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, and the metatarsal bones of the foot.

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The awl handle is then withdrawn and removed for advancement of the implantable nail.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

Here's an analysis of the provided text regarding the Small Bone Fixation System, focusing on acceptance criteria and the study proving it:

Summary of Acceptance Criteria and Device Performance for the Small Bone Fixation System

The provided documentation does not detail specific, quantitative acceptance criteria for the device's clinical performance (e.g., fracture healing rates, complication rates). Instead, the acceptance criteria are rooted in compliance with recognized consensus standards and demonstrating substantial equivalence to predicate devices through technological characteristics, biocompatibility, and bench testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion Type	Specific Criteria/Standard Adhered To	Reported Device Performance/Evidence
Material Standards	ASTM F138-97: Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673)	"The materials meet the requirements of the previously referenced recognized consensus standards."
	ASTM F899-95: Stainless Steel Billet, Bar and Wire for Surgical Instruments	"The materials meet the requirements of the previously referenced recognized consensus standards."
Surface Treatment	ASTM F86-91: Surface Preparation and Marking of Metallic Surgical Implants	"demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy."
Device Specifications	ASTM F366-82 (Reapproved 1993): Fixation Pins and Wires	"demonstrated through biocompatibility and bench testing in accordance with Hand Innovations design review policy."
Biocompatibility	Assessed for tissue/bone contact materials	"Tissue/bone contact materials... have been carefully selected for their long history of biocompatibility."
Technological Equivalence	17 technological characteristics compared to predicate devices	"Seventeen (17) technological characteristics of the Small Bone Fixation were compared to the predicate devices and found to be equivalent."
Safety and Effectiveness	Believed to be safe and effective, performs as well as or better than predicate device	"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 performs as well as or better than the predicate device."
Quality System Compliance	Design controls compliant with Quality System Regulation (21 CFR Part 820)	"The Small Bone Fixation System for the Hand was designed utilizing design controls compliant with the Quality System Regulation."
Manufacturing Practices	Manufactured per specifications and good practices	"The Small Bone Fixation System will be manufactured per specifications and good practices that ensure the device is safe and effective for its intended use."

Study Details:

The provided document describes a 510(k) premarket notification which, by its nature, relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive de novo clinical trials to prove safety and effectiveness from scratch.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of this 510(k) submission. The "test set" here refers to the actual device itself being evaluated against standards and predicate comparison, not a human clinical trial test set.
Data Provenance: The data provenance is primarily from bench testing and biocompatibility assessments conducted by Hand Innovations, Inc. (the manufacturer). It is internal company data derived from their design, material selection, and testing processes. There is no mention of data from human subjects or external clinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. Ground truth, in the traditional sense of clinical outcomes or expert consensus on medical images, is not established for a clinical test set in this 510(k) submission. The "ground truth" for material properties and technological characteristics is established by the specifications of the ASTM standards themselves and the design documentation/testing of the manufacturer.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of an adjudication process in the context of a clinical test set. The substantial equivalence determination is made by the FDA's Office of Device Evaluation based on the submission dossier.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC comparative effectiveness study was not performed. This type of study typically involves comparing the diagnostic or prognostic performance of different medical devices or AI algorithms when interpreted by multiple human readers, often with or without AI assistance. This submission focuses on the physical and material equivalence of a surgical implant.

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

No. This device is a physical surgical implant, not an algorithm or software-as-a-medical-device (SaMD). Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is primarily technical specifications defined by recognized consensus standards (ASTM standards) for materials and fixation pins/wires. Additionally, the technological characteristics of legally marketed predicate devices serve as a "ground truth" for comparison.
Biocompatibility uses "long history of biocompatibility" of the selected materials as part of its evidence base.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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Summary of Safety and Effectiveness for the Small Bone Fixation System for the Hand

Submitted by

Hand Innovations, Inc. 8905 SW 87th Avenue Suite 100 Miami, FL 33176-2227

K04 1157
page 1 of 3

	Phone: (800) 800-8188Fax: (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 21CFR § 888 3040

Identification of a Legally Marketed Predicate Device

Device Description

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subsequent to healing. The implantable nail will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable nail is percutaneously removed.

Intended Use

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 Me-. tallic 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 de-

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page 3 of 5

their long history of biocompatibility. The mater

vice 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 performs 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 use.

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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 with three stylized lines representing its wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2004

Mr. Al Weisenborn Hand Innovations, Inc. 8905 SW 87 Avenue, Suite 100 Miami, Florida 33176-2227

Re: K041157

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: April 30, 2004 Received: May 3, 2007

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 vours.

Sincerely yours,

Mark N Millman

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 1_of_1

510(k) Number (if known): K041157

Small Bone Fixation System Device Name:

Indications for Use:

Mark A. Milkerson

Division of General, Restorative, and Neurological Devices

K041157

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

510(k) Number.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.