(112 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses solely on the intended use for pain relief.
Yes
The device is intended for the "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which are therapeutic applications.
No
The "Intended Use / Indications for Use" states the device is for "symptomatic relief of chronic intractable pain, postoperative pain, and acute pain," which describes a therapeutic function, not a diagnostic one. There is no mention of identifying, measuring, or analyzing a condition.
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 Plus is not an IVD (In Vitro Diagnostic) 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. IVD devices 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 any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The Pointer Plus appears to be a device used for pain relief, likely through some form of stimulation or therapy, which falls outside the scope of IVD regulation.
N/A
Intended Use / Indications for Use
The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Product codes
GZJ
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Not Found
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.
Not Found
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
§ 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 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