(266 days)
Not Found
Not Found
No
The device description focuses on mechanical components (screws and washers) for bone fixation and does not mention any software, algorithms, or data processing capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
Yes
The device is used for bone fixation following trauma or osteotomy, which addresses a medical condition and restores function, thus classifying it as a therapeutic device.
No
The device description clearly states its purpose is for "bone fixation of the hand and foot following trauma or osteotomy," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it consists of "screws and washers," which are hardware components, not software.
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.
- Device Description: The SBi Forefoot Set consists of screws and washers used for internal fixation of bones. This is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is for bone fixation following trauma or osteotomy, which is a surgical procedure.
The description clearly indicates a device used within the body for structural support, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.
Product codes
HWC
Device Description
The SBi Forefoot Set consists of screws and washers that provide internal fixation of bones. The devices are supplied non-sterile and are available in various sizes and configurations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand and foot
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)
Documentation is provided which demonstrated the SBI Forefoot set to be substantially equivalent to other legally marketed devices.
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
§ 888.3040 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
K063635 of I PA
510(k) Summary
AUG 2 9 2007
| Manufacturer: | Small Bone Innovations
1711 S. Pennsylvania Avenue
Morrisville, PA 19067 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | Small Bone Innovations
James O' Connor
1711 South Pennsylvania Avenue
Morrisville, PA 19067
Phone (215) 428-1791 ext 254
Fax (215) 428-1795 |
| Proprietary Name: | SBI Forefoot Set |
| Classification name: | Class II, 888.3040- Screw, Fixation, Bone |
| Product Code: | HWC |
| Common/Usual Name: | Smooth or threaded metallic bone fixation fastener |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBI
Forefoot set to be substantially equivalent to other legally
marketed devices. |
| Device Description: | The SBi Forefoot Set consists of screws and washers that
provide internal fixation of bones. The devices are
supplied non-sterile and are available in various sizes and
configurations. |
| Indications for Use: | The SBi Forefoot Set is indicated for bone fixation of the
hand and foot following trauma or osteotomy. |
| Material: | The implants are made from implant grade 316LS
stainless steel (ASTM F138) or Ti6AL4V implantable
Titanium (ASTM F136). |
:
1
Image /page/1/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol on the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Robert Hoehn Regulatory Associate 505 Park Avenue, 14th Floor New York, New York 10022
AUG 2 9 2007
Re: K063635
Trade/Device Name: SBi Forefoot Set Regulation Number: 21 CFR 888,3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: July 16, 2007 Received: July 17, 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, listing 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, JFDA 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 legal]y marketed predicate device results in a classification for your device and thus, perroits 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 toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.http://
Sincerely yours,
Barbara Buchner
Mark N. Melkerson 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: 长巴6 3 635
Device Name: SBi Forefoot Set
Indications for Use:
The SBi Forefoot Set is indicated for bone fixation of the hand and foot following trauma or osteotomy.
Prescription Use √ (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
Alvarez Buchelin
(Divis Division of General, Restorative, and Neurological Devices
510(k) Number K063635