(15 days)
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.
U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.
U-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.
The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.
The provided text for K032640 does not contain sufficiently detailed information regarding quantitative acceptance criteria and a study that proves the device meets those criteria. The submission states: "The FFBU System performance has been verified according to the FFBU System Test Plan. The FFBU Test Plan and the summary of test results to date are included in this submission." However, the actual test plan, acceptance criteria, and specific results are not included in the provided snippets. The document focuses on regulatory approval based on substantial equivalence.
Therefore, I cannot populate the table or answer most of the questions as the specific performance data, study design, and ground truth establishment methods are not present in the provided text.
Based on the limited information, here's what can be inferred:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Quantitative) | Reported Device Performance |
|---|---|
| Not specified in provided text. | Not specified in provided text. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified.
4. Adjudication method
- Not specified (e.g., 2+1, 3+1, none).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not specified. The document focuses on substantial equivalence to a predicate device, USI-2000 Horizon, rather than a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not specified. This device is an ultrasound system and transducer, not an AI algorithm.
7. The type of ground truth used
- Not specified.
8. The sample size for the training set
- Not applicable/Not specified. This is a hardware/software modification of an ultrasound system, not an AI model that undergoes a training phase for image analysis.
9. How the ground truth for the training set was established
- Not applicable/Not specified. As it's not an AI model, there isn't a training set with established ground truth in the context of machine learning.
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SEP 1 1 2003
CONFIDENTIAL U-Systems Inc.510(k) Notification Device Modification
2.3 510(k) Summary
510(k) Summary for Traditional 510(k) U-Systems Ultrasound System U-Systems Inc.
Prepared August 15, 2003
| Product Name: | FFBU Diagnostic Ultrasound System | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Manufacturer: | U-Systems Inc.110 Rose Orchard WaySan Jose, CA 95134Telephone (408) 750-1323Fax (408) 571-8979 | ||||||||
| Generic 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: | 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 FFBU System modification is substantially equivalent to the original USI-2000 Horizon device cleared in 510(k) (K022517). The intended use and the technological characteristics of the modification are the same as the predicate device.
B. Device Description
The FFBU Diagnostic Ultrasound system represents hardware and software changes to the predicate device and changes it to a Track 3 system.
C. Intended 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.
D. Substantial Equivalence
The FFBU System is substantially equivalent to the USI-2000 Horizon System. with regard to intended use and technological characteristics.
E. Performance Data
The FFBU System performance has been verified according to the FFBU System Test Plan. The FFBU Test Plan and the summary of test results to date are included in this submission.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
SEP 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
U-Systems, Inc. % Mr. Heinz-Joerg Steneberg Responsible Third Party Official TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470
Re: K032640
Trade Name: U-Systems FFBU Diagnostic Ultrasound 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 IYO and ITX Dated: August 25, 2003 >> Received: August 27, 2003
Dear Mr. Steneberg:
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 FFBU Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
L9-5 XW 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
{2}------------------------------------------------
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 (OS) 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 – Mr. Steneberg
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
, i
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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CONFIDENTIAL. U-Systema Inc..510(k) Nulification Device Mndification
3.2. Diagnostic Ultrasvund Indications for Use Forms ( No New Indications for Use Previously Cleared Indications for Use) Diagnostic Ultrasound Indications for Use
510(k) Number(s):
Device Nume:
U-Systems FFBU Diagnostic Ultrasound 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 | |||||||||||
| 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 |
U-Systems FFBU Diagnostic Ultrasound System is intended for diagnostic breast examinations.
N = new indication
I' = previously cleared by I'I)A
(P) HASIL DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
016
Nancy C. Brogdon
(Division Sign-C Division of Reproductive, and Radiological Devices 510(k) Number
Prescription Use √
{5}------------------------------------------------
CONFIDENTIAL
U-Systems Inc.510(k) Notification Device Modification
Diagnostic Ultrasound Indications for Use
S10(k) Number:
Device Name:
L 9-S XW MHz Transduccr
| 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 | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid,testes) | N | |||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laparoscopic | ||||||||||
| Peripheral Vascular | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletalSuperficial |
1J-Systems L. 9-5 X W MI-12 Transducer is intended for diagnostic breast examinations.
- N = now indication P = previously cleared by FDA
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE (IN ANOTHER PAGE IF NEBIDBO) Concurrence of CDRH, Office of Device Evaluation (ODE)
017
Nancy C Brogdon
Prescription Use ✓
ାମ:
(Division Sign (Off) Division of Reproductive, Abdomi and Radiological Devices 510(k) Number _
§ 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.