POINTER PLUS by LHASA OMS, INC. | FDA 510(k) Summary

I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a US FDA 510(k) clearance letter for the "Pointer Plus" device (K060508). This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

The content focuses on:

The device name and regulatory information.
The FDA's review and determination of substantial equivalence.
General controls and regulations applicable to the device.
Contact information for further guidance.
Indications for Use: "The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain."

The letter does not contain any performance data, clinical study results, acceptance criteria, or details regarding how the substantial equivalence was demonstrated in terms of device performance. These details would typically be found in the 510(k) submission itself, which is not provided here.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle faces to the left. Encircling the eagle is the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.

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: K060508

Trade/Device Name: Pointer Plus 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.

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

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,

Herbert Remer MD

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

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

F. Indications for Use

510(k) Number (if known): K060508 Device Name: Pointer Plus

Indications For Use:

The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Prescription Use AND/OR × 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (Part

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Hebert Lemus

Concurrence of CDRH, Office of Device (Device (D) vision (Off)

Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number_kobo 508

Regulation Number and Section

§ 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).