(30 days)
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.
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.
The provided document is a 510(k) summary for the Riverpoint Medical HS Fiber Suture, a non-absorbable surgical suture. It details the device, its intended use, and comparative performance data against a predicate device to establish substantial equivalence for FDA clearance.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the HS Fiber Sutures meet requirements established by the United States Pharmacopeia (USP) for needle attachment and tensile strength. However, specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons, or specific detachment forces for needle attachment) and the reported device performance values against these criteria are not explicitly provided in this summary. Instead, it makes a general statement of compliance.
| Acceptance Criteria (Based on USP) | Reported Device Performance |
|---|---|
| Needle Attachment: Meets USP requirements | Meets USP requirements (Specific values not provided) |
| Tensile Strength: Meets USP requirements | Meets USP requirements (Specific values not provided) |
| Material Biocompatibility: Per ISO 10993-1:2009 | Evaluated and found acceptable (Specific test results not provided) |
| Endotoxin Quantities: Below recommended limits per FDA Guidance | Demonstrated to be below recommended limits (Specific values not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance tests (e.g., for needle attachment or tensile strength).
The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, given that it's a 510(k) submission to the FDA, the testing would have been conducted to international and U.S. standards. The tests are prospective in nature, as they are performed to demonstrate product quality and compliance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission, as the device is a surgical suture, not a diagnostic or AI-driven decision support system that requires expert consensus for ground truth. The "ground truth" here is objective physical and biological properties measured according to established standards (USP/ISO).
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where human interpretation or assessment is involved, often in diagnostic imaging or clinical endpoints. This is not applicable to the performance testing described for a surgical suture, which involves objective, standardized laboratory measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is not applicable to this device. This type of study is used to assess the change in human reader performance (e.g., radiologists, pathologists) when aided by an AI algorithm, compared to reading without AI. The HS Fiber Suture is a surgical implant, not an diagnostic or AI-assisted device.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study of an algorithm is not applicable to this device. The HS Fiber Suture is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the HS Fiber Suture is based on objective, standardized measurements of physical and biological properties. This includes:
- USP Performance Requirements: For metrics like tensile strength and needle attachment.
- ISO 10993-1:2009: For biological evaluation (biocompatibility).
- FDA Guidance on Pyrogens and Endotoxins Testing: For endotoxin quantification.
These are established scientific and regulatory standards that define acceptable performance for such devices.
8. Sample Size for the Training Set
This concept is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The HS Fiber Suture is a physical medical device, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth is not applicable to this device. The "ground truth" for demonstrating the safety and effectiveness of the suture is established through adherence to recognized manufacturing quality standards and performance specifications, as defined by organizations like USP and ISO.
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May 1, 2019
Riverpoint Medical Edwin Anderson VP Regulatory Affairs 825 NE 25th Ave. Portland, Oregon 97232
Re: K190817
Trade/Device Name: HS Fiber Suture Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT Dated: March 29, 2019 Received: April 1, 2019
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. 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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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,
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) K190817
Device Name HS Fiber Suture
Indications for Use (Describe)
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues 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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510(k) SUMMARY
Riverpoint Medical HS Fiber® Suture 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: | March 29, 2019 |
| Device Name: |
| Trade Name: | HS Fiber® Suture |
|---|---|
| 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) K153307 – HS Fiber SutureTape
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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.
Intended Use / Indications for Use
HS Fiber sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues 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: Ouestions and Answers."
Substantial Equivalence and Comparison of Technical Characteristics
The HS Fiber suture line extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS Fiber suture line extension has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device, HS Fiber suture cleared per K100006. Both the HS Fiber suture line extension and the predicate device are sterilized using the same processes, are composed of the same material (UHMWPE), and are tested per USP performance requirements for length, tensile strength and needle attachment. The minor difference in technical characteristics is limited to the color additives, and the line extension introduces the addition of two color additives that are FDA approved for use in polyethylene surgical sutures. These differences do not raise new questions of safety or effectiveness; therefore, the HS Fiber suture 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 Fiber suture line extension is substantially equivalent to the predicate device.
§ 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.