(180 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the addition of a standard NBP module.
No
The device measures non-invasive blood pressure, which is a diagnostic function, not a therapeutic one. Its intended use is for monitoring patients undergoing cardiac cath procedures.
Yes
The device, an NBP module, measures and displays non-invasive blood pressure, which is a physiological parameter used for diagnosis and monitoring of medical conditions. The stated "intended use" during cardiac cath procedures implies its role in providing vital information for patient assessment.
No
The device description explicitly states that the modification involves the addition of a "plug-in module," which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is a Noninvasive Blood Pressure (NBP) module added to a Cathstation. It measures blood pressure externally, not through analysis of bodily fluids or tissues.
- Intended Use: The intended use is for monitoring blood pressure during cardiac cath procedures. This is a physiological measurement, not an in vitro diagnostic test.
Therefore, the HP Cathstation with the NBP module is a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatic, and nonatal patients undergoing cardiac cath procedures. The intended use for the HP Cathstation NBP module is the same as the intended use for the legally marketed predicate device and several other products currently on the market.
Product codes
DSK, DXJ, DSF, DRT, DPS, DRW, DRR, DRQ, DQA, JOE
Device Description
The HP Cathstation is modified by the addition of the HP M1008B Noninessive Blood Pressure (NBP) plug-in module for display and recording of NBP numerics on the HP Cathstation.
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
adult, pediatic, and nonatal patients
Intended User / Care Setting
cardiac cath lab
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)
Performance specifications for this modification have been validated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
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OCT - 8 1996
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Submitted by: Rob Butler (contact person), Regulatory Approvals Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810 phone (508) 659-2785; fax (508) 687-8284
Summary prepared April 10, 1996.
Device Trade Name: Hewlett-Packard Model M1264B Cathstation Device Common Name: HP Cathstation (Cardiac Catheterization Recording System)
Classification Name: The following classifications apply to the HP Cathstation (the last classification listed is the only new classification as a result of this modification (in
| Panel | 21 CFR Section | Procode | Description | Tier |
|---|---|---|---|---|
| 74 CV | 870.1110 | DSK | Blood Pressure Computer | 2 |
| 74 CV | 870.2450 | DXJ | Medical Cathode-Ray Tube Display | 2 |
| 74 CV | 870.2810 | DSF | Paper Chart Recorder | 2 |
| 74 CV | 870.2300 | DRT | Cardiac Monitor | 2 |
| 74 CV | 870.2340 | DPS | Electrocardiograph | 2 |
| 74 CV | 870.2350 | DRW | ECG Lead Switching Adapter | 2 |
| 74 CV | 870.2050 | DRR | Biopotential Amplifier and Signal Conditioner | 2 |
| 74 CV | 870.2060 | DRQ | Transducer Signal Amplifier and Conditioner | 2 |
| 73 AN | 870.2700 | DQA | Oximeter | 2 |
| 74CV | 870.1130 | JOE | Noninvasive Blood Pressure Measurement System | 2 |
Predicate Device: For the HP Cathstation modification described in this 510(k) submission, the legally marketed devices to which we claim equivalence is the HP M1008B Noninsison, the Pressure module (K903771) used with the HP Component Monitoring System.
Device Description: The HP Cathstation is modified by the addition of the HP M1008B Noninessive Blood Pressure (NBP) plug-in moduled by the HD M1008)
Noninvasive Blood Pressure (NBP) plug-in module for display and recording of NBP numerics on the HP Cathstation.
Intended Use: As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatic, and nonatal patients undergoing cardiac cath procedures. The intended use for the HP Cathstation NBP module is the same as the intended use for the legally marketed predicate device and several other products currently on the market. Other
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aspects of this modification are also consistent with the predicate device. This modification adds established NBP measurement and reporting capabilities to the HP Cathstation, providing additional information to clinicians in the cath lab.
Technological Characteristics: The NBP plug-in module for the HP Cathstation has the same technological characteristics in acquiring NBP signals and computing and displaying NBP numerics as the legally marketed predicate device.
Description statements were not relied on alone to show substantial equivalence to legally marketed devices; instead, performance data from device validation is used as well. The comparison of intended use and technological features of this modification to the legally marketed predicate device taken together with the validation results and other information in this submission indicate that this modification is substantially equivalent to the legally marketed predicate device with regards to safety, effectiveness and intended use.
The safety of this modification is shown by compliance to relevant safety standards for medical devices, such as IBC 601 and UL 2601. Software safety is verified by hazard analysis and software validation to ensure the product performs as intended. Performance specifications for this modification have been validated.
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