The HORIZON 9000 WS (Cathlab) is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

Device Description

The Cathlab is capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature. Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats. The Cathlab runs on a UNIX/Sun Solaris* operating system on a SUN® computer that utilizes spowerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

AI/ML Overview

This document describes a Special 510(k) for a device modification of the Horizon 9000WS Cathlab, specifically replacing the Patient Front End (PFE) with a Cathlab Front End (CFE). The submission aims to demonstrate that the modified device is substantially equivalent to the predicate device.

Here's an analysis of the provided text, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as "acceptance criteria" but are embedded within the product specifications for the Cathlab Front End (CFE). The device performance is reported as meeting these specifications.

Parameter	Acceptance Criteria (CFE Specification)	Reported Device Performance
Input Circuit Parameters
Chassis Leakage Current	< 50 µA, Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical Apparatus," (SCLE) Dec, 1978 item 2.1.1.	< 50 µA, Meets or exceeds ANSI standard: "Safe Current Limits for Electromedical Apparatus," (SCLE) Dec, 1978 item 2.1.1.
ECG
Frequency Response (Monitor)	0.5 to 40 Hz	0.5 to 40 Hz
Frequency Response (Diagnostic)	0.05 to 150 Hz, -3 dB	0.05 to 150 Hz, -3 dB
Frequency Response (Exercise)	1 to 25 Hz, -3 dB	1 to 25 Hz, -3 dB
Input Impedance	Typical 20 MΩ; Min > 5 MΩ differential (DC to 10 Hz); 2.5 MΩ differential (10 to 100 Hz); 3 MΩ differential (at 10 Hz)	Typical 20 MΩ; Min > 5 MΩ differential (DC to 10 Hz); 2.5 MΩ differential (10 to 100 Hz); 3 MΩ differential (at 10 Hz)
Common Mode Rejection	At least 100 dB at 50/60 Hz (Without lead misbalance); 86 dB (with lead misbalance); In accordance with ANSI/AAMI EC11 (9) Para. 3.2.14.	At least 100 dB at 50/60 Hz (Without lead misbalance); 86 dB (with lead misbalance); In accordance with ANSI/AAMI EC11 (9) Para. 3.2.14.
Input Dynamic Range	±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8) Para. 3.2.9.1.	±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8) Para. 3.2.9.1.
Input Offset	± 300mV, as per ANSI/AAMI EC13 Para. 3.2.9.1.	± 300mV, as per ANSI/AAMI EC13 Para. 3.2.9.1.
Noise	Less than 30 μ V p-p referenced to input	Less than 30 μ V p-p referenced to input
Pacemaker Pulse Rejection	Reject pulses from 2.0 mV to 700 mV with 0.2 to 2.0 mSec pulse widths and ≥3.0mV for 0.1mSec pulse width	Reject pulses from 2.0 mV to 700 mV with 0.2 to 2.0 mSec pulse widths and ≥3.0mV for 0.1mSec pulse width
Defibrillator Protection	Up to 5 KV. Amplifier Recovery time: < 3 seconds	Up to 5 KV. Amplifier Recovery time: < 3 seconds
QRS Detection	0.25 to 5.0 mV, 70-120 msec width	0.25 to 5.0 mV, 70-120 msec width
