(497 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the suture, with no mention of AI or ML.
Yes
The device is a surgical suture used for soft tissue approximation and ligation, including use in cardiovascular and orthopedic surgeries for bone fixation, all of which are therapeutic interventions.
No
The device is a surgical suture used for approximation and/or ligation of soft tissues and bone fixation. Its intended use focuses on therapeutic surgical procedures rather than diagnosing medical conditions.
No
The device description clearly states it is a physical surgical suture made of UHMWPE, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general soft tissue approximation and/or ligation," and for use as a "bone fixation cerclage." These are surgical procedures performed directly on the patient's body.
- Device Description: The device is a surgical suture, an implant used within the body.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The anatomical sites listed are all locations within the human body where surgical procedures are performed.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for surgical repair and fixation.
N/A
Intended Use / Indications for Use
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:
- · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
- · Repair of long bone fracture due to trauma or reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
JDQ, GAT
Device Description
The Riverpoint Medical HS Fiber® Cerclage 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 Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, ankle, patella, shoulder (rewiring), long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital/clinic/surgical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing for the Riverpoint Medical HS Fiber Cerclage included sterilization validation per EN ISO14937:2009 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, biocompatibility testing per ISO 10993-1:2018 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2019 - Packaging for terminally sterilized medical devices --Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366-1: 2015- Medical devices -Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical HS Fiber Cerclage Suture performed as intended. Non-clinical mechanical testing was performed to verify the fixation performance for the HS Fiber Cerclage using tensile strength, knot strength, fatigue strength, creep, and wear debris with particle analysis. Results of the performance testing for the HS Fiber Cerclage device concluded that the device performed comparably to the predicate device in tensile strength, fatigue strength, creep, and wear debris. The tests performed demonstrated that the HS Fiber Cerclage met all requirements for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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July 26, 2023
Riverpoint Medical, LLC Edwin Anderson VP of Regulatory Affairs 815 NE 25th Ave Portland, Oregon 97232
Re: K220765
Trade/Device Name: HS Fiber® Cerclage Regulation Number: 21 CFR 888.3010 Regulation Name: Bone Fixation Cerclage Regulatory Class: Class II Product Code: JDQ, GAT Dated: July 13, 2023 Received: July 14, 2023
Dear Edwin 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220765
Device Name HS Fiber® Cerclage
Indications for Use (Describe)
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:
- · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
- · Repair of long bone fracture due to trauma or reconstruction.
| 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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510(k) SUMMARY
Riverpoint Medical HS Fiber® Cerclage
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Becca DeFrancia |
| (503) 517-8001 | |
| Date of Preparation: | July 13, 2023 |
Device Name
| Trade Name: | HS Fiber® Cerclage |
|---|---|
| Common or Usual Names: | Bone Fixation Cerclage, Suture |
| Classification Name: | 21 CFR 888.3010: Bone Fixation Cerclage |
| 21 CFR 878.5000: Nonabsorbable Poly(ethylene) Terephthalate | |
| Surgical Suture | |
| Device Classification |
Devi
| FDA Class: | II |
|---|---|
| Product Classification: | 888.3010, 878.5000 |
| Classification Code: | JDQ, GAT |
Predicate Device(s)
K170206 (Primary) – Arthrex FiberTape Cerclage
K100006 (Reference) – Riverpoint Medical HS Fiber (Polyblend)
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Image /page/4/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" inside of a green rounded square. To the right of the square is the word "RIVERPOINT" in all capital letters and in the same shade of green as the square.
Device Description
The Riverpoint Medical HS Fiber® Cerclage 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 Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
The classification for the HS Fiber Cerclage is FDA Class II device with product classification 21 CFR §878.5000, Product Code GAT and subsequent 21 CFR §888.3010, Product Code IDQ.
Indications for Use:
HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft or autograft tissue. When used as a bone fixation cerclage, the sutures are intended for:
- Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring. ●
- Repair of long bone fracture due to trauma or reconstruction. ●
Performance Data
The sutures used to construct the HS Fiber Cerclage meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE 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" were followed during the preparation of this submission.
Non-clinical performance testing for the Riverpoint Medical HS Fiber Cerclage included sterilization validation per EN ISO14937:2009 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices, biocompatibility testing per ISO 10993-1:2018 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2019 - Packaging for terminally sterilized medical devices --Part 1: Requirements for materials, sterile barrier systems and packaging systems, and a simulated use Usability Validation performed per EN62366-1: 2015- Medical devices -Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical HS Fiber Cerclage Suture performed as intended. Non-clinical mechanical testing was performed to verify the fixation performance for the HS Fiber Cerclage using tensile strength, knot strength, fatigue strength, creep, and wear debris with particle analysis. Results of the performance testing for the HS Fiber Cerclage device concluded that the device performed comparably to the predicate device in tensile strength, fatigue strength, creep, and wear debris. The tests performed demonstrated that the HS Fiber Cerclage met all requirements for its intended use.