BASIC, MODELS BASIC 1, BASIC 2, AND BASIC 3

{0}------------------------------------------------  Aty**s** Médical # 510(k) SUMMARY #### A. Submittor information | • Applicant's Name: | Company name: ATYS Sarl | |------------------------|--------------------------------| | | Managing Director: Denis PARZY | | • Applicant's Address: | 17 Parc d'activités d'Arbora | | | 69510 SOUCIEU EN JARREST | | | FRANCE | | • Telephone Number: | 33 (0)4 78 05 69 69 | | • Contact Person: | Christine TURLAT, Ph.D. | #### B. Device identification - · Proprietary Name: BASIC , including three models: BASIC 1, BASIC 2 and BASIC 3. - · Common Name: Vascular test system: peripheral Doppler with photo & pneumo plethysmography. - · Class: Regulatory Class II #### C. Identification of predicate device Predicate Devices: HOKANSON, TL 400 TOTALAB (K872517). BIOMEDIX, FLOSTAT VASCULAR LAB (K973644) IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562) #### D. Performance standards Conforms to the following voluntary standards: IEC 601-1, EN 60601-1-2, IEC 801-2,3,4,5 EN55011 (CISPR11). The quality system is ISO 9001 and EN 46001 approved and certified. #### E. Special Controls 510(k) Special Report #### F. Indications for Use The BASIC is a non-invasive diagnostic system to assist in the detection of peripheral vascular disease (arterial or venous). The BASIC is not intended to be used for fetal monitoring nor for fetal applications. The BASIC is not intended for ophthalmic applications. The BASIC is not intended for home use. The BASIC is not intended for use on non-intact skin or eyes. K012369 p.1/3 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Atys Médical. The logo consists of a circular emblem with a stylized "A" inside, followed by the word "Atys" in bold, and then the word "Médical" in a smaller, less bold font. The logo is black and white. K012369 p.2/3 #### G. device description The diagnosis with the BASIC is performed via four separate modalities, each of which can be used to test either the arterial or venous system. These four modalities are: - 4 and 8 MHz continuous wave Doppler. - · Photoplethysmography, - · Air plethysmography, - · Systolic pressure examination. The BASIC's principle of operation is based on: - · Doppler mode: the real time ultrasound measurement of blood velocity in the examined Dopper mode. the four inno anabound velocity in the examined vessel is displayed as a vessel. The time overation of the velocity is made with a 4 or 8 MHz probe. - · Photoplethysmography: The photo plethysmography probe is placed on a digit or taped to the skin surface. The photo plethysmography probe contains an infrared light source and a sensitive photocell. The light source directs infrared light into the skin. The allo a scholder. In measures the amount of light reflected off the blood cells. So, the receiving photocch measures in real time the change of the amount of blood in the photopromyonly homaply of the heart. It depicts it in a waveform. - · Air plethysmography: the real time measure of the change of blood volume in a limb. An Air-filled pressure cuff is used to measure these changes. By wrapping a pressure cuff An-Intod problems on a patient's leg, arm or digit, the blood flow at these locations can be quickly assessed. Relative limb volume increases with each heart beat. Air plethysmography measures this increase and depict it in a waveform. - pressure examination requires a Doppler probe or an arterial · Systolic Dystone probour - ensor and a pressure cuff to measure the patient's systolic pressure at different locations (legs, arms, digits). The important data are not the absolute value of the pressures but the pressure differences or ratio. The BASIC consists of the following components: - · The main console, - · The 4 and 8 MHz probes, - · The photo-plethysmography sensors, - · The cuffs (the cuffs are accessories not manufactured by Atys). The main consoles provides various indicators and controls designed to lead the operator through the sequential procedures needed for the operation of the BASIC. It contains a LCD screen and a thermal printer to display the parameters and charts associated with the tests. The console also houses the electrical and electronical components, the cuff inflate pump, {2}------------------------------------------------ # AtVS Médical K012369 p.3/3 the pressure sensor (that measures the pressure in the cuff). The device operates from 220 V supply. The 4 and 8 MHz probes are comprised of a sensor tip, a mechanical head, a cable and a The + and o MITZ pro068 are orises either two piezo electric transducers. The transducer transforms the electrical energy into acoustical energy and vice versa. The photo sensors are non focused sensors with two (arterial sensors) or four (vein sensors) emitters and a center receiver. ### H. Acoustic Output Maximum