PERCEPTION INC. GPS-XYZ DIAGNOSTIC ULTRASOUND SYSTEM

{0}------------------------------------------------ # DEC 17 1997 ## 510(K) SUMMARY # EXHIBIT #2 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. The assigned 5lO(k) number is: _______________________________________________________________________________________________________________________________________________ ## 1. Submitter's Identification: Perception Inc. 9344 N.W. 13th Street, Suite 200 Miami. Florida 33172 Contact Person: Mr. Jimmie Spraker --Date Summary Prepared: June 9, 1997 #### 2. Name of the Device :. Perception Inc. GPS-XYZ Diagnostic Ultrasound System #### 3. Predicate Device Information: - Aloka Model SSD650CL Ultrasound Systems and Transducers, 1) K# 925486/920374. - Bruel and Kiaer Diagnostic Ultrasound Type 3535 System and Transducers 2) 8549, 8434, 8536, 8537, 8551 and 8550, K#905198/914925. - Sharplan, USight 9010, K#945796. 3) - International Ultrasound Systems Inc., Model AU-530, Pre-amendment 4) Device. #### 4. Device Description: ## General Description The GPS-XYZ Diagnostic Ultrasound System device is a diagnostic ultrasound system which produces two-dimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There are no transcranial applications for this device. {1}------------------------------------------------ User interface is via an alphanumeric keypad and integrated trackball. The Perception Inc. GPS-XYZ Diagnostic Ultrasound System may be operated in M and B modes of inspection. The Perception Inc. GPS -XYZ Diagnostic Ultrasound System supports M, B, M&B, Dual B and Quad B display modes. All probes currently intended for use with the Perception Inc. GPS -XYZ Diagnostic Ultrasound System are either mechanical sector devices or electronic curved array, and make use of a fluid filled design. Transducer parameters are summarized in the following table: | PROBE | CENTER FREQ | TYPE | INSP. MODES | APPLIC. | |---------|-------------|-----------|-------------|----------------------------------------| | GP-3.0 | 2.8 MHz | MECH. SEC | M/B | Gen. Purpose/<br>Abdominal/<br>Cardiac | | CA-3.5 | 3.7 MHz | CONV. ARR | B | Abdominal | | PV-12.5 | 12.5 MHz | MECH SEC | M/B | Peripheral<br>Vascular | #### 5. Intended Use: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ The GPS-XYZ device is a diagnostic ultrasound system which produces twodimensional diagnostic ultrasonic images. The following intended uses are identified for the transducer applications: General Radiology, Abdominal, Cardiac and Vascular, with the use of ultrasonic probes from 2.8-12.5 MHz. There is no transcranial application for this device. ## 6. Comparison to Predicate Devices: We believe the Perception Inc. GPS -XYZ Diagnostic Ultrasound System to be substantially equivalent to ultrasound devices currently in commercial distribution in the U.S. A table of comparison outlining similarities and differences between the Perception Inc. GPS -XYZ Diagnostic Ultrasound System and predicate devices is attached to this summary. {2}------------------------------------------------ ## Discussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as Follows: This 510(k) submission is intended as a Track 1 type submission. Acoustic Output Reporting was prepared utilizing the following documents. - NEMA 1992, Acoustic output measurement standard for diagnostic ultrasound . equipment, NEMA Standard UD-21992. - FDA Center for Devices and Radiological Health 1985 510(k) Guide for ● Measuring and Reporting and Acoustic Output of Diagnostic Ultrasound Medical Devices, December, 1985, Revised, 1989, 1990, 1991, 1993, 1994 and 1995. -- Acoustic output of each system/transducer/mode/application combination was measured and calculated per the above documents. The following testing was conducted which revealed satisfactory testing results and compliance to applicable standards. - Maximum Acoustic Output Information . - Estimated In-Situ Intensity . - FDA In-Situ Intensity Limits . - Acoustic Output Information for each system/transducer/mode . combination The following testing was conducted by Intertec Testing Services: - UL-544, Third Edition . - Radiated and Conducted Emissions per CISPR 11 ● - Magnetic Field Emission per MIL-STD-482D, method RE101 ● - Electrostatic Discharge Immunity per IEC 801-2 . - Radiated Field Immunity (3 V/m, 26 MHZ to 1 Ghz, 100% Square Wave Modulation) - Steady State Voltage Fluctuations - Line Voltage Dropouts - Slow Line Voltage Sags and Surges . - . Fast Transients Bursts per IEC 801-4 - . Fast Line Voltage Surges - Conducted Energy Immunity per MIL-STD-462D, Method CS114 . - Magnetic Field Immunity per MIL-STD-482D, Method RS101 ● - Quasi-Static Electric Field Immunity {3}------------------------------------------------ None of the testing demonstrated any design characteristics that violated the requirements of the "FDA November 1993 Draft Reviewer Guidance for Pre-Market notification submissions, DCRND" or resulted in any safety hazards. It was Intertec Testing Services' conclusion that the device tested met all relevant requirements of the aforementioned quidance testing requirements. ## 8. Discussion of Clinical Tests Performed: ## Not Applicable ## 9. Conclusions: The Perception Inc. GPS-XYZ Diagnostic Ultrasound System has the same intended use as a combination of all cited predicates. All non-clinical testing and