ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1

K081843 · Aloka Co., Ltd. · LLZ · Jul 15, 2008 · Radiology

Device Facts

• Record ID: K081843
• Device Name: ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
• Applicant: Aloka Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

Device Story

DAS-RS1 is a software-based medical image system; operates on a PC workstation. Inputs: DICOM images and data downloaded from a single Aloka ultrasound system within the same facility. Processing: system reviews, stores, and analyzes data for report generation. Output: displayed images and printed reports. Used in clinical settings by healthcare professionals. Benefits: facilitates efficient review, storage, and reporting of diagnostic ultrasound examinations.

Clinical Evidence

No clinical data required. Bench testing performed to confirm conformance to design specifications, software development standards, and system compatibility with Aloka ultrasound devices. Usability and reliability evaluated in a clinical setting.

Technological Characteristics

Software-based system running on a PC workstation. DICOM compliant for image/data communication. Connectivity: single PC to single Aloka ultrasound system. Software development follows risk management processes and internal/independent quality system verification.

Indications for Use

Indicated for use by clinicians to acquire, read, display, store, and review DICOM ultrasound images and data, and to generate reports from Aloka diagnostic ultrasound systems.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Philips Medical Systems QLAB Software (K021966)

Submission Summary (Full Text)

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Model DAS-RS1

510(K)

JUL 1 5 2008

### 510(k) Summary

# Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

#### Date Prepared: 05/27/2008

## Section a):

| 1. Submitter: | Aloka Co., Ltd., 10 Fairfield Boulevard, Wallingford, CT 06492 |
|---------------|----------------------------------------------------------------|
|---------------|----------------------------------------------------------------|

| Contact Person: | Richard J. Cehovsky, RA/QA Coordinator,<br>Tel: [phone] Ext. 346, Fax: [phone] |
|-----------------|-------------------------------------------------------------------------------------------|
|-----------------|-------------------------------------------------------------------------------------------|

## 2. Device Name:

- Trade Name- DAS-RS1 (Ultrasound Data Analysis System), ◆
- . Classification Name: Picture Archiving and Communication System.
- . Classification Panel: Radiology,
- . CFR Section: 21 CFR 892.2050,
- Device Class: II, �
- Product Code: LLZ ●

### 3. Intended Use:

The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

### 4. Device Description:

The Aloka DAS-RS1 system is a software based medical image system. This system receives, reviews and store patient exam images and data, prepare/print reports and communicates with Aloka Ultrasound systems. This system has a PC workstation that can be used to analyze the data for report generation. The software allows for the download of DICOM files to a single PC from a single Aloka Ultrasound system located within the same facility.

## 5. Substantial Equivalence:

The Aloka DAS-RS1 is functionally comparable and substantially equivalent to the Philips Medical Systems QLAB Software (K021966). The DAS-RS1 has similar technological characteristics, key safety and effectiveness features and essentially the same intended use as the predicate device.

## 6. General Safety and Effectiveness

### Section b):

- 1. Non-Clinical Tests:
The DAS-RSI has been evaluated for conformance to its design specifications and applicable industry standards for software development. Risk management is ensured via risk analysis which is used to identify potential hazards. The potential hazards are controlled via software development, verification and validation. It is further verified for system compatibility with the Aloka Ultrasound device that it communicates to. Computer hardware is certified to applicable safety standards.

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#### 510(k) Summary

# Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92

Date Prepared: 05/27/2008

#### 2. Clinical Tests:

None Required to confirm safety and effectiveness. However, evaluation in a clinical setting was performed to ensure usability, reliability, reliability and compatibility within the intended environment.

## 7. Summary Conclusion:

The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001:2000 and ISO 13485: 2003 quality systems. The device is DICOM compliant and conforms to applicable medical safety standards and compliance is verified through internal and independent quality system and test verification. Intended uses and other key features of the device are consistent with traditional clinical practice, FDA guidelines and established methods of handling patient examination images and data. PACS devices and medical information systems in general have demonstrated a history of effective performance. Therefore, it is the opinion of Aloka Co., Ltd. that the Aloka DAS-RS1 system is substantially equivalent with respect to safety and effectiveness to devices currently cleared market.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, featuring three diagonal lines that curve and converge at the bottom.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 5 2008

Aloka Co., Ltd. % Mr. Tamas Borsai Division Manager, Medical Division TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K081843

Trade/Device Name: Aloka DAS-RS1 (Ultrasound Data Analysis System) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 26, 2008 Received: June 30, 2008

## Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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.

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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 letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if known):

Device Name:

Indications For Use:

Aloka DAS-RS1 (Ultrasound Data Analysis System)

The Aloka DAS-RS1 is intended to acquire, read, display, store and review DICOM image and data, including the ability to analyze and print reports primarily for Aloka diagnostic ultrasound systems.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arqui M. Khan

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number _

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