(31 days)
Not Found
Not Found
No
The description focuses on mechanical cutting and skin impedance feedback, with no mention of AI/ML terms or concepts.
Yes
The device is intended to relieve pressure from subungual hematomas by releasing fluid, which is a therapeutic intervention.
No
The device is intended to relieve pressure from subungual hematomas by cutting the nail to release fluid. This is a treatment procedure, not a diagnostic one which would involve identifying a condition.
No
The device description explicitly states it is a "battery-powered hand-held drill" and uses a "microcutting tool," indicating it is a hardware device with a physical mechanism for cutting.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to relieve pressure from subungual hematomas by cutting through nails to release fluid. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is a hand-held drill that cuts nails. This is a mechanical device used for a physical intervention.
- Lack of Diagnostic Elements: There is no mention of the device analyzing biological samples (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis. IVDs are specifically designed for these purposes.
The device's function is to perform a physical action (cutting the nail) to alleviate a symptom (pressure from a hematoma). This falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NWF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger and toe nails
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A variety of tests to fully demonstrate the PathFormer's mechanical, electrical, safety and performance characteristics have been provided in the 510(k) documentation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Donald C. Hugh, DDS, NAILeezer First Aid Manual Trephinating Drill
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Submitter: Path Scientific, LLC x
ﻟﻌﺴﻤ
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 |
| 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. | |
| 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. | |
| Discussion of tests | |
| and test results: | A variety of tests to fully demonstrate the PathFormer's mechanical, |
| electrical, safety and performance characteristics have been provided in | |
| the 510(k) documentation. | |
| Conclusion: | The testing reported in this 510(k) establishes the device is safe and |
| effective for its intended use and substantially equivalent to the predicate | |
| device. |
:
.
1
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.
2
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