The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. 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. Automatic scanning obtains multiple, sequential two-dimensional images which can be compiled into a three-dimensional data set for viewing in three planes.

Device Description

The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory is intended to provide automated data acquisition of ultrasound breast imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers the reflected ultrasound signal which is displayed on a computer screen. The accessory includes a mechanical apparatus for breast image acquisition, a video monitor to display the images, and related software. The patient stands next to system and mammography-like plates compress the breast. Tissue is electronically and mechanically scanned using linear array transducer through thin layer of water and sono-lucent film.

AI/ML Overview

The provided documentation for K022517 (U-Systems Ultrasound System USI-2000 with automated scanning accessory) includes a 510(k) summary and FDA clearance letter. However, it does not contain detailed information regarding acceptance criteria and a study proving the device meets those criteria, as typically expected for robust clinical performance validation.

The available information indicates a "substantial equivalence" pathway for clearance, meaning the device's technical characteristics and intended use are comparable to legally marketed predicate devices. This pathway often relies on demonstrating that the new device performs similarly to existing ones without necessarily requiring extensive new clinical performance studies with predefined acceptance criteria.

Based on the provided text, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:

Not explicitly stated: The document does not define specific performance metrics or thresholds (e.g., sensitivity, specificity, accuracy) that the device must meet to be considered effective.

Reported Device Performance:

The document states: "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures." This is a very general statement and does not provide specific performance results.
The FDA clearance letter confirms that the device is "substantially equivalent" to predicate devices, implying its performance is considered acceptable based on this comparison.

Performance Metric	Acceptance Criteria	Reported Device Performance Statement
Clinical Performance	Not explicitly defined	"The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures." (No specific metrics or values provided.)
Substantial Equivalence	Device is equivalent to predicate devices with regard to intended use and technological characteristics.	The FDA determined the device is substantially equivalent to the LABSONICS Ultrasound Breast Scanner and the Sonopsy LA System.

2. Sample Size for the Test Set and Data Provenance

Sample Size (Test Set): Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method

Adjudication Method: Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: It is not mentioned that an MRMC comparative effectiveness study was done.
Effect size of human reader improvement: Not applicable, as no MRMC study is mentioned.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: It is not mentioned that a standalone (algorithm only) performance study was done. The device is described as an "accessory" to an existing ultrasound system, and the clearance largely hinges on its equivalence to existing technologies.

7. Type of Ground Truth Used for the Test Set

Type of Ground Truth: Not specified.

8. Sample Size for the Training Set

Sample Size (Training Set): Not specified. (It's unclear if a traditional "training set" in the context of machine learning was even used, given the age of the document and the nature of the device as an ultrasound system accessory relying on known B-mode technology.)

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment (Training Set): Not specified.

Summary of Missing Information:

The provided 510(k) summary and FDA letter for K022517 primarily focus on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics. It lacks detailed clinical performance data, specific acceptance criteria, information about test or training sets, expert involvement, or adjudication methods that would be common in submissions for novel diagnostic algorithms or devices requiring extensive de novo clinical validation. The statement "The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures" is the closest the document comes to describing performance validation, but it provides no specifics.

Summary

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K 022617

510(k) Summary U-Systems Ultrasound System U-Systems INC.

Prepared November 1, 2002

Product Name:	USI-2000 Ultrasound System with automated scanning accessory
Manufacturer:	U-Systems Inc.
Generic Name	Diagnostic Ultrasound System accessory
Classification Name:	Ultrasound Imaging System and Transducers (Class II); Classification codes:
	IYO 892.1560 System, Imaging Pulsed Echo, Ultrasonic
	IYN 892.1550 System, Imaging, Pulsed Doppler, Ultrasonic
	ITX 892.1570 Transducer, Ultrasonic, Diagnostic
Contact Person:	Sheila W. Pickering Ph.D.2081 Longden CircleLos Altos, California 94024Telephone/Fax 650 969 6114e-mail: swpraga@aol.com

A. Legally Marketed Predicate Device

The modification to the USI-2000 is substantially equivalent to the LABSONICS Ultrasound Breast Scanner manufactured by LABSONICS, Inc. and the Sonopsy LA System manufactured by NeoVision, Inc., which have been placed in commercial distribution. The intended use and the technological characteristics of the modification are the same as the predicate devices.

