison of Technical Characteristics

The HS SutureTape Iine extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS SutureTape has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the HS SutureTape and the predicate device are sterilized using the same processes, are composed of the same material, and are tested per USP performance requirements for tensile strength, needle and attachment. The minor difference in technical characteristics is limited to the braiding configuration, and the line extension introduces a braiding configuration differing from the originally cleared device. These differences do not raise new questions of safety or effectiveness, therefore the HS SutureTape line extension is substantially equivalent to the currently marketed predicate device.

Conclusion

The information provided in this Special 510(k) demonstrates that the Riverpoint Medical HS SutureTape line extension is substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed 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.