The AU5 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

Device Description

Ultrasound Imaging System

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the AUS Biosound Esaote ultrasound imaging system:

Based on the provided document, there is no specific acceptance criteria table or detailed study proving the device meets particular performance metrics beyond substantial equivalence to a predicate device.

The document is a "Safety and Effectiveness Summary" submitted for 510(k) clearance, which is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, the AU4 Esaote (K#944485). The FDA's letter explicitly states, "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... to legally marketed predicate devices."

Therefore, most of the requested information cannot be extracted directly from this document, as a 510(k) submission generally does not require the same level of detailed performance study as, for example, a PMA application or a clinical trial for a novel device.

However, I can extract information related to the device comparison and the regulatory context.

Analysis of Acceptance Criteria and Study Data

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as specific performance thresholds (e.g., sensitivity, specificity, accuracy percentages). The primary "acceptance criterion" for 510(k) clearance in this context is substantial equivalence to the predicate device (AU4 Esaote).

Reported Device Performance: Instead of performance metrics, the document provides a "Comparison Chart for Substantial Equivalence" outlining technical and functional characteristics. The "performance" is implicitly deemed equivalent if these characteristics are similar or improved without raising new safety/effectiveness concerns.

General Characteristics	Predicate Device (AU4, K#944485)	Proposed Device (AU5)	"Acceptance" (Implicit)
Transducer Type	Annular Array, Mechanical Sector, Linear, Convex, Phased Array	Annular Array, Mechanical Sector, Linear, Convex, Phased Array	Equivalent
2D Freq MHz	2.5/15	2.5/15	Equivalent
PW Freq MHz	2.25/10	2.25/10	Equivalent
CW Freq MHz	2.25/5.0	2.25/5.0	Equivalent
Imaging Modes	Real-time/2D, M Mode, PW Doppler, CW Doppler, CFM Doppler, Power Doppler	Real-time/2D, M Mode, PW Doppler, CW Doppler, CFM Doppler, Power Doppler	Equivalent
Probes MHz (Annular array)	2.5, 3.5, 7.5, 10, 13	2.5, 3.5, 7.5, 10, 13	Equivalent
... (many other items)	...	...	Equivalent or Improved (e.g., Monitor size, DSM)
Monitor size (inches)	12	14	Improved
DSM (Dicom storage module)	No	Yes	New Feature

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: Not applicable/not mentioned. This type of 510(k) submission generally relies on technical comparisons and, potentially, internal verification and validation testing rather than large-scale clinical test sets with patient data.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/not mentioned for clinical performance data.

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

Not applicable/not mentioned. No clinical test set requiring expert ground truth establishment is described in the provided summary.

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

Not applicable/not mentioned.

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

No MRMC study discussed. This device is an ultrasound imaging system, not an AI-powered diagnostic tool, and the document predates widespread AI in medical imaging.

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

Not applicable. This device is an imaging system, not an algorithm, and is intended for human-in-the-loop operation (a physician using it for diagnostic imaging).

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

Not applicable/not mentioned as no clinical ground truth for performance evaluation of a test set is described. The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate device.

8. The sample size for the training set

Not applicable. This is an imaging hardware system, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of what the document does provide:

Device Name: AUS Biosound Esaote AU5 Ultrasound Imaging System
Predicate Device: AU4 Esaote (K#944485)
Intended Use: "by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications."
Method of demonstrating "effectiveness": Primarily through comparison of technical specifications and features to a legally marketed predicate device, showing substantial equivalence. Improved features such as a larger monitor and a Dicom storage module (DSM) are highlighted.
Regulatory Conclusion: The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This clearance is contingent on a post-clearance special report regarding acoustic output measurements based on production line devices.

Summary

{0}------------------------------------------------

AUG 26 1998

K98 0468

Safety and Effectiveness Summary AUS Biosound Esaote

Safety and Effectiveness Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(k) summaries specified in 21CFR¶807.92(a).

