The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Device Description

The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific output levels (track 1). Its function is to acquire ultrasound data in acoustical holography mode and display it on an LCD monitor.

AI/ML Overview

The provided text is a 510(k) summary for the Altair Model DEI System, an acoustical holography imaging system. It describes the device, its intended use, and its technological comparison to a predicate device. However, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as typically found in performance testing sections of a 510(k) submission.

The document primarily focuses on regulatory compliance (safety standards, substantial equivalence to a predicate device) and a general description of the device's technology and intended uses.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving their fulfillment based on the provided text. The requested information (points 1-9) is not present in this document.

Summary

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Advanced Diagnostics Inc.

NOV 1 4 2001

510(K) SUMMARY

K013291

This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary.

Submitted By: 1.

Advanced Diagnostics Incorporated 8112 304" Avenue SE Preston, WA 98050 Contact Person: Steve Hesler Director of Regulatory Affairs phone: 425 222 7169 fax: 425 222 7171 Date Prepared: 9/28/01

1. Proprietary Name:
  Altair Model DEI System (Diffractive Energy Imaging) Common/ Usual Name: Acoustical Holography Imaging System Classification Name: 90 NCS - KO01510

Predicate Device: 3.

The DEI System is system is system to the OS-2000 Optical Sonography system cleared via K100150, November 30, 2000 with the addition of on-screen measurement capability with associated calculations.

Device Description: 4.

The DEI System has been designed to meet the following product safety standards:

UL 2601 Standard for Medical Electrical Equipment Part 1: General . Requirements for Safety
. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers", September 30, 1997.
. "510(k) Guide for Measuring and Reporting Acoustic Output of Diagnostic Ultrasound Medical Devices", CDRH, 1985.

Intended Uses: 5.

The DEI System ultrasound imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

6. Technological Comparison to Predicate Device:

DEI System is similar to the predicate device in that both use an object transducer that is coupled to the patient by use of a water-path (immersion in water bath or use of water bladders) to transmit pulsed ultrasound through the targeted tissues. These transmitted pulses are then acoustically focused. The focused ultrasound beam is then combined

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with a second plane wave (reference wave) of the same frequency as the transmit wave. with a second plane wave (reference wave creates an interference The interaction of the ualismit wave and the releited system, forming an acoustic hologram of the object. The detector is illuminated with a colores (laser)
hologram of the object. The detector is illuminated with a following comments noogram of the object. The delector is manning is recorded with a COD video camera and resulting in a visual inlage. The viadal intage is roos. So while a may be stored to hard disk.

End of 510(k) Summary

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

OCT 13 2012

Mr. Steve C. Hesler Director of Quality and Regulatory Affairs Advanced Diagnostics, Inc. 8112 304th Ave. SE, Suite B PRESTON WA 98050

Re: K013291

Trade/Device Name: Altair Model DEI System, Diffractive Energy Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: NCS Dated: September 28, 2001 Received: October 2, 2001

Dear Mr. Hesler:

This letter corrects our substantially equivalent letter of November 14, 2001.

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 (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 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 the Act's requirements, including, but not limited to: registration and listing (21 CFR Part

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807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR-Part-801); please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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NOV 1 4 2001

Attachment 3

KDI3291

Ultrasound Device Indications Statement

K013291

4604540 510 (k) Number (if

known) : Device Name :

DEI System Optical Sonography System DEI System Optical Optical Gonging of human soft tissues

Intended Use: Mode of Operation

ClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combine(Specify)	AcousticHolography
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
Neurosurgical
Pediatric										P**
Small Organ(Specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular										P
Peripheral vessel
Laparoscopic										P
Musculo-skeletalConventional
Musculo-skeletalSuperficial										P
Other (specify)

E = added under Appendix E P = previously cleared by FDA; N = new indication; N = new indication;

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Nancy C. Brown
(Division Sign-Om
D. of Reproductiva, Allam
a ological Devices K013291
510(k) ivumber

measurment510k92701.doc

Page 1 of 1

Regulation Number and Section

N/A