(28 days)
No
The summary describes a mechanical device for orthopedic fixation and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as being used for "fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction," which implies a mechanical support or repair function rather than a therapeutic (treatment) function.
No
The device is described as an orthopedic implant for fixation of bone and soft tissue in reconstruction procedures, not for diagnosis. Its intended use focuses on treatment rather than detection or analysis of medical conditions.
No
The device description explicitly states it is comprised of a braided UHMWPE adjustable loop combined with a titanium plate, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction." This describes a surgical implant used directly within the body during a procedure.
- Device Description: The description details a physical implant made of UHMWPE and titanium, designed to be surgically placed.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose conditions, or monitor treatment. This device does not perform any such function.
The information clearly indicates this is a surgical implant used for mechanical support and fixation within the body, which falls under the category of a medical device, but not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MBI
Device Description
The Riverpoint Medical OrthoButton® AL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6A1-4V ELI per ASTM F136) plate. The device 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
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 Riverpoint Medical OrthoButton® AL included sterilization validation ISO 14937:2009 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 including biocompatibility ISO 10993-7:2008 for Biological evaluation of medical devices-Part 7 Ethylene Oxide Sterilzation Residuals, biocompatibility testing per ISO10993-1:2009 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - 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: 2008-Medical devices - Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical OrthoButton® AL performed as intended. LAL and rabbit pyrogencity testing has demonstrated that the OrthoButton® AL does not raise any additional concerns regarding pyrogenicity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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February 23, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Riverpoint Medical, LLC Rebecca DeFrancia Regulatory Affairs Associate 815 NE 25th Ave Portland. Oregon 97232
Re: K230212
Trade/Device Name: OrthoButton® AL Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: January 26, 2023 Received: January 26, 2023
Dear Rebecca DeFrancia:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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.
Sara S. Thompson -S
For
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230212
Device Name OrthoButton® AL
Indications for Use (Describe)
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.
| 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/0 description: The image shows the logo for Riverpoint. The logo consists of the letters "RP" in white on a green square, followed by the word "RIVERPOINT" in green. The logo is simple and modern, and the colors are eye-catching.
510(k) SUMMARY
Riverpoint Medical OrthoButton® AL with Expanded instructions for use
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: | Rebecca DeFrancia |
| (503) 517-8001 | |
| Date of Preparation: | January 25, 2023 |
Device Name
| Trade Name: | OrthoButton® AL |
|---|---|
| Common or Usual Names: | Suture Retention Device, Button Loop |
| Classification Name: | Fastener, Fixation, Non-Degradable, Soft Tissue |
Device Classification
| FDA Class: | II |
|---|---|
| Product Classification: | 888.3040: Smooth Or Threaded Metallic Bone Fixation |
| Fastener | |
| Classification Code: | MBI |
| Review Panel | Orthopedic |
| Premarket Review | Office of Product Evaluation and Quality |
| Office of Health Technologies 6 (OHT6)– Office of | |
| Orthopedic Devices | |
| Division of Restorative, Repair and Trauma Devices |
Predicate Device
K171060 – Riverpoint Medical OrthoButton® AL
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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 white on a green rounded square. To the right of the square is the word "RIVERPOINT" in green.
Reference Device
K100652 - Arthex ACL Tightrope
Device Description
The Riverpoint Medical OrthoButton® AL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6A1-4V ELI per ASTM F136) plate. The device is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.
The classification for the OrthoButton® AL 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 Riverpoint Medical OrthoButton® AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
Performance Data
Non-clinical performance testing for the Riverpoint Medical OrthoButton® AL included sterilization validation ISO 14937:2009 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 including biocompatibility ISO 10993-7:2008 for Biological evaluation of medical devices-Part 7 Ethylene Oxide Sterilzation Residuals, biocompatibility testing per ISO10993-1:2009 - Biological Evaluation of Medical Devices, stability testing on the product and packaging per ISO 11607-1:2006 - 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: 2008-Medical devices - Application of usability engineering to medical devices. All acceptance criteria were met, and the Riverpoint Medical OrthoButton® AL performed as intended. LAL and rabbit pyrogencity testing has demonstrated that the OrthoButton® AL does not raise any additional concerns regarding pyrogenicity.
Substantial Equivalence and Comparison of Technical Characteristics
The OrthoButton® AL with expanded instructions for use is substantially equivalent to the previously cleared OrthoButton® AL cleared per K171060 "predicate device." The OrthoButton® AL has the same intended use, the same principles of operation, and the same technological characteristics as the predicate device. Both the OrthoButton® AL and the predicate device are comprised of the same materials, packaged using the same packaging materials and sterilized using the same processes. The OrthoButton® AL subject device contains slight labeling differences from the OrthoButton® AL predicate device in the following way: the instructions for use clarification for double button tibial fixation. However, this labelling characteristic for double button tibial fixation configuration is within the range of currently marketed devices including "reference device" Arthrex ACL Tightrope cleared per K100652.
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Therefore, the OrthoButton® AL "subject device" is substantially equivalent to the predicate device in both labelling and intended use and does not raise any issues of safety or effectiveness.
Conclusion
The information provided in this Special 510(k) demonstrates that the Riverpoint Medical OrthoButton® AL subject device with expanded instructions for use is substantially equivalent to the predicate device.