(90 days)
Not Found
No
The description focuses on combining existing technologies and software from predicate devices, with no mention of AI or ML capabilities. The "anti-Misuse feature" is a simple lock facility, not an AI-driven system.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for the relief and management of symptomatic intractable pain" and "relaxation of muscle spasm," among other therapeutic applications.
No
This device is described as a TENS/EMS unit used for pain relief and muscle stimulation, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "portable TENS device" and a "portable EMS device," and details the use of a CPU, electrical components, and a PCB layout, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for pain relief (TENS) and muscle stimulation/re-education (EMS). These are therapeutic applications, not diagnostic tests performed on samples taken from the human body.
- Device Description: The description details a portable electrical stimulation device that applies electrical currents to the body. It does not describe a device that analyzes biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver electrical stimulation for therapeutic benefits.
N/A
Intended Use / Indications for Use
For the TENS function
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.
For the EMS function
The Ultima NMS/EMS is indicated for:
- Relaxation of muscle spasm .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation .
- Muscle re-education .
- Prevention of venous thrombosis of the calf . muscles immediately after surgery
- Maintaining or increasing range of motion .
Product codes (comma separated list FDA assigned to the subject device)
IPF, GZJ
Device Description
For the TENS function
A portable TENS device for pain relief.
For the EMS function
A portable EMS device for the re-education of muscles.
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)
The results of Bench Testing demonstrate that the output characteristics of the TensCare Ultima NMS/EMS are substantially equivalent to those of the two predicate devices.
Clinical Testing was not necessary as no new or innovative aspects have been introduced.
Bench Testing, VVT and Risk Analysis, including FMEA, demonstrate that the device performs as intended, with no harm to the User.
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.
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
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
i(02397)
MAR 0 3 2003
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared: | 19th November 2002 |
|---|---|
| Name of Device: | |
| Proprietary name: | TensCare Ultima NMS/EMS |
| Common name: | For the TENS function - TENS device |
| For the PMS/EMS function - Powered Muscle Stimulator | |
| Classification name: | For TENS functions |
| Stimulator, Nerve, Transcutaneous, for Pain Relief - 84GZJ; 21 CFR 882.5890. | |
| For EMS functions | |
| Powered Muscle Stimulator for re-education of muscles - IPF; 21 CFR 890.5850 | |
| Device Classification: | For both TENS & EMS functions - Class II |
| Predicate Device: | For the TENS function |
| TensCare Ultima TENS – (K020846) | |
| For the EMS function | |
| TensCare XL-Y3 - (K011543) | |
| Device Description: | For the TENS function |
| A portable TENS device for pain relief. | |
| For the EMS function | |
| A portable EMS device for the re-education of muscles. | |
| Intended Purpose/Use: | For the TENS function |
1
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
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.
For the EMS function
The Ultima NMS/EMS is indicated for:
- Relaxation of muscle spasm .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation .
- Muscle re-education .
- Prevention of venous thrombosis of the calf . muscles immediately after surgery
- Maintaining or increasing range of motion .
The Ultima NMS/EMS (the "New Device") brings together TENS and Powered Muscle Stimulator functions from two previously cleared for market devices; namely the Ultima TENS (K020846) for the TENS functions and the TensCare XL-Y3 (K011543) for the Powered Muscle Stimulator functions.
The electrical. EMC and software technologies used in the Ultima NMS/EMS (the 'New Device'), are identical to the Ultima TENS (the Predicate device - (K020846), in that the same CPU series is utilised (the difference being that the variant used has increased memory capacity).
In addition, the "New Device" uses the same passive and active electrical components and PCB layout, as the Predicate devices.
The Powered Muscle Stimulator functions are derived from software programmed into the CPU device and are based on and virtually identical to the Predicate device.
The TensCare Ultima NMS/EMS has a Doctor Important anti-Misuse feature: Lock facility, which means that at the Treating Physician's discretion, the patient has no
Technological Comparison:
2
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
| | | control over the devices outputs; the Programs
are pre-set by the Treating Physician. |
|--------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | • 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" is utilised to further
ensure no hazards exist. |
| Labelling Comparison: | | The Labelling is substantially equivalent to that
of the predicate devices. |
| Non-Clinical Testing: | | The results of Bench Testing demonstrate that
the output characteristics of the TensCare
Ultima NMS/EMS are substantially equivalent
to those of the two predicate devices. |
| Clinical Testing: | | Clinical Testing was not necessary as no new or
innovative aspects have been introduced. |
| Safety of the Combination functions: | | The TensCare Ultima NMS/EMS combines the
functions of a TENS device and an EMS
(Electrical Muscle Stimulator) or Powered
Muscle Stimulator, into one package. Bench
Testing, VVT and Risk Analysis, including
FMEA, demonstrate that the device performs as
intended, with no harm to the User. Also, it is
not possible to use the TENS and the EMS
functions simultaneously. Mechanical integrity
ensures that only one function can be selected at
any one time. |
| Further safety information: | | The "TensCare Ultima NMS/EMS" device has
been on the European Market for the past two |
3
SECTION 5 SUMMARY OF SAFETY AND EFFECTIVENESS
vears, in it's TENS form. 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. The Certificate of authority to CE Mark the "TensCare Ultima in accordance with the Medical Device Directive 93/42/EEC is included in Section 12 of this submission.
Conclusions:
The TensCare Ultima NMS/EMS is substantially equivalent to the predicate devices and any differences between the devices do not pose any new questions of safety and effectiveness.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 0 3 2003
TensCare Ltd. C/O: Mr. Bernard Tremaine Medical Device & QA Consultancy 76, Stockport Road Timperley, Chesire WA15 7SN. UK
Re: K023997 Dated: November 29, 2002 Received: December 3, 2002
Trade/Device Name: TensCare Ultima NMS/EMS Model XL-A3 Regulation Numbers: 21 CFR 890.5850 and 21 CFR 882.5890 Regulation Names: Powered muscle stimulator and Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Codes: IPF, GZJ
Dear Mr. Tremaine:
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
5
Page 2 - Mr. Tremaine
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 (OS) 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-. 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 yours,
Miriam 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
6
SECTION 2 GENERAL INFORMATION
INTENDED USE / PURPOSE STATEMENT
TensCare Ultima NMS/EMS
For the TENS function
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.
and;
For the EMS function
The Ultima NMS/EMS is indicated for the following;
- Relaxation of muscle spasm .
- Prevention or retardation of disuse atrophy .
- Increasing local blood circulation .
- Muscle re-education .
- Prevention of venous thrombosis of the calf . muscles immediately after surgery
- Maintaining or increasing range of motion .
iriam C. Provost
(Division Sign-Off) Division of General Restorative and Neurologics revices
510(k) Number: K023997