(64 days)
Not Found
No
The summary describes a standard medical device for monitoring CO2 and respiratory rate, with no mention of AI or ML in the intended use, device description, or performance studies. The focus is on compliance with electrical safety, EMC, and software standards.
No.
The device is strictly for monitoring carbon dioxide and respiration rate and alerting clinical personnel; it does not treat or alleviate a condition.
Yes
The device "provides a means of monitoring carbon dioxide and respiration rate" and "alert[s] clinical personnel when the concentration moves outside user-defined limits." It "provides a number display for CO2 and respiratory rate, and a capnograph waveform." This monitoring and alerting function by measuring physiological parameters aligns with the definition of a diagnostic device.
No
The device description explicitly states it is a "modular unit" that is "inserted into the bay within the monitors" and is a "sidestream or mainstream analyzer," indicating it is a physical hardware component, not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Capno Module, 92517, directly monitors physiological parameters (carbon dioxide and respiration rate) in vivo (within the living patient) by analyzing exhaled breath. It does not examine specimens derived from the human body in a laboratory setting.
- Intended Use: The intended use is to monitor carbon dioxide and respiration rate in patients and alert clinical personnel. This is a direct physiological monitoring function, not an in vitro diagnostic test.
Therefore, the Capno Module, 92517, falls under the category of a physiological monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Capno Module, 92517 (92517) 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 92517 is intended to be used with and controlled by a Spacelabs Healthcare monitors. The 92517 is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.
Product codes (comma separated list FDA assigned to the subject device)
CCK
Device Description
The Spacelabs Healthcare Capno Module, 92517 (92517) is an easy-to-use modular unit used with Spacelabs Healthcare Ultraview SL or XPREZZON monitors. The 92517 is inserted into the bay within the monitors. which is then used to control the 92517, and provide the user interface for the 92517.
The 92517 is a sidestream or mainstream analyzer intended to provide a measurement of the following parameters: carbon dioxide (CO2); and respiratory rate.
The monitor provides a number display for CO2 and respiratory rate, and a capnograph waveform. The 92517 is intended to be used primarily in the operating room environment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric and neonate patients
Intended User / Care Setting
qualified medical personnel.
operating room environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 92517 was tested for performance in accordance with the following Electrical Safety Standards: IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical electrical . equipment - Part 1. General requirements for safety; and UL 60601-1: 2003, Medical electrical equipment - Part 1. General . requirements for safety. Test results indicated that the 92517 complies with the Standards. The 92517 was tested for performance in accordance with the following Electromagnetic Compatibility (EMC) Standard: Testing IEC 60601-1-2: 2007, Medical electrical equipment -- Part 1-2: . General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -- Requirements and tests. Test results indicated that the 92517 complies with the Standards. Software device modifications made to the 92517 were designed and Software Testing developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with internal documentation and the following Standards and guidance documents: . . FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 . Sep 99; . FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical . electrical equipment - Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems; and . IEC 62304: 2006, Medical device software -- Software life cycle processes. Test results indicate that the 92517 complies with its predetermined specification and the Standards and guidance documents.
The 92517 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 92517 complies with its predetermined specification and with the applicable Standards.
Verification and validation activities were conducted to establish the performance and safety characteristics of the software device modifications made to the 92517. The results of these activities demonstrate that the 92517 is safe and effective when used in accordance with its intended use and labeling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1400 Carbon dioxide gas analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
0
んに30112
510(k) Summary
ﺎ
MAR 2 1 2013
·
t;
| Submission Date: | 08 January 2013 | ||
|---|---|---|---|
| Submitter: | Spacelabs Healthcare | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 | |||
| Submitter Contact: | Spacelabs Healthcare | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 | |||
| Mr. David J. Geraghty | |||
| Spacelabs Healthcare | |||
| Phone: +1 (425) 657-7200, ext 5889 | |||
| Fax: +1 (425) 657-7210 | |||
| Email: david.geraghty@spacelabs.com | |||
| Official Contact: | Thomas Kroenke | ||
| Principal Consultant | |||
| Speed To Market, Inc. | |||
| PO Box 3018 | |||
| Nederland, CO 80466 USA | |||
| tkroenke@speedtomarket.net | |||
| 303 956 4232 | |||
| Manufacturing Site: | Spacelabs Healthcare | ||
| 5150 220th Avenue SE | |||
| Issaquah, WA 98029 | |||
| Trade Name: | Spacelabs Healthcare Capno Module, 92517 | ||
| Common Name: | CO2 monitor | ||
| Classification Name: | Carbon dioxide gas analyzer | ||
| Classification | |||
| Regulation: | 21 CFR §868.1400 | ||
| Product Code: | CCK | ||
| Substantially | |||
| Equivalent Devices: | New Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Spacelabs Healthcare | |||
| Capno Module, 92517 | K121017 | Spacelabs Healthcare | |
| Capnography Pod | |||
| (92516) |
ﮨﮯ-ﺎ
1
510(k) Summary
The Spacelabs Healthcare Capno Module, 92517 (92517) is an easy-to-Device Description: use modular unit used with Spacelabs Healthcare Ultraview SL or XPREZZON monitors. The 92517 is inserted into the bay within the monitors. which is then used to control the 92517, and provide the user interface for the 92517.
