CAPNOGRAPHY PAD (92516)

K121017 · Spacelabs Healthcare · CCK · Jul 13, 2012 · Anesthesiology

Device Facts

• Record ID: K121017
• Device Name: CAPNOGRAPHY PAD (92516)
• Applicant: Spacelabs Healthcare
• Product Code: CCK · Anesthesiology
• Decision Date: Jul 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Spacelabs Healthcare Capnography Pod, Model 92516 (CapnoPod) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits. The CapnoPod is intended to be used with and controlled by a Spacelabs Healthcare monitors. The CapnoPod is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.

Device Story

CapnoPod (92516) is a modular sidestream CO2 analyzer; attaches to Spacelabs Qube Compact Monitor (91390). Qube provides user interface, power, and display for CO2 concentration, respiratory rate, and capnograph waveforms. Used primarily in operating room environments by qualified medical personnel. Device uses infrared sensor technology to measure CO2; alerts clinicians when concentrations exceed user-defined limits. Benefits include continuous respiratory monitoring to assist in clinical decision-making regarding patient ventilation status.

Clinical Evidence

Bench testing only. Performance verified against IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarm systems), and ISO 21647 (respiratory gas monitors). Software verified and validated per FDA guidance and IEC 60601-1-4.

Technological Characteristics

Sidestream infrared CO2 sensor; modular form factor; connects to Spacelabs Qube monitor. RR range 1.5-150 bpm. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, and ISO 21647.

Indications for Use

Indicated for monitoring carbon dioxide and respiration rate in adult, pediatric, and neonate patients under the direction of qualified medical personnel.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Spacelabs Multigas Module, Model 92518 (K112173)

Submission Summary (Full Text)

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K121017

# 510(k) Summary

| Submission Date: | 21 March 2012 | | | JUL 13 2012 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--|-------------------------------------------|
| Submitter: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029 | | | |
| Submitter Contact: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029<br>Mr. David J. Geraghty<br>Spacelabs Healthcare<br>Phone: [phone], ext 5889<br>Fax: [phone]<br>Email: [e-mail] | | | |
| Official Contact: | Thomas Kroenke<br>Principal Consultant<br>Speed To Market, Inc.<br>PO Box 3018<br>Nederland, CO 80466 USA<br>[e-mail]<br>303 956 4232 | | | |
| Manufacturing Site: | Spacelabs Healthcare<br>5150 220th Avenue SE<br>Issaquah, WA 98029 | | | |
| Trade Name: | Spacelabs Healthcare Capnography Pod (92516) | | | |
| Common Name: | CO2 monitor | | | |
| Classification Name: | Carbon dioxide gas analyzer | | | |
| Classification<br>Regulation: | 21 CFR §868.1400 | | | |
| Product Code: | CCK | | | |
| Substantially<br>Equivalent Devices: | New Spacelabs Model | Predicate<br>510(k) Number | | Predicate Manufacturer / Model |
| | Spacelabs Healthcare<br>Capnography Pod<br>(92516) | K112173 | | Spacelabs Multigas<br>Module, Model 92518 |

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## 510(k) Summary

The Spacelabs Healthcare Capnography Pod (92516) (CapnoPod) is an Device Description: easy-to-use modular unit in the Spacelabs Healthcare family of monitors). The CapnoPod is attached to the pod connection on the rear of a Qube Compact Monitor (91390) (Qube). The Qube is then used to control the CapnoPod, and provide the user interface for the CapnoPod.

> The CapnoPod is a sidestream analyzer intended to provide a measurement of the following parameters: carbon dioxide (CO2); and respiratory rate.

> The Qube displays information from the CapnoPod and is the user interface for the CapnoPod. The Qube provides a number display for CO2 and respiratory rate, and a capnograph waveform. The CapnoPod is intended to be used primarily in the operating room environment.

#### Intended Use: The Spacelabs Healthcare Capnography Pod, Model 92516 (CapnoPod) is intended to provide a means of monitoring carbon dioxide and respiration rate and alert clinical personnel when the concentration moves outside of user-defined limits.