biocompatibility testing revealed no new questions of safety or effectiveness. This, when compared to the predicate devices, the Perception Inc. GPS-XYZ Diagnostic Ultrasound System does not incorporate any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Perception Inc. Susan Goldstein-Falk C/O MDI Consultants Inc. 55 Northern Blvd. Suite 410 Great Neck. NY 11021 DEC 17 1997 Re: K972192 GPS-XYZ (Diagnostic Ultrasound System) Dated: August 25, 1997 Received: September 23, 1997 Regulatory Class II 21 CFR 892.1560/Procode 90 IYO Dear Ms. Goldstein-Falk: We have reviewed your section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. You may, therefore, market the device, subject to the general controls provisions Act (Act). The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. This determination of substantial equivalence applies to the following transducers intended for use with the GPS-XYZ, as described in your premarket notification: ## Transducer Model Number 3.0 MHz GP-3.0 3.5. MHz CA-3.5 12.5 MHz PV-12.5 If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (CFR Part 820) and that, through periodic QS inspections, the Food and Drug {5}------------------------------------------------ Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 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 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 market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its internet address "dsmo@fdadr.cdrh.fda.gov". If you have any questions regarding the content of this letter, please contact Maureen Butler at (301) 594-1212. Sincerely vours. Vinit C. Syam Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health {6}------------------------------------------------ Attachment #1 3 pages # CLINICAL APPLICATIONS/OPERATING MODES # TABLE A.1 # GP-3.0 General Purpose 3.0 MHz Mechanical Sector | Clinical | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |--------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------| | Application | | | | | | | | | | | | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | x | x | | | | | | | | | Intra-Operative<br>(Specify) | | | | | | | | | | | | Intra-Operative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(Specify) | | | | | | | | | | | | Neonatal | | | | | | | | | | | | Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | x | x | | | | | | | | | Trans-<br>Esophageal | | | | | | | | | | | | Trans-Rectal | | | | | | | | | | | | Trans-Vaginal | | | | | | | | | | | | Trans-Urethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral<br>Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-<br>Skeletal<br>Conventional | | | | | | | | | | | | Musculo-<br>Skeletal<br>Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | Daniel L. Severson (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number K972192 Prescription Use (Per 21 CFR 801.109) 89 {7}------------------------------------------------ # TABLE A.2 | Clinical Application | A | B | M | PWD | CWD | Color Doppler | Power (Amplitude) Doppler | Color Velocity Imaging | Combined (Specify) | Other (Specify) | |-------------------------------|---|---|---|-----|-----|---------------|---------------------------|------------------------|--------------------|-----------------| | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | X | | | | | | | | | | Intra-Operative (Specify) | | | | | | | | | | | | Intra-Operative Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ (Specify) | | | | | | | | | | | | Neonatal | | | | | | | | | | | | Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Trans-Esophageal | | | | | | | | | | | | Trans-Rectal | | | | | | | | | | | | Trans-Vaginal | | | | | | | | | | | | Trans-Urethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral Vascular | | | | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-Skeletal Conventional | | | | | | | | | | | | Musculo-Skeletal Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number: R972192 # CA-3.5 Curved Array 3.5 MHz Electronic Prescription Use (Per 21 CFR 801.109) V (Per 21 CFR 801.109) {8}------------------------------------------------ # TABLE A.3 | Clinical<br>Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |--------------------------------------|---|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|--------------------| | Opthalmic | | | | | | | | | | | | Fetal | | | | | | | | | | | | Abdominal | | | | | | | | | | | | Intra-Operative<br>(Specify) | | | | | | | | | | | | Intra-Operative<br>Neurological | | | | | | | | | | | | Pediatric | | | | | | | | | | | | Small Organ<br>(Specify) | | | | | | | | | | | | Neonatal | | | | | | | | | | | | Cephalic | | | | | | | | | | | | Adult Cephalic | | | | | | | | | | | | Cardiac | | | | | | | | | | | | Trans-<br>Esophageal | | | | | | | | | | | | Trans-Rectal | | | | | | | | | | | | Trans-Vaginal | | | | | | | | | | | | Trans-Urethral | | | | | | | | | | | | Intra-Luminal | | | | | | | | | | | | Peripheral<br>Vascular | | X | X | | | | | | | | | Laparoscopic | | | | | | | | | | | | Musculo-<br>Skeletal<br>Conventional | | | | | | | | | | | | Musculo-<br>Skeletal<br>Superficial | | | | | | | | | | | | Other (Specify) | | | | | | | | | | | # PV-12.5 Peripheral Vascular 12.5 MHZ Mechanical Sector Thind C. Senger (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K972192 510(k) Number _ Prescription Use (Per 21 CFR 801.109)