(90 days)
Not Found
No
The description details a standard TENS device with preset programs and user-adjustable amplitude, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that TENS stimulation is used for "symptomatic relief and management of chronic intractable pain" and "as an adjunctive treatment in the management of post-surgical and post-traumatic pain," which are therapeutic applications.
No
The device is a TENS unit used for pain relief, not for diagnosing medical conditions. Its intended use is described as symptomatic relief and management of pain.
No
The device description explicitly states it is a "handheld battery powered TENS device," indicating it is a physical hardware device that delivers electrical stimulation.
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 used for "symptomatic relief and management of chronic intractable pain" and as an "adjunctive treatment in the management of post-surgical and post-traumatic pain." This describes a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a "handheld battery powered TENS device" that provides electrical stimulation. This is consistent with a physical therapy or pain management device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The CEFAR Medical AB CEFAR Primo is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
Product codes (comma separated list FDA assigned to the subject device)
GZJ
Device Description
The CEFAR Primo is a handheld battery powered TENS device with two channels and nine preset stimulation programs. The two channels are separated and it is possible to stimulate with two different stimulation programs simultaneously, one on each channel.
Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.
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)
An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment and IEC EN 60601-2-10 regarding general safety for medical equipment TENS devices.
Notified body SEMKO AB, with ID 0413, has performed the external testing.
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
§ 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).
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APPENDIX I. SUMMARY AND CERTIFICATION
APPENDIX I A. 510(K) SUMMARY
Summary of Safety and Effectiveness
In accordance with 21 CFR 807.92, the following information constitutes the CEFAR Medical AB summary for the CEFAR Primo:
| SUBMITTER'S NAME: | CEFAR Medical AB |
|---|---|
| ADDRESS: | Scheelevagen 19F |
| SE-223 70 Lund | |
| Sweden | |
| CONTACT PERSON: | Constance Bundy |
| TELEPHONE NUMBER: | 763-574-1976 |
| FAX NUMBER: | 763-571-2437 |
| DATE OF SUBMISSION: | 11 March 2002 |
1. Identification of device
Proprietary Name: CEFAR Medical AB CEFAR Primo Common Name: Transcutaneous electrical nerve stimulator for pain relief (TENS) Classification Status: Class II per regulations 882.5890 Product Codes: GZJ
2. Equivalent devices
CEFAR Medical AB believes the CEFAR Primo is substantially equivalent to:
SMP-PLUS K982410 TENS-stimulator Rehabilicare
3. Description of the Device
The CEFAR Primo is a handheld battery powered TENS device with two channels and nine preset stimulation programs. The two channels are separated and it is possible to stimulate with two different stimulation programs simultaneously, one on each channel.
Program information and electrical current amplitude is displayed on a LCD. The user can set the amplitude in the range 0-60 mA for all programs.
4. Intended use
The CEFAR Medical AB CEFAR Primo is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
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ડ. Comparison to predicate device.
Comparison table
| Characteristic | SMP-PLUS
(Predicate device) | CEFAR Primo |
|------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use
statement | Identical | See Section 1 B Indications for
Use Statement |
| Prescription device | Yes | Yes |
| Number of channels | 2 | 2 |
| Open circuit detection | Yes | Yes |
| Transcutaneous current
delivery | Yes, through electrodes placed
on patients body | Yes, through electrodes placed
on patients body |
| LCD dislay | Yes, showing applied intensity
in mA and stimulation mode | Yes, showing applied intensity
in mA and stimulation
program |
| Power supply | Yes, battery operated 9V | Yes, battery operated 2x1.5 V |
| Software controlled
output | Yes | Yes |
| Continous stimulation | Yes, user set rate 2-125 Hz
and 40-300 $ \mu $ s | Yes, preset 80 Hz and 180 $ \mu $ s,
10 Hz and 180 $ \mu $ s and 80 Hz
and 60 $ \mu $ s |
| Burst | Yes, 8 pulses per burst 2 bursts
per second | Yes, 8 pulses per burst 2 bursts
per second |
| Modulated pulse
duration | Yes, 60% of set pulse width to
users set pulse width 40-300 $ \mu $ s | Yes, 70 -180 $ \mu $ s |
| Mixed frequency | Yes, alternates 60% of set
frequency to users set
frequency 2-125 Hz every 2.5
seconds | Yes, 2 Hz burst for 3 seconds
and 15 Hz or 80 Hz continuous
for 3 seconds |
| User control of output | Yes, push buttons | Yes, push buttons |
| Pulsed output | Yes, 2-125 Hz | Yes, 2-120 Hz |
| Pulse form | Asymmetric biphasic, zero net
DC | Asymmetric biphasic, zero net
DC |
| Maximum amplitude | 60 mA | 60 mA |
| Maximum pulse width | 300 $ \mu $ s | 180 $ \mu $ s |
| Maximum charge per
pulse | 18 $ \mu $ C | 10.8 $ \mu $ C |
Discussion of functional and safety testing. 6.
An extensive collection of tests has been conducted and successfully completed, including system validation in-house and external testing to show compliance with IEC EN 60 601-1-2 regarding EMC, IEC EN 60601-1 regarding general safety for medical equipment and IEC EN 60601-2-10 regarding general safety for medical equipment TENS devices.
Notified body SEMKO AB, with ID 0413, has performed the external testing.
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7. Conclusion
Based on extensive performance testing and a comparison to the predicate device, it is the conclusion of CEFAR Medical AB that the CEFAR Primo is substantially equivalent to devices already on the marked (cleared by the 510(k) process) and presents no new concerns about safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
JUN 1 0 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mrs. Constance G. Bundy CEFAR Medical AB C/O: C.G. Bundy and Associates, Inc. 6740 Riverview Terrace Minneapolis, Minnesota 55432
Re: K020803
Trade/Device Name: CEFAR Primo Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: GZJ Dated: March 11, 2002 Received: March 12, 2002
Dear Mrs Bundy:
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. This letter will allow you to begin marketing your device as described in your Section 510(k)
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Page 2 - Mrs. Bundy
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,
Mark A. Milkenen
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
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Page 1 of 1
B. INDICATIONS FOR USE
510(k) Number K020803
Device Name: CEFAR Primo
Indications for Use:
TENS stimulation is used for symptomatic relief and management of chronic intractable pain. It is also used as an adjunctive treatment in the management of post-surgical and post-traumatic pain. It has no curative value and should be used only in conjunction with medical supervision.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
for Mark N. Mikkelsen
(Division Sign Off)
(Division Sign-Off) Lision of General, Restorative and Neurological Devices
510(k) Number K030803
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