(69 days)
Not Found
Not Found
No
The device description focuses on mechanical components (plates and screws) for fracture fixation and does not mention any software, algorithms, or data processing capabilities indicative of AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is a plating system used for fixation of distal radial fractures, which is a therapeutic purpose.
No
Explanation: The device is described as a "Plating System" consisting of "plates and screws that provide internal fixation of the distal radius," which clearly indicates it is a surgical implant used for treatment, not diagnosis. Its purpose is to fix fractures, not to identify or analyze medical conditions.
No
The device description explicitly states it consists of "plates and screws" which are physical hardware components used for internal fixation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The SBi Distal Radius Volar Plating System is a system of plates and screws designed for internal fixation of bone fractures. It is surgically implanted into the body to stabilize a broken bone.
- Intended Use: The intended use is to fix distal radial fractures, which is a surgical procedure to repair a broken bone, not to analyze a specimen from the body.
Therefore, based on the provided information, the SBi Distal Radius Volar Plating System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SBi Distal Radius (DR) Volar Plating System is intended for use in fixation of distal radial fractures.
The implants are intended for one time use only
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The SBi Distal Radius (DR) Plating System consists of plates and screws that provide internal fixation of the distal radius. The devices are supplied non-sterile and are available in various sizes and configurations. There are several plate configurations in right and left hand orientations. The System also includes an assortment of cortical and cancellous screws some of which can be locked into the plates at varying angles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal radius
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): 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.
Not Found
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
§ 888.3030 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: | MAY 30 2007
Small Bone Innovations
1380 South Pennsylvania Avenue
Morrisville, PA 19067
215-428-1791
215-428-1795 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
1380 South Pennsylvania Avenue
Morrisville, PA 19067 |
| Proprietary Name: | SBi Distal Radius Volar Plating System |
| Classification name: | Class II, 888.3030 - Single/multiple component metallic
bone fixation appliances and accessories |
| Product Code: | HRS - Plate, Fixation, Bone |
| Common/Usual Name: | Single/multiple component metallic bone fixation
appliances and accessories |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBi
Distal Radius Volar Plating System to be substantially
equivalent to other legally marketed devices. |
| Device Description: | The SBi Distal Radius (DR) Plating System consists of
plates and screws that provide internal fixation of the
distal radius. The devices are supplied non-sterile and are
available in various sizes and configurations. There are
several plate configurations in right and left hand
orientations. The System also includes an assortment of
cortical and cancellous screws some of which can be
locked into the plates at varying angles. |
| Intended Use: | The SBi Distal Radius (DR) Volar Plating System is
intended for use in fixation of distal radial fractures.
The implants are intended for one time use only |
| | |
| Material: | The plates for the SBi DR Plating System are made from
Grade 1 titanium per ASTM F67. The screws for the SBi
DR Plating System are available in both Ti-6Al-7Nb per
ASTM F1295-05 or Ti-6Al-4V per ASTM F136. |
:
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 0 2007
Small Bone Innovations, Inc. % Mr. Robert Hoehn Regulatory Associate Musculoskeletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022
Re: K070793
Trade/Device Name: SBi Distal Radius Volar Plating System 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: May 23, 2007 Received: May 24, 2007
Dear Mr. 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
2
Page 2 - Mr. Robert Hoehn
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
for
Mark N. Melkerson
Der D.ascur
5/29/08
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number: K070793
Device Name: SBi Distal Radius Volar Plating System
Indications For Use:
The SBi Distal Radius Volar Plating System is intended for use in fixation of distal radial fractures.
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
(Division Sign-Off)
Sign-Off Division of General. Restorative, and Neurological Devices
510(k) Number L070793