(76 days)
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No
The summary describes a mechanical flushing device and makes no mention of AI or ML.
No
The device is described as a flushing unit for cleaning medical instruments, not for treating a disease or condition in a patient.
No
The device is described as a flushing unit for cleaning medical instruments, not for diagnosing medical conditions.
No
The device description explicitly states it is a "one time disposable, but totally recyclable flushing unit," indicating it is a physical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to flush out reusable biopsy forceps and cannulated instruments. This is a cleaning/maintenance function for medical devices, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces the cleaning function and highlights features related to practicality, consistency, and preventing damage or contamination of the instruments.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
Therefore, the Injecto Flush is a device used for the cleaning and maintenance of other medical instruments, not a diagnostic device itself.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments. The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit. In this day and age when cost containment plays a big factor in the medical profession, the Injecto Flush also offers the oppertunity for instutions and health facilities to do away with one time expensive disposable instruments and revert to a reusable instrument but, inexpensive flushing device with no additional risks of any kind.
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)
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
DEC 30 1996
SUMMARY
The Injecto Flush was designed to give a more practial and consistsnt way of flushing out reusable biopsy forcepts and canulated instruments.
The Injecto Flush was also designed to have no effect on on the break down of instrumentation nor any possibility of cross contamination. The Injecto Flush is a one time disposable, but totally recyclable flushing unit.
In this day and age when cost containment plays a big factor in the medical profession, the Injecto Flush also offers the oppertunity for instutions and health facilities to do away with one time expensive disposable instruments and revert to a reusable instrument but, inexpensive flushing device with no additional risks of any kind.
9