(28 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a physical implant for orthopedic procedures, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as "intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction," indicating its use in treating medical conditions.
No
The device is described as an adjustable button loop intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction. Its function is to secure tissue, not to diagnose a condition.
No
The device description clearly states it is comprised of physical components (UHMWPE loop, titanium plate, sutures) and is sterilized, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction." This describes a surgical implant used directly on the patient's body.
- Device Description: The description details a physical device made of UHMWPE and titanium, designed for surgical implantation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The information provided describes a surgical implant, not a diagnostic tool used outside the body to analyze samples.
N/A
Intended Use / Indications for Use
The ProCinch, QuadCinch Adjustable Loop Device is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
Product codes (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Riverpoint Medical ProCinch, QuadCinch adjustable button loop is comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE, or polyester are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of blue or green color suture.
For configurations that do not have a titanium plate preattached, a titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and secure into place. The UHMWPE is available undyed (white), dyed blue, or with trace filaments of blue or green color suture. 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 ProCinch, QuadCinch is FDA Class II device with product classification 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone and soft tissue
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 ProCinch, QuadCinch included a sterilization adoption validation, biocompatibility testing per ISO10993-1:2018 -Biological Evaluation of Medical Devices, product packaging validation per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015-Medical devices - Application of usability engineering to medical devices. LAL and rabbit pyrogencity testing have demonstrated that the ProCinch, QuadCinch does not raise any additional concerns regarding pyrogenicity. Non-clinical mechanical testing was performed to verify the fixation strength of the ProCinch, QuadCinch using cyclic testing as compared to the predicate device. Results of performance testing for the ProCinch, QuadCinch device concluded that the device performed comparably to the predicate device and the validations performed demonstrated that the ProCinch, QuadCinch 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.
K202399 - Riverpoint Medical OrthoButton FL
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
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
February 21, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Riverpoint Medical Paulie Vagts Senior Regulatory Affairs Associate III 825 NE 25th Ave Portland, Oregon 97232
Re: K240194
Trade/Device Name: ProCinch, QuadCinch Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 24, 2024 Received: January 24, 2024
Dear Paulie Vagts:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Sara S. Thompson -S
For
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
ProCinch, QuadCinch
Indications for Use (Describe)
The ProCinch, QuadCinch Adjustable Loop Device is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon 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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Image /page/4/Picture/0 description: The image contains the logo for Riverpoint. The logo consists of the letters "RP" in a green square, followed by the word "RIVERPOINT" in green, sans-serif font. The logo is simple and modern, and the green color suggests that the company is environmentally friendly.
510(k) SUMMARY K240194 ProCinch, QuadCinch Adjustable Button Loop
Submitter Information
| Submitter's Name: | Riverpoint Medical |
|---|---|
| Address: | 825 NE 25th Ave. |
| Portland, OR 97232 | |
| Phone Number: | (503) 517-8001 or (971) 288-1083 |
| Fax Number: | (503) 517-8002 |
| Registration Number: | 3006981798 |
| Contact Person: | Paul Vagts |
| (503) 517-8001 | |
| Date of Preparation: | February 14th, 2024 |
| Trade Name: | ProCinch, QuadCinch |
| Common or Usual Names: | Suture Retention Device, Button Loop |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
| FDA Class: | II |
| Product Classification: | 888.3040: Smooth or threaded metallic bone |
| fixation fastener | |
| Classification Code: | MBI |
Predicate Device
K202399 - Riverpoint Medical OrthoButton FL
Device Description
The Riverpoint Medical ProCinch, QuadCinch adjustable button loop is comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate. Additional non-absorbable sutures consisting of UHMWPE, or polyester are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of blue or green color suture.
For configurations that do not have a titanium plate preattached, a titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and
5
Image /page/5/Picture/0 description: The image contains the logo for Riverpoint. The logo consists of the letters "RP" in a green square on the left, followed by the word "RIVERPOINT" in green, sans-serif font. The logo is simple and modern, and the green color suggests a connection to nature or sustainability.
secure into place. The UHMWPE is available undyed (white), dyed blue, or with trace filaments of blue or green color suture. 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 ProCinch, QuadCinch is FDA Class II device with product classification 21 CFR §888.3040: Smooth or threaded metallic bone fixation fastener, Product Code MBI.
