(112 days)
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No
The document describes a multi-parameter patient monitor and does not mention AI, ML, or related technologies.
No
The device is indicated for monitoring various physiological parameters, not for treating conditions.
Yes
Explanation: The device is described as a "monitor" for "monitoring of hemodynamic, respiratory, ventilatory, and relaxation status" of patients, which involves observing and assessing physiological parameters that aid in diagnosing medical conditions.
No
The device description is not available, but the intended use clearly describes a hardware monitor (Datex-Ohmeda Cardiocap 5) with accessories for monitoring various physiological parameters, which are inherently hardware-based measurements.
Based on the provided information, the Datex-Ohmeda Cardiocap 5 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Cardiocap 5 Function: The description clearly states the Cardiocap 5 is for "indoor monitoring of hemodynamic, respiratory, ventilatory and relaxation status of all hospital patients." This involves directly monitoring physiological parameters within the patient's body (in vivo) using sensors and other non-invasive or minimally invasive methods (like ECG, NIBP, SpO2, etc.).
The device is a patient monitor, not a device for testing samples in a lab setting.
N/A
Intended Use / Indications for Use
The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.
Product codes
74 MLD, 74 DPS, 73 BZQ, 74 DQA, 74 DXN, 80 FLL, 74 DSK, 73 KOI, 73 CCK, 73 CBR, 73 CCL, 73 CBQ, 73 CBS, 73 CCI, 73 BZG
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Impedance Respiration measurement is indicated for patients ages 3 and up.
Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up.
Intended User / Care Setting
The monitor is indicated for usc by qualified medical personnel only.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three parallel lines that curve and resemble a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 1 1999
Mr. Joel C. Kent Datex-Ohmeda, Inc. 3 Highwood Drive Tewksbury, MA 01876
K992323 Re: Cardiocap 5 (Models F-MX and F-MXG) and Accessories Regulatory Class: III (three) Product Codes:
| 74 MLD | (ST-Segment with Alarms) |
|---|---|
| 74 DPS | (ECG) |
| 73 BZQ | (Breathing Frequency Monitor) |
| 74 DQA | (Sp02) |
| 74 DXN | (NIBP) |
| 80 FLL | (Temperature) |
| 74 DSK | (Invasive Blood Pressure) |
| 73 KOI | (NeuroMuscular Transmission, NMT) |
| 73 CCK | (Analyzer, Gas, CO2, Gaseous-Phase) |
| 73 CBR | (Analyzer, Gas, N2O, Gaseous-Phase) |
| 73 CCL | (Analyzer, Gas, O2, Gaseous-Phase) |
| 73 CBQ | (Analyzer, Gas, Enflurane, Gaseous-Phase) |
| 73 CBS | (Analyzer, Gas, Halothane, Gaseous-Phase) |
| 73 CCI | (Analyzer, Gas, Nitrogen, Gaseous-Phase) |
| 73 BZG | (Diagnostic Spirometer) |
Dated: July 7, 1999 Received: July 12, 1999
Dear Mr. Kent:
We have reviewed your Section 510(k) 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 qeneral 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.
1
Page 2 - Mr. Joel C. Kent
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K992323 510(k) Number (if known): _
Device Name: Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories
Indications For Use:
The Datex-Ohmeda Cardiocap 5 (Models F-MX, F-MXG) and accessories is indicated for indoor monitoring of hcmodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all huspital patients.
Impedance Respiration measurement is indicated for patients ages 3 and up.
Cardiocap 5 is indicated for patients with weight from 5 kg (11 lb.) up.
The monitor is indicated for usc by qualified medical personnel only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular, Respiratory, Over-The-Counter Use __
and Neurological Devices
510(k) Number K992323 (Optional Format 1-2-96)