(23 days)
No
The description focuses on conventional ultrasound technology, hardware components, and basic measurement/storage functions. There is no mention of AI, ML, or advanced image analysis techniques that would typically indicate the use of such technologies.
No
The "Intended Use / Indications for Use" section states that the devices are "diagnostic ultrasound systems designed to be used for general pelvic imaging," and there is no mention of therapeutic application.
Yes
The 'Intended Use / Indications for Use' section explicitly states that these are "diagnostic ultrasound systems." Additionally, the device records images and allows for measurements and calculations of organ, muscle, and tissue structures, which are functions of a diagnostic device.
No
The device description explicitly states that the system contains hardware components such as an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, and a USB 2.0 interface, in addition to the software. It also utilizes ultrasound probes and cables.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a diagnostic ultrasound system. It uses ultrasound waves to create images of internal structures (organs, muscle, tissue) within the pelvic region. This is an in vivo diagnostic method, meaning it is performed on a living organism.
- Lack of Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on specimens taken from the body.
Therefore, the Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are diagnostic imaging devices, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Note 1: Abdominal - Pelvic, Solid Organs, Aneurysms, Bladder Note 2: Small Organ - Testes, Prostate Note 3: Includes imaging for guidance of biopsy.
Product codes (comma separated list FDA assigned to the subject device)
IYO, ITX
Device Description
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable and host software application used in Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a self contained portable, multiplemode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.
User-customized parameter settings for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.
Patient contact materials have been used in accordance to their intended use and are described below for each individual transducers were previously cleared for use on other Systems (K070907).
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a B-Mode ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz.
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, and calculate angles. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device Interson USB Ultrasound Probe System, K070907.
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound interfaces with the Interson USB Ultrasound Probe System software to collect the ultrasound images, measurements, and calculations. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound allows for the entry of patient information and generates reports from the recorded ultrasound images, measurements, and calculations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
Ultrasonographic crystal
Anatomical Site
Pelvic region, Abdominal, Small Organs (Testes, Prostate), Trans-rectal, Trans-vaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound did not require clinical studies to support substantial equivalence.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
The Prometheus Group % Mr. Joshua Bird Senior Software Engineer 1 Washington Street. Suite 303 DOVER NH 03820
Re: K160792
Trade/Device Name: Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, ITX Dated: March 25, 2016 Received: March 29, 2016
Dear Mr. Bird:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160792
Device Name
Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound
Indications for Use (Describe)
Morpheus® RealTime Ultrasound, Pathway® RealTime Utrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.
Type of Use (Select one or both, as applicable)
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Diagnostic Ultrasound Indications for Use
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime System: Ultrasound, QuickScan® Bladder Ultrasound
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging & | |||||||||
| Other | Abdominal | N | Note 1 | ||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | N | Note 2 | |||||||
| Note 3 | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | N | Note 3 | |||||||
| Trans-vaginal | N | Note 3 | |||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac Adult | |||||||||
| Cardiac | Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
N = new indication
Note 1: Abdominal - Pelvic, Solid Organs, Aneurysms, Bladder
Note 2: Small Organ - Testes, Prostate
Note 3: Includes imaging for guidance of biopsy.
