(89 days)
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Not Found
No
The provided text does not contain any mention of AI, ML, deep learning, image processing, or any other terms typically associated with AI/ML technology in medical devices. The description focuses on the device's function as a respiratory mechanics monitor.
No
The device is described as a "handheld respiratory mechanics graphic monitor" for "monitoring mechanically ventilated or supported pediatric and adult patients." Its purpose is monitoring, not treating or providing therapy.
No
The device is described as a "respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport" for "monitoring mechanically ventilated or supported pediatric and adult patients." Its purpose is monitoring, not diagnosing conditions.
Unknown
The provided text describes a handheld respiratory mechanics graphic monitor. While it doesn't explicitly mention hardware components, the description "handheld" strongly implies a physical device, not just software. Without a "Device Description" section, it's impossible to definitively confirm if it's software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "handheld respiratory mechanics graphic monitor" for monitoring mechanically ventilated or supported patients. This involves measuring physiological parameters related to breathing, not analyzing samples taken from the body (like blood, urine, or tissue) to diagnose or monitor a medical condition.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or other materials to perform tests on samples.
The device appears to be a medical device used for monitoring physiological functions directly on the patient.
N/A
Intended Use / Indications for Use
Meteor is a handheld respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport, either land or air. It is intended for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml. Meteor can be used for either continuous (Meteor 200) or spot check usage (Meteor 100 and 200). It is not intended to be used as an apnea monitor. No alarms are provided.
Product codes
73 BZC
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
pediatric and adult patients
Intended User / Care Setting
hospital clinical environment and transport, either land or air.
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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).
0
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 circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 4 1998
Mr. Mark S. Storsved CardioPulmonary Technologies, Inc. W260 N9311 Highway J Colgate, WI 53017
Re: K982487 Meteor Handheld Respiratory Mechanics Monitor Regulatory Class: II (two) Product Code: 73 BZC Dated: July 15, 1998 Received: July 17, 1998
Dear Mr. Storsved:
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 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 (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 regulation (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 regulatory 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 regulations.
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Page 2 - Mr. Mark S. Storsved
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 leqally 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
2
510(k) Number (if known):
49824 Q 7
Device Name:
CPT, Inc. Meteor Respiratory Mechanics Monitor(s)
て
ﻠ
Indications for use:
Meteor is a handheld respiratory mechanics graphic monitor intended for use in the hospital clinical environment and transport, either land or air.
It is intended for monitoring mechanically ventilated or supported pediatric and adult patients with tidal volumes greater than 100 ml.
Meteor can be used for either continuous (Meteor 200) or spot check usage (Meteor 100 and 200).
It is not intended to be used as an apnea monitor. No alarms are provided.
Warning: Federal law restricts the use or sale of this device by or on the order of a physician.
Warning: Do not use this device in the presence of flammable anesthetics.
Warning: Do not use this device in the presence of magnetic resonance imaging, MRI, equipment.
Warning: In accessing patient conditions, Meteor is intended only as an adjunct measurement.
Warning: Use of Meteor 100 / 200 in the presence of high concentrations of oxygen, heliumoxygen mixtures and anestetic agents may cause errors in the reported flow measurements.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Kam Werdon
(Division Sign-Off) Division of Cardiovascular. Respiratory, and Neurological Devices 510(k) Number
Prescription Use
(Per 21 CFR801.109)
OR
Over the Counter Use
(Optional Format 1-2-96)