The CapnoPod is intended to be used with and controlled by a Spacelabs Healthcare monitors. The CapnoPod is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.

### Technology Comparison:

The CapnoPod employs the same technological characteristics as the predicate device.

| Characteristic | Predicate Device | Proposed Device |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Parameters | Carbon dioxide (CO₂); oxygen (O₂) and<br>nitrous oxide (N₂O); anesthetic agents<br>including: desflurane, enflurane,<br>halothane, isoflurane, and sevorflurane;<br>respiratory rate; and calculated MAC<br>and age-dependent MAC values. | Carbon dioxide (CO₂); and<br>respiratory rate. |
| EtCO₂ | Yes | Same |
| FiCO₂ | Yes | Same |
| Measurement<br>Technology | Infrared Sensor | Same |
| Sampling<br>Technique | Sidestream | Same |
| Respiration Rate<br>(RR) Range | 4 to 60 breaths per minute (bpm) | 1.5 to 150 bpm |
| RR Accuracy | $\u00b1$ 1 bpm | Same |

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## 510(k) Summary i

Summary of Performance Testing:

| Electrical Safety | The CapnoPod was tested for performance in accordance with the<br>following Standards:<br>IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical electrical<br>equipment - Part 1. General requirements for safety; and UL 60601-1: 2003, Medical electrical equipment - Part 1. General<br>requirements for safety. Test results indicated that the CapnoPod complies with the Standards. |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic<br>Compatibility (EMC)<br>Testing | The CapnoPod was tested for performance in accordance with the<br>following Standard:<br>IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Electromagnetic compatibility – Requirements<br>and tests. Test results indicated that the CapnoPod complies with the Standards. |
| Software Testing | Software device modifications made to the CapnoPod were designed<br>and developed according to a robust software development process, and<br>were rigorously verified and validated.<br>Software information is provided in accordance with internal<br>documentation and the following Standards and guidance documents: FDA guidance: The content of premarket submissions for software<br>contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09<br>Sep 99; FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical<br>electrical equipment - Part 1-4: General requirements for safety –<br>Collateral Standard: Programmable electrical medical systems. Test results indicate that the CapnoPod complies with its predetermined<br>specification and the Standards and guidance documents. |

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### 510(k) Summary

| Performance Testing | The CapnoPod was tested for performance in accordance with internal documentation and the following Standards: | | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| • | IEC 60601-1-8: 2006, Medical electrical equipment – Part 1-8: General requirements for basic safety and essential performance – Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems; and | | |
| • | ISO 21647: 2004, Medical electrical equipment – Particular requirements for the basic safety and essential performance of respiratory gas monitors. | | |
| Test results indicated that the CapnoPod complies with its | | | |

Test results indicated that the CapnoPod complies with its predetermined specification and with the applicable Standards.

Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the CapnoPod. The results of these activities demonstrate that the CapnoPod is safe and effective when used in accordance with its intended use and labeling.

Therefore, the CapnoPod is considered substantially equivalent to the predicate device.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Spacelabs Healthcare C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated P.O. Box 3018 Nederland. Colorado 80466

JUL 30 2012

Re: K121017

Trade/Device Name: Spacelabs Healthcare Capnography Pod (92516) Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: June 13, 2012 Received: June 15, 2012

Dear Mr. Kroenke:

This letter corrects our substantially equivalent letter of July 13, 2012.

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 (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 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. Kroenke

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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#### Indications for Use

| 510(k) Number (if known): | K121017 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Spacelabs Healthcare Capnography Pod (92516) |
| Indications for Use: | The Spacelabs Healthcare Capnography Pod, Model 92516<br>(CapnoPod) is intended to provide a means of monitoring carbon<br>dioxide and respiration rate and alert clinical personnel when the<br>concentration moves outside of user-defined limits.<br><br>The CapnoPod is intended to be used with and controlled by a<br>Spacelabs Healthcare monitors. The CapnoPod is intended to be<br>used for monitoring adult, pediatric and neonate patients, under<br>the direction of qualified medical personnel. |

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
CDRH, Office of Device

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: _

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