Synchronous Defibrillation Signal	Pulse Width: 100 ms; Amplitude: 5 Vdc into 500Ω, short-circuit proof	Pulse Width: 100 ms; Amplitude: 5 Vdc into 500Ω, short-circuit proof
ECG Analog Output	1 Volt / mVolt	1 Volt / mVolt
Heart Rate
Range	20 to 350 bpm	20 to 350 bpm
Accuracy	Within 2 bpm	Within 2 bpm
Response Time	Less than 7 sec for step change of 60 bpm from a base of 60 bpm	Less than 7 sec for step change of 60 bpm from a base of 60 bpm
Blood Pressure
Input Sensitivity	5 μvolts/volt/mmHg	5 μvolts/volt/mmHg
Transducer Excitation	5 Volt	5 Volt
Ranges	-50 to +300 mmHg	-50 to +300 mmHg
Max Variation during Zero	± 2 mmHg	± 2 mmHg
Zero Accuracy	± 0.2 mmHg	± 0.2 mmHg
Zero Drift	Less than +/- 0.2 mmHg in 24 hours	Less than +/- 0.2 mmHg in 24 hours
Transducer Load Impedance	300 – 600Ω	300 – 600Ω
Linearity	Better than 1% of full scale	Better than 1% of full scale
Common Mode Rejection	80 dB minimum (reference to chassis 50/60Hz)	80 dB minimum (reference to chassis 50/60Hz)
Frequency Response	DC to 12 Hz (DC to 40 Hz optional)	DC to 12 Hz (DC to 40 Hz optional)
Cardiac Output
Range	0.5 to 20 liter/minute	0.5 to 20 liter/minute
Frequency Response	DC to 15 Hz	DC to 15 Hz
Blood Temperature Range	27 °C to 45°C	27 °C to 45°C
Injectate Temperature Range	0°C to 25°C. (32°F to 77°F)	0°C to 25°C. (32°F to 77°F)
Accuracy	Blood Temp ± 0.05°C; Inj. Temp ± 0.2 °C	Blood Temp ± 0.05°C; Inj. Temp ± 0.2 °C
Linearity	Better than 1% of full scale	Better than 1% of full scale
Temperature
Range	27 °C to 45°C	27 °C to 45°C
Accuracy	± 0.2°C	± 0.2°C
Respiration
Frequency Response	0.13 to 2.5 Hz., 3 dB bandwidth	0.13 to 2.5 Hz., 3 dB bandwidth
Range	8 to 150 bpm	8 to 150 bpm
Excitation	65 kHz	65 kHz
Pulse Oximetry (SpO2)
Probe Type	Masimo™ reusable or disposable	Masimo™ reusable or disposable
Range	0% to 100%	0% to 100%
Pulse Rate Range	20-250 bpm, below 20 displays zero	20-250 bpm, below 20 displays zero
Rate Accuracy	± 3 bpm	± 3 bpm
SpO2 Accuracy (Adult)	±2 digits between 70% and 100%; ±3 digits between 50% and 70%	±2 digits between 70% and 100%; ±3 digits between 50% and 70%
SpO2 Accuracy (Neonatal)	±3 digits between 70% and 95%	±3 digits between 70% and 95%
Auxiliary Inputs
Input Voltage	+/-5 Volt	+/-5 Volt
Frequency Response	DC to 120 Hz	DC to 120 Hz
Non-Invasive Blood Pressure (NIBP)
Method	Oscillometric	Oscillometric
Initial Inflation	150 mmHg (adult); 120 mmHg (pediatric)	150 mmHg (adult); 120 mmHg (pediatric)
Pressure Accuracy	Overall ± 3 mmHg, full scale	Overall ± 3 mmHg, full scale
Defib. Pulse Protection	5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per IEC 60601-2-27 (12), clauses 17, 101 and 102	5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and per IEC 60601-2-27 (12), clauses 17, 101 and 102
Degree of protection against electrical shock	Type CF and BF (ECG, IBP and CO = CF; NIBP and SpO2 = BF)	Type CF and BF (ECG, IBP and CO = CF; NIBP and SpO2 = BF)
Electrosurgical Interference Suppression	Yes	Yes

