The Intramedullary 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. The optional locking device may be used to minimize axial and rotational motion of the implantable nail during healing.

Device Description

The Intramedullary Fixation System for the Hand is a sterile, single use, disposable device that is delivered non-toxic. The Intramedullary Fixation System for the Hand consists of the Slotted Awl Assembly, the Implantable Nail Handle Assembly, 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 The awl handle is then withdrawn and removed for advancement of the implantable nail.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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Intramedullary Fixation System for the Hand, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standard Met	Reported Device Performance
Material Standards	ASTM F138-97	Meets requirements
	ASTM F899-95	Meets requirements
	ASTM F86-91	Meets requirements
Fixation Pins/Wires	ASTM F366-82 (Reapproved 1993)	Meets requirements
Biocompatibility	Long history of biocompatibility (materials meet referenced standards)	Materials carefully selected and meet requirements
Bench Testing - Equivalence to Predicate	Stiffness/Yield, Cutting Geometry Comparison, Drilling Test	Demonstrated equivalence to predicate device (K-wire manufactured by MicroAire Surgical Equipment)
Safety and Efficacy	(Implicit through meeting standards and bench testing)	Safe and effective, performs as well as or better than the predicate device
Quality System	Design controls compliant with Quality System Regulation	Designed utilizing compliant design controls
Manufacturing	Manufactured per specifications and good practices	Manufactured per specifications and good practices to ensure safety and effectiveness

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

Sample Size for Test Set: Not explicitly stated as a numerical sample size for a clinical test set. The submission focuses on bench testing and material standards compliance.
Data Provenance: The 'data' primarily comes from:
- Bench tests: Conducted to establish safety and efficacy.
- Material standards compliance: Based on the properties of the materials used in the device.
- Comparison to a predicate device: The K-wire manufactured by MicroAire Surgical Equipment.
Retrospective or Prospective: Not applicable as a clinical study with retrospective/prospective patient data is not described. The studies were laboratory-based (bench testing) and materials analysis.

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

Number of Experts: Not applicable. Ground truth, in this context, refers to established engineering standards, material properties, and comparative performance against a predicate device.
Qualifications of Experts: Not applicable for establishing ground truth in this type of submission. The 'expertise' lies in the established ASTM standards and the technical assessment by the manufacturers and presumably, the FDA reviewers.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There was no human interpretation or adjudication described for the bench test results or material compliance. The results would be objectively measured against predefined criteria or the predicate device's performance.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done.
Effect Size of AI: Not applicable, as this device submission predates widespread AI integration in medical devices of this type and does not involve AI.

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

Standalone Performance: No, a standalone algorithm performance study was not done. This device is a mechanical implant, not an AI or software algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth:
- Engineering Standards: Adherence to recognized ASTM standards for materials and fixation pins/wires.
- Predicate Device Performance: Performance data from the legally marketed predicate device (K-wire by MicroAire Surgical Equipment) served as a benchmark for equivalence in bench testing (stiffness/yield, cutting geometry, drilling).
- Biocompatibility Data: Established history of biocompatibility for the materials used.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI or machine learning model that requires a "training set." The design and manufacturing processes are iterative, but there is no specific "training set" in the computational sense.

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

Ground Truth Establishment for Training Set: Not applicable. As there is no training set, there is no ground truth established for one. The design and validation relied on established engineering principles, material science, and comparison to existing, proven devices.

Summary

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510(k), Intramedullary Fixation System for the Hand (IFS)

Fixation System for the Hand

Submitted by

DEC 2 0 2001

Hand Innovations, Inc. 8905 SW 87th Avenue Suite 100 Miami, FL 33176-2227 Phone: (305) 412-8010 Fax: (305) 412-8060

Contact Person:	Al Weisenborn
Device Trade Name:	Intramedullary Fixation System for the Hand
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 Intramedullary Fixation System for the Hand is substantially equivalent to the Intramedullary Fixation System for the Hand that is legally manufactured by Medcanica and marketed pursuant to premarket notification K991064.

Device Description

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

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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.

Intended Use

Summary of Technological Characteristics

Twelve (12) technological characteristics of the Intramedullary Fixation System for the Hand were compared to the K-wire manufactured by MicroAire Surgical Equipment and found to be equivalent.

Summary of Performance Data

The Intramedullary 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

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ASTM F366 82 (Reapproved 1993), Standard Specification for Fixation Pins . and Wires
Additionally, nine (9) bench tests were performed to establish the safety and efficacy of the device.

Bench testing of both devices also demonstrated equivalence. Testing included stiffness/vield. cutting geometry comparison, and drilling test.

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 Intramedullary Fixation System for the Hand meets the requirements of the stated standards and embodies technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device. The Intramedullary Fixation System for the Hand was designed utilizing design controls compliant with the Quality System Regulation. The Intramedullary Fixation System for the Hand will be manufactured per specifications and good practices that ensure the device is safe and effective for its intended use.

K013424/
page 30 of 3

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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 features a stylized image of an eagle with three stripes representing the feathers. The eagle is facing to the left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 0 2001

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

Re: K013424

Trade/Device Name: Intramedullary Fixation System for the Hand Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HTY Dated: October 9, 2001 Received: October 16, 2001

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 with the proval of a proval 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 This letter will and if your your the FDA finding of substantial equivalence of your J ro(k) promation noarketed 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 If you dosire uposition in the diagnostic devices), please contact the alle additionally 21 Of Crick 659. Additionally, for questions on the promotion Onloo of Coing of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to prematice) 4057. Thiso, promo note are rogg). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 6382041 or (301) 4436597 or at its Internet address HYPERLINK http://www.fda.gov/cdrh/dsma/dsmamain.html http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

signature

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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The Indications for Use

Page 1 of 1

KO1 3424 510(k) Number (if known):

Intramedullary Fixation System for the Hand Device Name:

Indications for Use:

The Intramedullary 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. The pars and one ing device may be used to minimize optional rotational motion of the implantable nail during healing.

signature

Division Sign-Off Division of General, Restorative and Neurological Devices

510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

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.