The Perception's GPS-RST Ultrasound System is a PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system which produces diagnostic ultrasonic images and blood flow spectral analysis through user friendly operation. User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-RST Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-RST Diagnostic Ultrasound System supports M, B, M&B, Dual B, Quad B. D and D/B, display modes. All probes currently intended for use with the Perception GPS-RST Diagnostic Ultrasound System are either mechanical sector devices or electronic linear array, and make use of a fluid filled design.

AI/ML Overview

The provided 510(k) summary for the Perception Inc. GPS-RST Diagnostic Ultrasound System does not contain information regarding acceptance criteria for clinical performance or any clinical study to prove the device meets such criteria.

The document states "Discussion of Clinical Test Performed: Not Applicable" {3}, indicating that no clinical tests were performed for this submission. The 510(k) focuses entirely on non-clinical testing to demonstrate substantial equivalence to predicate devices, primarily concerning acoustic output and electrical safety standards.

Therefore, I cannot populate the requested tables and information regarding acceptance criteria and clinical study details. The document explicitly declares that no clinical tests were conducted.

Summary

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JUN - 8 1998

510(k) SUMMARY

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 510(k) number is: K974890

1. Submitter's Identification :

Perception Inc. 9344 N.W. 13th Street, Suite 200 Miami. Florida 33172 Contact Person : Mr. Jorge Millan

Date Summary Prepared: December 5, 1997

2. Name of the Device :

GPS-RST Diagnostic Ultrasound System Perception

3. Predicate Device Information :

1. Aloka Co. K963616 Model SSD-1700

2. Diasonics Ultrasound

Models	Synergy	K935024
	CFM800	K924079
	EchoPac	K962662

1. Perception Inc. K#972973. Model GPS-TUV

4. Device Description :

General Description

The following intended uses are identified for the transducer applications: General radiology, Abdominal, Cardiac and Vascular, with the use of

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ultrasonic probes from 3.0-12.5 MHz. There are no transcranial applications for this device.

User interface is via an alphanumeric keypad, trackball and Icon-driven graphical interface. The Perception Inc. GPS-RST Diagnostic Ultrasound System may be operated in M /B /D modes of inspection. The Perception GPS-RST Diagnostic Ultrasound System supports M, B, M&B, Dual B, Quad B. D and D/B, display modes.

All probes currently intended for use with the Perception GPS-RST Diagnostic Ultrasound System are either mechanical sector devices or electronic linear array, and make use of a fluid filled design. Transducer parameters are summarized in the following table:

PROBE	CENTER FREQ	TYPE	INSP.MODES	APPLICAT.
GP-3.0	2.8 MHz	MECH.SEC	M/B/D	Gen.Purpose/Abdominal/Cardiac
LA-7.5	7.5 MHz	LINEAR.ARR	M/B/D	PeripheralVascular
PV-12.5	12.5 MHz	MECH SEC	M/B	PeripheralVascular

5. Intended Use:

See Attachment.

6. Comparison to Predicate Devices:

We believe the Perception Inc. GPS-RST 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-RST Diagnostic Ultrasound System and predicate devices is attached to this summary.

7. Discussion on Non-Clinical Test Performed for Determination of Substantial Equivalence are as Follows:

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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 a contract testing laboratory:

UL-544. Third Edition .
Radiated and Conducted Emissions per CISPR 11 ●
Magnetic Field Emissions 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 . i 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 RS 101 ●
Quasi-Static Electric Field Immunity .

None of the testing demonstrated any design characteristics that violated the requirements of the September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, Center for Devices and Radiological Health" or resulted in any safety hazards. It was the contract testing Laboratory's conclusions that the

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device tested met all relevant requirements of the aforementioned guidance testing requirements.

8. Discussion of Clinical Test Performed:

Not Applicable

9. Conclusions:

The Perception Inc. GPS-RST 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-RST Diagnostic Ultrasound System does not incorporated any significant changes in intended use, method of operations, material or design that could affect safety or effectiveness.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 1998

Susan D. Goldstein-Falk Official Correspondent Perception, Inc. 9344 N.W. 13th Street, Suite 200 Miami, FL 33178

K974880 Re : GPS-RST Diagnostic Ultrasound System May 1, 1998 Dated: Received: May 4, 1998 Requlatory class: II 21 CFR 892.1550/Procode: 90 IYN 90 IYO 21 CFR 892.1560/Procode:

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 The general controls provisions of the Act include provisions Act (Act). 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 Perception GPS-RST Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

MHz Mechanical Sector GP - 3.0 LA - 7.5 MHz Linear Array PV - 12.5 MHz Mechanical Sector

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. র্ব substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Susan D. Goldstein-Falk

This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G, (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.q., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 Other general information on your responsibilities under the Act may 807.97). be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David h. Szymm
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

Enclosure

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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

						Mode of Operations
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		X	X		X
Intraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonathal Cephalic
Adult Cephalic
Cardiac		X	X		X
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		X	X	X
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

GPS-RST - ULTRASOUND SYSTEM

Prescription Use ...... (Per 21 CFR (an 109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number __

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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operations
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		X	X		X
ntraoperative(specify)
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonathal Cephalic
Adult Cephalic
Cardiac		X	X		X
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

GP-3.0 MHz Mechanical Sector-Transducer

N= new indication; -P= previously cleared by FDA; E= Added under Appendix E

Additional Comments: NONE

David C. Severson
Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use _ (Per 21 CFR 801.109)

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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operations
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative(specify
IntraoperativeNeurological
Pediatric
Small Organ (specify)
Neonathal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		X	X	X
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

LA-7.5 MHz Linear Array-Transducer

N= new indication; P= previously cleared by FDA; E= Added under Appendix E

Additional Comments: NONE

David A. Severson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

Prescription Use _ (Per 21 CFR 801.109)

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Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operations
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
ntraoperative(specify
Intraoperative
Neurological
Pediatric
Small Organ (specify)
Neonathal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vascular		X		X
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

PV-12.5 MHz Mechanical Sector-Transducer

N = new indication; P = previously cleared by FDA; + = Added under +pp

Additional Comments: NONE

Daniel A. Segarra
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic

Prescription Use _ (Per 21 CFR 801.109)

Radiological Devices
510(k) Number K974880

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.