(202 days)
Diagnostic ultrasound imaging and Doppler analysis of the human body... Medical disciplines that use transesophageal diagnostic ultrasound include Cardiology, Surgery and Trauma.
The Aloka UST-5258-5 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka UST-5258-5 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The provided text is a 510(k) summary for the Aloka UST-5258-5 diagnostic ultrasound transducer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not available in this document.
However, based on the information provided, we can infer some aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence in technological characteristics and safety to a predicate device (Aloka UST-5228-5).
| Acceptance Criteria (Inferred) | Reported Device Performance (as stated in the document) |
|---|---|
| Same diagnostic ultrasound applications as predicate device | The UST-5258-5 is indicated for the same diagnostic ultrasound applications as other products currently marketed by Aloka and others. (Implies satisfactory performance for these applications.) |
| Same gray-scale and Doppler abilities as predicate device | The UST-5258-5 has the same gray-scale and Doppler abilities as other products currently offered by Aloka and others. (Implies equivalent image quality and Doppler functionality.) |
| Uses essentially the same technologies | The UST-5258-5 uses essentially the same technologies for imaging, Doppler functions, and signal processing as other products currently marketed by Aloka and others. (Implies equivalent functionality and performance due to shared underlying technology.) |
| Same method of use as predicate device | The UST-5258-5 has the same method of use as other products currently marketed by Aloka and others. (Implies similar operational performance for users.) |
| Acoustic power output levels below FDA maximum | The UST-5258-5 acoustic power output levels are below the maximum levels allowed by the FDA. (Implies compliance with safety standards regarding acoustic output.) |
| Subject to the same Quality Assurance systems | The UST-5258-5 is subjected to the same Quality Assurance systems in development and production as other products currently marketed by Aloka. (Implies consistent manufacturing quality and control, leading to expected performance.) |
| Patient contact materials safety | The patient contact materials used in the UST-5258-5 have been evaluated for safety via the same standards and methods as other products marketed by Aloka and others. These materials have been found to be safe for the intended uses. (Implies meeting biocompatibility and safety standards.) |
| Compliance with electrical and physical safety standards | The UST-5258-5 complies with the same electrical and physical safety standards as other products currently marketed by Aloka and others. (Implies meeting regulatory safety requirements.) |
| Functionality (transmitting and receiving sound waves, imaging, Doppler) | The Aloka UST-5258-5 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body... differences in the acoustic impedance... reflect... energy back to the transducer... processed into an image. The Aloka UST-5258-5 transducer can also use the Doppler shift... to detect and display flow. (Demonstrates basic operational functionality.) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document primarily focuses on demonstrating substantial equivalence through a comparison of device characteristics rather than a separate clinical or performance study with a defined test set.
- Data Provenance: Not specified. Given the nature of a 510(k) submission for substantial equivalence based on technical characteristics, it's unlikely that a test set with specific data provenance (country, retrospective/prospective) was used in the way one would for a clinical trial of a novel device. The "data" here would be the technical specifications and existing safety data of the device itself and its predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not specified. Since there is no explicit mention of a test set requiring ground truth establishment by experts, this information is not present. The "ground truth" for a substantial equivalence claim is often the established performance and safety of the predicate device.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/not specified. There is no indication of a test set requiring adjudication in the context of this 510(k) summary.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This is a submission for a diagnostic ultrasound transducer, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is an ultrasound transducer, a hardware component that requires a human operator and an ultrasound system. It does not operate as a standalone algorithm.
7. The type of ground truth used:
- Ground Truth: In the context of this 510(k) for substantial equivalence, the "ground truth" and basis for comparison are the well-established performance, safety, and technological characteristics of the predicate device (Aloka UST-5228-5) and other legally marketed diagnostic ultrasound transducers. The assumption is that if the new device shares these characteristics and meets safety standards, its performance will be equivalent and acceptable.
8. The sample size for the training set:
- Sample Size: Not applicable/not specified. Ultrasound transducers are hardware devices; they do not have "training sets" in the sense of machine learning algorithms. Their design and functionality are based on engineering principles and established medical imaging physics.
9. How the ground truth for the training set was established:
- Ground Truth Establishment: Not applicable/not specified. As there is no training set, there is no ground truth to establish for it.
