(98 days)
Not Found
No
The summary describes a standard ultrasound system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance study sections.
No.
The device is described as a "diagnostic ultrasound system" intended for "ultrasound imaging" and collecting "echocardiographic views of the heart," which are diagnostic functions, not therapeutic ones.
Yes
The device is described as a "diagnostic ultrasound system" in the "Device Description" section, and its intended use is for "ultrasound imaging of the human heart" to assist qualified physicians.
No
The device description explicitly states it includes a "4-lead electrocardiograpic (ECG) module and patient connections," indicating the presence of hardware components beyond just software.
Based on the provided information, the Ultra DCI 5000 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "ultrasound imaging of the human heart." This is an in vivo (within the living body) diagnostic imaging procedure, not an in vitro (outside the living body) test performed on biological samples.
- Device Description: The description details a diagnostic ultrasound system that collects and displays images of the heart. This aligns with in vivo imaging.
- Anatomical Site: The device is used on the "human heart," which is an internal organ within the living body.
- Input Imaging Modality: Ultrasound is an in vivo imaging modality.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to diagnose diseases or other conditions. The Ultra DCI 5000 System operates directly on the patient's body to produce images.
N/A
Intended Use / Indications for Use
The Ultra DCI 5000 System is intended for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
Product codes
IYO, ITX
Device Description
The Ultra DCI Model 5000 is a general purpose, mobile, software-controlled, diagnostic ultrasound system designed to provide the user with the ability to collect standard 2D brightness mode (B-mode) echocardiographic views of the heart, visualize these views and store the collected data for later visualization. The device includes a 4-lead electrocardiograpic (ECG) module and patient connections to collect and display a single ECG trace (PQRST wave) along with the B-mode imagery.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human heart
Indicated Patient Age Range
Adult and pediatric
Intended User / Care Setting
Qualified physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
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.(b)
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.
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FDA /ODE/ CDRH February 5, 2010
MAY 2 1 2010
Page 3
510(k) Summary
Ultra DCI Model 5000
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:
Ultrasound Medical Devices dba Epsilon Imaging, Inc. 3917 Research Park Drive, Suite B7 Ann Arbor, Michigan 48108
Contact Person:
Paul Kortesoja Director of Operations Phone: (734) 369-5102 Fax: (734) 369-5120
Date Prepared:
February 3, 2010
Proprietary Name: Ultra DCI Model 5000
Common/ Usual Name:
Diagnostic Ultrasound System
Classification Name:
21 CFR §892.1560 Ultrasonic Pulsed Echo Imaging System (Product Code IYO) 21 CFR §892.1570 Diagnostic Ultrasound Transducer (Product Code ITX)
Predicate Devices:
K022567 cleared as the Sequoia Diagnostic Ultrasound System Signature II and K024236 cleared as the Ultrasound Scanner Type 2400.
Device Description:
The Ultra DC1 Model 5000 is a general purpose, mobile, software-controlled, diagnostic ultrasound system designed to provide the user with the ability to collect standard 2D brightness mode (B-mode) echocardiographic views of the heart, visualize these views and store the collected data for later visualization. The device includes a 4-lead electrocardiograpic (ECG) module and patient connections to collect and display a single ECG trace (PQRST wave) along with the B-mode imagery.
The Ultra DCI Model 5000 has been designed to meet the following product safety standards:
- NEMA UD-2 Measurement Standard (1998)
- IEC 60601-1:1988+A1:1991+A2:1995, Medical electrical equipment Part 1: General . requirements for safety.
1
FDA /ODE/ CDRH February 5, 2010
- IEC 60601-1-2:2001+A1:2004 Medical electrical equipment Part 1-2: General . requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- IEC 60601-2-37 (2004), (2005) Amendment 2, Medical Electrical Equipment- Part 2-. 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment.
