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 Description

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.

AI/ML Overview

The Datex-Ohmeda Cardiocap 5 (Rev B) and its accessories, including the N-XOSAT option, are patient monitoring devices. The provided text outlines the declaration of substantial equivalence to a predicate device (Datex-Ohmeda Cardiocap 5 Rev A, K992323) rather than a direct study demonstrating acceptance criteria met for a novel device. The basis for acceptance is demonstrating that the new device is as safe and effective as the predicate device by showing identical intended use, substantially identical indications for use, and similar technological characteristics, with any differences not raising new questions of safety or effectiveness.

Here's an analysis based on the provided text, focusing on how the new device's equivalence and safety/effectiveness were established:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by the predicate device's performance and compliance with relevant standards. The "reported device performance" is implicitly that it meets or maintains these standards.

Acceptance Criterion (Implicit)	Reported Device Performance (as stated in submission)
Intended Use Equivalence: Same intended purpose as the predicate device.	"The Datex-Ohmeda Cardiocap 5 (REV. B) and accessories is substantially equivalent... in legally marketed (predicate) Datex-Ohmeda Cardiocap 5 Rev A (K992323). The intended use of the devices have not changed."
Indications for Use Equivalence: Nearly identical indications for use as the predicate, with minor enhancements not raising new concerns.	"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." (This addition is presented as an enhancement, not a new safety concern).
Technological Characteristics Equivalence: Key measurement parameters and core technology are identical or similar.	"The Cardiocap 5 REV. B measurement of ECG, SpO2, Temperature, invasive and non-invasive 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."
Safety and Effectiveness: No new questions of safety and effectiveness are raised by the changes.	"The comparisons above as well as supporting data and analysis shows that there are no new questions of safety and effectiveness for the Cardiocap/5 Rev B and accessories described in this submission is substantially equivalent to the predicate device." "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." "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."
Compliance with Standards: Adherence to recognized national and international safety and performance standards.	The device "complies with the safety standards below" and lists numerous IEC, EN, CAN/CSA, ISO, and AAMI standards (e.g., IEC 601-1, IEC 601-2-27, ISO 9919, AAMI EC13-1992, AAMI SP10-92).
Software Validation: Software changes are validated.	"The software was updated to incorporate those changes noted below but otherwise is the same as the predicate. ...software validation and verification of specifications." (Mention of S-XANE99 rev.01 and S-XCCA99 rev.01 compatibility with S-ARR99).
Hardware Changes (if any) do not impact safety/performance or are properly accounted for.	"The hardware is essentially the same with the exception of adding a new quick pushbutton key for simpler access to the recorder trend function." "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)."

2. Sample Size Used for the Test Set and Data Provenance:

The document describes non-clinical testing for compliance with standards rather than a clinical study with a "test set" of patients. The evaluations are primarily engineering and bench testing, software validation, and verification against established performance specifications and regulatory standards. There is no mention of a patient-based test set or data provenance (e.g., country of origin, retrospective/prospective). The N-XOSAT option mentions "monitoring hospital patients under clinical motion conditions," implying some level of testing for this specific feature, but no details on sample size or study design are provided in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

Not applicable. This is not a study requiring expert-established ground truth for patient outcomes or diagnoses. The "ground truth" for non-clinical testing refers to compliance with predefined engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of a human-read test set requiring adjudication in the context of this 510(k) submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was mentioned or performed as described in the provided text. The submission focuses on substantial equivalence to an existing device, not on demonstrating an improvement in human reader performance with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not explicitly detailed as a separate study. The device itself is a patient monitor, which inherently provides information to a human operator. The "software validation and verification of specifications" would constitute an assessment of the algorithm's performance in its specific functions (e.g., ST analysis, gas analysis, NIBP measurement) in a standalone capacity against its own internal specifications and relevant standards.

7. The Type of Ground Truth Used:

For the non-clinical testing, the "ground truth" refers to:

Engineering Specifications: The device's performance parameters (e.g., accuracy of ECG, SpO2, NIBP measurements) are verified against internal design specifications derived from industry standards and clinical requirements.
Regulatory Standards: Compliance with the listed mandatory and voluntary standards (e.g., IEC 601-1, AAMI SP10-92) serves as a "ground truth" for safety and basic performance acceptance.
Predicate Device Performance: The predicate device itself acts as a "ground truth" benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This document does not describe the development or validation of machine learning algorithms that typically require training sets. The "software validation" mentioned would refer to traditional software engineering quality assurance.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for machine learning.

Summary

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K012837

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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: 781-449-8685 Fax: 781-433-1344

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 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.

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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.

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 (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
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.(b)
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.