(55 days)
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No
The summary describes a simple mechanical device (K-wires) and contains no mention of AI, ML, image processing, or any related concepts.
No.
The device is used for fixation and reconstruction of bone and as guide pins, which is a structural or supportive function, not a therapeutic one that treats or cures a disease or condition.
No
Explanation: The SBI K-Wires are described as implants used for fixation of bone fractures, bone reconstruction, and as guide pins for other implants. Their function is therapeutic/interventional rather than diagnostic (detecting or identifying a medical condition).
No
The device description clearly states it is a physical medical device (K-Wires) used for bone fixation and reconstruction, not a software application.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that the SBI K-Wires are used for the "fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants." This is a surgical device used directly on the patient's body for structural support and guidance during procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided information, the SBI K-Wires are a surgical implant/instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SBI K-Wires are indicated for use in fixation of bone fractures, for bone feconstruction, and as guide pins for insertion of other implants.
Product codes
HTY
Device Description
SBI K-Wires are provided non-sterile. They range in diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
KOSlues
AUG 1 0 2005 510(k) Summary
Manufacturer: Small Bone Innovations 1711 S. Pennsylvania Avenue Morrisville, PA 19067 Submitted By: Donald W. Guthner, Vice President Musculoskeletal Clinical Regulatory Advisers 505 Park Avenue, 14th Floor New York, NY 10022 dguthner@mcrallc.com 212-586-0250 - Office 212-750-2112 - Fax Proprietary Name: SBI K-Wires Class II, 888.3040 - Smooth or threaded metallic bone Classification name: fixation fastener Common/Usual Name: Bone fixation fasteners Substantial Equivalence: Documentation is provided which demonstrated the SBI K -Wires to be substantially equivalent to other legally marketed devices. SBI K-Wires are provided non-sterile. They range in Device Description: diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point. Intended Use: SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants Material: 316L (per ASTM F 138), Titanium 6AL4V-ELI (per ASTM F 136-92), and Cobalt Chrome Alloys
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181
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 0 2005
Small Bone Innovations, LLC c/o Mr. Donald W. Guthner Vice President Musculosketletal Clinical Regulatory Advisers, LLC 505 Park Avenue, 14th Floor New York, New York 10022
Re: K051605
Trade/Device Name: SBI K-Wires Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: June 7, 2005 Received: June 16, 2005
Dear Mr. Guthner:
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.
2
Page 2 - Mr. Donald W. Guthner, Vice President
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,
Stupt. Clurdu
Mark N. Melkerson
Acting 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:
nevice Name: SBI K-Wires
Indications For Use:
The SBI K-Wires are indicated for use in fixation of bone fractures, for bone feconstruction, and as guide pins for insertion of other implants.
Prescription Use V Part 21 CFR 801 Subpart D)
A SHEET ALL COMPLE AND AN
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
Stypt Rhodes
Avision of General, Restorative and Neurological Devices
Number K051605