MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES

K012837 · Datex-Ohmeda · MLD · Sep 14, 2001 · Cardiovascular

Device Facts

• Record ID: K012837
• Device Name: MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESSORIES
• Applicant: Datex-Ohmeda
• Product Code: MLD · Cardiovascular
• Decision Date: Sep 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Datex-Ohmeda Cardiocap/5 is intended for use as part of the Datex-Ohmeda family of multi-parameter patient monitors. It is available with a set of factory-configured options, two different monitor software options and accessories. The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients. With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions. Impedance Respiration measurement is indicated for patients ages 3 years and older. Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more. The monitor is indicated for use by qualified medical personnel only.

Device Story

Multi-parameter patient monitor; factory-configured for hemodynamic, respiratory, ventilatory, and neuromuscular transmission (NMT) monitoring. Inputs: ECG, SpO2, temperature, NIBP, invasive pressure, airway gases (CO2, O2, N2O, anesthetic agents), and spirometry data. Transforms inputs via internal processing to display real-time waveforms, numeric values, and alarms. Used in hospital settings by qualified medical personnel. Features include ST-segment analysis, impedance respiration, and optional enhanced oximetry (N-XOSAT/Nellcor). Output provides clinicians with continuous physiological status updates to inform clinical decision-making and patient management. Supports networking to Datex-Ohmeda systems.

Clinical Evidence

Bench testing only. Compliance verified against standards including IEC 60601-1, IEC 60601-2-27 (cardiac monitors), IEC 60601-2-30 (NIBP), IEC 60601-2-34 (invasive pressure), ISO 9919 (SpO2), ISO 9918 (capnography), and ISO 11196 (anesthetic gas monitors). No clinical trial data presented.

Technological Characteristics

Multi-parameter monitor; factory-configured. Sensing: ECG, impedance, NIBP, SpO2, invasive pressure, gas analysis (CO2, O2, N2O, anesthetic agents), NMT. Connectivity: Networked to Datex-Ohmeda network. Software: Upgradeable, supports anesthesia or critical care configurations. Standards: IEC 60601-1, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, ISO 9919, ISO 9918, ISO 7767, ISO 11196, IEC 60601-2-40, AAMI EC13, AAMI SP10.

Indications for Use

Indicated for indoor monitoring of hemodynamic, respiratory, ventilatory, and relaxation status in hospital patients weighing ≥5 kg. Impedance respiration indicated for patients ≥3 years. N-XOSAT option indicated for SpO2 monitoring during clinical motion. For use by qualified medical personnel only.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Datex-Ohmeda Cardiocap 5 Rev A (K992323)

Reference Devices

• Datex-Ohmeda CS/3 Arrhythmia Workstation (K974747)

Submission Summary (Full Text)

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K012837

Page 1 of 4

SEP 1 4 2001

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# Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda Cardiocap 5 (Rev B) and accessorles

# GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

### COMPANY NAME/ADDRESS/PHONE/FAX:

Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492 USA Tel: [phone] Fax: [phone]

### NAME OF CONTACT: Mr. Joel Kent

DATE:

August 18, 2001

### DEVICE NAME as required by 807.92(a)(2)

### TRADE NAME:

Datex-Ohmeda Cardiocap 5 (Rev B) and accessories

### COMMON NAME:

Patient Monitor and accessories

### CLASSIFICATION NAME:

The following Class III classification appears applicable:

Monitor, ST-segment with alarm 870.1025

The following Class II classifications appear applicable:

| Analyzer, Gas, Carbon-Dioxide, Gaseous-phase | 868.1400 |
|----------------------------------------------|----------|
| Transducer signal amplifier and conditioner | 870.2060 |
| Oximeter | 870.2700 |
| Ear Oximeter | 870.2710 |
| Cardiac Monitor | 870.2300 |
| Electrocardiographic Device | 870.2340 |
| Non-invasive blood pressure measurement sys. | 870.1130 |
| Stimulator, nerve, peripheral, electric | 868.2775 |
| Analyzer gas, Halothane, gaseous phase | 868.1620 |

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| Analyzer gas, Nitrous oxide, gaseous phase | 868.1700 |
|--------------------------------------------|----------|
| Analyzer gas, Oxygen, gaseous phase | 868.1720 |
| Spirometer , monitoring, w/wo alarm | 868.1850 |
| Clinical Electronic Thermometer | 880.2910 |

# NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The Datex-Ohmeda Cardiocap 5 Rev B and accessories is substantially equivalent ) in The Dates-Onlineda Caranovap legally marketed (predicate) Datex-Ohmeda Cardiocap 5 Rev A (K992323).

