(67 days)
6TGZE9
No
The summary describes a standard TENS device and makes no mention of AI or ML.
Yes.
The device's intended use is for "symptomatic relief of chronic intractable pain," which is a therapeutic purpose.
No
Explanation: The device is indicated for "symptomatic relief of chronic intractable pain" and is described as a "portable TENS device for pain relief," indicating a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states it is a "portable TENS device," which is a hardware device that delivers electrical stimulation. The summary also mentions "output characteristics" and "Bench Testing" related to these characteristics, further indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For the symptomatic relief of chronic intractable 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.
- Device Description: The device is described as a "portable TENS device for pain relief." TENS (Transcutaneous Electrical Nerve Stimulation) is a therapy that uses electrical currents to stimulate nerves and relieve pain. This is a physical therapy device, not a diagnostic one.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
The information provided clearly indicates a device intended for pain management through electrical stimulation, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
"For the symptomatic relief of chronic intractable pain"
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
A portable TENS device for pain relief.
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)
Bench Testing: the output characteristics of the TensCare Ultima are substantially equivalent to those of the two predicate devices.
Clinical Testing: not necessary as no new or innovative aspects have been introduced.
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.
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.
6TGZE9
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
MAY 2 1 2002
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
Date Summary Prepared:
12th March 2002
Name of Device:
Proprietary name:
TensCare Ultima
TENS device
Common name:
Classification name:
Stimulator, Nerve, Transcutaneous, for Pain Relief - 84GZJ; 21 CFR 882.5890.
Device Classification:
Predicate Device:
Device Description:
Intended Purpose/Use:
Technological Comparison:
Referer: 6TGZE9, 21 CFR 820.30...
Class II
FDTENS 2010 K994266
A portable TENS device for pain relief.
TENS is used for the relief and management of symptomatic intractable pain and/or as an adjunctive treatment in the management of postsurgical and post traumatic acute pain.
The TensCare Ultima XL-A1 has basic technological characteristics that are substantially equivalent to the predicate device. The same Microprocessor is used to control all functions and the use of pre-set output energy levels selectable by depression of a Button (as opposed to rotational control knobs on the predicate devices) is the same on both units. The electronic circuitry is virtually identical. and the use of 'shrouded patient cable connectors' to comply with FDA's Final Rule "Medical Devices: Establishment of Performance Standards for Electrode Lead Wires and Patient Cables", applies to both units.
1
K020846
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
The Labelling is substantially equivalent to that Labelling Comparison: of the predicate device. The results of Bench Testing demonstrate that Non-Clinical Testing: the output characteristics of the TensCare Ultima are substantially equivalent to those of the two predicate devices. Clinical Testing was not necessary as no new or Clinical Testing: innovative aspects have been introduced. The TensCare "Ultima XL- A1" device has Further safety information: been on the European Market for the past 5 months. During this time a review of Customer Complaints, Returned Product and the results of Post Market Feedback, has demonstrated that the product has performed as Intended, to it's Specified Requirements. The data analysed is summarised in this submission and the full data
is available upon request.
Conclusions:
The TensCare "Ulitima XL-A1" is substantially equivalent to the predicate device and any differences between the devices do not pose any new questions of safety and effectiveness.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is arranged to follow the curve of the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 2002
TensCare Ltd. C/O Bernard J. Tremaine Medical Device & QA Consultancy 76, Stockport Road Timperley, Cheshire WA15 7SN United Kingdom
Re: K020846
Trade/Device Name: Ultima TENS Model XL-A1 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: March 12, 2002 Received: March 15, 2002
Dear Mr. Tremaine:
We have reviewed your Section 510(k) premarket notification of intent to market the device wf nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conniner of the 11th 11th 20, 1978, in eccordance with the provisions of the Federal Food, Drug, de nees may o ocen rollation of require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, mererere, mains of the Act include requirements for annual registration, listing of general controlly profice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back acceral 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 r rouse be advised that i be mination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any I vacual bakated and equirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
3
Page 2 - Mr. Bernard J. Tremaine
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable the electronic forum in the quality systems (QB) regulations 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) This letter witi anow you to oegin maine of substantial equivalence of your device to a legally prematicate 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 11 you desire specific acrison. 0 for in vitro diagnostic devices), please contact the Office of additionally 21 - 11 France 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 594-669 office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation onlined, "Misoranang responsibilities under the Act may be obtained from the Other general informational 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 yours,
uriam C. Provost
for 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
4
SECTION 2 GENERAL INFORMATION
INTENDED USE / PURPOSE STATEMENT
Ultima Tens XL-A1
"For the symptomatic relief of chronic intractable pain"
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K020846