The 92517 is a sidestream or mainstream analyzer intended to provide a measurement of the following parameters: carbon dioxide (CO2); and respiratory rate.
The monitor provides a number display for CO2 and respiratory rate, and a capnograph waveform. The 92517 is intended to be used primarily in the operating room environment.
Intended Use: The Capno Module, 92517 (92517) 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 92517 is intended to be used with and controlled by a Spacelabs Healthcare monitors. The 92517 is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.
Technology Comparison: . The 92517 employs the same technological characteristics as the predicate device.
| Characteristic | Predicate Device | Proposed Device |
|---|---|---|
| Parameters | Carbon dioxide (CO2); and | |
| respiratory rate. | Same | |
| EtCO2 | Yes | Same |
| FiCO2 | Yes | Same |
| Measurement | ||
| Technology | Infrared Sensor | Same |
| Sampling | ||
| Technique | Sidestream | Sidestream and mainstream |
2
510(k) Summary
Summary of Performance Testing:
The 92517 was tested for performance in accordance with the following Electrical Safety Standards: IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical electrical . equipment - Part 1. General requirements for safety; and UL 60601-1: 2003, Medical electrical equipment - Part 1. General . requirements for safety. Test results indicated that the 92517 complies with the Standards. The 92517 was tested for performance in accordance with the following Electromagnetic Compatibility (EMC) Standard: Testing IEC 60601-1-2: 2007, Medical electrical equipment -- Part 1-2: . General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility -- Requirements and tests. Test results indicated that the 92517 complies with the Standards. Software device modifications made to the 92517 were designed and Software Testing developed according to a robust software development process, and were rigorously verified and validated. Software information is provided in accordance with internal documentation and the following Standards and guidance documents: . . FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 . Sep 99; . FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medical . electrical equipment - Part 1-4: General requirements for safety -Collateral Standard: Programmable electrical medical systems; and . IEC 62304: 2006, Medical device software -- Software life cycle processes. Test results indicate that the 92517 complies with its predetermined
specification and the Standards and guidance documents.
3
510(k) Summary
Performance Testing
The 92517 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 92517 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 92517. The results of these activities demonstrate that the 92517 is safe and effective when used in accordance with its intended use and labeling.
Therefore, the 92517 is considered substantially equivalent to the predicate device.
4
Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and appears to be the heading of a document or publication. The words are stacked on a single line.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2013
Spacelabs Healthcare C/O Mr. Thomas Kroenke Principal Consultant Speed To Market, Incorporated P.O. Box 3018 NEDERLAND CO 80466
Re: K130112
Trade/Device Name: Spacelabs Healthcare Capno Module, 92517 Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: February 14, 2013 Received: February 22, 2013
Dear Mr. Kroenke:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
5
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 devicerelated 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Image /page/5/Figure/7 description: The image shows the text "Kwame O. Ulmer for". The text is in black and white, and the font is simple and easy to read. The letters "O.U" are stylized with a geometric pattern. The word "for" is smaller than the rest of the text.
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name:
Indications for Use:
K 130 112
Spacelabs Healthcare Capno Module, 92517
The Capno Module, 92517 (92517) 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 92517 is intended to be used with and controlled by a Spacelabs Healthcare monitors. The 92517 is intended to be used for monitoring adult, pediatric and neonate patients, under the direction of qualified medical personnel.
Prescription Use (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)
Lester W. Schultheis 2013.03.12 12:11:55 =04'00'
(Division Sign-Off) (Division Sign-On)
Division of Anestheslology, General Hospital Infection Control, Dental Devices
1130112 510(k) Number.
Page 1 of 1