(112 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technologies in medical devices. The intended use and device description (though not found) do not suggest AI/ML functionality.
Yes
The device is intended for the "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which are therapeutic applications.
No
The device's intended use is for "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which describes a therapeutic rather than a diagnostic function.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, the Pointer-Excel is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain." This describes a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention anything about analyzing biological samples, using reagents, or providing diagnostic information.
Therefore, the Pointer-Excel is a device intended for pain relief, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Product codes
GZJ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services, USA. The seal features a stylized eagle with three stripes emanating from its head, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 19 2006
Lhasa OMS, Inc. % Mr. Mark W. Sheehan Regulatory Affairs Officer 230 Libbey Parkway Weymouth, Massachusetts 02189
Re: K060517
Trade/Device Name: Pointer Excel Regulatory Number: 21 CFR 882.5890 Regulatory Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ Dated: June 5, 2006 Received: June 6. 2006
Dear Mr. Sheehan:
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 - Mr. Mark W. Sheehan
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Hubert Lemmons
Mark N. Molkerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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F. Indications for Use
510(k) Number (if known): K060517 Device Name: Pointer Excel
Indications for Use:
The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Prescription Use X . AND/OR !1 CFR 810 Subpart D) (21 CFR 801 Subpart C)
Over-The-Counter Use (Part
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON NOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Dev eneral, Restorative. and Neurological Device
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510(k) Number K060517