807.92(a)(1)

Submitter Information

Colleen Hittle, Official Correspondent 8000 Castleway Drive Indianapolis, IN 46250 (317) 849-1916 Phone: (317) 577-9070 Facsimile:

Colleen Hittle Contact Person:

January 27, 1998 Date: June 1, 1998 Revised:

807.92(a)(2)

AUS Trade Name:

Ultrasound Imaging System Common Name:

System, Imaging, Pulsed Doppler, Ultrasonic Classification Name(s):

Classification Number: 90IYN; 90IYO

807.92(a)(3)

Predicate Device(s)

K94485 AU4 Esaote

Additional Substantial Equivalence Information is provided in the following substantial Equivalence Comparison Table.

{1}------------------------------------------------

Safety and Effectiveness Summary AUS Biosound Esaote

807.92(a)(5)

彩

Intended Use(s)

The AU5 ultrasound imaging system is intended to be used by a physician for diagnostic imaging in cardiac, abdominal, peripheral vessel and fetal applications.

...

{2}------------------------------------------------

Safety and Effectiveness Summary AUS Biosound Esaote

Comparison Chart for Substantial Equivalence

General Characteristics	Esaote	Esaote
	AU5	AU4 (K#944485)

Transducer Type	Annular Array	Annular Array
	Mechanical Sector	Mechanical Sector
	Linear	Linear
	Convex	Convex
	Phased Array	Phased Array
2D Freq MHz	2.5/15	2.5/15
PW Freq MHz	2.25/10	2.25/10
CW Freq MHz	2.25/5.0	2.25/5.0
Imaging Modes	Real-time/2D	Real-time/2D
	M Mode	M Mode
	PW Doppler	PW Doppler
	CW Doppler	CW Doppler
	CFM Doppler	CFM Doppler
	Power Doppler	Power Doppler
Probes MHz
Annular array	2.5, 3.5, 7.5, 10, 13	2.5, 3.5, 7.5, 10, 13
Mechanical Sector	13	13
Linear	3.5 - 7.5	3.5 - 7.5
Convex	3.5 - 5.0	3.5 - 5.0
Multifrequency probes	Yes	Yes
Special probes	IVT transvaginal	IVT transvaginal
	TRT transrectal	TRT transrectal
Biopsy attachments	Linear Array	Linear Array
	Convex	Convex
Monitor size (inches)	14	12
Programmabillity	6 presets	6 presets
Pulsed/CW Doppler	Yes	Yes
HIPRF	No	No
2D Updating	Yes	Yes
CW steerable	Yes	Yes
Audio stereo	Yes	Yes
Color doppler upgrade	Yes	Yes
ECG	Option	Option
Computer interface	centronics output	centronics output
DSM (Dicom storage module)	Yes	No
External size - width	540 mm	540 mm

{3}------------------------------------------------

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

AUG 26 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Colleen Hittle Official Correspondent Biosound Esaote 8000 Castleway Drive Indianapolis, IN 46350

K980468 Re: AU5 Ultrasound Imaging System Regulatory Class: II/21 CFR 892.1550 Product Code: 90 IYN Dated: July 27, 1998 Received: July 28, 1998

Dear Ms. Hittle:

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 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 AU5 Ultrasound Imaging System, as described in your premarket notification:

Transducer Model Number

CA11, CA13, CA711A, IOE13A, IVT12, LA12, LA13A, LA14, TRT12, LP13A, P10A, P12A, PT10A, PA11A, SMA50, SMA32

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. ਜੋ 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.

{4}------------------------------------------------

Page 2 - Colleen Hittle

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.

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. Tt 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 The FDA finding of substantial equivalence of your premarket notification. 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".

{5}------------------------------------------------

Page 3 - Colleen Hittle

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

Simind W. de yomm
Lillian Xin, Ph.D.

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

Enclosures

. .. .

Regulation Number and Section

§ 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.