2. Sample size used for the test set and the data provenance

The document does not specify a separate "test set" in the context of image-based AI or diagnostic algorithm evaluation. Instead, it states that "The Cathlab with the CFE has been subject to extensive safety and performance testing to ensure that the signals/waveforms sent by the CFE to the Cathlab have the same characteristics as those sent by the PFE to the Cathlab." This implies a comparative testing approach rather than a traditional test set for an algorithm.

The data provenance is not explicitly detailed. It can be inferred that the testing was performed by "Mennen Medical Ltd." (Israel) and an "independent testing laboratory" for electrical safety and EMC. There's no mention of country of origin of data in terms of patient population or images, as this is a physiological monitoring device rather than an imaging or diagnostic device. The testing describes the performance characteristics of the hardware and software, not historical patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physiological monitor, not an AI or imaging diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here is adherence to technical specifications and industry standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as there is no specific "test set" for diagnostic accuracy with human-expert adjudication in this context. The adjudication method for meeting technical standards would typically involve verification by qualified engineers/testers against established metrics.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document pertains to a hardware modification for a physiological monitoring device and does not involve AI for interpretation or improvement of human reader performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physiological monitor; its performance is described in terms of its ability to acquire and display patient data, not as a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" used for this device modification is based on technical specifications, industry standards (e.g., ANSI/AAMI, IEC), and the performance characteristics of the predicate device (Horizon 9000WS Cathlab with PFE). The goal was to ensure the modified CFE matched or exceeded the performance of the existing PFE.

8. The sample size for the training set

Not applicable. This document describes a hardware device modification, not a machine learning model that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for a machine learning model described.

Summary

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OCT 1 5 2003

Food and Drug Administration Device Modification - Horizon 9000WS Cathlab: Special 510(k) for new PFE (Patient Front End) for Cathlab

Image /page/0/Picture/2 description: The image shows the logo for Mennen Medical. The logo consists of a lowercase letter 'm' inside of a black circle. The text 'mennenmedical' is written below the logo, with 'mennen' in black and 'medical' in a lighter color.

Mennen Medical Ltd., 4 Hayarden Street, Yavne PO Box 102, Rehovot 76100 Israel

Date: 16 September 2003

Topic: 510(k) Safety and Effectiveness Summary as per 21 CFR Section 807.92(c) Special 510(k): Device Modification - Horizon 9000WS Cathlab

Establishment Name, Registration Number and Address:

Name:	Mennen Medical Ltd.
Registration Number	9611022
Operator Number:	9011766
Address:	4 Hayarden Street, Yavne, 81228, Israel
Postal Address:	PO Box 102,Rehovot, 76100, Israel
Tel:	+972-8-9323333
Fax:	+972-8-9328510
Contact person:	Asher Kassel, Director of Regulatory Affairs
To:	Food and Drug AdministrationCenter for Devices and Radiological HealthDocument Mail Center (HFZ-401)9200 Corporate BoulevardRockville MD, 20850
Attn.:	Document Control Clerk
From:	Asher Kassel, Director of Regulatory Affairs
Product Name:
Proprietary:	Horizon 9000WS
Common:	Cathlab
Mennen Medical Part Number:	960-100-020 (full system)
FDA Classification of Cathlab:
Classification Name:	Programmable diagnostic computer
Classification Number:	21 CFR 870.1425
Classification:	Class II
Product Code:	DXG

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Performance Standards: None promulgated

Voluntary Standards: IEC 60601-1: General Requirement for Safety for Medical Electrical Systems - part 1, (1988); Amendment 1 - 1991-11 Amendment 2 - 1995-03

IEC 60601-1-2 (2001):

Medical electrical equipment. General requirements for Safety. Electromagnetic Compatibility Requirements and Tests.

IEC 60602-2-27 (1994):

Medical electrical equipment, Part 2, Requirements for safety of electrocardiograph monitoring equipment.

IEC 60601-2-30 (1995):

Medical electrical equipment, Part 2 - requirements for safety of automatic cycling indirect blood pressure monitoring equipment

IEC 60601-2-34 (1994):

Medical electrical equipment, Part 2 - Particular requirements for the safety of direct blood pressure monitoring equipment

IEC 60601-2-49 (2001):

Particular Requirements for the safety of multifunction patient monitoring equipment

Terminology:

PFE = Patient Front End, and refers to the data acquisition module of the Horizon 9000WS, the predicate device before modification

CFE = Cathlab Front End, and refers to the data acquisition module of the Horizon 9000WS after modification, the subject of this Special 510(k).

Predicate Device:

· Horizon 9000WS Cathlab with PFE K940415 and K991775

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General Description of the Horizon 9000WS Cathlab

The Cathlab runs on a UNIX/Sun Solaris* operating system on a SUN® computer that utilizes spowerful, real-time software to control the system operation and to process the vital patient sign data measurements acquired from the Physiological Front End or entered manually at the keyboard. The Thermal Array Chart Recorder provides a continuous recording of all monitored vital signs, patient ID, time and date during the procedures. A Laser Printer is provided in addition to the Chart Recorder in the central console. This provides printouts of textual and graphical summaries of all patient data and catheterization procedures.

