(31 days)
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.
The Path Scientific, LLC. PathFormer is a battery-powered hand-held drill that cuts holes in fingernails and toenails using mesoscissioning technology. It cuts the nail with a microcutting tool, using skin impedance as the feedback mechanism for stopping the cutting intervention.
This document describes the PathFormer device, a battery-powered hand-held drill for relieving pressure from subungual hematomas (including black toe) by cutting holes in nails. The 510(k) summary provides a high-level overview, but a detailed study proving the device meets specific acceptance criteria is not present in the provided text.
Based on the information provided, here's what can be extracted and what is not available:
1. Table of acceptance criteria and reported device performance:
The provided text does not include a formal table of acceptance criteria or specific reported device performance metrics. The "Discussion of tests and test results" section merely states: "A variety of tests to fully demonstrate the PathFormer's mechanical, electrical, safety and performance characteristics have been provided in the 510(k) documentation." This is a general statement and does not provide quantifiable acceptance criteria or the results of those tests.
2. Sample size used for the test set and the data provenance:
This information is not available in the provided text. The document refers to "tests" but does not specify the sample size or the origin of any data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available in the provided text. Given the device's function involves a physical intervention (cutting nails), the concept of "ground truth" established by experts in the context of diagnostic accuracy is not directly applicable in the same way as for an imaging or AI diagnostic device. However, if performance tests involved expert assessment of the cutting process or outcome, this detail is missing.
4. Adjudication method for the test set:
This information is not available in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable to the PathFormer device. The PathFormer is a tool for a physical procedure, not an AI-assisted diagnostic or interpretative device that augments human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable to the PathFormer device. The PathFormer is a physical device operated by a human, not an algorithm.
7. The type of ground truth used:
This information is not explicitly available in the provided text. For a device like PathFormer, "ground truth" would likely relate to objective measurements of its cutting ability, safety features (e.g., stopping when skin is detected), and effectiveness in relieving pressure without causing harm. These would be established through engineering and performance testing rather than expert-derived diagnostic labels.
8. The sample size for the training set:
This is not applicable to the PathFormer device in the context of machine learning. The device is a mechanical tool, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
In summary:
The provided 510(k) summary indicates that various mechanical, electrical, safety, and performance characteristics were tested for the PathFormer device. However, it does not provide the specific details requested regarding acceptance criteria, sample sizes, data provenance, expert involvement, or adjudication methods that would be typically found in a detailed study report for diagnostic or AI-powered devices. The focus of the 510(k) summary is to state that these tests were conducted and that based on them, the device is considered safe and effective and substantially equivalent to a predicate device.
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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-helddrill that cuts holes in fingernails and toenails using mesoscissioningtechnology. It cuts the nail with a microcutting tool, using skinimpedance as the feedback mechanism for stopping the cuttingintervention. |
| Intended Use: | The PathFormer device is intended for use in relieving pressure fromsubungual hematomas (including black toe). It cuts through finger andtoe nails to release fluid accumulated in the underlying nail bed. |
| Discussion of testsand test results: | A variety of tests to fully demonstrate the PathFormer's mechanical,electrical, safety and performance characteristics have been provided inthe 510(k) documentation. |
| Conclusion: | The testing reported in this 510(k) establishes the device is safe andeffective for its intended use and substantially equivalent to the predicatedevice. |
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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 (240) 276-0115. 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/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
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.