(43 days)
Not Found
Not Found
No
There is no mention of AI, ML, or related concepts in the provided text. The summary focuses on substantial equivalence based on performance studies, which is a standard regulatory pathway and doesn't inherently imply AI/ML use.
No
The provided text does not contain any information regarding the intended use or function of the device, making it impossible to determine if it is a therapeutic device. The "Summary of Performance Studies" only speaks to substantial equivalence for safety and effectiveness without describing what the device actually does.
No
The provided text does not contain an "Intended Use / Indications for Use" section, which would typically describe if the device is intended for diagnosis. The performance study summary only states that the device raises no new safety or effectiveness concerns and is substantially equivalent to predicate devices, but it does not specify the function of the 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 provided information, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The provided text lacks key information typically found in a submission for an IVD. Specifically, the "Intended Use / Indications for Use" section is "Not Found". This section is crucial for identifying if a device is intended for the in vitro examination of specimens derived from the human body.
- Other relevant sections are also missing. Information about the device description, input imaging modality, anatomical site, patient age range, intended user, and details about training and test sets are all "Not Found". While not all of these are strictly required for an IVD, their absence makes it harder to infer the device's nature.
The only information that could potentially hint at it NOT being an IVD is the mention of "image processing" and "AI, DNN, or ML" being "Not Found". IVDs often involve analyzing biological samples, which might not always involve image processing or AI in the same way as some other medical devices. However, this is not a definitive indicator.
In conclusion, without the "Intended Use / Indications for Use" and more details about the device's function, we cannot confirm or deny if it is an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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.
Not Found
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
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
0
PREMARKET 510(k) NOTIFICATION SUMMARY/CONCLUSION
APR 1 5 1997
Conclusion
1
The submitted device meets the requirements of the Proposed Rule from 21 CFR Parts 895 and 897 regarding Protected Design Leadwires. Further, samples of the submitted device passed all applicable sections of the voluntary standard ANSVAAMI EC53-1995. Also, samples of the submitted device passed additional testing, not a part of any standard. Based on the test results outlined in the Specifications Section of this Premarket 510(k) Notification, it is concluded that the submitted device raises no new concerns of safety or effectiveness, and should be considered Substantially Equivalent to the predicate devices listed in this submission.