(100 days)
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.
The Spacelabs Healthcare Capnography Pod (92516) (CapnoPod) is an 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.
The provided text is a 510(k) Summary for the Spacelabs Healthcare Capnography Pod (92516). While it describes various tests conducted (electrical safety, EMC, software, and performance to standards), it does not contain the specific details required to fully address your request in the format you've outlined.
Specifically, the document primarily focuses on demonstrating compliance with recognized standards and internal documentation for safety and software development, rather than a clinical study with detailed acceptance criteria and reported device performance in terms of clinical accuracy or effectiveness.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device / Implied) | Reported Device Performance (from CapnoPod) |
|---|---|---|
| Carbon Dioxide (CO₂) | Yes (same as predicate) | Same |
| Respiratory Rate (RR) Range | 4 to 60 breaths per minute (bpm) (from predicate) | 1.5 to 150 bpm |
| RR Accuracy | ± 1 bpm (From predicate and stated as "Same") | ± 1 bpm |
| Electrical Safety | Compliance with IEC 60601-1, UL 60601-1 | Complies with the Standards |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2 | Complies with the Standards |
| Software Testing | Compliance with FDA guidance, IEC 60601-1-4 | Complies with predetermined specification and Standards |
| Performance Testing (General) | Compliance with IEC 60601-1-8, ISO 21647 | Complies with predetermined specification and applicable Standards |
Missing Information for this table: Specific quantitative acceptance criteria for CO2 measurement accuracy, response time, or specific error margins. The document states "Same" for EtCO2 and FiCO2, implying the predicate's performance is met, but doesn't explicitly state what that predicate performance is beyond "Yes" (meaning it measures it).
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for any of the performance tests. The document mentions "test results indicated that the CapnoPod complies..." but doesn't detail the number of units tested, number of measurements, or patient data used.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). The tests referenced are primarily bench testing against standards ("internal documentation and the following Standards").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Experts and Qualifications: Not applicable or not stated. The performance tests seem to be against established physical standards and regulatory requirements, not clinical expert ground truth for interpretation.
4. Adjudication method for the test set
- Adjudication Method: Not applicable or not stated. This type of adjudication is typically for subjective assessments or discrepancy resolution in clinical image review, which is not the nature of the tests described for this device.
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
- MRMC Study: No. This device is a CO2 monitor, not an AI-powered diagnostic imaging tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The "Performance Testing" section and the detailed technology comparison describe the device's inherent measurement capabilities. While not explicitly termed "standalone algorithm performance," the testing against standards would represent the device's performance independent of operator interpretation beyond initial setup and monitoring. The software testing also validates the internal logic. However, it's not an "algorithm" in the sense of a complex AI model.
7. The type of ground truth used
- Type of Ground Truth: The ground truth for the performance testing appears to be established industry standards and physical measurements (e.g., calibrated gas mixtures for CO2, known respiration rates for RR testing, specified electrical and EMC conditions). For software, it was compliance with "predetermined specification" and guidance documents.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable or not stated. This device is not described as using machine learning or AI that would require a "training set" in the conventional sense. Its functionality is based on established infrared sensor technology.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there's no mention of a training set for an AI/ML model, the establishment of ground truth for such a set is not relevant.
In summary: The 510(k) summary provided for the Capnography Pod primarily demonstrates compliance with electrical safety, EMC, software development processes, and general performance standards. It lacks the detailed clinical study information (like sample sizes for test sets, expert consensus, MRMC studies, or AI training set details) that would be common for more complex diagnostic AI/ML medical devices. The performance validation relies heavily on meeting established technical specifications and regulatory standards for medical device monitors.
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510(k) Summary
| Submission Date: | 21 March 2012 | JUL 13 2012 | ||
|---|---|---|---|---|
| Submitter: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029 | |||
| Submitter Contact: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029Mr. David J. GeraghtySpacelabs HealthcarePhone: +1 (425) 657-7200, ext 5889Fax: +1 (425) 657-7210Email: david.geraghty@spacelabs.com | |||
| Official Contact: | Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232 | |||
| Manufacturing Site: | Spacelabs Healthcare5150 220th Avenue SEIssaquah, WA 98029 | |||
| Trade Name: | Spacelabs Healthcare Capnography Pod (92516) | |||
| Common Name: | CO2 monitor | |||
| Classification Name: | Carbon dioxide gas analyzer | |||
| ClassificationRegulation: | 21 CFR §868.1400 | |||
| Product Code: | CCK | |||
| SubstantiallyEquivalent Devices: | New Spacelabs Model | Predicate510(k) Number | Predicate Manufacturer / Model | |
| Spacelabs HealthcareCapnography Pod(92516) | K112173 | Spacelabs MultigasModule, Model 92518 |
Page I of 4
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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) andnitrous oxide (N₂O); anesthetic agentsincluding: desflurane, enflurane,halothane, isoflurane, and sevorflurane;respiratory rate; and calculated MACand age-dependent MAC values. | Carbon dioxide (CO₂); andrespiratory rate. |
| EtCO₂ | Yes | Same |
| FiCO₂ | Yes | Same |
| MeasurementTechnology | Infrared Sensor | Same |
| SamplingTechnique | Sidestream | Same |
| Respiration Rate(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 thefollowing Standards:IEC 60601-1: 1988, Am1: 1991, Am2: 1995, Medical electricalequipment - Part 1. General requirements for safety; and UL 60601-1: 2003, Medical electrical equipment - Part 1. Generalrequirements for safety. Test results indicated that the CapnoPod complies with the Standards. |
|---|---|
| ElectromagneticCompatibility (EMC)Testing | The CapnoPod was tested for performance in accordance with thefollowing Standard:IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic compatibility – Requirementsand tests. Test results indicated that the CapnoPod complies with the Standards. |
| Software Testing | Software device modifications made to the CapnoPod were designedand developed according to a robust software development process, andwere rigorously verified and validated.Software information is provided in accordance with internaldocumentation and the following Standards and guidance documents: FDA guidance: The content of premarket submissions for softwarecontained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09Sep 99; FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, 11 Jan 02; IEC 60601-1-4: 2000, Medical electrical equipment Medicalelectrical equipment - Part 1-4: General requirements for safety –Collateral Standard: Programmable electrical medical systems. Test results indicate that the CapnoPod complies with its predeterminedspecification 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 (800) 638-2041 or (301) 796-7100 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(CapnoPod) is intended to provide a means of monitoring carbondioxide and respiration rate and alert clinical personnel when theconcentration moves outside of user-defined limits.The CapnoPod is intended to be used with and controlled by aSpacelabs Healthcare monitors. The CapnoPod is intended to beused for monitoring adult, pediatric and neonate patients, underthe 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: _
Page 1 of 1
§ 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).