#### DEVICE DESCRIPTION as required by 807.92(a)(4)

The Cardiocap 5 monitor is a multi-parameter monitor that is factory configured. The monitor provides basic hemodynamic monitoring of ECG, SpO2, Temp, NIBP and Invasive provides outs addition to the hemodynamic monitoring it can be configured with Gas monitoring which are: CO2, N2O, O2, Anesthetic Agents with agent identification and Patient Spirometry TM .

The Cardiocap 5 monitor software available is for Anesthesia or Critical Care. The customer upon purchase for optimized use of monitor can select the software for application.

In addition the Cardiocap 5 rev. B will offer other options and enhanced features. These features are the following:

OSAT - Enhanced D-O Oximetry (SpO2) performance NSAT - Nellcor Oximetry XP w/2 temp - Invasive pressure with 2 temp feature Rec. w/2 key - Recorder with 2 direct key function

Because the Cardiocap 5 monitor is factory-configured for cost-effectiveness and compactness, the parameters and optional thermal array recorder cannot be upgraded later. Software is upgradeable.

Cardiocap 5 is based on the same state-of-the-art monitoring and user interface technology, including menu logic and alarm philosophy, as the S/5 monitors. The Cardiocap 5 can also be networked to the Datex-Ohmeda Network.

The hemodynamic frame (F-MX) and hemodynamic with gases frame (F-MXG) both include ECG with ST analysis and impedance respiration, SpO2, 1 temperature, and noninvasive blood pressure. Invasive blood pressures (2 channels) and second temperature is an option for both models. Airway gas options are for hemodynamic with gases frame .

The Cardiocap 5 monitor now extends its feature sets to allow flexibility of customerpreferred oximetry options. These new oximetry features replace the functionality of the original oximetry offering. (Only one oximetry option is available at a time.

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### INTENDED USE as required by 807.92(a)(5)

The Datex-Ohmeda Cardiocap/5 is intended for use as part of the Datex-Ohmeda family of multi-parameter patient monitors. It is available with a set of factory-configured options, two different monitor software options and accessories.

The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients.

With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions.

Impedance Respiration measurement is indicated for patients ages 3 years and older. Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more. The monitor is indicated for use by qualified medical personnel only

# SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda Cardiocap 5 Rev B is substantially equivalent to Datex-Ohmeda Cardiocap 5 Rev A (K992323). The intended use of the devices have not changed. The indications for use for Cardiocap 5 REV B. and the predicate is nearly identical. Information about the N-XOSAT monitoring SPO2 during clinical motion conditions was added.

The software was updated to incorporate those changes noted below but otherwise is the same as the predicate. The hardware is essentially the same with the exception of adding a new quick pushbutton key for simpler access to the recorder trend function.

[ Various feature improvement updates, and requests by customers, manufacturing, and service on minor (non-safety) related changes.

O A change from Cardiocap Rev. A to the subsequent version A+ (current production version) is related to the Datex-Ohmeda Cardiocap/5 software S-XANE99 rev.01 and S-XCCA99 rev.01 There were no hardware changes involved. This software change makes the Datex-Ohmeda Cardiocap/5 (Models F-MX, F-MXG) and accessories compatible with the Datex-Ohmeda CS/3 Arrhythmia Workstation (K974747) equipped with software S-ARR99 (K974747).

[ The Cardiocap 5 REV. B measurement of ECG, SpO2, Temperature, invasive and noninvasive blood pressures together with respiration, CO2, O2, N2O, Anesthetic Agents and Agent ID, Patient Spirometry™, NMT, recorder and datacard/network functionality are all identical to the predicate Cardiocap/5 Rev A (see attached table). The Cardiocap 5 REV. B and predicate use almost all the same accessories.

