(36 days)
Not Found
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML in medical imaging.
No.
The device is described as a "Diagnostic Ultrasound System" intended for "evaluation" and "imaging," which indicates a diagnostic rather than therapeutic purpose.
Yes
The device description explicitly states, "The Aloka Prosound 6 Diagnostic Ultrasound System is a full feature imaging and analysis system." Additionally, the predicate device is also named "Diagnostic Ultrasound System."
No
The device description explicitly states it consists of a "mobile console" with hardware components like a keyboard, specialized controls, and a video display, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis. The intended use and device description clearly state that this is a diagnostic ultrasound system used for imaging within the body.
- The device description focuses on imaging and analysis of internal structures. It doesn't mention any analysis of biological samples.
- The anatomical sites listed are all internal body parts.
Therefore, the Aloka Prosound 6 Diagnostic Ultrasound System is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic applications.
Product codes
IYN, IYO, ITX
Device Description
The Aloka Prosound 6 Diagnostic Ultrasound System is a full feature imaging and analysis system. It consist of a mobile console that provides acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a video display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal, Intraoperative (abdominal, thoracic & vascular)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physician
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)
Non-clinical Tests: The device and its transducers have been evaluated for acoustic output, biocompatibility, cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical and mechanical safety, and have been found to conform with applicable medical device safety standards. Clinical Tests: None Required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Mode! Prosound 6
510(K)
| 510(k) Summary of Safety and Effectiveness | FEB 2 9 2008 | |
|---|---|---|
| Prepared in accordance with 21 CFR Part 807.92 | ||
| Section a): | ||
| 1. Submitter: | Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 | |
| Contact Person: | Richard J. Cehovsky, RA/QA Coordinator, | |
| Tel: (203)269-5088 Ext. 346, Fax: 203-269-6075 | ||
| Date Prepared: | 2/6/2008 | |
| 2. Device Name: | Aloka Prosound 6 Diagnostic Ultrasound System | |
| Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90 IYN | ||
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90 ITX | ||
| Ultrasonic Pulsed Echo Imaging System., 21 CFR 892.1560, 90 IYO | ||
| 3. Marketed Device: | Aloka SSD-1400 Diagnostic Ultrasound System K972465, (90-IYN, ITX, IYO) | |
| (A device currently in commercial distribution) | ||
| 4. Device Description: | The Aloka Prosound 6 Diagnostic Ultrasound System is a full feature imaging and | |
| analysis system. It consist of a mobile console that provides acquisition, processing and | ||
| display capability. The user interface includes a computer keyboard, specialized controls and | ||
| a video display. | ||
| 5. Indications for Use: | The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, | |
| Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), | ||
| Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative | ||
| (abdominal, thoracic & vascular) applications. The device is not indicated for Ophthalmic | ||
| applications. | ||
| 6.Comparison w/ Predicate Device: | The Aloka Prosound 6 is technically comparable and substantially equivalent to the | |
| current Aloka SSD-1400-(K972465). It has the same technological characteristics, key | ||
| safety and effectiveness features, physical design, construction, materials and has the same | ||
| intended uses and basic operating modes as the predicate device. | ||
| Section b): | ||
| 1. Non-clinical Tests: | The device and its transducers have been evaluated for acoustic output, biocompatibility, | |
| cleaning & disinfection effectiveness, electromagnetic compatibility, as well as electrical | ||
| and mechanical safety, and have been found to conform with applicable medical device | ||
| safety standards. | ||
| 2. Clinical Tests: | None Required. | |
| 3. Conclusion: | Intended uses and other key features are consistent with traditional clinical practices, FDA | |
| guidelines and established methods of patient examination. The design, development and | ||
| quality process of the manufacturer confirms with 21 CFR 820, ISO 9001:2000 and ISO | ||
| 13485 quality systems. The device conforms to applicable medical device safety standards | ||
| and compliance is verified through independent evaluation with ongoing factory | ||
| surveillance. Diagnostic ultrasound has accumulated a long history of safe and effectiveness | ||
| performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka ProSound 6 |
Diagnostic Ultrasound System and its transducers is substantially equivalent with respect to safety and effectiveness to its predicate and other currently cleared Aloka systems.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 9 2008
Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K080176
Trade/Device Name: Aloka Prosound 6 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: February 13, 2008 Received: February 15, 2008
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket 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 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). 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Aloka Prosound 6 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
| UST-672-5/7.5 | UST-5413 | UST-9124 |
|---|---|---|
| UST-676P | UST-5542 | UST-9127 |
| UST-987-7.5 | UST-5710-7.5 | UST-9133 |
| UST-995-7.5 | UST-9102U-3.5 | UST-MC11-873 |
| UST-5045P-3.5 | UST-9123 |
2
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.g., 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
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Page 3 – Mr. Tamas Borsai
If you have any questions regarding the content of this letter, please contact Ms. Lauren Hefner at (240) 276-3666.
Sincerely yours,
Hore In Whing
Fri 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
510(K) Number (if known): Device Name: Indications For Use:
Aloka Prosound 6
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Peripheral Vascular, Transrectal, Transvaginal and Intraoperative (abdominal, thoracic & vascular) applications.
The device is not indicated for Ophthalmic applications.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorn M. Whan
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number .
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