(28 days)
'K171060'
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a surgical implant, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended for fixation of bone and soft tissue in orthopedic procedures, which is a structural and mechanical function rather than a therapeutic one that would involve treating a disease or disorder.
No.
The device is described as being "intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction," indicating it is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines physical components made of UHMWPE and titanium, which are hardware materials. The device is intended for surgical implantation, further indicating it is a physical medical device, not software.
Based on the provided information, the Riverpoint Medical OrthoButton FL™ is not an IVD (In Vitro Diagnostic) device.
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 on the patient's body.
- Device Description: The description details a physical implant made of UHMWPE and titanium, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health, diagnosis, or treatment.
IVD devices are used to perform tests on samples taken from the body, while this device is a surgical implant used within the body.
N/A
Intended Use / Indications for Use
The Riverpoint Medical OrthoButton FL™ 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 FL™ is available in multiple configurations, see device specifications in Attachment 1. Configurations may be comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate, Additional non-absorbable sutures consisting of UHMWPE, nylon, polyester, or polypropylene 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 black, blue, or green color suture.
For configurations that do not have a titanium plate preattached, the 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, dyed black or with trace filaments of black, blue, or green color suture. Available Suture sizes are standard according to USP and EP requirements (dependent on suture type). The OrthoButton FLTM device is provided sterile for single use.
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
Not Found
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 FL™ 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 ISO10993-1:2018 - 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: 2015- Medical devices -Application of usability engineering to medical devices. Entotoxin/pyrogenicity testing, performed per ANSI/AAMI ST72:2019, USP , and USP . All acceptance criteria were met, and the Riverpoint Medical OrthoButton FL performed as intended.
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.
Not Found
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
September 18, 2020
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 Amanda Cole Regulatory Affairs Associate 825 NE 25th Avenue Portland, Oregon 97232
Re: K202399
Trade/Device Name: OrthoButton FLTM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: August 20, 2020 Received: August 21, 2020
Dear Ms. Cole:
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
1
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 medical devices and radiation-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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202399
Device Name OrthoButton FLTM
Indications for Use (Describe)
The Riverpoint Medical OrthoButton FL™ 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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3
510(k) SUMMARY
Riverpoint Medical OrthoButton FLTM Line Extension
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: | Edwin Anderson |
| (503) 517-8001 |
Date of Preparation:
Device Name
| Trade Name: | OrthoButton FLTM |
|---|---|
| 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 |
| Classification Code: | MBI |
| Review Panel | Orthopedic |
| Premarket Review | Office of Device Evaluation |
| Division of Orthopedic Devices (DOD) | |
| Joint and Fixation Devices Branch |
Predicate Device
K171060 – Riverpoint Medical OrthoButton® AL
4
Device Description
The Riverpoint Medical OrthoButton FL™ is available in multiple configurations, see device specifications in Attachment 1. Configurations may be comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate, Additional non-absorbable sutures consisting of UHMWPE, nylon, polyester, or polypropylene 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 black, blue, or green color suture.
For configurations that do not have a titanium plate preattached, the 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, dyed black or with trace filaments of black, blue, or green color suture. Available Suture sizes are standard according to USP and EP requirements (dependent on suture type). The OrthoButton FLTM device is provided sterile for single use.
Intended Use / Indications for Use
The Riverpoint Medical OrthoButton FL™ 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 FL™ 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 ISO10993-1:2018 - 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: 2015- Medical devices -Application of usability engineering to medical devices. Entotoxin/pyrogenicity testing, performed per ANSI/AAMI ST72:2019, USP , and USP . All acceptance criteria were met, and the Riverpoint Medical OrthoButton FL performed as intended.
Substantial Equivalence and Comparison of Technical Characteristics
The OrthoButton FLTM has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device. Both the OrthoButton FLTM and the predicate device are sterilized using the same processes, are composed of the same materials, and are tested per the same performance requirements. The minor difference in technical characteristics is limited to the packaging which allows the user to assemble the device prior to the procedure and affixing a clip-on button component for configurations without a preattached button. These minor differences do not raise new questions of safety or effectiveness; therefore, the OrthoButton FLTM line extension is substantially equivalent to the currently marketed OrthoButton®AL predicate device.
5
Conclusion
The information provided in this Special 510(k) demonstrates that the Riverpoint Medical OrthoButton FLTM line extension is substantially equivalent to the predicate device.