[ The only paramater differences are to add a 2nd temperature option (specification is the same as predicate) and to add options for two additional SPO2 measurement options N-XNSAT (Nellcor oximetry) and N-XOSAT (D-O enhanced oximetry).

In summary, it is evident that the main features and indications for use are substantially equivalent with the predicate Cardiocap/5 Rev A device (K992323). The comparisons above as well as supporting data and analysis shows that there are no new questions of

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safety and effectiveness for the Cardiocap/5 Rev B and accessories described in this submission is substantially equivalent to the predicate device.

## SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

- IEC 601-1 (1988) + Amendment 1 (1991) + Amendment 2 (1995) 사
- EN 60601-1 (1990) + A1 (1993) + A2 (1995) + A12 (1993) I
- CAN/CSA C22.2 No. 601-1-M90 (1990) + S1 (1994) 비
- t IEC 601-2-27 (1994) / EN 60601-2-27 (1994)
- IEC 601-2-30 (1995) / EN 60601-2-30 (1995) l
- 1 IEC 601-2-34 (1994) / EN 60601-2-34 (1995)
- 1 ISO 9919 (1992) / EN865 (1996)
- s ISO 9918 (1993) / EN864 (1996)
- ISO 7767: Oxygen monitors for monitoring patient breathing mixtures Safety I requirements
- 피 ISO 11196:95+Corr. 1:97 / EN 11196:1997: Anaesthetic gas monitors
- l IEC 60601-2-40:1998: Electromyographs and evoked response equipment
- ll AAMI EC13-1992: Cardiac Monitors, heart rate meters and alarms
- AAMI SP10-92: Electronic or automated sphygmomanometers. Note: AAMI SP10A-에 1996 Amendment is considered not to apply to the Cardiocap 5 since intended use is from 5 kg (11 lb.) up and the amendment gives requirements for neonatal use.

#### Conclusion:

The summary above shows that there are no new questions of safety and effectiveness for Datex-Ohmeda Cardiocap 5 (REV. B) and accessories as compared to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a family or group of people.

Public Health Service

SEP 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joel C. Kent Datex-Ohmeda 86 Pilgrim Road Needham, MA 02492

Re: K012837

Trade Name: Datex-Ohmeda Cardiocap 5 (REV. B) and accessories Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia detector and alarm Regulatory Class: Class III (three) Product Code: MLD Dated: August 19, 2001 Received: August 23, 2001

Dear Mr. Kent:

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. Joel C. Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I tease of deviloed that I Draination that your device complies with other requirements of the Act that I Drilles and regulations administered by other Federal agencies. You must or any I vith 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 CFR Part 607); moonly (21 CFR Part 820); and if applicable, the electronic form in the quality bybolins (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) I ms lotter will and wy your e FDA finding of substantial equivalence of your device to a legally premated predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF ICT at 60%. Additionally, for questions on the promotion and advertising of Compinance at (301) 597 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Outer general mironmation turers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Qak Mteh
James F. Dillard III

James E. Dillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kolo 8337 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda Cardiocap 5 (REV. B) and accessories

### Indications For Use:

The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories are indicated for indoor monitoring of hemodynamic (ECG, Impedance respiration, NIBP, Temperature, SPO2 and invasive pressure) , respiratory (CO2, O2, N2O, respiration rate, anesthetic agent and agent identification), ventilatory (airway pressure, volume and flow) and relaxation status (NMT) of all hospital patients.

With the N-XOSAT option, monitoring of arterial oxygen saturation includes monitoring hospital patients under clinical motion conditions.

Impedance Respiration measurement is indicated for patients ages 3 years and older.

Cardiocap/5 is indicated for patients weighing 5 kg (11 lb.) or more.

The monitor is indicated for use by qualified medical personnel only.

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X | |
|---------------------------------------|----|--------------------------|
| | OR | Over-The-Counter Use |
| | | (Optional Format 1-2-96) |

Division of Cardiovascular & Respiratory Devices

| 510(k) Number | K012837 |
|---------------|---------|
|---------------|---------|

Nabatah