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.

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The awl handle is then withdrawn and removed for advancement of the implantable nail.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.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel AI or diagnostic device would.

Based on the provided text, the "acceptance criteria" and "device performance" are primarily framed around compliance with recognized consensus standards and demonstrating "substantial equivalence" to existing, legally marketed devices.

Here's an analysis of the provided information, structured around the requested points, with observations where information is not explicitly available:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance
Material Composition	ASTM F138-97: Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel	Meets requirements of ASTM F138-97
	ASTM F899-95: Stainless Steel Billet, Bar and Wire for Surgical Instruments	Meets requirements of ASTM F899-95
Surface Preparation	ASTM F86-91: Practice for Surface Preparation and Marking of Metallic Surgical Implants	Meets requirements of ASTM F86-91
Fixation Pins/Wires	ASTM F366-82 (Reapproved 1993): Standard Specification for Fixation Pins and Wires	Meets requirements of ASTM F366-82 (Reapproved 1993)
Biocompatibility	Compliance with recognized consensus standards for tissue/bone contact materials	Tissue/bone contact materials have a long history of biocompatibility and meet referenced standards.
Technological Characteristics	Substantial equivalence to predicate devices (K994232 and K013424) on 17 characteristics	Seventeen (17) technological characteristics were compared and found to be equivalent to predicate devices.
Safety & Effectiveness	Performed as well as or better than the predicate device.	Believed to be safe and effective, and perform as well as or better than the predicate device due to standards compliance and technological equivalence.
Quality System	Device designed and manufactured under design controls compliant with Quality System Regulation	Designed utilizing design controls compliant with the Quality System Regulation; will be manufactured per specifications and good practices.

2. Sample size used for the test set and the data provenance:

The document describes bench testing for material and mechanical properties, not a clinical "test set" in the sense of patient data. There is no mention of a specific sample size for a test set of patient data.
Data provenance for the bench testing is not specified beyond "Hand Innovations design review policy." There is no mention of country of origin or whether a "test set" involved retrospective or prospective data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a mechanical fixation system, not a diagnostic or AI device that requires expert-established ground truth for a test set of patient data. The "ground truth" here is compliance with engineering and material standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable as there is no mention of a test set involving human judgment or interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a medical device for bone fixation, not an AI or diagnostic tool that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a mechanical medical device, not an algorithm. Bench testing was performed on the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this submission is adherence to recognized consensus standards (ASTM F138, F899, F86, F366) for material properties and manufacturing practices, and technological equivalence to predicate devices. There is no mention of clinical outcomes data in the context of this 510(k) submission for establishing ground truth.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing follow established engineering principles and quality system regulations.

9. How the ground truth for the training set was established:

Not applicable for the same reason as point 8.

Summary

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K033406/31 Page 19 of 21

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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.

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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.

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

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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

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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.

PLEASE DO NOT WRITE BFILOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K033406

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Prescription Use X (Per 21 CFR 801.109) ાર

Over-The-Counter Use

(Optional Format 1-2-96)

Hand Innovations, Inc.

Regulation Number and Section

§ 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.