(69 days)
Not Found
No
The description focuses on standard signal processing and analysis techniques (Heart Rate Variability Analysis, Autonomic Function assessment) using a microprocessor-based system. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
No
The device is described as a monitor biomedical acquisition system that collects data for analysis, not for treatment.
Yes
The device is described as performing "Heart Rate Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis," which indicates it is used to assess medical conditions and provide insights for diagnosis.
No
The device description explicitly states it is a "microprocessor based, monitor biomedical acquisition system" that collects analog signals and converts them to digital data via a USB connection. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro - "in glass"). This device directly measures physiological signals from the human body (in vivo - "in the living").
- The device description clearly states it collects ECG and Plethysmograph signals from the human body. These are direct physiological measurements, not analyses of samples like blood, urine, or tissue.
- The intended use and device description focus on noninvasive measurements of pulse waveforms and heart rate. This aligns with in vivo monitoring, not in vitro analysis.
Therefore, based on the provided text, the Critical Care Assessment device is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
Product codes (comma separated list FDA assigned to the subject device)
JOM
Device Description
Critical Care Assessment device is a microprocessor based, monitor biomedical acquisition system - it identifies, classifies, and collects ECG and Plethysmograph signals from the human body. The analog signals are converted to digital data and transferred to the personal computer via isolated USB connection. This isolation separates the human body from the main power system to ensure maximum patient safety. The patient data collected from the unit is used to perform Heart Rath Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical clinics, healthcare practices and in out-patient department of hospitals.
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)
Critical Care Assessment has met the requirements for QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98). Met the General Requirements for Safety and Collateral Standard Safety Requirements for Medical Electrical Systems (IEC 60601-1 (1998) with Am. 1 (1991), Am. 2 (1995). Also, complies with Electromagnetic Compatibility Test (UL 601-1 (2003).
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.
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
§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.
(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).
0
Critical Patient Care, Inc.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number:
1. Applicant Information:
Date Prepared:
December 15, 2009
Name: Address: Critical Patient Care, Inc. 4005 Blackhawk Street Edinburg, TX 78539
Phone: 1 888-874-7608
Contact Person: Phone Number: Fax Number:
Marie Cosgrove 210-810-9062 877 321 5676 mariecosgrove@criticalcareassessment.com
Device system Information: 2.
| Classification: | JOM/ClassII/870.2780 |
|---|---|
| Trade Name: | 'Critical Care Assessment' |
| Common Name: | Plethysmograph, photoelectric, pneumatic or hydraulic |
| Regulation Number: | 21 CFR 870.2780 |
3. Substantial Equivalence:
ANSHA -QHRV1
Reason for submission:
Reason for submission:
- 2.00 + 0.00
Reason for submission:
Re-labeling device under new trade name.
Performance:
The functions are substantially equivalent to the predicate.
Intended Use: 4.
Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoelectric plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
1
Critical Patient Care, Inc.
5. Description of the Device
Critical Care Assessment device is a microprocessor based, monitor biomedical acquisition system - it identifies, classifies, and collects ECG and Plethysmograph signals from the human body. The analog signals are converted to digital data and transferred to the personal computer via isolated USB connection. This isolation separates the human body from the main power system to ensure maximum patient safety. The patient data collected from the unit is used to perform Heart Rath Variability Analysis and obtain several detailed assessment of the Autonomic Function (Autonomic Nervous System Balance), Blood flow, Stress, Fitness and the overall health risk analysis.
6. Compatison to Predicate Device:
All materials used have gone through the same identical performance testing as the legally marketed predicate device 'ANSHA-QHRVI' marketed under 510k K083735. Both devices are identical in all areas of design, materials used, software, function and application to the predicate device and have undergone through the same performance testing. The only difference is the labeling of the device.
7. Comparison Summary of Non-Clinical Data Submitted:
Critical Care Assessment has met the requirements for QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98). Met the General Requirements for Safety and Collateral Standard Safety Requirements for Medical Electrical Systems (IEC 60601-1 (1998) with Am. 1 (1991), Am. 2 (1995). Also, complies with Electromagnetic Compatibility Test (UL 601-1 (2003). This performance testing is identical to the predicate device.
8. Argument for Substantial Equivalence to Predicate Devices
The intended use and the technological characteristics of Critical Care Assessment™ are the same as the predicate device and therefore we believe it is Substantially Equivalent to it.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized representation of a caduceus, a symbol often associated with medicine and healthcare, with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Critical Patient Care, Inc. c/o Ms. Paula Wilkerson Sr. Reviewer, Sr. Staff Engineer - Medical Devices Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, OH 44087
SEP 2 1 2010
Re: K101983
Trade/Device Name: Critical Care Assessment Regulatory Number: 21 CFR 870.2780 Regulation Name: Plethysmograph, Photoelectric, Pneumatic or Hydraulic Regulatory Class: II (two) Product Code: JOM Dated: September 3, 2010 Received: September 7, 2010
Dear Ms. Wilkerson:
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 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 – Ms. Paula Wilkerson
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); medical device reporting (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/ycm115809.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.
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Duma R. Vahner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
101983
Critical Patient Care, Inc.
Indications for Use
SEP 2 1 2010
510K Number (if known)
Device system Name:
'Critical Care Assessment'
Indications for Use: 'Critical Care Assessment' is intended for noninvasive measurements of pulse waveforms by photoclective plethysmography and heart rate electrocardiograph. The system is intended for use of patients in medical clinics, healthcare practices and in out-patient department of hospitals.
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Description of the Device
(Division Sign-Off)
Division of Cardiovascular Devices
Page 2 of 12
510(k) Number_k