∑ Prescriptive Use (Part 21 CFR 801.109)
4
Diagnostic Ultrasound Indications for Use
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime System: Ultrasound, QuickScan® Bladder Ultrasound
Transducer: GP 3.5 MHz / AB 3.5 MHz Mechanical Sector Probe
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Fetal Imaging & | ||||||||
| Other | Abdominal | P | Note 1 | |||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | P | Note 2 | ||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
P = previously cleared by FDA, K070907
Note 1: Abdominal - Pelvic, Solid Organs, Aneurysms, Bladder
Note 2: Small Organ - Testes, Prostate
2 Prescriptive Use (Part 21 CFR 801.109)
5
Diagnostic Ultrasound Indications for Use
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime System: Ultrasound, QuickScan® Bladder Ultrasound
ER 12 MHz / ES 12 MHz Mechanical Sector Probe Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* | ||||||||
| (Specify) | |||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal | |||||||||
| Fetal Imaging & | |||||||||
| Other | Abdominal | ||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | P | ||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal | |||||||||
| (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | ||||||||
| Cardiac Pediatric | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | Peripheral vessel | ||||||||
| Vessel | Other (Specify) |
P = previously cleared by FDA, K070907
Z Prescriptive Use (Part 21 CFR 801.109)
6
Diagnostic Ultrasound Indications for Use
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime System: Ultrasound, QuickScan® Bladder Ultrasound
EC 7.5 MHz / EB 7.5 MHz Mechanical Sector Probe Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | P | |||||||
| Trans-vaginal | P | Note 3 | ||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | Peripheral vessel | |||||||
| Vessel | Other (Specify) |
P = previously cleared by FDA, K070907
Note 3: Includes imaging for guidance of biopsy. X Prescriptive Use (Part 21 CFR 801.109)
7
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with 21 CFR, Part 807, Subpart E, Section 807.92.
Submitter's name, address, telephone number, contact person:
The Prometheus Group® 1 Washington Street Suite 303 Dover, NH 03820 Joshua Bird Senior Software Engineer Telephone: (603) 749-0733 Fax: (603) 749-0511 Email: jbird@theprogrp.com Prepared February 26, 2016
Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name:
Diagnostic Ultrasound System and Accessories
Proprietary Name:
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound
Classification Names:
| CFR Number | Product Code | |
|---|---|---|
| Ultrasound Pulsed Echo Imaging System | 892.1560 | 90-IYO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |
8
Predicate Device:
Device Name: Interson USB Ultrasound Probe System
Manufacturer: Interson Corporation
510(k) Number:
K070907
The Prometheus Group® believes that Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are substantially equivalent to the currently marketed Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound have the same technological characteristics, safety and effectiveness features, comparable intended uses, and basic operating modes.
Device Description:
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable and host software application used in Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a self contained portable, multiplemode, and multiple-application ultrasound imaging system. The system contains an ultrasound generator/receiver, analog to digital converter, microcontroller, control logic, USB 2.0 interface and control offering a full complement of conventional operating modes, software-based parameter controls, and video recording.
User-customized parameter settings for the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit power, images controls selection, and Time Gain Compensation (TGC). Controls are also provided to select display format and to utilize the cine function.
9
Patient contact materials have been used in accordance to their intended use and are described below for each individual transducers were previously cleared for use on other Systems (K070907).
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are a B-Mode ultrasound scanner, which provides high resolution, high penetration performance. Probes are supported in frequencies from 2.5 MHz to 12.0 MHz.
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound provides various measuring functions. It can measure distances and calculate areas, circumferences and volumes, and calculate angles. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound supports the Cine function (capable of storing up to 512 sequential images). Management of patient history is possible by image-storage function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The same clinical uses were cleared for the predicate device Interson USB Ultrasound Probe System, K070907.
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound interfaces with the Interson USB Ultrasound Probe System software to collect the ultrasound images, measurements, and calculations. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound allows for the entry of patient information and generates reports from the recorded ultrasound images, measurements, and calculations.
Morpheus® RealTime Ultrasound
The Prometheus Group® Morpheus® RealTime Ultrasound allows the user to select up to 10 ultrasound images from an exam to include in the report. Additionally the user can input notes on the exam which are also included in the report. The report is formatted to be printed on standard 8 1/2" X 11" paper.
10
Pathway® RealTime Ultrasound
The Prometheus Group® Morpheus® RealTime Ultrasound allows the user to select up to 10 ultrasound images from an exam to include in the report. Additionally the user can input notes on the exam which are also included in the report. The report is formatted to be printed on standard 8 1/2" X 11" paper.
QuickScan® Bladder Ultrasound
The Prometheus Group® QuickScan® Bladder Ultrasound generates a condensed report containing a single image with the measurements and calculations recorded during the exam. The report is formatted to be printed on 80 mm thermal printer paper.