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510(k) SUMMARY 1.
This summary statement complies with 21 CFR, section 807.92 as amended March 14, 1995.
This premarket notification has been submitted by Aloka Co., Ltd. and covers the Aloka UST-5258-5 diagnostic ultrasound transducer. The address is:
10 Fairfield Boulevard Wallingford, CT 06492
The contact person is Paul D. Smolenski, Manager, Quality and Regulatory Affairs.
The proprietary name is the Aloka UST-5258-5 diagnostic ultrasound transducer. The common name for this type of device is a diagnostic ultrasound transducer.
The item in this submission is covered under the following classification:
90 ITX - Transducer, Ultrasonic, Diagnostic
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II
The Aloka UST-5258-5 is substantially equivalent to the Aloka UST-5228-5 diagnostic ultrasound transducer.
The Aloka UST-5258-5 functions in the same manner as other diagnostic ultrasound devices. High frequency sound waves are transmitted into the body by a piezo-electric transducer. In the body, differences in the acoustic impedance of different tissues reflect a certain amount of the ultrasound energy back to the transducer, where it is transmitted via the probe cable to the system console and processed into an image. The Aloka UST-5258-5 transducer can also use the Doppler shift of sound reflected from moving tissues (blood) to detect and display flow.
The Aloka UST-5258-5, like other marketed diagnostic ultrasound transducers, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
The Aloka UST-5258-5 diagnostic ultrasound transducer is similar in technological characteristics to ultrasound transducers marketed by Aloka and others:
- The UST-5258-5 is indicated for the same diagnostic ultrasound applications as other � products currently marketed by Aloka and others.
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- The UST-5258-5 has the same gray-scale and Doppler abilities as other products currently offered by Aloka and others.
- The UST-5258-5 uses essentially the same technologies for imaging, Doppler functions and signal processing as other products currently marketed by Aloka and others.
- The UST-5258-5 has the same method of use as other products currently marketed by . Aloka and others.
- The UST-5258-5 acoustic power output levels are below the maximum levels . allowed by the FDA.
- The UST-5258-5 is subjected to the same Quality Assurance systems in development . and production as other products currently marketed by Aloka.
- The patient contact materials used in the UST-5258-5 have been evaluated for safety . via the same standards and methods as other products marketed by Aloka and others. These materials have been found to be safe for the intended uses.
- The UST-5258-5 complies with the same electrical and physical safety standards as . other products currently marketed by Aloka and others.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 3 1997
Paul D. Smolenski Manager, Ouality and Regulatory Affairs Aloka Company, LTD. 10 Fairfield Blvd. Wallingford, CT 06492-7502
Re: K964549 ALOKA UST-5258 Diagnostic Ultrasound Transducer Dated: March 12, 1997 Received: March 13, 1997 Regulatory Class: II 21 CFR 892.1570/Procode: 90 ITX
Dear Mr. Smolenski:
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 transducer intended for use with the SSD-1700 as described in your premarket notification:
Transducer Model Number
5 MHZ UST-5258
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 for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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.
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Page 2 - Mr. Paul Smolenski
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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 tol!-free 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 Maureen Butler at (301) 594-1212.
Sincerely yours,
Daniel A. Seymon
for
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
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Indications for Use Summary
Device Name: Aloka UST-5258-5 Diagnostic Ultrasound Transducer 510(k) Number: Unknown at time of submission
Intended Use: Diagnostic ultrasound imaging and Doppler analysis of the human body... Medical disciplines that use transesophageal diagnostic ultrasound include Cardiology, Surgery and Trauma.
| Modes of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|
| Clinical | ্ | B | M | PWD | CWD | Color Flow | Combined | Other |
| Applications | Mapping | |||||||
| Ophthalmic | ||||||||
| Fetal | ||||||||
| Abdominal | ||||||||
| Small Organ | ||||||||
| Cardiac | B/M, B/PWD, M/CFM,B/CFM/PWD | |||||||
| Peripheral | ||||||||
| Vessel | ||||||||
| Other* | B/M, B/PWD, M/CFM,B/CFM/PWD |
*Intraoperative, Trauma.
David A. Segeum
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 9400 510(k) Number
Prescription Use (Per 21 CFR 801.109)
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.