(53 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the physical components, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is used for the "fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction," which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device description indicates its use for "fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction," which is a treatment or surgical function, not a diagnostic one.
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 implant, not software.
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: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health status, diagnosis, or treatment.
IVD devices are used in vitro (in glass, or outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (in the body) as a surgical implant.
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 ALTM is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6Al-4V ELI per ASTM F136) plate. The 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 AL 110 included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, 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 simulated use Usability Validation performed per EN62366: 2008- Medical devices - Application of usability engineering to medical devices. The Riverpoint Medical OrthoButton AL™ was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions. All acceptance criteria were met, and the Riverpoint Medical OrthoButton AL" 100 performed as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Public Health Service
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2017
Riverpoint Medical Mr. Nathan Cook Director of Quality Assurance 825 NE 25th Avenue Portland, Oregon 97232
Re: K171060
Trade/Device Name: OrthoButton AL TM Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 15, 2017 Received: May 15, 2017
Dear Mr. Cook:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known): K171060
Device Name: OrthoButton ALTM
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.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
Image /page/3/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green square with rounded corners, inside of which are the letters "RP" in white. To the right of the square is the word "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
K171060
510(k) SUMMARY
Riverpoint Medical OrthoButton® 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: | Nathan Cook |
| (503) 517-8001 | |
| Date of Preparation: | March 31, 2017 |
Device Name
| Trade Name: | OrthoButton ALTM |
|---|---|
| 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
K160655 – Riverpoint Medical OrthoButton CL
4
Image /page/4/Picture/0 description: The image contains the logo for Riverpoint Medical. The logo consists of a green square with rounded corners, inside of which are the letters "RP" in white. To the right of the square is the word "RIVERPOINT" in bold, black letters, with the word "MEDICAL" in smaller, black letters underneath.
Device Description
The Riverpoint Medical OrthoButton ALTM is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6Al-4V ELI per ASTM F136) plate. The device is provided sterile for single use.
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 110 included sterilization validation per ISO11135-1:2007 - Sterilization of Health Care Products Ethylene Oxide Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for medical devices, 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 simulated use Usability Validation performed per EN62366: 2008- Medical devices - Application of usability engineering to medical devices. The Riverpoint Medical OrthoButton AL™ was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions. All acceptance criteria were met, and the Riverpoint Medical OrthoButton AL" 100 performed as intended.
Substantial Equivalence and Comparison of Technical Characteristics
The OrthoButton AL™ line extension is as safe and effective as the previously cleared OrthoButton CL®. The OrthoButton AL™ 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 AL 111 and the predicate device are sterilized using the same processes, are composed of the same material, and are tested per the same performance requirements. LAL and rabbit pyrogencity testing has demonstrated that the OrthoButton AL 100 does not raise any additional concerns regarding pyrogenicity. The minor difference in technical characteristics is limited to the ability for adjustment of the loop length. This difference does not raise new questions of safety or effectiveness; therefore, the OrthoButton ALTM 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 OrthoButton ALTM line extension is substantially equivalent to the predicate device.