(27 days)
Not Found
Not Found
No
The summary describes a system for programming and logging data for a neurostimulator, but there is no mention of AI, ML, or any related concepts like image processing, deep learning, or training/test sets. The "optimization of performance" described appears to be a user-driven process, not an automated AI/ML algorithm.
Yes
The device is indicated for spinal cord stimulation in the treatment of chronic pain of the trunk and limbs, which is a therapeutic application.
No
The device, "PainDoc", is described as being intended to assist in "determining the optimum performance" of a spinal cord stimulator and to program it, not to diagnose a medical condition. While it interacts with a medical treatment, its function is for optimization and programming, not diagnosis. The "ANS Neurostimulation system" is a treatment device, not a diagnostic one.
No
The device description is not available, but the intended use clearly describes a "Spinal Cord Stimulation (SCS) system" and a "stimulator," which are hardware components. The software component ("PainDoc") is used to program and log data for this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for Spinal Cord Stimulation (SCS) to treat chronic pain of the trunk and limbs. This is a therapeutic intervention performed in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform such examinations.
- Device Description (though not found): The description of the PainDoc component further supports this by mentioning programming a stimulator and recording stimulation effects, all related to the in vivo stimulation process.
Therefore, the ANS Neurostimulation system, as described, is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The PainDoc is intended to assist clinicians and patients in determining the optimum performance while automatically logging procedures data. PainDoc also allows the patient to assist in the optimization of performance by leading them through a series of combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
Product codes
GZB
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal Cord, trunk and limbs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians and patients
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
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
6 2002 JUN
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Rashmi Moza Regulatory Affairs Specialist Advanced neuromodulation Systems, Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024
Re: K021518
Trade/Device Name: PainDoc Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted Spinal Cord Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZB Dated: May 9, 2002 Received: May 10, 2002
Dear Ms. Moza:
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
1
Page 2 - Ms. Rashmi Moza
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely vours.
Sincerery, yours,
Mark N Millkens
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Device Name: PainDoc®
Indications for Use:
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The PainDoc is intended to assist clinicians and patients in determining the optimum performance while automatically logging procedures data. PainDoc also allows the patient to assist in the optimization of performance by leading them through a series of combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Wilkerson
Division of General, Restorative and Neurological Devices
510(k) Number K0215
Prescription Use (Per 21 CFR 801.109) Or
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________