PATHFORMER

K052770 · Path Scientific, LLC · NWF · Oct 31, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K052770
• Device Name: PATHFORMER
• Applicant: Path Scientific, LLC
• Product Code: NWF · General, Plastic Surgery
• Decision Date: Oct 31, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The PathFormer device is intended for use in relieving pressure from subungual hematomas (including black toe). It cuts through finger and toe nails to release fluid accumulated in the underlying nail bed.

Device Story

PathFormer is a battery-powered, hand-held drill designed for subungual hematoma treatment. It utilizes 'mesoscissioning' technology to cut through fingernails and toenails. The device incorporates a skin impedance feedback mechanism that automatically stops the cutting intervention upon reaching the nail bed, preventing injury to underlying tissue. Used in clinical settings to release accumulated fluid, the device allows healthcare providers to perform the procedure with controlled depth. By relieving pressure, it provides symptomatic relief for patients suffering from subungual hematomas.

Clinical Evidence

Bench testing only. The manufacturer provided mechanical, electrical, safety, and performance testing to demonstrate substantial equivalence.

Technological Characteristics

Battery-powered hand-held drill; utilizes microcutting tool; skin impedance sensing for feedback-controlled automatic stop; dimensions/form factor: hand-held; energy source: battery.

Indications for Use

Indicated for patients requiring pressure relief from subungual hematomas, including black toe, by cutting through finger or toe nails to drain accumulated fluid.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Donald C. Hugh, DDS, NAILeezer First Aid Manual Trephinating Drill

Submission Summary (Full Text)

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Submitter: Path Scientific, LLC x

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## 510(k) SUMMARY

| Submitter Name: | Path Scientific, LLC |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | T.R. Gowrishankar, Ph.D. |
| Address: | 82 Hillside Drive |
| | Carlisle, MA 01741 |
| Phone Number: | 978-369-7315 |
| Fax Number: | 978-369-7325 |
| Date Prepared: | September 30, 2005 |
| Device Trade Name: | PathFormer |
| Classification Names, | Surgical Instrument Motors and Accessories/Attachments |
| Classification # | 21 CFR 878.4820 |
| Predicate Devices: | Donald C. Hugh, DDS, NAILeezer First Aid Manual Trephinating Drill |
| Device Description: | The Path Scientific, LLC. PathFormer is a battery-powered hand-held<br>drill that cuts holes in fingernails and toenails using mesoscissioning<br>technology. It cuts the nail with a microcutting tool, using skin<br>impedance as the feedback mechanism for stopping the cutting<br>intervention. |
| Intended Use: | The PathFormer device is intended for use in relieving pressure from<br>subungual hematomas (including black toe). It cuts through finger and<br>toe nails to release fluid accumulated in the underlying nail bed. |
| Discussion of tests<br>and test results: | A variety of tests to fully demonstrate the PathFormer's mechanical,<br>electrical, safety and performance characteristics have been provided in<br>the 510(k) documentation. |
| Conclusion: | The testing reported in this 510(k) establishes the device is safe and<br>effective for its intended use and substantially equivalent to the predicate<br>device. |

:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around the perimeter of the circle.

OCT 3 1 2005

and Drug Administratio Corporate Boulevaro kville MD 20850

Path Scientific, LLC c/o Patsy J. Trisler, J.D., RAC Regulatory Consultant Regulatory & Clinical Compliance Consulting -Medical Devices-5600 Wisconsin Avenue #509 Chevy Chase, Maryland 20815

Re: K052770

Trade/Device Name: PathFormer Regulation Number: 21 CFR 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: NWF Dated: September 30, 2005 Received: September 30, 2005

Dear Ms. Trisler:

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- Patsy J. Trisler, J.D., RAC

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

barbara Paulin

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Submitter. Path Scientific, LLC

## Indications for Use

510(k) Number (if known): K052770

Device Name: PathFormer

Indications for Use:

The PathFormer device is intended for use in relieving pressure from subungual hematomas (including black toe). It cuts through finger and toe nails to release fluid accumulated in the underlying nail bed.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

Barbara Buchup
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number K052770

Section 3.0