(219 days)
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight < 30g
- Visual status indicator
The provided document is a 510(k) clearance letter and summary for the Medical Gas Analyzer (AG200). It does not contain information about a study proving the device meets its acceptance criteria.
The document states: "the subject device does not require clinical test data to support substantial equivalence." This means that the device was cleared based on its similarity to existing devices and bench testing, rather than a clinical study demonstrating its performance against specific acceptance criteria in a real-world setting.
Therefore, I cannot provide the requested information about the study proving the device meets acceptance criteria, the sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, or training set details as they are not present in the provided text.
However, I can extract the acceptance criteria as reported in the document through comparison with the predicate device, although these are not explicitly presented as "acceptance criteria" but rather as "device performance" parameters.
1. Table of Acceptance Criteria and Reported Device Performance (as implied by comparison to predicate/reference devices):
| Parameter | Medical Gas Analyzer (AG200) Reported Performance | Predicate Device (K123043) | Acceptance Criteria (Implied by Substantial Equivalence) |
|---|---|---|---|
| CO2 Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | Within ±(0.2 vol% + 2% of reading) for 0 to 15 vol% |
| N2O Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | 0 to 100 vol%, ±(2 vol% + 2% of reading) | Within ±(2 vol% + 2% of reading) for 0 to 100 vol% |
| Halothane, Enflurane, Isoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 8 vol% |
| Sevoflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 10 vol% |
| Desflurane Accuracy (dry single gases at 22±5℃ and 1013±40hPa) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | Within ±(0.15 vol% + 5% of reading) for 0 to 22 vol% |
| CO2 Accuracy (all conditions) | ±(0.3 vol% + 4% of reading) | ±(0.3 vol% + 4% of reading) | Within ±(0.3 vol% + 4% of reading) |
| N2O Accuracy (all conditions) | ±(2 vol% + 5% of reading) | ±(2 vol% + 5% of reading) | Within ±(2 vol% + 5% of reading) |
| Agents Accuracy (all conditions) | ±(0.2 vol% + 10% of reading) | ±(0.2 vol% + 10% of reading) | Within ±(0.2 vol% + 10% of reading) |
| Respiration Rate Range | 0 to 150 breaths/min | 2 to 150 breaths/min | 0 to 150 breaths/min (implied by compliance with ISO 80601-2-55 despite difference in predicate's lower limit) |
| Respiration Rate Accuracy | ±1 breaths/min | ±1 breaths/min | Within ±1 breaths/min |
| Anaesthetic Agents Threshold | 0.2 vol% | 0.15 vol% (with caveats) | 0.2 vol% deemed acceptable as verified by bench test and compliance with ISO 80601-2-55. |
| Warm-up time | 10-180 seconds | < 20 seconds (agent identification enabled and full accuracy) | 10-180 seconds, as verified by bench test and consistent with specified operating temperature range. |
| Data Update Frequency | 20Hz | 20Hz | 20Hz |
| Total System Response Time | <1 second | <1 second | <1 second |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "bench tests" and "software validation testing" but does not provide details on the number of samples or test cases used.
- Data Provenance: Not applicable, as no human clinical or retrospective/prospective data is mentioned. The testing described is "bench testing" and "software validation testing," which are laboratory-based and device-centric.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe the establishment of a ground truth by experts for a test set. Testing was primarily technical compliance ("bench tests") and software validation. For the manual anesthetic agent selection, it mentions "qualified clinicians" but no specific number or qualifications are provided, nor is their role in establishing "ground truth" for the device's performance defined.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of an adjudication method, as the tests were not clinical studies requiring expert review of medical data.
