FETAL ASSESSMENT CAP

K992580 · Acuson Corp. · IYO · Oct 18, 1999 · Radiology

Device Facts

• Record ID: K992580
• Device Name: FETAL ASSESSMENT CAP
• Applicant: Acuson Corp.
• Product Code: IYO · Radiology
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1560
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Fetal Assessment CAP@ 1.1 is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional image processing. Fetal Assessment CAP can import digital 2D or 3D image file formats for 3D display. The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses.

Device Story

Fetal Assessment CAP 1.1 is a software module for Windows NT 4.0 systems; imports digital 2D or 3D ultrasound B-mode images from TomTec acquisition stations or compatible ultrasound systems. Device performs 3D reconstruction and surface rendering of imported data; provides qualitative 3D visualization without measurement functionality. Used in clinical settings by healthcare professionals to assist in diagnostic imaging; output displayed as 3D structures to aid clinical assessment. Benefits include enhanced visualization of anatomical structures for diagnostic review.

Clinical Evidence

Bench testing only. Software validation performed at module and system levels according to internal protocols. Results confirmed device performance conforms to design intent and system specifications.

Technological Characteristics

Software-based 3D image processing module; runs on Microsoft Windows NT 4.0. Inputs: digital 2D/3D ultrasound B-mode image files. Processing: 3D reconstruction and surface rendering. Connectivity: imports data from ultrasound systems. No measurement functionality. Qualitative visualization only.

Indications for Use

Indicated for use with previously cleared B-mode ultrasound systems for 3D image processing in obstetrics, gynecology, small organ, abdominal, endocavity, neurological, and intraoperative clinical applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TomTec Echo-View (K934139)

Submission Summary (Full Text)

{0}------------------------------------------------

OCT 1 8 1999

Image /page/0/Picture/3 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent a company that specializes in imaging technology.

K 992580 81072

July 23, 1999

# 510(k) Summary Fetal Assessment CAP

# Name and Address

Acuson Corporation 1220 Charleston Road Mountain View, CA 94043

## Contact Person

William E. Welch Manager, Regulatory Affairs Phone [phone] FAX [phone]

## Common, Classification & Proprietary Names

| Common Name: | Digital Ultrasound Image Analysis System |
|----------------------|----------------------------------------------|
| Classification Name: | Ultrasonic Pulsed Echo Imaging System |
| Proprietary Name: | Fetal assessment CAP or 3D Surface Rendering |

## Predicate Device

TomTec Echo-View K934139

## Device Description

The Fetal Assessment CAP® 1.1 is a software module for high performance computer systems based on Microsoft Windows NT™ 4.0 operating system standards. Fetal Assessment CAP® 1.1 is proprietary software for the analysis, storage, retrieval and reconstruction of ultrasound B-mode images.

The data can be acquired by a TomTec acquisition station or B-mode (2D) acquisition capable Ultrasound systems. With the Fetal Assessment CAP a 3 dimensional display can be reconstructed.

{1}------------------------------------------------

Image /page/1/Picture/2 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.

#### Intended Use

Fetal Assessment CAP@ 1.1 is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional image processing.

Fetal Assessment CAP can import digital 2D or 3D image file formats for 3D display.

The software can be used with ultrasound systems previously cleared for Bmode imaging in obstetrics, gynecology, small organ, abdominal, endocavity, neuriological, and intraoperative uses. I

## Technological Characteristics Comparison

The Fetal assessment Cap is mainly a clinical application oriented set of the Echo-View system. The Acquisition methods are comparable to the EchoScan Acquisition methods. While the EchoView system provides diverse measurement functions, the Fetal Assessment CAP is a simple to use, qualitative 3D ultrasound tool, which provides 3D structures without any measurement functionality.

#### Test Discussion

Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.

#### Test Conclusions

Test results support the conclusion that actual device performance satisfics the design intent. Actual device performance as tested internally conforms to the system performance specifications.

July 23, 1999 William E. Welch

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 1999

William E. Welch Manager, Requlatory Affairs Acuson Corporation 1220 Charleston Road P.O. Box 7393 Mountain View, CA 94039-7393 Re: K992580

3D Surface Rendering and Fetal Assessment CAP (Clinical Application Package) Dated: July 27, 1999 Received: August 2, 1999 Requiatory Class: Il 21 CFR 892.1560/Procode: 90 IYO

Dear Mr. Welch:

We have reviewed your Section 510(k) 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.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any oblication you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# K 992580

# Diagnostic Ultrasound Indications for Use Form

#### Ultrasound System: See Comments Below

#### Transducer: See Comments Below

| Clinical<br>Applications | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Ampl.)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other<br>(Specify) | |
|---------------------------------------|---|---|---|-----|-----|-------------------------------------------------------------|-----------------------------|------------------------------|-----------------------|--------------------|--|
| Ophthalmic | | | | | | | | | | | |
| Fetal | | P | | | | | | | | | |
| Abdominal | | P | | | | | | | | | |
| Intra-operative<br>(Specify) | | P | | | | | | | | | |
| Intra-operative<br>Neurological | | P | | | | | | | | | |
| Pediatric | | P | | | | | | | | | |
| Small Organ<br>- Thyroid | | P | | | | | | | | | |
| - Breast<br>- Testicle | | P | | | | | | | | | |
| Neonatal<br>Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Trans-esophageal | | | | | | | | | | | |
| Trans-Rectal | | P | | | | | | | | | |
| Trans-Vaginal | | P | | | | | | | | | |
| Trans-Urethral | | | | | | | | | | | |
| Intra-Luminal | | | | | | | | | | | |
| Peripheral<br>Vascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
| Musculo-Skeletal<br>Conventional | | | | | | | | | | | |
| Musculo-Skeletal<br>Superficial | | | | | | | | | | | |
| Other (Specify)<br>N = New Indication | | | | | | P = Previously cleared by FDA<br>E = Added under Appendix E | | | | | |

Additional Comments:_3D_Surface_Rendering_software can be used with any previously cleared ultrasound system and transducers capable of B-mode imaging and cleared for the above indications for use.

PI FASE DO NOT WRITE REI OW THIS I INF CONTINITIE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use *Yes*

David A. Seymore
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Dey 510(k) Number