(112 days)
The Pointer-Excel is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Not Found
This looks like a 510(k) clearance letter for a medical device called "Pointer Excel," a transcutaneous electrical nerve stimulator (TENS) for pain relief.
The provided document is a regulatory clearance letter, not a study report or a document that would contain the detailed information requested about acceptance criteria and study methodologies. Therefore, I cannot extract the specific information you've asked for from this text.
Here's why and what kind of document would typically contain that information:
- 510(k) Clearance Letter: This letter from the FDA confirms that a new device is "substantially equivalent" to a legally marketed predicate device. This process primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performance as a predicate device, often without requiring extensive new clinical trials like those needed for a Premarket Approval (PMA).
- Missing Information: The letter does not detail specific acceptance criteria, performance metrics, sample sizes, data provenance, expert qualifications, ground truth establishment, or study designs (like MRMC or standalone performance studies). This type of data would typically be found in:
- The 510(k) submission document itself (which is much more extensive than this letter).
- Clinical study reports or validation reports that the manufacturer might have submitted as part of their 510(k) application to demonstrate substantial equivalence, especially if performance data was required.
- Scientific publications if the device underwent independent research.
Therefore, I cannot provide the requested table and study details based on the provided text.
If you had access to the full 510(k) submission for K060517, it might contain some of this information, particularly if performance data was submitted to support substantial equivalence.
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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
§ 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).