The Distal Radius Fracture Repair System was previously cleared under 510(k) No. K023007. The system consists of a volar stabilization plate, bone screws, fixation pegs, dorsal intrafocal nail-plate, three fixed angle bone pegs and two locking screws. This 510(k) is being submitted as a modification to the original 510(k) No. K023007 to update and standardize the sterilization cycle. The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s). The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft. Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide. A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336. The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include Titanium TI-6AL-4V ELI and Stainless Steel 440C and SST-17-4. The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. The system is packaged in a high tempered plastic sterilization tray.

AI/ML Overview

This is a 510(k) summary for a medical device (Distal Radius Fracture Repair Kit/System), not an AI/algorithm-driven device. Therefore, the requested information about acceptance criteria and studies proving the device meets those criteria, particularly regarding performance metrics like those for AI, is not applicable in the context of this document.

The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K023007) based on material, intended use, manufacturing, and sterilization process.

Here's why the requested information cannot be provided from the given text:

No Acceptance Criteria for AI/Performance: The submission is for a traditional surgical implant system (plates, screws, pegs). There are no performance metrics or acceptance criteria related to accuracy, sensitivity, specificity, or other AI-specific measures. The "performance" discussed is in the context of the physical properties and function of the orthopedic implants, not an AI algorithm.
No Study Data for AI/Performance: Consequently, there are no studies detailed that would "prove the device meets acceptance criteria" in terms of AI performance. The focus is on demonstrating that the modified device (primarily changes to sterilization cycle) is as safe and effective as the predicate device.
No AI, therefore no ground truth, training/test sets, or experts for AI: Because this is not an AI device, there are no concepts of "training set," "test set," "ground truth," "number of experts," or "adjudication methods" in the context of AI performance evaluation.
No MRMC Comparative Effectiveness Study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable here.
No Standalone Algorithm Performance: This is a physical device, not an algorithm, so standalone algorithm performance is irrelevant.

Summary of what can be extracted from the document:

Device: Distal Radius Fracture Repair System (implants and instruments)
Intended Use: Fixation of fractures and osteotomies involving the distal radius.
Key Change in this Submission (K030198): Update and standardize the sterilization cycle.
Substantial Equivalence Claim: The modified device is substantially equivalent to the previously cleared Distal Radius Fracture Repair System (K023007) regarding intended use, materials, biocompatibility, and overall performance characteristics.
Study (Implicit): The "study" here is the demonstration of substantial equivalence, relying on:
- Comparison to Predicate Device: A detailed comparison table (page 4) highlighting similarities in features like manufacturer, packaging, sterilization method (non-sterile, recommend steam), intended use, implant period (permanent), material of construction (Titanium, Stainless Steel), available configurations, number of pegs/screws, peg/screw lengths, and specialized instruments.
- Sterilization Validation (Not detailed in the provided text, but implied by the "update and standardize the sterilization cycle" statement): The manufacturer would have conducted validation studies (e.g., microbial challenges, sterility assurance level (SAL) testing) to ensure the new sterilization cycle is effective, but these studies are not described in this summary.

In essence, this document is a regulatory submission for a physical medical device, not an AI/machine learning product. Therefore, the requested information tailored to AI evaluation is not present.

Summary

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510(k) Summary of Safety and Effectiveness

K030198
page 1 of 4

1. Manufacturer and Contact Information:

Manufacturer& U. S. Distributor	Hand Innovations, Inc.8905 S. W. 87th AvenueMiami, FL 33175-2227
Contact Information:	Richard D. Bliss, Jr.Quality Systems Engineering510 Stonemont DriveWeston, FL 33326Telephone: (954) 385-1690Fax: (954) 385-1256

2. Device Classification Name:

The Orthopedic Devices Panel has classified the single/multiple component metallic bone fixation appliances and accessories as Class II. Reference 21 CFR 888.3030.

3. Intended Use:

The Distal Radius Fracture Repair Kit is intended for the fixation of fractures and osteotomies involving the distal radius.

4. Device Description and Characteristics

This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) 1990 and the FDA Modernization Act of 1997 (FDAMA).

The Distal Volar Radius Plate (DVR) consists of a stabilization plate, bone screws, and fixation pegs. The 3.5 mm screws are used to affix the proximal segment of the plate to the diaphysis. Pegs or screws are used for the distal bone fragment(s).

The Distal Dorsal Nail-Plate (DNP) is a bone stabilization device consisting of an intrafocal nail-plate to which three-fixed angle bone pegs and two locking screws are attached. It has a narrow distal plate-like section that lies on the surface of the distal fragment and a proximal nail-like section that is introduced into the diaphysis of the radius through the fracture site. Fixed angle pegs are used to fix the distal fragment(s) to the plate section and locking screws are used to lock the proximal fragment inside the radial shaft.

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K030198
page 2 of 4

Other components used in the implantation process are identified as the DNP Jig Set of Stainless Steel SST 17-4. These items consist of the DNP Jig (left or right), drill guide, screw jig and screw guide.

A standard awl, which is a manual tool, used to increase the size of a hole or tunnel by scraping in rotation is a standard catalog item manufactured by from K-Medic under catalog no. KM-48-336.