Base Configuration: Cathlab parameters

4 Invasive Blood Pressure channels
. Diagnostic 7 or 12 Lead ECG
Non-invasive Blood Pressure .
Thermodilution cardiac output
Pulse Oximetry (SpO2)
24 channel thermal array chart recorder .

Horizon 9000 WS Options:

Full Disclosure ●
Off-line workstations ●
Remote Interactive terminal ●
Angiography Analysis Package ●
Cardiology Data Base and Inventory ●
Optomagnetic or CDR drive .
Choice of Console Table regular, enhanced or compact .

Intended Use of the Horizon 9000WS Cathlab:

The Horizon 9000 WS Cathlab is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, invasive blood pressure, pulse oximetry, respiration, cardiac output and body temperature.

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

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K032997
page 4/10

Summary of the technological characteristics of the CFE of the Horizon 9000WS Cathlab

The following tables summarize data on the CFE (modified device) of the Horizon 9000WS Cathlab:

CFE of Horizon 9000WS Cathlab
Part/Option Number	960-551-010 (CFE)
Dimensions (H x W x D)	24 x 22 x 10 cm (9 x 11 x 4")
Input Circuit Parameters	CFE
Chassis Leakage Current	All patient signal inputs fully isolated (<50 $\mu$ A).Meets or exceeds ANSI standard: "Safe Current Limits forElectromedical Apparatus," (SCLE) Dec, 1978 item 2.1.1.

	CFE
ECG	7 or 12 leads
Frequency Response	Monitor Mode: 0.5 to 40 Hz
	Diagnostic: 0.05 to 150 Hz,
	Exercise: 1 to 25 Hz, -3 dB
Input Impedance:	Typical 20 MΩ
	Minimum greater than:
	5 MΩ differential, DC to 10 Hz; 2.5 MΩ differential 10 to 100Hz. 3 MΩ differential at 10 Hz
Common Mode Rejection:	At least 100 dB at 50/60 Hz Without lead misbalance86 db with lead misbalance
	The common mode rejection ratio is in accordance withANSI/AAMI EC11 (9) Para. 3.2.14.
Input Dynamic Range:	±5mV p-p at a rate up to 320mV/sec, as per ANSI/AAMI EC13(8)Para. 3.2.9.1.
Input offset	± 300mV, as per ANSI/AAMI
	EC13 Para. 3.2.9.1.
Gain:	Manual selection of 250, 500, 1000, 2000, 4000 and 8000 x ECG.Signal impressed across selected lead
Noise:	Less than 30 μ V p-p referenced to input

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K 032997
page 5/10

ECG	CFE
Pacemaker PulseRejection:	Reject pulses from:2.0 mV to 700 mV pulses of 0.2 to 2.0 mSec pulse widths and≥3.0mV for 0.1mSec pulse width
Defibrillator Protection:	Up to 5 KV. AmplifierRecovery time: < 3 seconds
Lead Fault Sense:	On any ECG electrode
QRS Detection:	0.25 to 5.0 mV, 70-120 msec width
Synchronous DefibrillationSignal:	Pulse Width: 100 ms.Amplitude: 5 Vdc amplitude into 500Ω, short-circuit proof
ECG Analog Output:	1 Volt / mVolt

