(77 days)
Not Found
No
The document describes standard ultrasound imaging software and hardware without mentioning any AI or ML capabilities.
No.
The device is intended for "episodic assessment of cardiac function" and for obtaining images; it does not claim to treat any condition.
Yes
The device is intended for the "episodic assessment of cardiac function using transesophageal echocardiography," which is a diagnostic activity. The "Performance Studies" also mention that the color flow mode supports "the assessment of cardiac function," further indicating a diagnostic purpose.
No
The device description explicitly lists three main components, two of which are hardware: an Ultrasound Machine and an Ultrasound Probe (ClariTEE). While there is also Ultrasound Imaging Software, the device is a system that includes hardware components.
Based on the provided information, the ImaCor Zura system with ClariTEE probe 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 ImaCor Zura system uses transesophageal echocardiography (TEE) to assess cardiac function. This is a non-invasive imaging technique that uses ultrasound waves to create images of the heart from within the esophagus.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly images the heart using ultrasound.
Therefore, the ImaCor Zura system falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ImaCor Zura with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography (TEE).
The ImaCor Zura TEE System is indicated for use in clinical settings, including long term settings such as the ICU. for an indwelling time period not to exceed 72 hours.
The ImaCor Zura system with ClariTEE probe is not intended for pediatric use
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, DXK, ITX
Device Description
The ImaCor Zura system with ClariTEE probe consists of three main components:
-
Ultrasound Machine: A TEE predicate device optimized for use with ImaCor ClariTEE probe.
-
Ultrasound Probe (ClariTEE formerly known as the Blue Probe in K080223): A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images.
-
Ultrasound Imaging Software: The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37.
Latest software version enables two modes of operation; type B and color flow Doppler. The subsequent version cleared for marketing under K080223 enabled type B only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Transesophageal Echocardiography
Anatomical Site
Cardiac
Indicated Patient Age Range
Not intended for pediatric use
Intended User / Care Setting
Clinical settings, including long term settings such as the ICU.
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)
Performance data using a flow phantom demonstrates the effectiveness of the design modification; the addition of a color flow mode of operation to support the assessment of cardiac function. All other aspects of the intended use were verified pursuant to the original 510k for the ImaCor Zura (K080223).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
ImaCor Zura (K080223), Ultrasonix Medical SonixTouch with TEEIMA transducer (K083095), Ultrasonix Medical Modulo Ultrasound Scanner (K042326)
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the word "Imacor" in a bold, sans-serif font. The letters are black, and the word is slightly tilted to the right. The "o" in "Imacor" is stylized with a heart shape, and there is some decorative flourish around the heart. The image is simple and clear, with a focus on the word itself.
JUN 2 5 2010
K.ooSSS
Zura system 510 K for software modification
04/09/2010
TAB V - 510(K) SUMMARY PAGE 1
510(K) SUMMARY
ImaCor Zura system with ClariTEE probe
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
ImaCor Inc 50 Charles Lindbergh Blvd Suite 200 Uniondale, NY 11553 Phone: (516) 393-0970 Facsimile: (516) 393-0969 Contact Person: Richard C. Lanzillotto Date Prepared: January 13, 2010
Name of Device and Name/Address of Sponsor
ImaCor Zura system with ClariTEE probe
ImaCor Inc 50 Charles Lindbergh Blvd Suite 200 Uniondale, NY 11553
Common or Usual Name
Transesophageal Echo Imaging System
Classification Name
Ultrasonic Pulsed Doppler Imaging System (892.1550) Ultrasonic Pulsed Echo Imaging System (892.1560) with a Diagnostic Ultrasonic Transducer (892.1570) or Echocardiograph (870.2330)
1
Image /page/1/Picture/0 description: The image shows the word "Imacor" in a bold, sans-serif font. The letters are black, and the word is slightly angled upwards from left to right. The "o" in "Imacor" has a design element that looks like a leaf or a stylized heart shape. The image has a slightly distressed or textured appearance, as if it were printed on a rough surface.
Zura system 510 K for software modification
TAB V - 510(K) SUMMARY PAGE 2
Product Codes IYN, IYO, DXK, ITX,
Device Class II
Predicate Devices
ImaCor Zura (K080223) Ultrasonix Medical SonixTouch with TEEIMA transducer (K083095) Ultrasonix Medical Modulo Ultrasound Scanner (K042326)
Intended Use / Indications for Use
The intended use of the ImaCor Zura with ClariTEE is identical to that of the ImaCor Zura (K080223).
The ImaCor Zura with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography (TEE).
The ImaCor Zura TEE System is indicated for use in clinical settings, including long term settings such as the ICU. for an indwelling time period not to exceed 72 hours.
Technological Characteristics
The ImaCor Zura system with ClariTEE probe consists of three main components:
- Ultrasound Machine:
A TEE predicate device optimized for use with ImaCor ClariTEE probe.
