(83 days)
Not Found
No
The device description details a purely mechanical system for bone fixation. There is no mention of software, algorithms, or any computational components that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is indicated for the "fixation of extra-articular fractures" which is a therapeutic intervention. It is designed to stabilize bone fractures to facilitate healing, which falls under the definition of a therapeutic device.
No
The device is a Small Bone Fixation System, designed for the fixation of bone fractures in the hand, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (Slotted Awl Assembly, Implantable Nail Handle Assembly, polymer Nail Cap, Exchange Guide and Bend Tube, optional locking device) and procedures involving their use in surgical fixation. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "Small Bone Fixation System" used for the "fixation of extra-articular fractures of the long bones of the hand". It is an implantable device used directly on the bone to stabilize fractures.
- No Mention of Specimen Analysis: There is no mention of collecting or analyzing any biological specimens from the patient. The device is used surgically to repair bone fractures.
Therefore, this device falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.
Product codes
HTY
Device Description
The Small Bone Fixation System is a sterile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.
Prior to use,the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.
The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail insertion site. The nail is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.
In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.
An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking sleeve are simultaneously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones of the hand including the metacarpals and the proximal and middle phalanges.
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)
The Small Bone Fixation System for the Hand meets the requirements of the following recognized consensus standards.
- ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 Nickel-. 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire . for Surgical Instruments
- ASTM F86 91, Standard Practice for Surface Preparation and Marking of Metal-. lic Surgical Implants
- ASTM F366 82 (Reapproved 1993), Standard Specification for Fixation Pins . and Wires
This has been demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy. The tissue/bone contact materials of the device have been carefully selected for their long history of biocompatibility. The materials meet the requirements of the previously referenced recognized consensus standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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K033406/31 Page 19 of 21
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Image /page/0/Figure/4 description: The image shows a title card with the words "Summary of Safety and Effectiveness for the Small Bone Fixation System for the Hand". The text is centered and in a sans-serif font. The title card is surrounded by a black border.
Submitted by
Hand Innovations, Inc. 8905 SW 87th Avenue Suite 100 Miami, FL 33176-2227 Phonc: (800) 800-8188 Fax: (305) 412-8060
| Contact Person: | Al Weisenborn |
|---|---|
| Device Trade Name: | Small Bone Fixation System |
| Common Name: | K-Wire |
| Classification Name: | Smooth or threaded metallic bone fixation fastener, per 21 CFR |
| § 888.3040 |
Identification of a Legally Marketed Predicate Device
The Small Bone Fixation System is substantially equivalent to the Intramedullary Fixation Systems and the Phalangeal Fixation Systems that are legally manufactured and marketed pursuant to premarket notifications K994232 and K013424.
Device Description
The Small Bone Fixation System is a stcrile, single use, disposable device that is delivered non-toxic. The Small Bone Fixation System consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, polymer Nail Cap and Exchange Guide and Bend Tube.
Prior to use,the implantable nail assembly is nested in the slotted awl assembly. The slotted awl assembly has a trocar point. The implantable nail has a blunt point that is positioned just behind the trocar point of the slotted awl. The sharp point of the slotted awl assembly is passed through a small incision. A holc is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the slotted awl handle is held stationary while the implantable nail is then advanced distally from the base of the metacarpal bone.
The awl handle is then withdrawn and removed for advancement of the implantable nail. The implantable nail is then cut adjacent to the nail handle. Using the bending tube end of the exchange guide and bend tube the implantable nail is bent to 90° with the apex of the bend at the implantable nail inscrtion site. The nail is trimmed so that the end is below the
1
K633406 S/L
Page 20 of 21
skin. The small piece remaining will facilitate removal of the implantable nail subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.
In the event that it is desired to reform the implantable nail or implant a smaller nail, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable nail into the medullar space. Once the medullar space is accessed, the nail is removed. Another nail may be placed into the medulla by inserting it into the groove of the exchange guide. After the nail has been inserted into the medullar space, remove the exchange guide.
An optional locking device may be used to minimize rotation of the implantable nail. The device consists of a pointed stainless steel cannula mounted to a polymeric handle. After the implantable nail is bent to a 90-degree angle, the locking sleeve is positioned over the end of the implantable nail and manually advanced downward through the cortical perforation and into the metaphysis. The locking device is then advanced until tactile feedback confirms ratchet engagement. The locking device may be further advance to the desired depth. When resistance is felt, the locking nail is impacted into its final position with a few sharp taps. The nail and locking slecve are simultancously trimmed. The polymer nail cap may be placed over the end of the nail during the healing period.
Intended Use
The Small Bone Fixation System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.
Summary of Technological Characteristics
Seventeen (17) technological characteristics of the Small Bone Fixation were compared to the predicate devices and found to be equivalent.
Summary of Performance Data
The Small Bone Fixation System for the Hand meets the requirements of the following recognized consensus standards.
- ASTM F138 97, Standard Specification for Wrought 18 Chromium-14 Nickel-. 2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)
- ASTM F899 95, Standard Specification for Stainless Steel Billet, Bar and Wire . for Surgical Instruments
- ASTM F86 91, Standard Practice for Surface Preparation and Marking of Metal-. lic Surgical Implants
- ASTM F366 82 (Reapproved 1993), Standard Specification for Fixation Pins . and Wires
2
This has been demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy. The tissue/bone contact materials of the device have been carefully selected for their long history of biocompatibility. The materials meet the requirements of the previously referenced recognized consensus standards.
Since the Small Bone Fixation System meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate devices, we believe the device is safe and effective and pcrforms as well as or better than the predicate device. The Small Bone Fixation System for the Hand was designed utilizing design controls compliant with the Quality System Regulation. The Small Bone Fixation System will be manufactured per specifications and good practices that ensure the device is safe and effective for its intended usc.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 5 2004
Mr. Al Weisenborn Hand Innovations, Inc. 8905 SW 87th Avenue, Suite 100 Miami, Florida 33176-2227
Re: K033406
Trade/Device Name: Small Bone fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: December 16, 2003 Received: December 17, 2003
Dear Mr. Weisenborn:
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 - Mr. Al Weisenborn
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 (301) 594-4659. 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/dsma/dsmamain.html
Sincerely yours,
Mark N Millican
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
Page_I_of_1
510(k) Number (if known): K033406-S1
Small Bone Fixation System Device Name:
Indications for Use:
Bone Fixation System is indi-Small The cated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal and middle phalanges.
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Hand Innovations, Inc.