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Heart Rate	CFE
Range:	20 to 350 bpm
Accuracy:	Within 2 bpm.
Response Time:	Less than 7 sec for step change of 60 bpm from a base of 60 bpm
Blood Pressure
Input Sensitivity:	5 μvolts/volt/mmHg
Transducer Excitation:	5 Volt
Ranges:	-50 to +300 mmHg
Maximum variation duringzero:	± 2 mmHg
Zero Accuracy:	± 0.2 mmHg
Zero Drift:	Less than +/- 0.2 mmHg in 24 hours
Transducer Load Impedance:	300 – 600Ω
Linearity:	Better than 1% of full scale
Common Mode Rejection:	80 dB minimum (reference to chassis 50/60Hz)
Frequency Response:	DC to 12 Hz(DC to 40 Hz optional)
Cardiac Output	CFE
Range:	0.5 to 20 liter/minute
Frequency Response:	DC to 15 Hz.
Blood Temperature Range:	27 °C to 45°C
Injectate Temperature Range:	0°C to 25°C. (32°F to 77°F)
Accuracy:	Blood Temp ± 0.05°C; Inj. Temp ± 0.2 °C
Linearity:	Better than 1% of full scale
Temperature	CFE
Range:	27 °C to 45°C.
Accuracy:	± 0.2°C.
Respiration	CFE
Frequency Response:	0.13 to 2.5 Hz., 3 dB bandwidth.
Range:	8 to 150 bpm.
Excitation:	65 kHz
Pulse Oximetry (SpO2)	CFE
Probe Type:	Masimo™ reusable or disposable
Range:	0% to 100%
Pulse Rate Range:	20-250 bpm, below 20 displays zero
Rate Accuracy:	± 3 bpm
SpO2 Accuracy:	Determined by specific sensor:Adult: ±2 digits between 70% and 100%±3 digits between 50% and 70%.Neonatal: ±3 digits between 70% and 95%
Auxiliary Inputs	CFE
Input Voltage:	+/-5 Volt
Frequency Response:	DC to 120 Hz

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Non-Invasive BloodPressure (NIBP)	CFE
Method:	Oscillometric
Initial Inflation:	150 mmHg (adult)120 mmHg (pediatric).
Pressure Accuracy:	Overall ± 3 mmHg, full scale.

Defib. Pulse Protection	5KV as per ANSI/AAMI EC13 (9), clause 3.2.2.2 and perIEC 60601-2-27 (12), clauses 17,101 and 102
Degree of protectionagainst electrical shock	Type CF and BF.ECG, IBP and CO = CFNIBP and SpO2 = BF
ElectrosurgicalInterference Suppression	Yes
Displayed Waveforms	CFE
ECG	Up to 12 lead
BP	Up to 4, separate or superimposed
Respiration	1
SpO2	1
Displayed NumericParameters	1
Heart Rate	Yes
Respiration Rate	Yes
SpO2	Yes
BP - Systolic, Diastolic,Mean	Yes
Temperature	2

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Alarm Indications	No
Display Functions	CFE
Change ECG LeadSelection	YES
Display of ArrhythmiaInformation	YES
Data Review: Trends	YES
Data Review: Tabular	YES
User defined ConfigurationSetup	YES
User defined DefaultSettings	YES
Accessories	Compatible with Mennen Medical Envoy patient monitor

Conclusion of technological characteristics:

We consider the Horizon 9000WS Cathlab with the CFE to be substantially equivalent to the Horizon 9000WS Cathlab with the PFE. We submit that any differences between the two modules:

fall within the scope of a Special 510(k) Device Modification and .
do not raise any new issues of safety and effectiveness ●

Testing

The Cathlab with the CFE has been subject to extensive safety and performance testing in order to ensure that the signals/waveforms sent by the CFE to the Cathlab have the same characteristics as those sent by the PFE to the Cathlab.

Final testing for the whole Cathlab system included various performance tests designed to ensure that the device meets all functional requirements and performance specifications. Electrical Safety testing and EMC testing were performed by an independent testing laboratory to ensure that the device complies to applicable industry and safety standards.

Indications for Use

There is no change to the Indications for Use for the Cathlab with CFE. Mennen intends to use the CFE of the Cathlab for "acquiring and displaying essential patient data" according to the approved "Indications for Use" in K991775. The full "Indications for Use" appear on page 9 below.

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K032997
page 10/10

INDICATIONS FOR USE

Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and ,numerical, can be stored, recorded, analyzed and presented in a variety of report formats.

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Image /page/10/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three stripes extending from its head, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Mennen Medical Ltd. c/o Mr. Asher Kassel Department of Regulatory Affairs P.O. Box 102 Rehovot 76100 ISRAEL

Re: K032997 Trade Name: Horizon 9000WS Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DXG Dated: September 24, 2003 Received: September 25, 2003

Dear Mr. Kassel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Asher Kassel

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

MHepernar

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

UMefelmay
(Division Sign-Off)
Division of Cardiovascular Devi

510(k) Number

Regulation Number and Section

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).