(77 days)
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
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.
The ImaCor Zura system with ClariTEE probe, a Transesophageal Echo Imaging System, received 510(k) clearance for software modification. The primary change was the addition of a color flow Doppler mode of operation.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device (ImaCor Zura K080223) | "The intended use of the ImaCor Zura with ClariTEE is identical to that of the ImaCor Zura (K080223)." |
| Indications for Use | For episodic assessment of cardiac function using TEE; indicated for clinical settings including ICU for indwelling time not exceeding 72 hours; not for pediatric 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." (Verbatim from K100989) |
| Technological Characteristics | Similar to predicate devices, with specified modifications related to the probe and software. | System consists of ultrasound machine (predicate optimized for ClariTEE), ClariTEE probe (miniaturized TEE probe for longer dwell time, flexed for images), and ultrasound imaging software (controls functions, 20-minute continuous imaging interlock, max probe face temp limited by IEC 60601-2-37). |
| Software Modes | Addition of color flow Doppler mode to support cardiac function assessment. | "Latest software version enables two modes of operation; type B and color flow Doppler." |
| Safety - Acoustic Energy | Limit potential unintentional exposure of patient's mucosal tissue to acoustic energy. | "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." |
| Safety - Probe Temperature | Maximum probe face temperature limited by FDA consensus standard IEC 60601-2-37. | "Maximum probe face temperature is limited according to FDA consensus standard IEC 60601-2-37." |
| Effectiveness (New Feature) | Color flow mode effectively demonstrates design modification for assessing cardiac function. | "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." |
| Overall Safety & Effectiveness | As safe and effective as predicate devices. | "The ImaCor Zura System with ClariTEE probe is as safe and effective as the predicate devices." (Claim of Substantial Equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "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."
- Test Set Sample Size: Not specified for the flow phantom. Flow phantom studies typically involve simulating various flow conditions but don't involve human subject sample sizes in the traditional sense.
- Data Provenance: The study was conducted on a "flow phantom," which is a controlled, laboratory-based setup designed to simulate fluid flow. This implies an in-vitro or ex-vivo experimental setting, not human subject data. The country of origin is not specified, but the submission is to the US FDA, so presumably the testing was done in a manner compliant with US regulatory expectations, likely in the US or a country with comparable standards. It is a prospective test specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance data was gathered from a "flow phantom" for the new color flow mode. This type of testing typically relies on engineering specifications and physical measurements (e.g., flow velocity, direction accuracy) rather than expert human interpretation to establish ground truth for the device's technical function.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the performance data cited is from a "flow phantom," which means the "ground truth" for evaluating the function of the color flow mode would be based on the known parameters of the phantom and direct measurements from the device, not on expert adjudication of medical images.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document only mentions performance data from a "flow phantom" and a claim of substantial equivalence to predicate devices based on this and other characteristics.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
Yes, a standalone performance assessment was done for the device's new feature (color flow mode) using a "flow phantom." This is an algorithm-only evaluation in the sense that the device's ability to accurately depict flow was tested independently of human interpretation of clinical images. The data pertains to the technical function of the device itself.
7. The Type of Ground Truth Used
For the specific performance data cited (color flow mode), the ground truth was known physical properties and measurements of the flow phantom. This is typically based on pre-established parameters of the phantom and/or reference measurements from other calibrated equipment, not on expert consensus, pathology, or outcomes data, as those relate more to clinical accuracy studies.
8. The Sample Size for the Training Set
Not applicable to this 510(k) submission. This submission is for modifications to an existing device (software change to add color flow Doppler), not the initial development of an AI algorithm that would require a distinct training set. The "performance data" refers to validation testing, not model training.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set or an AI algorithm being independently trained in this 510(k) summary. The submission focuses on modifications to an existing, cleared ultrasound system and probe.
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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)
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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:
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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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
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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.
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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)
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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
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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 | ColorDoppler | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| FetalImaging &Other | ||||||||
| Cardiac | Cardiac | |||||||
| Adult | ||||||||
| Cardiac | ||||||||
| Pediatric | ||||||||
| Intravascular(Cardiac) | ||||||||
| Trans-esoph(Cardiac) | P | N | ||||||
| Intracardiac | ||||||||
| Other | ||||||||
| PeripheralVessel |
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
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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 | ColorDoppler | Combined(Specify) | Other(Specify) |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| FetalImaging &Other | ||||||||
| Cardiac | CardiacAdultCardiacPediatricIntravascular(Cardiac)Trans-esoph(Cardiac)IntracardiacOther | P | N | |||||
| PeripheralVessel |
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
§ 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.