(16 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.
The ABUS system, with automated ultrasound im-aging of the breast, gives the radiologist a cost effective solution for reviewing the ultrasound images with the corresponding mammogram. The FFBU Diagnostic Ultrasound System modification represents limited hardware and software changes to the Sponsor's predicate device.
The provided document is a 510(k) summary for the U-Systems ABUS Diagnostic Ultrasound System, dated September 14, 2005. This submission focuses on modifications to an already cleared predicate device (FFBU Diagnostic Ultrasound System, K032640), as well as comparing it to other legally marketed devices.
Crucially, this document only describes the device and its intended use, and affirms that its performance has been verified according to the U-Systems' Design Control process (compliant with 21 CFR Part 820.30). It does not contain specific acceptance criteria, performance data, or details of a clinical study proving the device meets acceptance criteria.
The sections on "Performance Data" ([0], E) and "Indications for Use" ([5], [6], [7], [8], [9]) indicate that the device's technical performance and clinical applications are deemed substantially equivalent or consistent with existing cleared devices for certain modes (e.g., B-mode, Harmonic Imaging, Spatial Compounding) and for specific transducers (L9-5XW, L10-5XW, L12-6XW). The "Notes" on the Indications for Use forms also point to new capabilities (Harmonic Imaging, Spatial Compounding) being added for the small organ (breast, thyroid, testes) application.
Therefore, I cannot provide the requested table or detailed study information because the provided text does not contain this information. The submission aims to demonstrate substantial equivalence based on technical specifications and intended use consistent with predicate devices, rather than a new standalone clinical efficacy study with specific acceptance criteria and performance metrics.
In summary, the provided text does not contain:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details of a study with ground truth establishment.
- Information on the number of experts or their qualifications for ground truth.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Results of a standalone performance study.
- Details on the type of ground truth used for performance evaluation.
- Sample size for the training set or how ground truth was established for it.
{0}------------------------------------------------
SEP 1 4 2005
2.2 510(k) Summary
510(k) Summary for Special 510(k) Notification U-Systems Diagnostic Ultrasound System
Prepared July 29, 2005
| Product Name: | Modified FFBU Diagnostic Ultrasound System[ABUS Diagnostic Ultrasound System] |
|---|---|
| --------------- | ----------------------------------------------------------------------------------- |
U-Systems Inc. Manufacturer: 110 Rose Orchard Way San Jose, CA 95134 Telephone (408) 750-1323 Fax (408) 571-8979
Diagnostic Ultrasound System Generic Name:
Classification Name: Ultrasound Imaging System and Transducers (Class II); Classification codes: System, Imaging Pulsed Echo, Ultrasonic 892.1560 IYO
Transducer, Ultrasonic, Diagnostic 892.1570 ITX
Contact Person: Robert F. Lawrence. 110 Rose Orchard Way San Jose, California 95134 Telephone 408 750 1323 e-mail: blawrnece@u-sys.com
A. Legally Marketed Predicate Device
The ABUS System modification is substantially equivalent to the sponsor's original FFBU device (K032640) as well as Siemens Antares DUS (K023720) and the ContextVision Sharp Image View (K024028). The intended use and the technological characteristics of the modification are the same as the predicate devices.
B. Device Description
The ABUS system, with automated ultrasound im-aging of the breast, gives the radiologist a cost effective solution for reviewing the ultrasound images with the corresponding mammogram.
The FFBU Diagnostic Ultrasound System modification represents limited hardware and software changes to the Sponsor's predicate device.
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 ABUS System modification is substantially equivalent to the original FFBU device (K032640) as well as Siemens Antares DUS (K023720) and the ContextVision Sharp Image View (K024028).
E. PERFORMANCE DATA
The ABUS System performance has been verified according to the U-Systems process for Design Control which is compliant with 21 CFR Part 820.30.
{1}------------------------------------------------
2.3 510(k) Diagnostic Ultrasound Indications for Use Form
The ultrasound intended use categories are identical to the "small parts" indication in The unfasound intended ase categories are in institution of System. The modified FFBU: cleared for the FFD Diagnosic Offessonnely and Spatial Compounding capability and is B-nilode as well as Tarmomo Imaging, and Speckle Reduction feature has been avallable with three micul array transal indication for use forms show the added to the software. The following and well as forms for the new modes and new transducers.
{2}------------------------------------------------
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of an eagle with three lines representing its wings.