The components of this system will be packaged together and will also be available individually. The materials used for the various components in Distal Radius Fracture Repair System include the following:

Name	Part No.	Material Composition
Volar Plate, Right		Titanium TI-6AL-4V ELI
Volar Plate, Left		Titanium TI-6AL-4V ELI
Dorsal Nail Plate Right	DRW-067	Titanium TI-6AL-4V ELI
Dorsal Nail Plate Left	DRW-054	Titanium TI-6AL-4VELI
Peg Volar Plate(14,16,18,20,22,24,26,28mm) 010, DRW-055/DRW-056 (Table DRW-20)	DRW-005/056	Titanium TI-6AL-4V ELI
Threaded peg 2.5 mm(14,16,18,20,22,24,26,28mm) 033, DRW-057/DRW-058 (Table DRW-026)	DRW-028/033	Titanium TI-6AL-4V ELI
Screw, 2.5mm (14,16,18,20,22,24,26,28mm)	DRW-034/039, DRW-059/DRW-060	Titanium TI-6AL-4V ELI
Peg Driver Assembly	DRW-016	Stainless Steel 440C
Drill Guide	DRW-017	Stainless Steel 440C
DNP Jig, Left	DRW-062	Stainless Steel SST-17-4
DNP Jig, Right	DRW-063	Stainless Steel SST-17-4
DNP Screw Jig	DRW-064	Stainless Steel SST-17-4
DNP Screw Guide	DRW-065	Stainless Steel SST-17-4
DNP Drill Guide	DRW-066	Stainless Steel SST-17-4
Depth Gauge	Supplied by K-Medic	Off the shelf catalog item.
Drill, 2.0mm	Supplied by Microaire	Off the shelf catalog item.
Awl	Supplied by K-Medic	Off the shelf catalog item.
Name	Part No.	Material Composition
Screw Holding Sleeve	Supplied by K-Medic	Off the shelf catalog item.
Drill, 2.5 mm	Supplied by Microaire	Off the shelf catalog item.
Drill, 1.8 mm	Supplied by Microaire	Off the shelf catalog item.
Hex Driver	Supplied by K-Medic	Off the shelf catalog item.
Plate Bender	Supplied by K-Medic	Off the shelf catalog item.
Tissue Guide	Supplied by K-Medic	Off the shelf catalog item.
Screw Rack	DRW-018	Not a device.
Sterilization Tray	DRW-019	Not a device.

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Kozol98

The components within this system will be provided as non-sterile for steam sterilization by health care professionals prior to use. Instructions for sterilizations are contained in the package insert. The kit components will also be available separately provided as non-sterile for steam sterilization by the healthcare professional.

The system is packaged in a high tempered plastic sterilization tray. The tray is provided with inserts to retain the components. The tray is placed in a polymeric bag and placed into a shipping carton. All components sold separately are packaged in polymeric pouches.

See Modification of Device Section for the Kit Manufacturer's Certification Statement containing a complete listing of all components.

5. Substantial Equivalence

Hand Innovations Inc. considers the modifications to this Distal Radius Fracture Repair System to be substantially equivalent to the Distal Radius Fracture Repair System. 510(k) No. K023007 that cleared FDA on December 5, 2002. with regard to the intended use, materials, biocompatibility and overall performance characteristics. The current labeling for the Distal Radius Fracture Repair System has been revised to reflect the change in the sterilization cycle.

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030198
page 4 of 4

Summary of Substantial Equivalence

Feature	Distal Radius FractureRepair Kit	Distal Radius FractureRepair Kit(Predicate Device)
Manufacturer	Hand Innovations, Inc.	Hand Innovations, Inc.
Packaging	Tempered Plastic suitablefor steam sterilization	Tempered Plastic suitableFor stem sterilization.
Sterilization method	Provided non-sterileRecommend steamsterilization	Provided non-sterileRecommend steamsterilization
Intended use	Distal Radius FractureRepair System is intendedfor the fixation of fracturesand osteotomies involvingthe distal radius.	Distal Radius FractureRepair System is intendedfor the fixation of fracturesand osteotomies involvingthe distal radius.
Implant Period	Permanent	Permanent
Material of Construction	Plates: Titanium	Plates: Titanium
Available configurations	Pegs and Screws: Titaniumand Stainless SteelRight and LeftVolar and Dorsal	Pegs and Screws: TitaniumAnd Stainless SteelRight and LeftVolar and Dorsal
No. of buttress pegs	5 each size	5 each size
No. of Cortex Screws	8 each size	8 each size
Buttress Peg Length mm	16, 18, 20, 22, 24, 26, 28	16, 18, 20, 22, 24, 26, 28
Cortex Screw Length mm	10, 12, 14, 16, 18	10, 12, 14, 16, 18
Specialized instrumentsincluded in tray	Bending toolDrill GuideDepth GaugePeg DriverScrew DriverDNP Jig Right & Left	Bending ToolDrill GuideDepth GagePeg DriverScrew DriverDNP Jig Right & Left
Tool and componentseparators and holders intray	Yes	Yes

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Image /page/4/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 1 2003

Hand Innovations, Inc. c/o Mr. Richard D. Bliss, Jr. Ouality System Engineering 510 Stonemont Drive Weston, Fl 33326

Re: K030198

Trade Name: Distal Radius Fracture Repair System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: January 20, 2003 Received: January 21, 2003

Dear Mr. Bliss:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Richard D. Bliss, Jr.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Mark A. Mckennon

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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030198

Device Name:

Distal Radius Fracture Repair System

Indications for Use:

The Distal Radius Fracture Repair System is intended for the fixation of fractures and osteotomies involving the distal radius.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use or Over-The-Counter Use (Pre 21 CFR 801.109) (Optional Format 1-2-96)

Mark A. Milliman

ivision Sign-Off) Division of General, Restorative al Devices

90(k) Number __ K030198

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.