The PCW" is supplied as a single length threaded stainless steel wire or pin. The pin is selftapping and self-cutting and does not vary in length or diameter. The engineering drawings include diameter and length information. However, the pins are nominally six inches in length and fifty-nine thousandths diameter. The pins are intended for small bone applications (fractures and osteotomies) including distal fragments of long bones. The principal areas of use are the upper extremity and the hands and feet. The pins may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible. The primary use of the wires is percutaneous, that is, without the need for an external fixatior as in the case of "hammer-toes" or similar phlangeal or small bone losteotomies. The secondary use of the wires is in association with the use of an external fixation device as a means to secure and fix small fragments until healing is complete. MMT supplies instrumentation designed specifically to interface with this implant system. Their use of general manual orthopaedic instrumentation is not recommended for the insertion of this device. The screws are made from stainless steel alloy.

AI/ML Overview

The provided text describes a medical device, the PCW™ Percutaneous Compression Wire, and its 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document focuses on:

Device Identification: Trade name, common name, classification, establishment information.
Regulatory Compliance: References to ISO standards (ISO 9001-2000, ISO-5832-3,1996(E)) for manufacturing and materials, and general controls for Class II devices.
Labeling: Warning and caution statements.
Equivalent Devices: Comparison to predicate devices (Synvasive k-wires, Miltex Steinmann pins) based on basic design, features, and intended use.
Device Description: Material (316 LVM, ASTM F138), dimensions, and general application (small bone fractures and osteotomies).
Intended Use: A comprehensive list of specific fracture types and fusions for which the device is intended.
FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices and authorizing marketing, subject to general controls.

Key Missing Information:
The document does not include:

Quantitative acceptance criteria for device performance.
Details of any performance study (e.g., mechanical testing, clinical trials, usability studies).
Data provenance, sample sizes, or expert qualifications for any testing.
Information on MRMC studies or standalone algorithm performance.
The type or establishment of ground truth for any evaluation.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary details are not present in the provided text. The FDA's substantial equivalence determination for this device relies on its similarity to existing, legally marketed predicate devices, implying that its performance is implicitly accepted as equivalent to those devices, rather than through a new, explicit performance study described in this submission.

Summary

{0}------------------------------------------------

JUL 1 4 2003

KO31050

510(k) Premarket Notification

Summary of Safety Information

The state of the contraction of the comments of the comments of

PCW" Percutaneous January 12.

ನ್ನು

Device Name:

Trade Name: Common Name: Classification Name: PCW™ Percutaneous Compression Wire k-wire

Smooth & threaded metallic bone fixation fasteners

Establishment Name & Registration Number:

Millennium Medical Technologies, Inc. (MMT) Name: 1724527 Number:

Classification:

ProCode: HWC

Performance Standards (Section 514 compliance):

Food and Drug Administration mandated Performance standards for bone screws are not in effect. MMT intends to comply with all voluntary Performance Standards applicable to the PCW™ Percutaneous Compression Wire system. At the present time, The device is produced according to ISO 9001-2000 regulations covering medical devices. In addition, the materials used to construct the device meet ISO-5832-3,1996(E).

Special Controls:

All Class II devices are subject to Special Controls. No FDA mandated special controls are in effect for this device at the present time.

Labeling:

The labeling of the device includes the following statements:

Federal (United States) Law restricts this device to sale by or on the order of a Warning: physician only.

Mixing of dissimilar metals can accelerate the corrosion process. The CAUTION: components of this system must NOT be used with implants of other material composition. Components of the PCW™ Percutaneous Compression Wire should NOT be used with screws or components from any other system or manufacturer.

Equivalent Device(s):

PCW™ Percutaneous Compression Wire may be directly contrasted with the following equivalent devices:

Synvasive k-wires, Synvasive Technology, Inc., K961522
Miltex Steinmann pins, Miltex, Inc. K013888 .

Both referenced devices are essentially identical (clinically speaking) to the PCW™ Percutaneous Compression Wire in terms of basic design, features and intended use.

Description of the Device:

{1}------------------------------------------------

K031050
page 2 of 2

mass compatible. The primary use of the wires is percutaneous, that is, without the need for an external fixatior as in the case of "hammer-toes" or similar phlangeal or small bone losteotomies. The secondary use of the wires is in association with the use of an external fixation device as a means to secure and fix small fragments until healing is complete. MMT supplies instrumentation designed specifically to interface with this implant system. Their use of general manual orthopaedic instrumentation is not recommended for the insertion of this device. The screws are made from stainless steel alloy. Material standard(s) are as specified in the table below:

316 LVM	ASTM F1381ڪ ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو ويو	100COOL

The instruments are made from 17-4 instrument grade stainless steel.

Instrumentation/accessories:

Compression Wires (5 sizes) .
Compression nut .
Locking nut ●
Socket wrench
PCW Tray ◆

Intended Use:

Scaphoid fractures .
Lunate fractures ●
Capitate .
Carpal fractures & non-unions ●
Capitellum fractures .
Humeral head fractures .
. Trapezial fractures
Metacarpal and metatarsal fractures .
Phalangeal fractures .
Distal radial fractures ●
Ulnar styloid fractures
Osteo-chrondral fractures .
Small joint fusions .
. Glenoid fractures
Intercarpal fusions .
Interphalangeal fractures .
Metatarsal osteotomies ●
Tarsal fusions ●
Malleolar fractures .
Hammer toe fixation

Applicant / Sponsor Name / Address:

Millennium Medical Technologies, Inc. 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 – 505.988.7234 fax

Contact Person:

Mr. Fred Kolb Millennium Medical Technologies, Inc. 460 St. Michaels Drive, Suite 901 Santa Fe, New Mexico, 87505 505.988.7595 - 505.988.7234 fax

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head facing right, with three parallel lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle, with the department name at the bottom and "USA" at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Millennium Medical Technologies, Inc. c/o Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389

JUL 1 4 2003

Re: K031050

Trade/Device Name: PCW™ Percutaneous Compression Wire Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 26, 2003 Received: June 13, 2003

Dear Mr. Schlerf:

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. Iisting 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

{3}------------------------------------------------

Page 2 - Mr. David W. Schlerf

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.

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.

Muriam C. Provost

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

{4}------------------------------------------------

KD31050 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

PCW™ Percutaneous Compression Wire Device Name:

Indications For Use:

Percutaneous Compression Wire system for the fixation of osseous fragments or fractures of small bones, including:

Scaphoid fractures .
Lunate fractures .
. Capitate
Carpal fractures & non-unions .
Capitellum fractures ●
Humeral head fractures .
Trapezial fractures ●
Metacarpal and metatarsal fractures .
Phalangeal fractures ●
Distal radial fractures .
Ulnar styloid fractures ●
Osteo-chrondral fractures .
Small joint fusions ●
Glenoid fractures ●
Intercarpal fusions ●
Interphalangeal fractures .
Metatarsal osteotomies ●
� Tarsal fusions
Malleolar fractures ●
Hammer toe fixation ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

510(k) Number _$\qquad$ $K03/050$

Prescription Use	____________
------------------	--------------

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

(Per 21 CFR 801.109)

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.