B. Device Description

C. Intended Use

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D. Substantial Equivalence

The USI-2000 is substantially equivalent to the LABSONICS Ultrasound Breast Scanner manufactured by LABSONICS, Inc. and the Sonopsy LA System manufactured by NeoVision, Inc. with regard to intended use and technological characteristics

E. Performance Data

The USI-2000 accessory's performance has been validated according to the company's quality assurance procedures.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three abstract human profiles facing to the right, arranged in a cascading manner.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

U-Systems, Inc. % Ms. Sheila Pickering, Ph.D. 2081 Longden Circle LOS ALTOS CA 94024

Re: K022517

Trade Name: USI-2000 Ultrasound System with Automated Scanning Accessory Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: November 1, 2002 Received: November 5, 2002

Dear Dr. Pickering:

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 USI-2000 Ultrasound System, as described in your premarket notification:

Transducer Model Number

7.5 MHz 10 MHz L9.5 (XW) MHz

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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 (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 (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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address *http://www.fda.gov/cdrh/dsmamain.html''.

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Page 3 – Dr. Pickering

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

Sincerely yours,

Rate Peller
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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1.1 Diagnostic Ultrasound Indications for Use

510(k) Number(s):	K022517
Device Name:	USI-2000
	Diagnostic Ultrasound Pulsed Echo SystemDiagnostic Ultrasound Pulsed Doppler Imaging System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis 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		P	P	P		P	P		Note !
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)		P	P	P		P	P		Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular		P	P	P		P	P		Note 1
Musculo-skeletal		P	P	P		P	P		Note 1
Conventional
Musculo-skeletalSuperficial

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy. The USI Horizon Automated Scanning accessory is intended for breast examinations.

N = new indication 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)

Rach Paley
(Division Sign Off)

Prescription Use √

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022517
003

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Diagnostic Ultrasound Indications for Use

510(k) Number:	K022517
Device Name:	7.5 MHz Transducer
	Diagnostic Ultrasound Transduc

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis 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	P	P	P			P	P	Note 1
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)	P	P	P			P	P	Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular	P	P	P			P	P	Note 1
Musculo-skeletalConventional	P	P	P			P	P	Note 1
Musculo-skeletalSuperficial

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy. The USI Horizon Automated Scanning accessory is intended for breast examinations.

N = new indication 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)

Roch Phelps
__, and I am sorry for the inconvenience.

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022-

Prescription Use

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Diagnostic Ultrasound Indications for Use

510(k) Number:	K022517
Device Name:	10 MHz Transducer

Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)*	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		Note 1
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)		P	P	P		P	P		Note 1
Neonatal Cephalic
Adult Cephalic
Cardiac
Tranesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laproscopic
Peripheral Vascular		P	P	P		P	P		Note 1
Musculo-skeletalConventional		P	P	P		P	P		Note 1
Musculo-skeletalSuperficial

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Color Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy. The USI Horizon Automated Scanning accessory is intended for breast examinations.

N = new indication P = previously cleared by FDA

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

Prescription Use

✓

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K022517 010
510(k) Number

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Diagnostic Ultrasound Indications for

K022517 510(k) Number:

Device Name:

L 9.5 (XW) MHz Transducer Diagnostic Ultrasound Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	Color	Amplitude	Color	Combined	Other
						Doppler	Doppler	VelocityImaging	(specify)*	(specify)
Ophthalmic
Fetal
Abdominal		P
Intraoperative (specify)
IntraoperativeNeurological
Pediatric
Small Organ (breast,thyroid, testes)		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Laparoscopic
Peripheral Vascular
Musculo-skeletal
Conventional
Musculo-skeletalSuperficial

Note 1: Combined includes: B/M; B/PWD; B/Color Doppler; B/Amplitude Doppler; B/Color Doppler/PWD and B/Amplitude Doppler/PWD

The USI Needle Guide accessory is intended for small parts use for breast biopsy. The USI Horizon Automated Scanning accessory is intended for breast examinations.

N = new indication

P = previously cleared by FDA

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

Prescription Use

Re
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K022517
011

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FDA Submission Cover Sheet

510(k) Number (if known): K022517

Device Name: Modification: U-Systems USI-2000 Diagnostic Ultrasound System

Indications For Use:

The USI-2000 Diagnostic Ultrasound System is being modified to include an accessory for use with the existing diagnostic ultrasound system. 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. Imaging is based on B-mode ultrasound technique using electronic focusing. High-gain electronics recovers reflected ultrasound signals displayed on a computer screen. Automatic scanning obtains multiple, sequential two-dimensional images, which can be compiled into a three-dimensional data set for viewing in three planes.

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

Concurrence Of CDRH, Office Of Device Evaluation (ODE)
Prescription Use (Per 21CFR 801)
	OR
	Over-The-Counter Use

	(Division Sign-Off)
	Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022517 012

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.