Intended Use / Indications for Use
The ProCinch, QuadCinch is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
Performance Data
The sutures used to construct the ProCinch. QuadCinch meet requirements established by the United States Pharmacopeia (USP), except for diameter. The UHMWPE, polyester, or polyblend sutures are tested per USP performance requirements for tensile strength. Non-clinical performance testing for the ProCinch, QuadCinch included a sterilization adoption validation, biocompatibility testing per ISO10993-1:2018 -Biological Evaluation of Medical Devices, product packaging validation per ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems, usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015-Medical devices - Application of usability engineering to medical devices. LAL and rabbit pyrogencity testing have demonstrated that the ProCinch, QuadCinch does not raise any additional concerns regarding pyrogenicity. Non-clinical mechanical testing was performed to verify the fixation strength of the ProCinch, QuadCinch using cyclic testing as compared to the predicate device. Results of performance testing for the ProCinch, QuadCinch device concluded that the device performed comparably to the predicate device and the validations performed demonstrated that the ProCinch, QuadCinch met all requirements for its intended use.
Substantial Equivalence and Comparison of Technical Characteristics
As reflected in the following substantial equivalence table, the ProCinch, QuadCinch has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the ProCinch, QuadCinch and the predicate device are sterilized using the same processes, are composed of the same materials, and are tested per the same performance requirements.
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Image /page/6/Picture/0 description: The image shows the logo for Riverpoint. The logo consists of the letters RP in a green rounded square. To the right of the square is the word RIVERPOINT in green, bold, sans-serif font.
| Device | Riverpoint Medical
ProCinch, QuadCinch
Adjustable Button Loop | Riverpoint Medical
OrthoButton AL Adjustable
Button Loop
(K171060, K230212) | Comparison |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use /
Indications for Use | The Riverpoint Medical
ProCinch, QuadCinch is intended
for use in the fixation of bone and
soft tissue in orthopedic
procedures requiring ligament or
tendon reconstruction. | The Riverpoint Medical
OrthoButton AL is intended for
use in the fixation of bone and
soft tissue in orthopedic
procedures requiring ligament or
tendon reconstruction. | Identical |
| Loop Material | UHMWPE/Polyester | UHMWPE/Polyester | Identical |
| Additional Sutures | UHMWPE, polyester | UHMWPE, nylon, polyester,
polypropylene | Included |
| Color Additive | 21CFR74 | 21CFR74 and 21CFR73 | Included |
| Button Material | Titanium (Ti-6AI-4V ELI per
ASTM F136) | Titanium (Ti-6AI-4V ELI per
ASTM F136) | Identical |
| Finished Loop Length | 15-60mm | 15-60mm | Identical |
| Regulation Number | 888.3040 | 888.3040 | Identical |
| Regulatory Class | II | II | Identical |
| Prescription or OTC | Prescription | Prescription | Identical |
| Product Code | MBI | MBI | Identical |
| Principle of Operation | Manual fixation | Manual fixation | Identical |
| Packaging | Tyvek/Poly Pouch | Tyvek/Poly Pouch | Identical |
| Biocompatibility | Biocompatible per ISO 10993 | Biocompatible per ISO 10993 | Identical |
| Sterilization | EtO Sterilization | EtO Sterilization | Identical |
| Shelf Life | 5 Years | 5 Years | Identical |
The minor difference in technical characteristics is limited to 1) the subject device is provided with the adjustable loop fully assembled whereas the predicate device is assembled intraoperatively and 2) new packaging insert. These minor differences do not raise new questions of safety or effectiveness; therefore, the ProCinch, QuadCinch is substantially equivalent to the currently marketed OrthoButton FL predicate device.
Conclusion
The information provided in this Special 510(k) demonstrates that the Riverpoint Medical ProCinch, QuadCinch is substantially equivalent to the predicate device.