(147 days)
Not Found
No
The summary describes a blood sampler and explicitly states that AI, DNN, or ML were not found.
No
The device is described as an "arterial blood sampler" used for analysis, indicating a diagnostic purpose rather than a therapeutic one. It collects blood for testing, not to treat a condition.
Yes
The device is described as an "Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses," which are all diagnostic measurements.
No
The device description clearly indicates a physical, preheparinized arterial blood sampler, which is a hardware component.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is an "Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses." These analyses are performed in vitro (outside the body) on the collected blood sample to provide diagnostic information about a patient's health status.
- Device Description: The description further clarifies that it's a "Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses." This reinforces its role in collecting samples for in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood) to provide information for the diagnosis, treatment, or prevention of disease. This device fits that description perfectly.
N/A
Intended Use / Indications for Use
Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
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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.
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).
Not Found
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
RADIOMETER AMERICA INC.
MEDICAL DIVISION
Exhibit IX
1 SHARON DRIVE, WESTLAKE, OHIO 44146-1508 800-738-0800, 218-871-8900 FAX 216-892-8117
OCT 29 1996
510(k) SUMMARY SUBJECT:
- Donald L. Baker FROM: Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145 (216)871-8900, Ext. 287 or 1-800-736-0600 Fax (216)871-8117
- DATE: May 16, 1996
- PRODUCT: Trade Name -PICO Common Name - PICO Arterial Blood Sampler Classification Name - Kit, Sampling, Arterial Blood
PREDICATE
- Qualistick, Pulsator, B-D, QS90 Smooth ETM DEVICE:
PRODUCT
- DESCRIPTION: Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.
INTENDED
- USE: Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.
TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE:
PICO product line is technologically similar to the Smooth ETM product line.
SUBSTANTIAL
EQUIVALENCE: The PICO product line is substantially equivalent in features, intended use, and characteristics to the current Smooth ETM product line (K896514) marketed by Radiometer America Inc. The significant difference from Smooth ETM to the new PICO design is the addition of metabolite and oximetry to the product labeling.