(191 days)
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.
The USI Needle Guide accessory is intended for small parts use for breast biopsy.
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
The provided FDA 510(k) summary for the U-Systems Ultrasound System USI-2000 with Needle Guide does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or information commonly found in AI/ML device studies.
The document states:
- "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures." This is a very generic statement and does not provide specific performance data, methodology, or results.
Therefore, I cannot extract the detailed information requested in your prompt based on the provided text. The document primarily focuses on demonstrating substantial equivalence to a predicate device and indicating new uses for the existing ultrasound system with the addition of a needle guide accessory.
The concepts of "acceptance criteria," "test set sample size," "ground truth experts," "adjudication methods," "MRMC studies," and "standalone performance" are typical for regulatory submissions of AI/ML-driven medical devices. This document predates the widespread regulatory consideration of such devices (JUN 0 5 2002).
To explicitly address your request, here's what the document shows (or, more accurately, doesn't show regarding performance studies):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures." (No specific performance metrics provided) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified.
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)
- Not specified. The concept of "ground truth" as it relates to expert consensus for a test set is not discussed in this submission regarding device performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not specified.
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 was mentioned. The device is an ultrasound system with a needle guide accessory, not an AI-driven interpretation tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- This is not an AI/ML algorithm; it's a physical accessory that displays graphics on an ultrasound screen. Thus, the concept of "standalone performance" for an algorithm isn't applicable or discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified in the context of a performance study for the needle guide.
8. The sample size for the training set
- Not applicable/not specified. This submission is for a physical ultrasound accessory, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable/not specified.
Summary of what is available:
- Device: U-Systems Ultrasound System USI-2000 with Needle Guide accessory.
- Purpose of Accessory: Displays graphics depicting the position and future path of a rigid interventional instrument (e.g., biopsy needle, aspiration needle) on a computer monitor screen alongside the ultrasound image.
- Intended Use: Clinical interventions and anatomical structures where ultrasound is currently used for visualizing such procedures, specifically for small parts use (breast biopsy).
- Predicate Device: UltraGuide 1000 System.
- Performance Claim: "The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures," but no specific data or metrics are provided in the public summary. The FDA granted clearance based on substantial equivalence and a required post-clearance special report on acoustic output measurements.
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JUN 0 5 2002
2.4 510(k) Summary
510(k) Summary
U-Systems Ultrasound System U-Systems INC.
Prepared November 21, 2001
| Product Name: | USI-2000 Ultrasound System with Needle Guide |
|---|---|
| Manufacturer: | U-Systems Inc. |
| Generic Name | Diagnostic Ultrasound System accessory |
| Classification Name: | Ultrasound Imaging System and Transducers (Class II); Classificationcodes:IYO 892.1560 System, Imaging Pulsed Echo, UltrasonicIYN 892.1550 System, Imaging, Pulsed Doppler, UltrasonicITX 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 UltraGuide 1000 System.
B. Device Description
Indications For Use:
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle, or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
C. Intended Use
The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.
D. Substantial Equivalence
The USI-2000 is substantially equivalent to the UltraGuide 1000 System, which is currently in commercial distribution.
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CONFIDENTIAL
U-Systems Inc.510(k) Notification
Device Modification
E. Performance Data
The USI-2000 Needle Guide performance has been validated according to the company's quality assurance procedures.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features an abstract image of three human profiles facing right, stacked on top of each other. The profiles are black and have a stylized, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD. 20850
JUN 0 5 2002
U-Systems, Inc. % Sheila W. Pickering, Ph.D. · 2081 Longden Circle LOS ALTOS CA 94024
Re: K013902
Trade Name: U-Systems USI-2000 Diagnostic Ultrasound System Addition of Needle Guide 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: May 1, 2002 Received: May 6, 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 U-Systems USI-2000 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
7.5 MHz Transducer 10 MHz Transducer
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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,
Nancy C. Brogdon
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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vstems Inc. 5100k) Notification
16013902
FDA Submission Cover Sheet
510(k) Number (if known): K003479 Ko 13902
Device Name: Modified U-Systems USI-2000 Diagnostic Ultrasound System
Indications For Use:
The modified USI-2000 includes an accessory for use with the existing diagnostic ultrasound system. The accessory displays graphics depicting the position and future path of a rigid interventional instrument, such as a biopsy needle or an aspiration needle, on a computer monitor screen that also shows the ultrasound image of the target organs.
The accessory is intended to be used in clinical interventions and for anatomical structures where ultrasound is currently used for visualizing such procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence Of CDRH, Office Of Device Evaluation (ODE) | ||||
|---|---|---|---|---|
| Prescription Use | OR | Over-The-Counter Use | ||
| (Per 21CFR 801) |
| (Division Sign-Off) | Nancy C brogdon |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K013902 |
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Diagnostic Ultrasound Indications for Use
510(k) Number(s):
Device Name:
USI-2000 Diagnostic Ultrasound Pulsed Echo System Diagnostic Ultrasound Pulsed Doppler Imaging System
Intended Use:
| Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | A | B | M | PWD | CWD | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify)* | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | Note ! | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid,testes) | N | N | N | N | N | Note 1 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Tranesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laproscopic | ||||||||||
| Peripheral Vascular | N | N | N | N | N | Note 1 | ||||
| Musculo-skeletal | N | N | N | N | N | Note 1 | ||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial |
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.
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)
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductive, Abdominal, Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number __________________________________________________________________________________________________
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use
510(k) Number:
Device Name:
7.5 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify)* | Other(specify) |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | Note 1 | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid,testes) | N | N | N | N | N | Note 1 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Tranesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laproscopic | ||||||||||
| Peripheral Vascular | N | N | N | N | N | Note 1 | ||||
| Musculo-skeletalConventional | N | N | N | N | N | 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.
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)
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdomina and Radiological Devic 510(k) Number
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use
510(k) Number:
Device Name:
10 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 | ColorDoppler | AmplitudeDoppler | ColorVelocityImaging | Combined(specify)* | Other(specify)* |
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | N | N | N | N | N | Note 1 | ||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid,testes) | N | N | N | N | N | Note 1 | ||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Tranesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laproscopic | ||||||||||
| Peripheral Vascular | N | N | N | N | N | Note 1 | ||||
| Musculo-skeletal | N | N | N | N | N | Note 1 | ||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial |
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.
- 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)
ා ! O(k) Number
Nancy C Brogdon
Division Sign-Off)
usion of Reproductive, Abdominal,
Radiological Devices
§ 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.