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:
- Not applicable. No MRMC comparative effectiveness study was conducted. The device is a Medical Gas Analyzer, not an AI-assisted diagnostic or interpretive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The testing described, primarily "bench tests" and "software validation testing," assesses the device's performance in a standalone capacity (algorithm only). However, the results are presented as "Pass" for compliance with standards rather than specific performance metrics (e.g., accuracy, precision) in a standalone context beyond what is listed in the performance table. The distinction of "standalone performance" as it typically applies to AI algorithms is not explicitly made, but the listed performance characteristics are inherent to the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the bench tests, the ground truth would be established by reference measurement devices or calibrated gas mixtures with known concentrations, as well as adherence to the requirements outlined in standards like ISO 80601-2-55. This is typically a known, controlled input.
8. The sample size for the training set:
- Not applicable. The device is a hardware-based gas analyzer with software; it is not an AI/machine learning device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. As noted above, the device does not use a "training set" in the context of machine learning.
FDA 510(k) Clearance Letter - Medical Gas Analyzer (AG200)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
August 28, 2025
Prior Care Science Technology LTD
John Liu
RA Manager
Area F2 ,2F, Building 1, Bao'an Avenue Industrial Zone,
Yabian Xueziwei, Yabian Community, Shajing Subdictrict, Bao'
Shenzhen, GD 518101
China
Re: K250148
Trade/Device Name: Medical Gas Analyzer (AG200)
Regulation Number: 21 CFR 868.1400
Regulation Name: Carbon Dioxide Gas Analyzer
Regulatory Class: Class II
Product Code: CCK, CBR, CBS, CBQ, NHQ, NHP, NHO
Dated: July 23, 2025
Received: July 23, 2025
Dear John Liu:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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K250148 - John Liu Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
Page 3
K250148 - John Liu Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bradley Q. Quinn -S
Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known)
K250148
Device Name
Medical Gas Analyzer (AG200)
Indications for Use (Describe)
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
Medical Gas Analyzer_Traditional 510k Submission
510(k) Summary
This summary of 510(k) information is submitted as required by requirements of 21 CFR 807.92.
1. Submitter's Identification
Applicant: Prior Care Science Technology LTD
Address: Area F2 ,2F, Building 1, Bao'an Avenue Industrial Zone, Yabian Xueziwei, Yabian Community, Shajing Subdictrict, Bao'an District, Shenzhen City, Guangdong Province, China
Contact person: Xiong Menglong
General Manager
Tel: +86-13787119781
E-mail: jacky@prior-care.com
Prepared by: Mr. John Liu
E-mail: john0086@aliyun.com
Company: Prior Care Science Technology LTD
Date prepared: July. 18, 2025
2. Subject device information
Device: Multigas Monitor
Device Trade Name: Medical Gas Analyzer
Model: AG200
Regulation Name: Carbon dioxide gas analyzer
Regulatory Class: II
Product Code: CCK
Regulation Number: 21 CFR 868.1400
Review Panel: Anesthesiology
Page 6
3. Predicate device information
Predicate device
510(k) Number: K123043
Trade/ Device Name: IRMA-Infrared Mainstream Gas Analyzer
Manufacturer: PHASEIN AB/ Masimo Sweden AB
Regulation Name: Carbon dioxide gas analyzer
Regulatory Class: II
Product Code: CCK
Regulation Number: 21 CFR 868.1400
Review Panel: Anesthesiology
Reference device
510(k) Number: K042601
Trade/ Device Name: CAPNOSTAT 5 CO2 sensor
Manufacturer: Respironics Novametrix, LLC
Regulation Name: Carbon dioxide gas analyzer
Regulatory Class: II
Product Code: CCK
Regulation Number: 21 CFR 868.1400
Review Panel: Anesthesiology
4. Device description
The Medical Gas Analyzer is a mainstream respiratory gas analyzer based on infrared gas spectrometry. It is intended to be connected to another medical host device for display of respiratory parameters. It is connected to the patient breathing circuit via the Airway Adapter. This premarket submission adds the C50 Multi-parameter Patient Monitor as a host backboard display to AG200. The C50 Multi-parameter Patient Monitor produced by Shenzhen Comen Medical Instruments Co., Ltd., which has obtained FDA's 510K clearance (K191106).
