(180 days)
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.
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.
The provided text describes a 510(k) submission for a modification to the Hewlett-Packard Model M1264B Cathstation, specifically the addition of an HP M1008B Noninvasive Blood Pressure (NBP) plug-in module.
However, the document is a Summary of Safety and Effectiveness, which typically outlines the device and its intended use, but does not contain the detailed acceptance criteria and study results for performance validation. It states that "Performance specifications for this modification have been validated," but it does not provide the specifics of those validations.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The document explicitly mentions:
- No detailed acceptance criteria.
- No reported device performance figures.
- No information on sample sizes for test or training sets.
- No details on data provenance.
- No mention of experts or ground truth establishment.
- No adjudication method is described.
- No MRMC or standalone study details are provided.
- No information on how ground truth was established for training or testing.
The document focuses on:
- Identifying the device and predicate device.
- Stating its intended use.
- Claiming substantial equivalence based on technological characteristics and the general statement that performance specifications have been validated, along with compliance to safety 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.
7
§ 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).