An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of 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.

Specific Indications for Use:

The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient's breast when used with an automatic scanning linear array transducer or a handheld transducer. The device is not intended to be used as a replacement for screening mammography.

Device Description

The ABUS system with automated ultrasound imaging of the breast, gives the radiologist a cost-effective solution for reviewing the ultrasound images with the corresponding mammogram.

The modification to the sponsor's predicate device consists of the addition of the accessory of a conventional handheld ultrasound transducer, and modification to the software to control the new transducer.

AI/ML Overview

This 510(k) premarket notification for the Automated Breast Ultrasound System (ABUS) does not contain information about specific acceptance criteria or an analytical study comparing the device's performance against predefined metrics.

The document details a modification to an existing device, primarily the addition of a handheld ultrasound transducer and associated software changes. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing new performance data against acceptance criteria.

Here's a breakdown of why the requested information is largely absent, based on the provided text:

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

Absent. The document states: "The ABUS System will successfully complete integration testing, beta testing, and verification and validation prior to market release." This indicates future testing, not performance data from a completed study against specific acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Absent. No test set is described or referenced in terms of sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Absent. As no test set is described, no information on ground truth experts is provided.

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

Absent. No test set or adjudication method is described.

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

Absent. The device is an ultrasound imaging system, not an AI-powered diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

Absent. This device is a hardware and software system for image acquisition and display, not an algorithm in the sense of a standalone diagnostic AI. Performance is inherently "human-in-the-loop" as it requires a clinician to operate and interpret.

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

Absent. No ground truth is mentioned.

8. The sample size for the training set

Absent. This submission does not describe any machine learning or AI components that would require a "training set." It focuses on a hardware and software modification to an existing medical imaging system.

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

Absent. See point 8.

Explanation of the Submission Type:

This is a 510(k) submission, specifically for a modification to an existing device. For device modifications, the primary goal is often to demonstrate "substantial equivalence" to a predicate device, meaning it's as safe and effective as a device already on the market. This typically involves showing that the new features or changes do not raise new questions of safety or effectiveness and that the technological characteristics are comparable.

In this case, U-Systems Inc. is adding a conventional handheld ultrasound transducer and modifying the software to control the new transducer. This type of change often relies on existing performance data for the predicate device and the general understanding that conventional ultrasound transducers are well-established technology. Therefore, extensive new clinical performance studies or specific acceptance criteria for a new "device performance" (beyond ensuring the system functions as intended and meets technical specifications for ultrasound imaging) are not typically required for this type of modification. The "Performance data" section explicitly states these tests "will successfully complete" prior to market release, indicating these are internal verification and validation activities rather than formal clinical studies for regulatory clearance.

Summary

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K080930

AUG - 7 2008

510(k) Summary

Modified Automated Breast Ultrasound System (ABUS)

Prepared April 1, 2008

Product Name:	Automated Breast Ultrasound System (ABUS)
Manufacturer:	U-Systems Inc.110 Rose Orchard WaySan Jose, CA 95134Telephone (408) 750-0777Fax (408) 571-0771
Common Name:	Diagnostic Ultrasound System
Classification Name:	Ultrasound Imaging System and Transducers (Class II);
Classification Codes:	IYO, 892.1560, System, Imaging Pulsed Echo, UltrasonicITX, 892.1570, Transducer, Ultrasonic, Diagnostic
Contact Person:	Lisa Scott110 Rose Orchard WaySan Jose, California 95134Telephone 408-750-1373e-mail: lscott@u-systems.com

A. Legally Marketed Predicate Device

The Company believes that the modified ABUS is substantially equivalent to the previously cleared U-Systems - ABUS (K052355), as well as the Siemens - Antares DUS (K023720).

The intended use and the technological characteristics of the device are the same as the predicate devices.

B. Device Description

The ABUS system with automated ultrasound imaging of the breast, gives the radiologist a cost-effective solution for reviewing the ultrasound images with the corresponding mammogram.

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C. Intended Use

General Indication for Use

Specific Indications for Use

D. Substantial Equivalence

The ABUS System modification is substantially equivalent to the sponsor's original ABUS device (K052355) as well as the Sicmens Antares DUS (K023720. The intended usc and the technological characteristics of the device are the same as the predicate devices.

E. Performance data

The ABUS System will successfully complete integration testing, beta testing, and verification and validation prior to market release.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

AUG - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Scott Vice President, Regulatory Affairs and Quality Assurance U-Systems, Inc. 110 Rose Orchard Way SAN JOSE CA 95134

Re: K080930

Trade/Device Name: Automated Breast Ultrasound System (ABUS) Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO and ITX Dated: June 27, 2008 Received: June 30, 2008

Dear Ms. Scott:

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 Automated Breast Ultrasound System (ABUS), as described in your premarket notification:

Transducer Model Number

L9-5XW MHz L10-5XW MHz L12-6 MHz L15-6 MHz

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

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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 (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.

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

If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.

Sincerely yours,

Herbert Leinen

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number:

Device Name: Automated Breast Ultrasound System (ABUS)

General Indication for Use:

An ultrasound pulsed echo imaging system is intended to project a pulsed sound beam into body tissue to determine the depth of location of the tissue interfacts 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 accessritis.

Specific Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use ☑	OR	Over-The-Counter Use
(Part 21 CFR § 801 Subpart D)		(Part 21 CFR § 801 Subpart C)

Hula Remm

(Division Sign-Off) Division of Reproductive, Abdomin Ra "inlogical Devices 310(K) Number _

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510(k) Number(s): Device Name:

Automated Breast Ultrasound System (ABUS)

Intended Use: Diagnostic ultrasound imaging of the human body as follows:Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (breast, thyroid,testes)		P								P
Neonatal Cephalic										Note 1,2
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laparoscopic
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial

Note 1: Harmonic Imaging Note 2: Spatial Compounding

P = previously cleared by FDA

......

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
iological Devices
(k) Number	K080930

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510(k) Number:

L9-5XW MHz Transducer (automated scanner) Device Name: Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (breast, thyroid,testes)		P								PNote 1,
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial

Note 1: Harmonic Imaging Note 2: Spatial Compounding

P = previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Heidi Reiner

(Division Sign-Off) (Division Sign-On)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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510(k) Number:

Device Name:

L10-5XW MHz Transducer (automated scanner) Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric										P
Small Organ (breast, thyroid,testes)		P								P Note 1.
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular
Musculo-skeletalConventional
Musculo-skeletalSuperficial

Note 1: Harmonic Imaging Note 2: Spatial Compounding

P == previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONTI A KITE DEEON THREAD of Device Evaluation (ODE)

Hulu Reiner

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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510(k) Number:

Device Name:

L12-6 MHz Transducer (automated scanner) Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (breast, thyroid,testes)		P								PNote 1 &2
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial

Note 1: Harmonic Imaging Note 2: Spatial Compounding

P = previously cleared by FDA

(PLEASE DO NOT WRITE BELOW THIS LINE/CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jules Reimer

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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510(k) Number:

Device Name:

L15-6 MHz Transducer (handheld probe) Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (breast, thyroid,testes)		N
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial

N = new indication

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Lener

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 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.