-
Ultrasound Probe (ClariTEE formerly known as the Blue Probe in K080223): A miniaturized TEE probe optimized for longer dwell time relative to standard TEE probes enables use in longer term clinical settings such as the ICU. The probe distal tip is flexed upward transiently to obtain standard TEE images.
-
Ultrasound Imaging Software:
2
Zura system 510 K for software modification
TAB V - 510(K) SUMMARY PAGE 3
The software controls standard ultrasound machine functions such as imaging, recording and measuring. Continuous imaging is limited by a 20 minute software interlock should the operator mistakenly leave the machine in continuous imaging mode, thus limiting the potential unintentional exposure of the patient's mucosal tissue to acoustic energy. Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37.
Latest software version enables two modes of operation; type B and color flow Doppler. The subsequent version cleared for marketing under K080223 enabled type B only.
Performance Data
Performance data using a flow phantom demonstrates the effectiveness of the design modification; the addition of a color flow mode of operation to support the assessment of cardiac function. All other aspects of the intended use were verified pursuant to the original 510k for the ImaCor Zura (K080223).
Substantial Equivalence
The ImaCor Zura System with ClariTEE probe is as safe and effective as the predicate devices. The ImaCor Zura with ClariTEE probe has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the ImaCor Zura with ClariTEE probe and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ImaCor Zura is as safe and effective as the predicates. Thus, the ImaCor Zura with ClariTEE probe is substantially equivalent to the predicate devices.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Image /page/3/Picture/3 description: The image shows a date written in black ink. The date is "JUN 25 2010". The month is abbreviated to three letters, and the day is written as a single digit.
Mr. Richard Lanzillotto Director of Regulatory Affairs ImaCor, Inc. 50 Charles Lindbergh Blvd., Suite 200 UNIONDALE NY 11553
Re: K100989
Trade/Device Name: ImaCor Zura system with ClariTEE probe Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: June 15, 2010 Received: June 16, 2010
Dear Mr. Lanzillotto:
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 ImaCor Zura system with ClariTEE probe, as described in your premarket notification:
Transducer Model Number
ClariTEE probe
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.
4
Page 2 - Mr. Lanzillotto
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 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,
Robert St. Pierre (Jr.)
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)
5
Ima Cor
04/09/2010
Zura system 510 K for software modification
Indications for Use Statement
510(k) Number (if known):
Device Name: ImaCor Zura system with ClariTEE probe
Indications for Use:
The ImaCor Zura system with ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU. for an indwelling time period not to exceed 72 hours. The ImaCor Zura system with ClariTEE probe is not intended for pediatric use
Prescription Use__ V (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert A. Booker, Jr.
(Division Sign-Off)
Division of Radiological Devi Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K100989/
Page _________________________________________________________________________________________________________________________________________________________________________ of
6
RESPONSE TO FDA AI LETTER ITEM 1
TAB IV - INDICATIONS FOR USE STATEMENT
Indications for Use Statement
510(k) Number (if known):
Device Name: ImaCor Zura system Indications for Use:
510K.
The ImaCor Zura system is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ImaCor system is not intended for pediatric use
| General | Specific | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other
(Specify) |
|-----------------------------|----------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal
Imaging &
Other | | | | | | | | |
| Cardiac | Cardiac | | | | | | | |
| | Adult | | | | | | | |
| | Cardiac | | | | | | | |
| | Pediatric | | | | | | | |
| | Intravascular
(Cardiac) | | | | | | | |
| | Trans-esoph
(Cardiac) | P | | | | N | | |
| | Intracardiac | | | | | | | |
| | Other | | | | | | | |
| Peripheral
Vessel | | | | | | | | |
w indication: P this appendix Over-The-Counter Prescription Use _ V AND/OR Use (Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
Robert Becker
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K100904
7
Indications for Use Statement
510(k) Number (if known): ___K100989
Device Name: ImaCor ClariTEE probe Indications for Use:
The ImaCor ClariTEE probe is intended for use in the episodic assessment of cardiac function using transesophageal echocardiography. It is indicated for use in clinical settings, including long term settings such as the ICU, for an indwelling time period not to exceed 72 hours. The ClariTEE probe is not intended for pediatric use.
| General | Specific | B | M | PWD | CWD | Color
Doppler | Combined
(Specify) | Other
(Specify) |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|-----------------------|--------------------|
| Ophthalmic | | | | | | | | |
| Fetal
Imaging &
Other | | | | | | | | |
| Cardiac | Cardiac
Adult
Cardiac
Pediatric
Intravascular
(Cardiac)
Trans-esoph
(Cardiac)
Intracardiac
Other | P | | | | N | | |
| Peripheral
Vessel | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under this appendix Over-The-Counter Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Use
(Part 21 C.F.R. 801 Subpart D) Subpart C)
(21 C.F.R. 807
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page _ of _
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K __K100989