(219 days)
Not Found
Unknown
The provided 510(k) summary is incomplete and lacks information about the device description, intended use, and any mention of AI/ML or related technologies. The only information available is the predicate devices, which does not provide enough context to determine the presence of AI/ML.
No.
The provided information only lists predicate devices, which are often other diagnostic or imaging tools. Without details on the device's function or intended use, it cannot be confirmed as therapeutic.
No
The provided information only lists predicate devices, which does not directly indicate whether the device itself is diagnostic. There is no information about its intended use, function, or performance to determine if it is a diagnostic device.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the information provided, it is highly likely that this device is not an IVD (In Vitro Diagnostic).
Here's why:
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Lack of Key IVD Information: The provided text is completely devoid of information typically found in descriptions of IVD devices. This includes:
- Intended Use/Indications for Use: IVDs are defined by their intended use in examining specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This crucial information is "Not Found".
- Device Description: While a general device description might not explicitly state "IVD", the lack of any description makes it impossible to assess if it involves the analysis of biological samples.
- Input Imaging Modality/Anatomical Site: While not all IVDs involve imaging, many do. The absence of this information further suggests it's not an imaging-based IVD.
- Performance Studies/Key Metrics: IVDs require rigorous performance studies to demonstrate their accuracy and reliability in analyzing biological samples. The complete absence of this information is a strong indicator it's not an IVD.
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Predicate Devices: The listed predicate devices (VMX, VM1, VM PLUS) are likely related to the device in question. Without knowing what these devices are, it's difficult to say definitively. However, if these are not known IVD devices, it further supports the conclusion.
In summary, the complete lack of any information related to the analysis of biological specimens or diagnostic purposes, combined with the absence of performance data, strongly suggests this device is not an IVD.
To confirm definitively, you would need to find the actual Intended Use/Indications for Use statement for this device.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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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
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
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.1860 Peak-flow meter for spirometry.
(a)
Identification. A peak-flow meter for spirometry is a device used to measure a patient's maximum ventilatory flow rate.(b)
Classification. Class II (performance standards).
0
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Clement Clarke
APPENDIX 1
JAN - 2 1997
PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS. I further certify that I am aware of the types of problems to which the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 AND VM PLUS is susceptible and that the following summary of the types and causes of safety and/or effectiveness problems about the VMX MINI-LOG FLOWMETER, VENTILOMETER VM1 and VM PLUS is complete and accurate:
Safety Problems 1.
- No safety problems should be experienced during use of the device for its intended purpose, a) and none have been reported for either the VMX, VM1 or VM PLUS. The device complies fully with International BS EN 1SO 60601-1 Standard "MEDICAL ELECTRICAL EQUIPMENT; GENERAL SAFETY REQUIREMENTS".
- b) General Medical Standards of cleanliness should be observed in maintaining the instrument. and the mouthpiece should be routinely sterilised in accordance with the Users Instructions.
2. Effectiveness Problems
DATE: ...
Low battery power will prevent use of the instrument, but visual indication of this is shown on the instrument display, allowing time for a replacement to be fitted.
PRINTED NAME OF PERSON REQUIRED TO SUBMIT 510 (K)
..............................................................................................................................................................................
- SIGNATURE OF PERSON,REQUIRED TO SUBMIT 510 (K)
- ..............................................................................................................................................................................
- TITLE OF PERSON SUBMITTING 510 (K)
.......................QUALITY ASSURANCE MANAGER .............................................................................................................................
- NAME OF COMPANY : CLEMENT CLARKE INTERNATIONAL LIMITED