(160 days)
Not Found
No
The device description and performance studies focus on traditional ultrasound technology and regulatory compliance testing, with no mention of AI or ML.
No.
The device is clearly indicated for "Diagnostic ultrasound imaging or fluid flow analysis", making it a diagnostic device rather than a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". The "Device Description" also refers to it as a "diagnostic ultrasound and pulsed Doppler imaging system".
No
The device description explicitly states it is a "PC (computer) based and controlled real time, two dimensional, mechanical sector and electronic array diagnostic ultrasound and pulsed Doppler imaging system" and mentions "All probes currently intended for use... are either mechanical sector devices or electronic linear array". This indicates the device includes significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This examination is performed outside of the living body (in vitro).
- Device Description: The description clearly states that the Perception's GPS-RST Ultrasound System is a diagnostic ultrasound system that produces images and blood flow analysis of the human body. This is an in vivo (within the living body) diagnostic method.
- Intended Use: The intended use is "Diagnostic ultrasound imaging or fluid flow analysis of the human body," which aligns with in vivo imaging.
- Lack of Specimen Handling: There is no mention of collecting or analyzing specimens from the body.
The device is a diagnostic imaging system that uses ultrasound waves to visualize internal structures and blood flow within the living patient. This is distinct from the analysis of biological samples in a laboratory setting, which is the hallmark of IVDs.
N/A
Intended Use / Indications for Use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
For GP-3.0 MHz Mechanical Sector-Transducer:
Clinical Application: Abdominal, Cardiac
Mode of Operations: B, M, PWD (for Abdominal and Cardiac)
For LA-7.5 MHz Linear Array-Transducer:
Clinical Application: Peripheral Vascular
Mode of Operations: B, M, PWD
For PV-12.5 MHz Mechanical Sector-Transducer:
Clinical Application: Peripheral Vascular
Mode of Operations: B, M
Product codes (comma separated list FDA assigned to the subject device)
90 IYN, 90 IYO
Device Description
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.
The following intended uses are identified for the transducer applications: General radiology, Abdominal, Cardiac and Vascular, with the use of 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Abdominal, Cardiac, Peripheral Vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K963616, K935024, K924079, K962662, K#972973
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 :
-
- Aloka Co. K963616 Model SSD-1700
2. Diasonics Ultrasound
| Models | Synergy | K935024 |
|---|---|---|
| CFM800 | K924079 | |
| EchoPac | K962662 |
-
- Perception Inc. K#972973. Model GPS-TUV
4. Device Description :
General Description
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.
The following intended uses are identified for the transducer applications: General radiology, Abdominal, Cardiac and Vascular, with the use of
1
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 | Peripheral |
| Vascular | ||||
| PV-12.5 | 12.5 MHz | MECH SEC | M/B | Peripheral |
| Vascular |
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:
2
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
3
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.
4
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.
5
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
6
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | X | X | |||||||
| Intraoperative(specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | X | X | |||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | X | X | X | |||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| 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 __
XI
7
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | X | X | X | |||||||
| ntraoperative(specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (specify) | ||||||||||
| Neonathal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | X | X | X | |||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Peripheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial | ||||||||||
| 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)
8
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 | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative(specify | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonathal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | X | X | X | ||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| 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)
9
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 | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | 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-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| Superficial | |||||||||||
| 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