(168 days)
Not Found
No
The document describes a traditional ultrasound system using acoustical holography and does not mention any AI or ML components in its description, intended use, or performance studies.
No.
The device is described as a "diagnostic ultrasound system" intended for "ultrasound imaging" and "biopsy capability," which indicates diagnostic rather than therapeutic use.
Yes
The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging of human soft tissues," and the "Device Description" calls it a "diagnostic ultrasound system."
No
The device description explicitly states it is a "general purpose, software-controlled, diagnostic ultrasound system" and details hardware components like a transducer, water-path coupling, detector device, coherent light source (laser), CCD video camera, and LCD monitor. While software is a key component, it is integrated with and controls significant hardware.
Based on the provided text, 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 the device is a "diagnostic ultrasound imaging system." It uses ultrasound waves transmitted through the body to create images of internal tissues. This is an in vivo (within the living body) diagnostic method, not an in vitro one.
- Intended Use: The intended uses listed (imaging of soft tissues, small parts, musculoskeletal, etc.) are all based on imaging the body directly, not analyzing samples taken from the body.
- Device Description: The description details the use of transducers, water-paths, and the creation of acoustic holograms from transmitted ultrasound pulses. This process is entirely focused on imaging the internal structure of the body.
Therefore, the DEI System is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DEI System acoustical holography imaging system is intended for the following uses: Small Parts, Pediatrics, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. Diagnostic ultrasound imaging of human soft tissues. Breast biopsy.
Product codes (comma separated list FDA assigned to the subject device)
NCS
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Acoustical Holography
Anatomical Site
Small Parts, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Breast, Human soft tissues
Indicated Patient Age Range
Pediatrics
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
MAY 1 0 2002
Advanced Diagnostics Inc.
ાં રેક્સ્થા
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.
1
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
2
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
3
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
4
Attachment 1
Ultrasound Device Indications Statement
510 (k) Number (if known) : Device Name :
Avera Model DU System
Diagnostic ultrasound imaging of human soft tissues Intended Use:
ratio
| Mode of Operation
Clinical
Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Acoustic
Holography |
|----------------------------------------------|---|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|------------------------|
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative
Abdominal | | | | | | | | | | |
| Neurosurgical | | | | | | | | | | |
| Pediatric | | | | | | | | | | P |
| Small Organ
(Specify) | | | | | | | | | | P1 |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | P |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | P |
| Musculo-skeletal
Superficial | | | | | | | | | | 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