SONOS 5500 IMAGING SYSTEM by HEWLETT-PACKARD CO.

The new intra-operative transducer has equivalent functionality to the existing transducer now being used. The new intra-operative transducer has new patient contact materials.

AI/ML Overview

This 510(k) submission (K971116) is for a new intra-operative imaging transducer (Model 21380A) for the Sonos 5500 Imaging System. The submission states that the only significant change from the predicate device (21275A, K944048) is the new patient contact materials. Therefore, the studies and acceptance criteria are focused on ensuring the safety and equivalence of these new materials and the continued functionality of the transducer.

Since the device is a transducer for an ultrasound imaging system and the core functionality is claimed to be the same as the predicate device, with changes only to patient contact materials, the acceptance criteria and supporting studies are centered on material biocompatibility and continued equivalent imaging performance, rather than a clinical efficacy study with human readers or complex diagnostic accuracy metrics.

Here's an attempt to structure the information based on the provided text, acknowledging that detailed study methodologies are not fully present in this summary document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Equivalent functionality to predicate device (21275A)	"The new transducer has equivalent functionality to the existing transducer now being used." (Claimed)
Same scientific concepts as predicate device	"Scientific Concepts: same as existing intra-operative transducer" (Claimed)
No significant differences in safety between 21380A and 21275A	"There are no significant differences in safety and efficacy between the 21275A and 21380A transducers." (Claimed)
No significant differences in efficacy between 21380A and 21275A	"There are no significant differences in safety and efficacy between the 21275A and 21380A transducers." (Claimed)
Biocompatibility of new patient contact materials	Implied: The need to file a 510(k) is specifically due to "new patient contact materials," which necessitates demonstrating their safety, typically through biocompatibility testing. The document states a "detailed comparison of the transducers can be found in the 510(k) report," which would contain these details, but they are not in the provided summary.
Continued intended use for diagnostic ultrasound imaging of the human body in specified applications (Intra-Operative: Cardiovascular, Pediatric, Cardiac Adult, Cardiac Pediatric, Peripheral Vessel)	The "Ultrasound Device Indications Statement" confirms these applications for the 21380A transducer, implying functionality for these uses.

Study Information

The provided 510(k) summary is high-level and does not offer explicit details on sample sizes, data provenance, expert qualifications, or adjudication methods for specific studies. Instead, it relies on the concept of "substantial equivalence" to a predicate device.

1. Sample sizes used for the test set and the data provenance:

Not explicitly stated for a clinical test set. The submission refers to a "detailed comparison of the transducers" in the full 510(k) report, which would likely include technical performance data. For the new patient contact materials, biocompatibility testing would have been performed on material samples, not patient data.
Data Provenance: Not specified, but given the nature of a 510(k) for a transducer, the "data" would likely originate from internal engineering and safety testing, rather than a large-scale clinical trial with patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable in the context of this 510(k) summary. This submission is not based on a diagnostic accuracy study requiring expert adjudication of images or clinical outcomes. The "ground truth" for the material change would be laboratory testing results for biocompatibility and engineering specifications for performance.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. As this is not a diagnostic accuracy study, there is no need for expert adjudication of medical cases.

4. 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:

No. This is an ultrasound transducer, not an AI-powered diagnostic algorithm. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this submission.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This device is a transducer, a hardware component of an imaging system, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For functionality and efficacy: The ground truth is implied to be the established performance characteristics and clinical utility of the predicate device (21275A). The new device asserts "equivalent functionality" and "no significant differences in safety and efficacy." Supporting data would typically involve technical performance metrics (e.g., image resolution, penetration, Doppler accuracy) compared against specifications and potentially the predicate device.
For safety (new patient contact materials): The ground truth would be established through biocompatibility testing (e.g., cytotoxicity, sensitization, irritation tests as per ISO 10993 standards) against established safety limits for medical devices.

7. The sample size for the training set:

Not applicable. This device is a hardware component. There is no "training set" in the context of machine learning.

8. How the ground truth for the training set was established:

Not applicable. There is no "training set" for this type of device submission.

Summary

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K971116

JAN 1 2 1998

Attachment C Intraoperative Imaging Transducer

510(k) Summary of Safety and Effectiveness: 21 CFR 807.92

1. Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date Summary was prepared: March 3,1997
1. Trade Name of Platform: Sonos 5500 Imaging System (upgrade to Sonos 2500 system) Model Number of Transducer: 21380A Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ <

Identification of Predicate Device:

The predicate device for this submittal is the existing Intra-Operative transducer (21275A) which was reviewed by FDA on the 77030A system that was submitted as part of K944048.

Description of the device or modification being submitted for premarket approval.

Functionality: The new transducer has equivalent functionality to the existing transducer now being used.

Scientific Concepts: same as existing intra-operative transducer

Significant Characteristics of the Modification: The new intra-operative transducer has new patient contact materials. It is this change that creates the need to file a 510(k) with the FDA.

Statement of Intended Use: No change from existing intra-operative transducers reviewed during 510(k) K944048.
Predicate Device Comparison: There are no significant differences in safety and efficacy between the 21275A and 21380A transducers. A detailed comparision of the transducers can be found in the 510(k) report.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 2 1998

Paul Schrader Regulatory Affairs Hewlett Packard Company Medical Products Group 3000 Minuteman Road Andover, MA 01810

K971116 Re: Intra-Operative Imaging Transducer 21380A Dated: October 7, 1997 Received: October 14, 1997 Requlatory Class: II 21 CFR 892.1570/Procode 90 ITX

Dear Mr. Schrader:

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 aqainst misbranding and adulteration.

This determination of substantial equivalence applies to the 21380A transducer intended for use with the SONOS 5500 System.

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 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 Failure to comply with the GMP regulation may result in assumptions. 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.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR, Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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Page 2 - Paul Schrader

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 Paul M. Gammell, Ph.D. at (301) 594-1212.

Sincerely yours,

David h. Syson

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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Ultrasound Device Indications Statement

Fill out one form for each ultrasound system or transducer

Pg_1_of Pg_1_

510(k) # (if known) : K971116 Device Name: Phased Array Transducer (21380A)

Indications for Use : Diagnostic Ultrasound Imaging of the human body in the applications detailed below.

	Mode of Operation
Clinical Applications	A	B	M	PWD	CWD	ColorDoppler	Power(Amplitude)Doppler	ColorVelocityImaging	Combined(Specify)	Other(Specify)
Opthalmic	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Fetal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Abdominal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Intra-Operative:Cardiovascular	N/A	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	N/A
Intra-OperativeNeurological	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Pediatric	N/A	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	N/A
Small Organ (Specify)	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Neonatal Cephalic	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Adult Cephalic	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Cardiac Adult	N/A	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	N/A
Cardiac Pediatric	N/A	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	N/A
Trans-esophageal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Trans-rectal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Trans-vaginal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Intra-Luminal	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Trans-urethral	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A
Peripheral Vessel	N/A	Yes	Yes	Yes	Yes	Yes	Yes	Yes	Yes	N/A
Laproscopic	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A	N/A

Other Indications or Modes: Combined modes are : B+M, B+M+CVI, B+PW.

(Please Do Not Write Below This Line-Continue On Another Page If Needed) Concurrence of CDRH, Ofice of Device Evaluation (ODE)

Vind h. Sypm
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number.

Prescription Use (Per 21 CRR 801.109)

Regulation Number and Section

§ 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.