(127 days)
Not Found
No
The document describes a standard ultrasound system with software modifications to support a new transducer. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or automated image analysis beyond basic signal processing. The focus is on image acquisition and display, not intelligent interpretation or analysis.
No.
The device is used for diagnostic imaging (ultrasound imaging of the breast) and is not intended to treat any condition.
Yes
The device is described as an "ultrasound pulsed echo imaging system" used for "B-mode ultrasonic imaging of a patient's breast," which helps determine the "depth of location of the tissue interfaces." This aligns with the definition of a diagnostic device, which is used to identify or determine the nature of a disease or condition. It is intended to provide images that radiologists can review, indicating a diagnostic purpose.
No
The device description explicitly states the addition of a conventional handheld ultrasound transducer and modifications to the software to control the new transducer. This indicates the device includes hardware components (the transducer) in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an ultrasound pulsed echo imaging system. It projects sound waves into the body and uses the echoes to create images of internal tissues. This is an in vivo (within the living body) imaging technique, not an in vitro test.
- Intended Use: The intended use is for imaging a patient's breast as an adjunct to mammography. This is a diagnostic imaging procedure, not an in vitro diagnostic test.
- Device Description: The description focuses on the hardware (transducers) and software for controlling the imaging process. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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 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.
Product codes
IYO, ITX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Breast
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ABUS System will successfully complete integration testing, beta testing, and verification and validation prior to market release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
§ 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.
0
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 Way | |
| San Jose, CA 95134 | |
| Telephone (408) 750-0777 | |
| Fax (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, Ultrasonic |
| ITX, 892.1570, Transducer, Ultrasonic, Diagnostic | |
| Contact Person: | Lisa Scott |
| 110 Rose Orchard Way | |
| San Jose, California 95134 | |
| Telephone 408-750-1373 | |
| e-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.
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.
1
C. Intended Use
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 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.
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.
2
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
3
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)
4
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:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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 _
5
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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 |
.
1
6
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 | Color | |||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify)* | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Pediatric | |||||||||||
| Small Organ (breast, thyroid, | |||||||||||
| testes) | P | P | |||||||||
| Note 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
7
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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-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)
CONTI A KITE DEEON THREAD of Device Evaluation (ODE)
Hulu Reiner
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
8
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 | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify)* | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | ||||||||||
| Abdominal | ||||||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative Neurological | ||||||||||
| Pediatric | ||||||||||
| Small Organ (breast, thyroid, | ||||||||||
| testes) | P | P | ||||||||
| Note 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
9
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 | Color | ||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | 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