HP CATHSTATION - MODEL M1264B

K961401 · Hewlett-Packard Co. · DPS · Oct 8, 1996 · Cardiovascular

Device Facts

• Record ID: K961401
• Device Name: HP CATHSTATION - MODEL M1264B
• Applicant: Hewlett-Packard Co.
• Product Code: DPS · Cardiovascular
• Decision Date: Oct 8, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatric, and neonatal 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 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.

Device Story

HP Cathstation is a cardiac catheterization recording system; modified to include HP M1008B Noninvasive Blood Pressure (NBP) plug-in module. Device acquires NBP signals; computes and displays NBP numerics. Used in cardiac cath labs by clinicians to monitor patients during procedures. Provides real-time NBP data to assist clinical decision-making and patient management during cardiac interventions.

Clinical Evidence

Bench testing only. Validation of performance specifications and software hazard analysis conducted to ensure the modified system performs as intended.

Technological Characteristics

NBP plug-in module; utilizes same signal acquisition and computation technology as predicate. Compliance with IEC 601 and UL 2601 safety standards. Software validation and hazard analysis performed.

Indications for Use

Indicated for adult, pediatric, and neonatal patients undergoing cardiac catheterization procedures in a cardiac cath lab setting.

Regulatory Classification

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.

Predicate Devices

• HP M1008B Noninvasive Blood Pressure module (K903771)

Submission Summary (Full Text)

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K961401

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 [phone]; fax [phone]

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):

| 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 Noninvasive Blood Pressure module (K903771) used with the HP Component Monitoring System.

Device Description: The HP Cathstation is modified by the addition of the HP M1008B 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, pediatric, and neonatal 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 IEC 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.