R-TEST EVOLUTION 3

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the word "NOVACOR" in a bold, sans-serif font. Above the word is a barcode-like symbol, consisting of a series of vertical lines of varying widths. The word is in all caps, with the letters evenly spaced. ## JUN 1 0 2004 4, passage Saint Antoine 92508 Rucil Malmaison Cedex 08 France K040753 Tel : +33 1 41 39 01 61 Fax : +33 1 41 39 01 99 01/29/2004 ### SAFETY & EFFECTIVENESS DATA SUMMARY Classification Name : Common/Usual Name: Proprietary Name: Electrocardiograph ECG Event Recorder R-Test Evolution 3 Establishment Registration Number : 9612397 Reg. Number : 8702800 Classification : Class II Performance Standards : Devices are manufactured according EN 60-601-1, 93/42/EEC – European Medical Device Directive, EN 46002, ISO 9001 (2000) and ISO 13485 (1996). Material Composition : Ag/AgCl Electrodes Testing conducted to assure safety and effectiveness include but is not limited to : Testing conducted for conformity to these standards EN 60601-1 EN 60601-1-1 EN 60601-1-1-2 En 60601-1-14 En 5501 l Note : This testing will be completed, reviewed and approved prior to release and distribution of this product. {1}------------------------------------------------ 4, passage Saint Antoine 92508 Rueil Malmaison Cedex 08 France Tel : +33 1 41 39 01 61 Fax : +33 1 41 39 01 99 01/29/2004 ### SAFETY & EFFECTIVENESS DATA SUMMARY Description of the modified device : The R-Test Evolution 3 is a miniature ambulatory ECG Recorder, which is easy to connect to the patient. The most advanced version (automatic mode) is capable of memorizing the most significant pathological I he most atranoou version (datomatic attes patient's continuous heart rate, and is capable of up to eight days ambulatory recording. The system consists of a unit weighing about 40 grams and includes a lightweight cable which can be I ho system consists or a une welging wount any discomfort. The R-Test Evolution 3 is connected to the patient by the electrodes and the cable. Cardiac events are memorized by the R-Test Evolution 3 and then transferred for interpretation : - either by a decoder, the Decotest to an electrocardiograph (or an ECG monitor), or to a computer, " - or by a cable directly to a computer. ﮯ This transfer is generally done at the physician's surgery at the following visit. It can also be t the stansferred by phone or by e-mail, by modem, either from the patient's home, or from the office of a physician working in connection with an interpretation center. ph storal workering in 3 can also transmit real time ECG recordings by telephone; and after reading or r no t read evel and the R-Test Evolution 3 can continue recording any further pathological events which may occur on the same patient. Using a computer enables you to : - define the conditions and criteria of the recordings to be made by the R-Test Evolution 3, - - to select, organize and store the patient data and the results of a procedure, and to print them using specific report parameters. Intended use : The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. This version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. {2}------------------------------------------------ Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 1 0 2004 Novacor, S.A. c/o Ms. Dominique Grenier 4 Passage Saint-Antoine 92508 Rueil-Malmaison Cedex FRANCE Re: K040753 Trade Name: R-test Evolution 3 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: II (two) Product Code: MLO Dated: March 19, 2004 Received: March 24, 2004 Dear Ms. Grenier: We have reviewed your Section 510(k) premarket not intent to market the device We have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and have determined the devices marketed in interstate for use stated in the enclosure) to regary manced prouter Americal Device Amendments, or to commerce prior to May 28, 1976, the enactment and consisses of the Federal Food. D commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug, devices that have been reclassified in accordance with approval application (PMA). and Cosmetic Act (Act) that do not require approval astronomissions of the Act . The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, saoject to the gents for annual registration, listing of general controls provisions of the Act include required statist misbranding an general controls provisions of the Act merate requirements 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 If your device is classified (see above) mo chair case in existems on the vice can may be subject to such additional controls. Existing major regulations alfective EDA may may be subject to such additions, Title 21, Parts 800 to 898. In addion, FDA may be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addion, FDA may be found in the Code of Federal Regarations, and any and register. {3}------------------------------------------------ Page 2 – Ms. Dominique Grenier Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loase of action and 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 or any I odotal blacked and 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. product radianon of to begin marketing your device as described in your Section 510(k) I mis letter will anow you've ought inding of substantial equivalence of your device to a legally premainer notificate 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 It you dosir office of Compliance at (301) 594-4648. 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 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, Neil R. Ogden Bram D. Zuckerman, M.D Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: R-TEST EVOLUTION 3 Indications For Use: The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. As the R-Test Evolution (previous model), this version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. The registered data could be sent by a modem or by an e-mail application software. Neik1 Ogl (Division Sign-Off) for B.O.Z BDZ Division of Cardiovascular Devices 510(k) Number Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR N. A Over-The-Counter Use (21 CFR 807 Subpart C) #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of