Indications for Use:
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound are diagnostic ultrasound systems designed to be used for general pelvic imaging. An ultrasonographic crystal within the probe records images of the organ, muscle, and tissue structures of the pelvic region. Measurements and calculations of the organ, muscle, and tissue structures can be recorded.
11
510(k) Premarket Notification
The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, QuickScan® Bladder Ultrasound
| Technological
Characteristics | | Subject Device:
The Prometheus Group®
Morpheus® RealTime
Ultrasound | Subject Device:
The Prometheus Group®
Pathway® RealTime
Ultrasound | Subject Device:
The Prometheus Group®
QuickScan® Bladder
Ultrasound | Predicate Device:
Interson USB Ultrasound
Probe System (K070907) |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | Lens | TPX brand Polymethyle
Pentene (PMP) | TPX brand Polymethyle
Pentene (PMP) | TPX brand Polymethyle
Pentene (PMP) | TPX brand Polymethyle
Pentene (PMP) |
| | Housing | Ertalyte brand
Polyetheylene
Terephthalate (PET-P),
Delrin | Ertalyte brand
Polyetheylene
Terephthalate (PET-P),
Delrin | Ertalyte brand
Polyetheylene
Terephthalate (PET-P),
Delrin | Ertalyte brand
Polyetheylene
Terephthalate (PET-P),
Delrin |
| Measurements | | Distance (mm),
Circumference (mm), Area
(mm²), Angle (degree) | Distance (mm),
Circumference (mm), Area
(mm²), Angle (degree) | Distance (mm),
Circumference (mm), Area
(mm²), Angle (degree) | Distance (mm),
Circumference (mm), Area
(mm²), Angle (degree) |
| Report | | Multiple page report
displaying up to 10 user
selectable images. The
report also displays notes
entered into the system by
the user. Printed on
standard 8 1/2" X 11"
paper. | Multiple page report
displaying up to 10 user
selectable images. The
report also displays notes
entered into the system by
the user. Printed on
standard 8 1/2" X 11"
paper. | Single page report
displaying a single image.
Printed on 80mm thermal
printer paper. | Single page report
displaying the first four
saved images. Printed on
standard 8 1/2" X 11"
paper. |
| Principle Operation | | Apply high voltage bursts to
Piezoelectric material in the
transducer and detect the
reflected echo to construct
2D images for diagnostic
purposes. | Apply high voltage bursts to
Piezoelectric material in the
transducer and detect the
reflected echo to construct
2D images for diagnostic
purposes. | Apply high voltage bursts to
Piezoelectric material in the
transducer and detect the
reflected echo to construct
2D images for diagnostic
purposes. | Apply high voltage bursts to
Piezoelectric material in the
transducer and detect the
reflected echo to construct
2D images for diagnostic
purposes. |
| Technological
Characteristics | Subject Device:
The Prometheus Group®
Morpheus® RealTime
Ultrasound | Subject Device:
The Prometheus Group®
Pathway® RealTime
Ultrasound | Subject Device:
The Prometheus Group®
QuickScan® Bladder
Ultrasound | Predicate Device:
Interson USB Ultrasound
Probe System (K070907) | |
| Transducer Probe
Design | Mechanical sector
ultrasound imaging probe
that connects directly to
host computer via Universal
Serial Bus (USB). Host
computer forms real-time
ultrasonic images of human
tissue without need for
additional electronics,
power supplies, or support
devices of any kind. | Mechanical sector
ultrasound imaging probe
that connects directly to
host computer via Universal
Serial Bus (USB). Host
computer forms real-time
ultrasonic images of human
tissue without need for
additional electronics,
power supplies, or support
devices of any kind. | Mechanical sector
ultrasound imaging probe
that connects directly to
host computer via Universal
Serial Bus (USB). Host
computer forms real-time
ultrasonic images of human
tissue without need for
additional electronics,
power supplies, or support
devices of any kind. | Mechanical sector
ultrasound imaging probe
that connects directly to
host computer via Universal
Serial Bus (USB). Host
computer forms real-time
ultrasonic images of human
tissue without need for
additional electronics,
power supplies, or support
devices of any kind. | |
| Acoustic Output
Limits:
All Applications | 'SPTA.3 94 mW/cm² (Max)
MI 1.9 (Max) | 'SPTA.3 94 mW/cm² (Max)
MI
1.9 (Max) | 'SPTA.3 94 mW/cm² (Max)
MI 1.9 (Max) | 'SPTA.3 94 mW/cm² (Max)
MI 1.9 (Max) | |
| Clinical Applications | Abdomen
OB/GYN
Urology | Abdomen
OB/GYN
Urology | Abdomen
OB/GYN
Urology | Abdomen
OB/GYN
Urology
Cardiac
Fetal Heart
Vascular
Pediatric
Neonatal Cephalic
Opthalmology
Extremity | |
12
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The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound utilize the ultrasound probes, cable, and host software application, which were previously cleared under K070907. These devices operate identically to the predicate devices in that piezoelectric material in the transducer is used as an ultrasound source to transmit sound waves into the body. Sound waves are reflected back to the transducer and converted to electrical signals that are processed and displayed as a 2D images.