acoustic output levels are below pre-amendment levels (track 1) for acoustic intensity for the investigation of peripheral vessels. #### I. Substantial Equivalence The technical characteristics are almost identical to those of the - · HOKANSON TL, 400 TOTALAB (K872517) - · BIOMEDIX, FLOSTAT VASCULAR LAB (K973644) - · IMEX MEDICAL SYSTEMS, IMEXLAB 9100 (K973562) previously cleared predicate devices. previously cleared predicate devices in terms of technical specifications, ultrasonic DIfferences that CAIST Detworld incess and methods of applications do not affect the relative safety or effectiveness of the BASIC. Accordingly, the BASIC is believed to be substantially equivalent to devices of the same Accordingly, the Driste to ly distributed in interstate commerce in United State. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle head facing left, with three parallel lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 0 2001 ATYS Medical % Mr. Mark Job 510(k) Program Manager TUV Product Service, Inc. 1775 Old Highway 8 NW Suite 104 NEW BRIGHTON MN 25112-1891 Re: K012369 BASIC 1, 2, and 3 (Peripheral Vascular Diagnostic Test System) Dated: July 23, 2001 Received: July 26, 2001 Regulatory Class: II 21 CFR 892.1550/Procode: 90 IYN 21 CFR 870.2780/Procode: 74 JOM #### Dear Mr. Job: Dour rail roof We have reviewed your Section 5 l (k) notification of intent to market the developed groupes We have reviewed your Section 310(x) notifications for use stated in the enclosure) to legally marketed predicate on to a device is substantially equivalent (on the mated of the Medical Device Amendents, or to devices of to devices of to devices of the Art (Art (Art Chication) (Antoney marked in interstate continete provisions of the Federal Food, Drug, and Cometic Act (Act.). You may, that have been reclassified in accordance with the provisions of the re that have been reclassined in accordance will the provisions of the Act. The general controls provisions of the Activities therefore, market the device, subject on the general controls of the reall and the 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 (Premater Approval), it may be subjections If your device is classined (See above) into clubs in (Openal Octable) or the found in the Code of Federal Regulations, to such additional controls. Existilly hajor regulations areemint to cornes compliance with the Current convertise of 1 CED Port Title 21, Parts 800 to 893. A substantally equivalion (QS) for Medical Devical Device) Devices (Ancal regulation (21 CFR Part Practice requirements, as set form in the Quality System toghtant (CDA) will verify such assumptions. Failure 820) and that, through periodic QS mspeciolis, the rod and Drag FDA may publish further announcements. to comply with the GMP regulation may result in regulatory action. In to comply with the Give regulation in regalitory ations on this response to your premarket notification submission to concerning your device in the Pederal Register. Trease nown respections of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification for your device and I his letter will allow you to begally marketed predicated in your betty prediction 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 additionally of the researching on the promotion on the promotion If you desire specific advice to your device of Compliance at (301) 594-4639. Additionally, for question, or the promotion diagnosite devices), please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information of your entitled, "Misoranding by relective to prehalker (21 cc Sr Scool Man Generes Assistance at its toll-free number (800) responsibilities under the Act may be obtained from the responsibilities under the Acc may be obtained from the 2017 of the providers/dsmaddsmamain.html". 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/c Sincerely vours. Nancy C. Bogdon Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure (s) {4}------------------------------------------------ # Indications for Use Statement | Ver/ 3 - 4/24/96 | | |---------------------------|----------------------------------------------------------------------------------------| | Applicant: ATYS | | | 510(k) Number (if known): | K012369 | | Device Name: BASIC | | | Indications For Use: | <ul><li>Photo-plethysmography module.</li><li>Pneumo-plethysmography module.