(49 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, image processing, or performance metrics typically associated with AI/ML devices.
Yes
Explanation: The device is a bone screw intended to stabilize and fix fractures, fusions, and osteotomies, which directly addresses a medical condition or injury.
No
The provided information indicates that the device, the Acute Bone Screw, is intended to stabilize and provide fixation for fractures, fusions, and osteotomies. This is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze medical conditions.
No
The device description clearly states it consists of physical bone screws made of titanium, 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 clearly states the device is for stabilizing and providing fixation for fractures, fusions, and osteotomies of the thorax. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone screw, a physical implant used in surgery.
- 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 treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) during surgery.
N/A
Intended Use / Indications for Use
The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).
Product codes
HWC
Device Description
The Acute Bone Screws consists of bone screws of varying lengths. The screws are partially and fully threaded, have a head with a hex drive, are cannulated or solid, and can be used with or without a plate or washer. The screws are manufactured out of titanium per ASTM F-136 and are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax (ribs, sternum, clavicle, scapula)
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
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Key Metrics
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
Acute Innovations LLC 5885 NW Cornelius Pass Road, Suite 200, Hillsboro, OR 97124
Phone: (503) 686-7200
Fax: (503) 645-9304
K06/206
JUN 19 2006
510(k) Summary
This summary regarding 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter Information: Acute Innovations LLC 5885 N.W. Cornelius Pass Road, Suite 200 Hillsboro, OR 97124-9432 USA Phone: (503) 686-7200 FAX: (503) 645-9304 Contact: Alyssa Thomas, Regulatory Specialist
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
|---|---|
| Common Name: | Screw, Fixation, Bone |
| Proprietary Name: | Acute Bone Screw |
| Proposed Regulatory Class: | Class II, 21 CFR 888.3040 |
| Device Product Code: | HWC |
| Legally Marketed Equivalent Device(s): | Macropore OS Reconstruction System K024169 |
| Acumed Cortical Bone Screw K942340 |
Device Description: The Acute Bone Screws consists of bone screws of varying lengths. The screws are partially and fully threaded, have a head with a hex drive, are cannulated or solid, and can be used with or without a plate or washer. The screws are manufactured out of titanium per ASTM F-136 and are provided non-sterile.
Intended Use: The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).
These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
Technological Characteristics: The Acute Bone Screws are made out of Titanium per ASTM F-136. The equivalent screw device listed for Acumed also use Titanium per ASTM F-136.
An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.
Based upon the similarities of the Acute Bone Screw and the predicate devices studied, the safety and effectiveness of the Acute Bone Screw is substantially equivalent to the predicate devices referenced,
Acute Innovations LLC Page 38
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus symbol. The caduceus is a symbol of medicine and health, and it is often used to represent healthcare organizations.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 19 2006
Acute Innovations LLC % Ms. Alyssa Thomas Regulatory Specialist 5885 N.W. Cornelius Pass Road, Suite 200 Hillsboro, Oregon 97124-7200
Re: K061206
Trade/Device Name: Acute Bone Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: April 20, 2006 Received: May 1, 2006
Dear Mr. Thomas:
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, 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.
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Page 2 – Ms. Alyssa Thomas
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,
Mark N. Melkerson
Mark N. Melkerson Director 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 (if known): _
Device Name: Acute Bone Screw
Indications For Use:
The Acute Bone Screw is a general purpose screw intended to stabilize and provide fixation for fractures, fusions, and osteotomies of the thorax (ribs, sternum, clavicle, scapula).
Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Haberter Lemmer
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061204
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