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

Small organ imaging is intended for the breast.

Breast biopsy.

Device Description

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

The DEI System is similar to the predicate device (OS-2000, K001510) in that both use an oblect 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 ultrasound beam is then combined with a second plane wave (reference wave) of the same frequency as the transmit wave. The interaction of the transmit wave and the reference wave creates an interference pattern on a target detector device within the enclosed system, forming an acoustic hologram of the object. The detector is illuminated with a coherent light source (laser) resulting in a visual image. The visual image is recorded with a CCD video camera and the images are displayed on a video monitor. Images may be stored to hard disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both allow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of focus (depth plane).

AI/ML Overview

The provided text describes the Avera Model DEI System, an acoustical holography imaging system that includes a real-time image-guided biopsy capability. However, the text does not contain any information about acceptance criteria or a study proving the device meets specific performance metrics.

The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to predicate devices and outlining the intended uses and technical comparisons. It does not include details on the following:

A table of acceptance criteria and the reported device performance: This information is missing.
Sample size used for the test set and the data provenance: This information is missing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is missing.
Adjudication method for the test set: This information is missing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: The document describes an "Acoustical Holography Imaging System" and a "biopsy feature," but it does not mention any AI component or human-in-the-loop performance studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: As there's no mention of an algorithm or AI, standalone performance is not discussed.
The type of ground truth used: This information is missing.
The sample size for the training set: This information is missing.
How the ground truth for the training set was established: This information is missing.

In summary, the provided text explains the regulatory clearance of the device and its technical description but does not offer any details regarding specific performance studies, acceptance criteria, or the methodology used to establish ground truth or assess performance.

Summary

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MAY 1 0 2002

Advanced Diagnostics Inc.

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510(k) Submission Biopsy Feature Avera Model DEI System

510(K) SUMMARY

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 3040 Avenue SE Preston, WA 98050 Contact Person: Steve Hesler Director of Regulatory Affairs phone: 425 222 7169 fax: 425 222 7171 Date Prepared: November 19, 2001 Proprietary Name: 2. Avera Model DEI System (Diffractive Energy Imaging) Common/ Usual Name:
- Acoustical Holography Imaging System Classification Name: 90 NCS
Predicate Device: 3.

The DEI System is substantially equivalent to the OS-2000 Optical Sonography system cleared via K100150, November 30, 2000 with the addition of real-time image-guided biopsy capability. The biopsy feature in the DEI system is substantially equivalent to the Sonopsy LA System marketed by US Surgical Corp per K980424, cleared August 7, 1998.

Device Description: 4.
The DEI System is a general purpose, software-controlled, diagnostic ultrasound system that complies with pre-amendment application-specific acoustic output levels (track 1). Its function is to acquire ultrasound data in accustical holography mode and display it on an LCD monitor.

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
ISO 109993 Biological Evaluation of Medical Devices Part 1: Evaluation and ● Testing
"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 acoustical holography imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Technological Comparison to Predicate Device: 6.
The DEI System is similar to the predicate device (OS-2000, K001510) in that both use an oblect 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.

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Advanced Diagnostics Inc.

These transmitted pulses are then acoustically focused ultrasound beam is then combined with a second plane wave (reference wave) of the same frequency as the transmit wave. The interaction of the transmit wave and the reference wave creates an interference pattern on a target detector device within the enclosed system, forming an acoustic hologram of the object. The detector is illuminated with a coherent light source (laser) resulting in a visual image. The visual image is recorded with a CCD video camera and the images are displayed on a video monitor. Images may be stored to hard disk. This modification to the predicate involves the addition of biopsy capability. The Avera is substantially equivalent to a predicate device, the Sonopsy LA System (K 980423) in that both allow real time image-guided biopsy within image guidance in 1 plane and an assist device to locate the plane of focus (depth plane).

・・・

End of 510(k) Summary

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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 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 in flight, composed of three curved lines.

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

OCT 1 3 2012

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

Re: K013886

Trade/Device Name: Avera Model DEI System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: NCS Dated: February 27, 2002 Received: March 1. 2002

Dear Mr. Hesler:

This letter corrects our substantially equivalent letter of May 10, 2002.

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/ucm1 15809.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/ReportalProblem/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.

Amalfo

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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Attachment 1

Ultrasound Device Indications Statement

510 (k) Number (if known) : Device Name :

Avera Model DU System

K013886

Diagnostic ultrasound imaging of human soft tissues Intended Use:

ratio

Mode of OperationClinicalApplication	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)	AcousticHolography
Ophthalmic
Fetal
Abdominal
IntraoperativeAbdominal
Neurosurgical
Pediatric										P
Small Organ(Specify)										P1
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel										P
Laparoscopic
Musculo-skeletalConventional										P
Musculo-skeletalSuperficial										P
Other (specify)										N2

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

Other Indications or Modes:

lions of Mouse.
Small organ imaging is intended for the breast 1

Breast biopsy 2

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc brogdon

Division Sign-Off, Division of Reproductive, Abdomina and Radiological Devices 610(k) Number

Prescription Use (Per 21 CFR 801.109)

AIK013886final.doc

Regulation Number and Section

N/A