The technological differences in clinical applications indicated for The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound systems versus those indicated for the Interson USB Ultrasound Probe System do not raise concerns for the safety and effectiveness of the device because the clinical applications indicated for The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound systems are a subset of the clinical applications indicated for the Interson USB Ultrasound Probe System. The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound system does not indicate any clinical applications outside of those indicated for the Interson USB Ultrasound Probe System. Additionally the clinical applications indicated for The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are independent of the clinical applications not indicated.
Morpheus® RealTime Ultrasound
The technological differences in the report The Prometheus Group® Morpheus® RealTime Ultrasound do not raise concerns for the safety and effectiveness of the device because the images and data displayed in The Prometheus Group® Morpheus® RealTime Ultrasound report would also be displayed in the Interson USB Ultrasound Probe System report. The ability to include more images and user notes on the exam in the report by The Prometheus Group® Morpheus® RealTime Ultrasound increase the effectiveness of the report by allowing the user to provide more evidence to substantiate the findings of the exam.
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Pathway® RealTime Ultrasound
The technological differences in the report The Prometheus Group® Pathway® RealTime Ultrasound do not raise concerns for the safety and effectiveness of the device because the images and data displayed in The Prometheus Group® Pathway® RealTime Ultrasound report would also be displayed in the Interson USB Ultrasound Probe System report. The ability to include more images and user notes on the exam in the report by The Prometheus Group® Pathway® RealTime Ultrasound increase the effectiveness of the report by allowing the user to provide more evidence to substantiate the findings of the exam.
QuickScan® Bladder Ultrasound
The technological differences in the report The Prometheus Group® QuickScan® Bladder Ultrasound do not raise concerns for the safety and effectiveness of the device because the images and data displayed in The Prometheus Group® QuickScan® Bladder Ultrasound report would also be displayed in the Interson USB Ultrasound Probe System report. The ability to include more images and user notes on the exam in the report by The Prometheus Group® QuickScan® Bladder Ultrasound would provide the same evidence to substantiate the findings as the Interson USB Ultrasound Probe System.
Nonclinical Tests and Standards Used:
The nonclinical tests performed on the Interson USB Ultrasound Probe System for clearance under 510(k) K070907 are applicable to The Prometheus Group® Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound as the Interson USB Ultrasound Probe System has not been modified by The Prometheus Group®.
Clinical Tests:
The Prometheus Group® Morpheus® RealTime Ultrasound. Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound did not require clinical studies to support substantial equivalence.
15
Conclusion:
The Prometheus Group® considers the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound devices to be as safe and effective as the predicate device. The performance of the subject device is substantially equivalent to the predicate device.
Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with medical device industry standards. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation. Diagnostic ultrasound has accumulated a long history of safe and effective performance.
Therefore, it is the opinion of The Prometheus Group® that the Morpheus® RealTime Ultrasound, Pathway® RealTime Ultrasound, and QuickScan® Bladder Ultrasound are substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.