CEFAR MEDICAL AB CEFAR PRIMO

K020803 · Cefar Medical AB · GZJ · Jun 10, 2002 · Neurology

Device Facts

• Record ID: K020803
• Device Name: CEFAR MEDICAL AB CEFAR PRIMO
• Applicant: Cefar Medical AB
• Product Code: GZJ · Neurology
• Decision Date: Jun 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CEFAR Primo is a handheld, battery-powered, two-channel transcutaneous electrical nerve stimulator (TENS). Device delivers electrical current through electrodes placed on patient's body to provide pain relief. User selects from nine preset stimulation programs via push buttons; LCD displays program information and current amplitude (0-60 mA). Device features include open circuit detection and software-controlled output. Operates using asymmetric biphasic, zero net DC pulses. Used in clinical or home settings under medical supervision. Output affects nerve stimulation to manage pain; provides symptomatic relief for chronic, post-surgical, or post-traumatic conditions.

Clinical Evidence

Bench testing only. Compliance with IEC EN 60601-1 (general safety), IEC EN 60601-1-2 (EMC), and IEC EN 60601-2-10 (TENS safety) verified by SEMKO AB (ID 0413).

Technological Characteristics

Handheld, battery-powered (2x1.5V). Two-channel TENS. Output: Asymmetric biphasic, zero net DC. Amplitude: 0-60 mA. Pulse width: 70-180 µs. Frequency: 2-120 Hz. LCD display. Software-controlled output. Standards: IEC EN 60601-1, IEC EN 60601-1-2, IEC EN 60601-2-10.

Indications for Use

Indicated for symptomatic relief and management of chronic intractable pain, and as adjunctive treatment for post-surgical and post-traumatic pain. For use under medical supervision.

Regulatory Classification

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.

Predicate Devices

• SMP-PLUS (K982410)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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.

{1}------------------------------------------------

#### ડ. Comparison to predicate device.

### Comparison table

| Characteristic | SMP-PLUS<br>(Predicate device) | CEFAR Primo |
|------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use<br>statement | Identical | See Section 1 B Indications for<br>Use Statement |
| Prescription device | Yes | Yes |
| Number of channels | 2 | 2 |
| Open circuit detection | Yes | Yes |
| Transcutaneous current<br>delivery | Yes, through electrodes placed<br>on patients body | Yes, through electrodes placed<br>on patients body |
| LCD dislay | Yes, showing applied intensity<br>in mA and stimulation mode | Yes, showing applied intensity<br>in mA and stimulation<br>program |
| Power supply | Yes, battery operated 9V | Yes, battery operated 2x1.5 V |
| Software controlled<br>output | Yes | Yes |
| Continous stimulation | Yes, user set rate 2-125 Hz<br>and 40-300 $ \mu $ s | Yes, preset 80 Hz and 180 $ \mu $ s,<br>10 Hz and 180 $ \mu $ s and 80 Hz<br>and 60 $ \mu $ s |
| Burst | Yes, 8 pulses per burst 2 bursts<br>per second | Yes, 8 pulses per burst 2 bursts<br>per second |
| Modulated pulse<br>duration | Yes, 60% of set pulse width to<br>users set pulse width 40-300 $ \mu $ s | Yes, 70 -180 $ \mu $ s |
| Mixed frequency | Yes, alternates 60% of set<br>frequency to users set<br>frequency 2-125 Hz every 2.5<br>seconds | Yes, 2 Hz burst for 3 seconds<br>and 15 Hz or 80 Hz continuous<br>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<br>DC | Asymmetric biphasic, zero net<br>DC |
| Maximum amplitude | 60 mA | 60 mA |
| Maximum pulse width | 300 $ \mu $ s | 180 $ \mu $ s |
| Maximum charge per<br>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.

{2}------------------------------------------------

#### 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.

3/3

{3}------------------------------------------------

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)

{4}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

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

6