FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130

{0}------------------------------------------------ K0 30297 APR 2 8 2003 . . Image /page/0/Picture/2 description: The image is a black and white logo for ENRAF NONIUS. The logo consists of the words "ENRAF NONIUS" stacked on top of each other in a bold, sans-serif font. Above the words are three horizontal lines that decrease in length from top to bottom. Below the words is a geometric shape that resembles an upside-down trapezoid with a pointed bottom. Partner for Life Image /page/0/Picture/3 description: The image is a black and white circular logo or seal. The text "EN ISO 9001 / EN 46001" is at the top of the circle, and "ZERTIFIZIERT CERTIFIED" is at the bottom. Inside the circle is a triangle above the text "TUV Rheinland Product Safety". Enraf-Nonius B.V. Röntgenweg 1, 2624 BD Delft P.O. Box 810, 2600 AV Delft The Netherlands Tel: +31 (0) 15 269 8400 Fax: +31 (0) 15 262 8351 Email: info@enraf-nonius.com Trade Register No.: 272.30.375 # 510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130 510(k) Number | Date of Preparation : | January 21, 2003 | |---------------------------------------------------------|------------------------------------------------------------------------------------------------------| | Contact Person : | Mr. Rick Coelet<br>Project Manager | | Device Name :<br>Common Name :<br>Classification Name : | Flexible Rubber Electrodes<br>Reusable electrodes for electrical stimulation<br>Electrode, Cutaneous | | Predicate Device : | K880699<br>Endomed CV405 and Accessories | # Device Description The Flexible Rubber Electrodes are a family of electrodes that are supplied as accessories to Enraf-Nonius B.V. nerve and muscle stimulation equipment. Depending on electrode size and connection terminals, the following parts apply: | 1460265 | 6 x 8 cm electrode with 4 mm female connection terminal | |---------|----------------------------------------------------------| | 1460272 | 4 x 6 cm electrode with 4 mm female connection terminal | | 1460274 | 8 x 12 cm electrode with 4 mm female connection terminal | | 3444128 | 4 x 6 cm electrode with 2 mm female connection terminal | | 3444129 | 6 x 8 cm electrode with 2 mm female connection terminal | | 3444130 | 8 x 12 cm electrode with 2 mm female connection terminal | The electrodes consist of carbon filled silicon rubber. For proper electrical contact with the patient the electrodes should be used in combination with moistened sponge pads. The electrode/sponge assembly is wrapped to the patient using fixation straps. Instructions for use are available in the Operating Instructions of the Enraf-Nonius B.V. nerve and muscle stimulators that the electrodes are to be used with. The following accessories apply: | 1460266 | Sponges Pads 6 x 8 cm, set of 4 pc | |---------|------------------------------------| | 1460273 | Sponges Pads 4 x 6 cm, set 4 pc | | 1460275 | Sponges Pads 8 x 12 cm, set 4 pc | | 3444020 | Fixation strap 100 x 3 cm | | 3444021 | Fixation strap 250 x 3 cm | {1}------------------------------------------------ #### 510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130 # Indications for Use Statement 510(k) Number : Enraf-Nonius B.V. Applicant : Device Name : Flexible Rubber Electrodes Indications for Use: Electrical Stimulation Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96) {2}------------------------------------------------ #### 510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130 # Substantial Equivalence Summary Electrodes 1460265, 1460272 combined with sponge pads 1460266 and 1460273, were already used as accessories to the Enraf-Nonius B.V. Endomed CV405 powered muscle stimulator, a device no longer in production. The electrodes were continued to be used with newer Enraf-Nonius B.V. stimulator designs marketed outside the USA. During this time the electrodes have undergone the following changes: - Electrode size 8 x 12 cm was added to the family . - Electrodes were made available with 2 mm female terminations ● - A new material formulation was used . #### Comparison of Technological Characteristics: | Device | New | Predicate | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------| | Maximum Current Density:<br>Electrode size : 4 x 6<br>Stimulation current : 100 mA r.m.s.<br>(IEC 60601-2-10 limit at frequencies above<br>1500 Hz) | 4.2 mA/cm² | 4.2 mA/cm² | | Maximum Power Density:<br>Electrode size : 4 x 6<br>Current type : Premodulated<br>carrier freq : 2 kHz<br>beat freq : 0 Hz<br>amplitude : 100 mA<br>Current type : Diadynamic DP<br>amplitude : 70 mA<br>(measured with sponge pads moistened with<br>tap water) | < 25 mW/cm²<br>< 50 mW/cm² | < 25 mW/cm²<br>< 50 mW/cm² | | Standards: | | | | IEC 60601-1 (1988+A1+A2) | Yes | Yes | | IEC 60601-2-10 (1987) | Yes | Yes | | MDD 93/42/EEC | Yes | Yes | | 21 CFR 898 | Yes | Yes | | Biocompatibilty according to ISO 10993: | | | | Cytotoxicity | Yes | Yes | | Skin Irritation | Yes | Yes | | Dermal Sensitization | Yes | Yes | {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three figures representing health, services, and human aspects. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Public Health Service APR 2 8 2003 Mr. Rick Coelet Enraf-Nonius, B.V. Rontgenweg 1, 2624 BD Delft P.O. Box 810, 2600 AV Delft The Netherlands Re: K030297 Trade/Device Name: Flexible Rubber Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 24, 2003 Received: January 28, 2003 Dear Mr. Coelet: 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 {4}------------------------------------------------ Page 2 - Mr. Rick Coelet 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), please contact the Office of Compliance at (301) 594- _ . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.qov/cdrh/dsma/dsmamain.html Sincerely vours. Sincerely yours, Mark N Wilkerson Celia M. Witten, M.D., Ph.D. Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Enclosure {5}------------------------------------------------ 510(k) Summary Flexible Rubber Electrodes 1460265/272/274 and 3444128/129/130 # Indications for Use Statement 510(k) Number : Ko30297 : Enraf-Nonius B.V. Applicant Device Name : Flexible Rubber Electrodes Indications for Use: Electrical Stimulation Mark N. Milken (Division Sign-Off) Division of General, Restorative and Neurological Devices KO30297 510(k) Number ________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)