Intended Uses:
The Ultra DCI 5000 System is intended for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
Technological Comparison to Predicate Devices:
The Ultra DCI Model 5000 is substantially equivalent to products that are already cleared for USA distribution, K022567 and K024236. The new and predicate devices transmit ultrasonic energy into patients, then perform post processing of received echoes to generate on-screen displays of anatomic structures within the body. All devices utilize B-mode imaging and all are indicated for cardiac use.
End of 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY 2 1 2010
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Paul Kortesoja Director of Operations Ultrasound Medical Devices, Inc. dba Epsilon Imaging, Inc. 3917 Research Park Drive, Suite B7 ANN ARBOR MI 48108
Re: K100363
Trade/Device Name: Ultra DCI Model 5000 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO Dated: April 9, 2010 Received: April 12, 2010
Dear Mr. Kortesoja:
We have reviewed your Section 510(k) premarket 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Ultra DCI Model 5000, as described in your premarket notification:
Transducer Model Number
U000004
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 895. 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
3
Page 2 - Mr. Kortesoja
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 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 market.
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.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely yours,
STA
Donald St. Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
4
Indications for Use
510(k) Number (if known): K100363
Device Name: ____Ultra DCI Model 5000
Indications for Use:
The Ultra DCI Model 5000 is indicated for use by, or on the order of, a qualified physician for ultrasound imaging of the human heart. The cardiac (adult and pediatric) application using Bmode imaging is supported.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
S.L.R
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K100363
Page 1 of
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RE: K100363 ATTACHMENT 2 – Indication for Use Table – System
System: Ultra DCI Model 5000
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical Application | Mode of Operation | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| General | |||||||||
| (Track 1 Only) | Specific | ||||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | ||||
| Doppler | Combined | ||||||||
| (Specify) | Other* (Specify) | ||||||||
| Ophthalmic | Ophthalmic | ||||||||
| Fetal Imaging & | |||||||||
| Other | Fetal | ||||||||
| Abdominal | |||||||||
| Intra-operative (Specify) | |||||||||
| Intra-operative (Neuro) | |||||||||
| Laparoscopic | |||||||||
| Pediatric | |||||||||
| Small Organ (Specify) | |||||||||
| Neonatal Cephalic | |||||||||
| Adult Cephalic | |||||||||
| Trans-rectal | |||||||||
| Trans-vaginal | |||||||||
| Trans-urethral | |||||||||
| Trans-esoph. (non-Card.) | |||||||||
| Musculo-skeletal | |||||||||
| (Conventional) | |||||||||
| Musculo-skeletal (Superficial) | |||||||||
| Intravascular | |||||||||
| Other (Specify) | |||||||||
| Cardiac | Cardiac Adult | N | N (B-mode | ||||||
| Harmonic) | |||||||||
| Cardiac Pediatric | N | N (B-mode | |||||||
| Harmonic) | |||||||||
| Intravascular (Cardiac) | |||||||||
| Trans-esoph. (Cardiac) | |||||||||
| Intra-cardiac | |||||||||
| Other (Specify) | |||||||||
| Peripheral | |||||||||
| Vessel | Peripheral vessel | ||||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Dopplex, 3-D
Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Jmaging,
WHA
(Division Sian-Of ion of Radiological Office of Ir iannostic Novice Evali
510K. K106363
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Image /page/6/Picture/0 description: The image shows the logo for Epsilon Imaging. The logo consists of a square graphic on the left, followed by the words "EPSILON" in a larger font size and "IMAGING" in a smaller font size. The square graphic contains a pattern of diagonal lines and textured areas. The text is in a simple, sans-serif font.
RE: K100363 ATTACHMENT 3 – Indication for Use Table – Transducer
Transducer: U000004
Intended Use: Diagnostic ultrasound imaging of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* (Specify) | |||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal Imaging & | ||||||||
| Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | N | N (B-mode | |||||
| Harmonic) | ||||||||
| Cardiac Pediatric | N | N (B-mode | ||||||
| Harmonic) | ||||||||
| Intravascular (Cardiac) | ||||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix * Examples of other modes of operation may include: A-mode, Amplitude Dopplex, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safer
510K