SEP 1 4 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
U-Systems, Inc. % Mr. Tamas Borsai Responsible Third Party Official TUV Rheinland of North America 1279 Quarry Lane, Suite A PLEASANTON CA 94566
Re: K052355
Trade Name: Automated Breast Ultrasound System, (Model ABUS) 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: IYO and ITX Dated: August 25, 2005 Received: August 29, 2005
Dear Mr. Borsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becasion soxined 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 mendments, 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 the general connents pro risting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for I mis decermination of ourseans Ultrasound System, (Model ABUS), as described in your premarket notification:
Transducer Model Number
| L9-5XW |
|---|
| L10-5XW |
| L12-6XW |
{3}------------------------------------------------
Page 2 – Mr. Borsai
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 It may of subject to such additions, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Peachas concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase oc advised that I Dri 3 issualles over device complies with other requirements of the Act that I DA has made a actorinmations administered by other Federal agencies. You must of any I ecoral statutes and regulance ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cr K Fat 807), labeling (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This détermination of substantial equivalence is granted on the condition that prior to shipping i ins determination of Substance special report. This report. This report should contain complete information, including acoustic output measurements based on production line devices, requested Information, increating acousine occasio of the Centember 30, 1997 "Information for Manufacturers III Appendix O, (Cherosof of the Octive Victor vio Clicksound Systems and Transducers." If the special Secking Marketing Clearantee or Diagnosable values (e.g., acoustic output greater than approved report is incomprete or commis anacept 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 The special cope to 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 nontication. The I Drivinanis of baction 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 11 you desire specific acripliance at (240) 276-0120. Also, please note the regulation entitled, Contact the Office of Oremarket notification" (21CFR Part 807.97). You may obtain Misoranding of reference to prementonibilities under the Act from the Division of Small other general information on Jour response Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
{4}------------------------------------------------
Page 3 - Mr. Borsai
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Nancyc brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
. . . . . . . .
. .
:
.
. . . . . . . .
. . . .
・
:
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K052355
Device Name: Automated Breast Ultrasound System. Model ABUS
General Indication for Use
Ocheral Indication 101 o imaging system is 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.
Specific Indications For Use
.
Specific 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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Part 21 CFR 801 Subpart D) | ✓ | OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
|---|---|---|---|
| ------------------------------------------------- | ----------------------------------------- | ---- | ------------------------------------------------ |
| (Division Sign-Off) | Nancy C. Broador |
|---|---|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K052355 |
CONFIDENTIAL, U-Systems Inc.Special 510(k)
Page 13 of 319
{6}------------------------------------------------
Diagnostic Ultrasound Indications for Use Forms (No New Indications for Use; Previously Cleared Indications for Use)
Diagnostic Ultrasound Indications for Use
510(k) Number(s):
Automated Breast Ultrasound System, Model ABUS Device Name:
| Clinical Application | 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 | NNote 1&2 | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Tranesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laproscopic | ||||||||||
| Peripheral Vascular | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| Superficial |
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
Note 1: Harmonic Imaging Note 2: Spatial Compounding
The USI FFBU System is intended for breast examinations.
Nancy C Hogdon
Division Sign-Off
Division of Reproductive, Abdominal
N = new indication P = previously cleared by FDA (Division Sign-Off Division of Reproductive. Ab and Radiological Devic 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
CONFIDENTIAL, U-Systems Inc.Special 510(k)
Page 26 of 319
{7}------------------------------------------------
Diagnostic Ultrasound Indications for Use
510(k) Number:
L9-5XW MHz Transducer 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 | NNote 1 & 2 | ||||||||
| 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
The USI FFBU System 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)
Nancy C. Hogdon
(Division Sign-Off)
(Division Sign-Off) (
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K052355
Prescription Use
CONFIDENTIAL, U-Systems Inc.Special 510(k)
Page 27 of 319
{8}------------------------------------------------
Diagnostic Ultrasound Indications for Use
510(k) Number:
L10-5XW MHz Transducer 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) | N | NNote 1&2 | ||||||||
| 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
The USI FFBU System 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)
Nancy C Brogdon
Prescription Use
(Division Sign-Off Division of Reproductive, and Radiological Devices 510(k) Number
CONFIDENTIAL, U-Systems Inc.Special 510(k)
Page 28 of 319
{9}------------------------------------------------
Diagnostic Ultrasound Indications for Use
510(k) Number:
L12-6XW MHz Transducer Device Name: 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) | N | NNote 1&2 | ||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | ||||||||||
| Tranesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethral | ||||||||||
| Intravascular | ||||||||||
| Laproscopic | ||||||||||
| Peripheral Vascular | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletalSuperficial |
Note 1: Harmonic Imaging
Note 2: Spatial Compounding
The USI FFBU System 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)
Prescription Use
Nancy C. Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K152355
CONFIDENTIAL, U-Systems Inc.Special 510(k)
Page 29 of 319
§ 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.