(393 days)
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No
The summary describes a revised version of a syringe filter, focusing on material changes and sterilization methods. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities.
No
The document describes a syringe filter, which is a component used in medical procedures, but it does not directly treat or diagnose a disease or condition. Its function is to filter.
No
Explanation: The document describes a "Syringefilter," which is a component used in medical procedures, likely for filtration purposes in conjunction with a syringe. Its function as described (passing Class VI testing, HIMA Challenge) points to its role in maintaining sterility or purity of substances, not in diagnosing a medical condition.
No
The device description clearly describes physical components (plastic housings, membrane) and manufacturing processes, indicating it is a hardware device, not software-only.
Based on the provided text, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Lack of IVD-specific language: The description focuses on the physical characteristics of a filter (housings, membrane, sterilization) and performance testing related to filtration (HIMA Challenge). There is no mention of analyzing biological samples, detecting analytes, diagnosing conditions, or any other activities typically associated with IVD devices.
- Focus on filtration: The device is described as a "Syringefilter" and the performance testing mentioned is the "HIMA Challenge," which is a standard test for sterilizing filters. This strongly suggests a device used for filtering fluids, likely for administration to a patient or for preparing solutions.
- No mention of diagnostic purpose: The "Intended Use / Indications for Use" section is present but the content is not provided. However, the rest of the description does not hint at any diagnostic purpose.
In summary, the information provided points towards a medical device used for filtration, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use is the same.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version.
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
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Intended User / Care Setting
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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)
Testing for both the original and the proposed versions of this fitter are the same. Both versions of the 0.2um have passed the HIMA Challenge.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 868.5130 Anesthesia conduction filter.
(a)
Identification. An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.(b)
Classification. Class II (performance standards).
0
APR - 4 1997
Appendix C
Summary of Safety and Effectiveness
A contraction of the commend of the consisted
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The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version. The intended use is the same. Testing for both the original and the proposed versions of this fitter are the same. Both versions of the 0.2um have passed the HIMA Challenge.