(69 days)
'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.
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.
Here's an analysis of the provided text regarding the device's acceptance criteria and study information:
Device Acceptance Criteria and Study Information:
Based on the provided 510(k) summary, the device, "Critical Care Assessment," is claiming substantial equivalence to a predicate device, "ANSHA-QHRV1" (K083735). The document indicates that the acceptance criteria and performance are identical to the predicate device because the submission is primarily for "re-labeling device under new trade name."
Therefore, the "acceptance criteria" for the "Critical Care Assessment" device are the same as those met by the predicate device "ANSHA-QHRV1." The "study" proving this device meets its acceptance criteria is a comparison to the predicate device, asserting that it has undergone the "same identical performance testing."
1. Table of Acceptance Criteria and Reported Device Performance
Given that the submission states the current device "met the requirements" previously established for the predicate, the reported device performance for "Critical Care Assessment" is presumed to meet the same standards.
| Acceptance Criteria (Met by Predicate Device ANSHA-QHRV1) | Reported Device Performance ("Critical Care Assessment") |
|---|---|
| QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98) | Met: The document explicitly states, "Critical Care Assessment™ has met the requirements for QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98)." |
| General Requirements for Safety and Collateral Standard Safety Requirements for Medical Electrical Systems (IEC 60601-1 (1998) with Am. 1 (1991), Am. 2 (1995)) | Met: The document states, "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))." |
| Electromagnetic Compatibility Test (UL 601-1 (2003)) | Met: The document states, "Also, complies with Electromagnetic Compatibility Test (UL 601-1 (2003))." |
| Functions are substantially equivalent to the predicate. | Substantially Equivalent: The document repeatedly asserts: "The functions are substantially equivalent to the predicate." and "All materials used have gone through the same identical performance testing as the legally marketed predicate device 'ANSHA-QHRVI' ... 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." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The provided document does not disclose any specific sample size for a test set or data provenance (country of origin, retrospective/prospective study design) for the "Critical Care Assessment" device. It relies entirely on the prior testing conducted for the predicate device, stating, "This performance testing is identical to the predicate device."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided document does not disclose any information about the number or qualifications of experts used to establish ground truth for any test set. The submission focuses on the device's technical specifications and substantial equivalence to a predicate.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided document does not disclose any information about adjudication methods used for a test set. This type of detail is typically not included in a 510(k) summary focused on substantial equivalence.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done as described. The device "Critical Care Assessment" is presented as a diagnostic tool for noninvasive measurements of pulse waveforms and heart rate, not an AI-assisted diagnostic aid for human readers. Its primary function pertains to signal acquisition and analysis, not interpretation enhancement for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device, "Critical Care Assessment," is described as a "microprocessor based, monitor biomedical acquisition system" that "identifies, classifies, and collects ECG and Plethysmograph signals." It performs "Heart Rate Variability Analysis and obtain several detailed assessment of the Autonomic Function, Blood flow, Stress, Fitness and the overall health risk analysis." This indicates an algorithm-only (standalone) performance in terms of its signal processing and analysis capabilities. However, no specific "standalone study" with detailed metrics is provided in this summary, other than the general statement that it met the required standards (ANSI-AAMI EC57-98, IEC 60601-1, UL 601-1).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for the validation of the algorithms in the predicate device. However, given the nature of the tests mentioned (QRS Detection and Heart Rate Variability & Algorithm Verification (ANSI-AAMI EC57-98)), the ground truth would typically be established through reference physiological measurements or expert annotation of physiological signals. It's likely that established medical standards and validated methods for heart rate and plethysmography served as the "ground truth."
8. The sample size for the training set
The provided document does not disclose any information about the sample size for a training set. As this is a 510(k) submission for a device claiming substantial equivalence, the focus is on meeting established performance standards rather than detailing the machine learning model's training specifics.
9. How the ground truth for the training set was established
The provided document does not disclose how ground truth for any training set was established. Similar to point 8, this level of detail is not part of this 510(k) summary, which is based on demonstrating equivalence to a previously cleared device.
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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.
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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.
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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.
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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
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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
§ 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).