</li></ul> | The pneumo-plethysmography module measures volume changes in limbs or digits. Relative limb volume increases with each heartbeat. The pneumo-plethysmography module measures this increase and depicts it as a waveform. The pneumo-plethysmography is also used in conjunction with the Doppler module or the photo-plethysmography module to measure the systolic blood pressure in limbs or digits. In this case, the pneumo-plethysmography module is used to inflate a cuff to perform the occlusion. The photo-plethysmography module: the amount of blood in the skin changes with each contraction of the heart. The Photo-plethysmography module measures this change and depicts it in a waveform. The photo-plethysmography module is also used in conjunction with the pneumo- plethysmography module (blood pressure cuffs) to measure the systolic blood pressure. The photo-plethysmography module detects the return of the blood after the occlusion. The pneumo-plethysmography module is not intended for neonatal applications. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96) RA II *Prescription Use* Nancy C. Hogdon 9 {5}------------------------------------------------ #### Diagnostic Ultrasound Indications for Use Form #### Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Diagnostic ultrasound imaging of fluid flow analysis of the | | Mode of Operation | | | | | | | | | | | |--------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--| | Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Amplitude<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(specify) | Other<br>(specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | N | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | | Musculo-skelotal Superficial | | | | | | | | | | | | | Other (specify) | | | | | | | | | | | | | N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | | | | Additional Comments: | BASIC - Peripheral Doppler | | | | | | | | | | | | 8 MHz Transducer | | | | | | | | | | | | | (PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)<br>Concurrence of CDRH, Office of Device Evaluation (DDE) | | | | | | | | | | | | Prescription Use (Per 21 CFR 801.109) Nancy C. Hoadon (Division Si Division of Reproductive, and Radiological Devic 510(k) Number ನ {6}------------------------------------------------ #### Diagnostic Ultrasound Indications for Use Form ## Fill out one form for each ultrasound system and each transducer. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: | Mode of Operation | | | | | | | | | | | |----------------------------------|---|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | Ophthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | Transrectal | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | Transurethral | | | | | | | | | | | | Intravascular | | | | | | | | | | | | Peripheral Vascular | | | | | N | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-skeletal<br>Conventional | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | Other (specify) | | | | | | | | | | | N= new Indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: BASIC - Peripheral Doppler 4 MHz Transducer (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) | (Division Sign-Off) | Nancy Brogdon | |---------------------------------------------------------------|---------------| | Division of Reproductive, Abdominal, and Radiological Devices | K012369 | | 510(k) Number | 3 | : {7}------------------------------------------------ ### Diagnostic Ultrasound Indications for Use Form # Fill out one form for each ultrasound system and each transducor. Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the hu | | Mode of Operation | | | | | | | | | | | |-----------------------------------------------------------------------------------------------|-------------------|---|---|-----|-----|---------------|-------------------|------------------------|--------------------|-----------------|--| | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Amplitude Doppler | Color Velocity Imaging | Combined (specify) | Other (specify) | | | Ophthalmic | | | | | | | | | | | | | Fetal | | | | | | | | | | | | | Abdominal | | | | | | | | | | | | | Intraoperative (specify) | | | | | | | | | | | | | Intraoperative Neurological | | | | | | | | | | | | | Pediatric | | | | | | | | | | | | | Small Organ (specify) | | | | | | | | | | | | | Neonatal Cephalic | | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | | Cardiac | | | | | | | | | | | | | Transesophageal | | | | | | | | | | | | | Transrectal | | | | | | | | | | | | | Transvaginal | | | | | | | | | | | | | Transurethral | | | | | | | | | | | | | Intravascular | | | | | | | | | | | | | Peripheral Vascular | | | | | N | | | | | | | | Laparoscopic | | | | | | | | | | | | | Musculo-skeletal Conventional | | | | | | | | | | | | | Musculo-skeletal Superficial | | | | | | | | | | | | | Other (specify)<br>N= new indication; P= previously cleared by FDA; E= added under Appendix E | | | | | | | | | | | | | Additional Comments: BASIC - Peripheral Doppler | | | | | | | | | | | | | 4 and 8 MHz transducers | | | | | | | | | | | | | (PLEASE DO NOT WRITE AFLOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED) | | | | | | | | | | | | | Concurrence of CDRH, Office of Device Evaluation (ODE) | | | | | | | | | | | | Prescription Use (Per 21 CFR 801.109) Nancy C. Brogdon a Ah