(117 days)
No
The summary describes a device using bio-impedance for cardiac output measurement and mentions standard performance testing against a predicate device. There is no mention of AI, ML, or related concepts in the description, intended use, or performance studies.
No
The device is described as a monitoring device that displays cardiac output; it does not mention any therapeutic function.
Yes
The device is intended to "monitor and display a patient's Cardiac Output," and while monitoring can be for various purposes, measuring and displaying a physiological parameter to inform medical assessment qualifies it as diagnostic, even if it's not explicitly stating 'diagnosis' of a specific disease.
No
The device description explicitly states it is a "portable, non-invasive, Cardiac Output measurement system" that "measures the Cardiac Output by employing the electrical bio-impedance measurement technique." This indicates the use of hardware components (electrodes, impedance measurement circuitry) to acquire the bio-impedance data, which is then likely processed by software. The performance studies also mention "Mechanical and EMC testing," which are typically associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "monitor and display a patient's Cardiac Output in units of Ltr/min." This is a physiological measurement taken directly from the patient's body.
- Device Description: The device measures Cardiac Output using "electrical bio-impedance measurement technique" applied to the "thorax." This is a non-invasive method of measuring a physiological parameter.
- 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.
The Cheetah Reliant is a device that measures a physiological parameter in vivo (within the living body), not in vitro (in a test tube or other artificial environment).
N/A
Intended Use / Indications for Use
The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.
Product codes
DSB
Device Description
The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thorax
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Bench testing, consisting of Raw Data obtained in advance from 44 patients in the Intensive Care unit of Ambroise Pare Hospital in France, as well as testing in the Human (23 volunteers), against 155 generation Nicom.
Summary of Performance Studies
Bench testing protocols were carried out throughout the various stages of product development. Final testing included Module level testing, Integration level testing, and finally System level testing. Testing demonstrated the safety and effectiveness of the tested devices.
Validation and verification protocols also included a comparative study of the Reliant performance vs. that of 1st generation NICOM System:
Bench testing, consisting of Raw Data obtained in advance from 44 patients in the Intensive Care unit of Ambroise Pare Hospital in France, as well as testing in the Human (23 volunteers), against 155 generation Nicom. The Bland-Altman showed symmetrical distribution for CO measurement differences around the bias, and a confidence level of 95%.
Mechanical and EMC testing was conducted per IEC/EN60601-1, UL 60601-1, and CSA C22.2 No. 601.1
Key Metrics
95% confidence level for CO measurement differences around the bias using Bland-Altman analysis.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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K072662
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SECTION 5: 510(k) Summary
Submitter
Cheetah Medical Inc. 2138 East 62nd Street, Suite 132 indianapolis, IN 46250 USA office: 317-842-3566 cell: 317-603-1822 fax: 203-413-6721
Contact Person
Benny Arazy Arazy Group Mizpe Aviv. Industrial Park 13 M. P. Misgav 20187. ISRAEL Tel: +972 (4) 994-7880 Fax: +972 (4) 994-4224 e-mail: benny@aarazygroup.com
Image /page/0/Figure/16 description: The image shows a logo for Cheetah Medical, Inc. The logo features a stylized outline of a cheetah in motion. The text "CHEETAH MEDICAL, INC." is printed below the cheetah graphic in a simple, sans-serif font.
JAN 16 2008
Date Prepared
January 2008
Device Information
Trade name: Cheetah Reliant Common name: Portable, non-invasive Cardiac Output monitoring device Classification Name: DSB - (21 CFR 870.2770, "Impedance plethymograph")
Devices to which substantial equivalence is claimed:
| 510(k) number | Trade or propriety name | Manufacturer |
|---|---|---|
| K042144 | Cheetah NICOM System | Cheetah Medical, Inc. |
Device Description
The Cheetah Reliant is a portable, non-invasive, Cardiac Output measurement system. The Cheetah Reliant measures the Cardiac Output by employing the electrical bio-impedance measurement technique. Electrical bio-impedance is the characteristic impedance of a volume of tissue and fluid. In the case of Cardiac Output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood.
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K072662
pg 2 of 2
Intended Use
The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.
Device Modification
13 generation Cheetah NICOM System (K042144) was modified to produce a compact, stand alone version - Cheetah Reliant. Modification includes the following: Smaller overall dimensions, the use of an embedded processing unit instead of an external laptop PC, and the addition of an integral LCD display.
A series of bench testing protocols were carried out, throughout the various stages of product development. Final testing included Module level testing, Integration level testing, and finally System level testing. Testing demonstrated the safety and effectiveness of the tested devices.
Validation and verification protocols also included a comparative study of the Reliant performance vs. that of 1st generation NICOM System:
Bench testing, consisting of Raw Data obtained in advance from 44 patients in the Intensive Care unit of Ambroise Pare Hospital in France, as well as testing in the Human (23 volunteers), against 155 generation Nicom. The Bland-Altman showed symmetrical distribution for CO measurement differences around the bias, and a confidence level of 95%.
Mechanical and EMC testing was conducted per IEC/EN60601-1, UL 60601-1, and CSA C22.2 No. 601.1
Conclusion
The Cheetah Reliant, the subject of this submission, constitutes a safe, reliable and effective medical device, meeting all the declared requirements of its intended use. The device presents no adverse health effects or safety risks to patients when used as intended.
The Cheetah Reliant has the same intended use and fundamental scientific technology as the predicate device - 1st generation Cheetah NICOM System (K042144).
The device was extensively tested - both Bench and in the human - against its predicate, and was found to be substantially equivalent
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three overlapping, curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
JAN 16 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cheetah Medical, Inc. c/o Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M.P. Misgav 20187 ISRAEL
Re: K072662
Trade/Device Name: Cheetah Reliant Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II (two) Product Code: DSB Dated: December 5, 2007 Received: December 21, 2007
Dear Mr. Arazy:
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 application (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 such 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.
3
Page 2 - Mr. Benny Arazy
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 Section 510(k) 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 the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram Zuckerman, MD Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K072662
Device Name: Cheetah Reliant
Indications for Use:
The Cheetah Reliant is a portable, non-invasive Cardiac Output monitoring device based on bio-impedance Cardiography. The Cheetah Reliant system is intended to monitor and display a patient's Cardiac Output in units of Ltr/min.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
K Number K072667