(23 days)
Not Found
Not Found
No
The summary describes a mechanical implant (a fusion plate and screws) and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is designed for fusion of carpal bones to address pain and loss of function due to various conditions like arthritis and fractures, thereby restoring function and alleviating symptoms.
No
Explanation: The device is described as a "fusion plate" intended for surgical implantation to fuse carpal bones as a treatment for various conditions. It does not mention any function related to identifying, analyzing, or monitoring health conditions or diseases.
No
The device description clearly states it is a physical plate and screws fabricated from implantable grade stainless steel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the surgical fusion of carpal bones in the hand to treat conditions like arthritis and fractures. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical implant (a plate and screws) made of stainless steel, designed to be surgically placed within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
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 a surgical procedure.
N/A
Intended Use / Indications for Use
The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
Product codes
HRS
Device Description
The SBI Carpal Fusion Plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carpal bones of the hand including; capitate, hamate, lunate, and triquetrum.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
510(k) Summary
| Manufacturer: | rms Company
8600 Evergreen Boulevard
Minneapolis, MN 55433
763-786-1520 - Office
763-783-5073 | OCT 20 2006 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitted By: | Small Bone Innovations
James O' Connor
505 Park Avenue, 14th Floor
New York, NY 10022
joconnor@totalsmallbone.com
215-428-1791 - Office
212-750-2112 - Fax | |
| Proprietary Name: | SBI Carpal Fusion Plate | |
| Classification name: | Class II, 888.3030 - Plate, Fixation, Bone | |
| Common/Usual Name: | Carpal Fusion Plate | |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
Carpal Fusion Plate to be substantially equivalent to other
legally marketed devices. | |
| Device Description: | The SBI Carpal Fusion Plate is a low profile single piece
construct designed to fit over the dorsal aspect of the carpal
bones in the hand. The plate has spherical holes or slots
that accommodate screws for fixation. The plate and
screws are fabricated from implantable grade stainless
steel. | |
| Intended Use: | The SBi Carpal Fusion Plate is designed for fusion of the
carpal bones of the hand including; capitate, hamate,
lunate, and triquetrum. The fusion plate is intended for use
in patients suffering from pain and/or loss of function due
to osteoarthritis, post-traumatic arthritis, fractures, revision
of failed partial wrist fusions, carpal instability, or
rheumatoid arthritis. The fusion plate is used in
conjunction with screws that fix the plate to the carpal
bones of the hand. | |
| Material: | The SBI Carpal Fusion plate is made from implantable
grade stainless steel. | |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations Inc. % Mr. Robert Hoehn 505 Park Avenue, 14th Floor New York, New York 10022
OC1 2 0 2006
Re: K062903
Trade/Device Name: SBI Carpal Fusion Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: September 15, 2006 Received: September 27, 2006
Dear Ms. Hoehn:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. ·
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
2
Page 2 – Mr. Robert Hoehn
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Milliken
Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: SBI Carpal Fusion Plate
Indications For Use:
The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, and triquetrum. The fusion plate is intendentifor use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate the carpal bones of the hand.
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Mark N. Mekean
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K062903