Page 7
The concentrations of CO2, N2O, Halothane, Enflurane, Isoflurane, Sevoflurane and Desflurane can be determined together with derived parameters such as waveform data and inspired / expired concentrations of all gases.
The mainstream probe airway adapter is inserted between the endotracheal tube and the breathing circuit, and the gas measurements are obtained through the windows in the sides of the adapter. Running on a standard low voltage DC 5V, the mainstream probe is designed with portability in mind and has low power consumption.
The mainstream gas analyzers are characterized by the following features:
- Low system integration complexity
- Low power consumption
- Fast startup time
- Low weight < 30g
- Visual status indicator
5. Indication for use/ Intended Use
The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane.
It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances.
Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care.
6. Substantial Equivalence Comparison
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
Page 8
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| Device name | Medical Gas Analyzer | Infrared Mainstream Gas Analyzer | CAPNOSTAT 5 CO2 sensor | NA |
| Model | AG200 | IMRA AX+ | CAPNOSTAT 5 | NA |
| Manufacturer | Prior Care Science Technology LTD | PHASEIN AB/ Masimo Sweden AB | Respironics Novametrix, LLC | NA |
| Regulation number | 21 CFR868.1400 | 21 CFR868.1400 | 21 CFR868.1400 | Substantially Equivalent. |
| Product code | CCK | CCK | CCK | Substantially Equivalent. |
| Prescription or OTC | Prescription Use | Prescription Use | Prescription Use | Substantially Equivalent. |
| Indication for use/ Intended use | The Medical Gas Analyzer is intended to be connected to other medical devices for monitoring of the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. It may be used in the operating suite, intensive care unit | The IRMA mainstream gas analyzer is intended to be connected to other medical devices for monitoring of breath rate and the breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane. It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory | The intended use of the Capnostat 5 CO2 sensor is to provide carbon dioxide monitoring to a host monitoring system during anesthesia/ recovery, in the intensive care unit (ICU), and in Emergency Medicine/ Transport or Respiratory care. | Compared with Predicate device: Breath rate monitoring capability is not incorporated in the subject device. (Different Note 01) Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the |
Page 9
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| and patient room for adult, pediatric and infant patients.The CO2 may also be used in the emergency medical services environment and road ambulances. Note: The Medical Gas Analyzer shall only be connected to medical devices approved by Prior-care. | care. It may be used in the operating suite, intensive care unit and patient room for adult, pediatric and infant patients. IRMA CO2 may also be used in the emergency medical services environment and road ambulances. Note: An IRMA mainstream gas analyzer shall only be connected to medical devices approved by PHASEIN. | equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||
| Intended patient population | Adult, pediatric and infant patients | Adult, pediatric and infant patients | Adult, pediatric and infant patients | Substantially Equivalent. |
| Principle of operation | Infrared gas spectrometry, no moving parts | Infrared gas spectrometry, no moving parts | Infrared absorption, no moving parts | Substantially Equivalent. |
| Energy source | Power by the matching backboard device; 4.5 - 5.5 VDC, max 1.5W | Power by the matching backboard device; 4.5 - 5.5 VDC, max 1.4W | Power by the matching backboard device | Substantially Equivalent. |
| Type of protection | Class II | Class II | Class II | Substantially Equivalent. |
| Degree of protection of Electrical Shock | Defibrillation proof BF-Applied Part | Defibrillation proof BF-Applied Part | Not specified | Compared with Predicate device: |
Page 10
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||||
| Protection against harm from liquid ingress | IP44 | IP44 | Not specified | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, |
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| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". Compared with Predicate device: Substantially Equivalent. | ||||
| Operating mode | Continuous | Continuous | Continuous | Substantially Equivalent. |
| Display type | No display, displayed by the matching backboard device | No display, displayed by the matching backboard device | No display, displayed by the matching backboard device | Substantially Equivalent. |
| Monitoring gas | The breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane | The breath rate and breathing gases CO2, N2O and the anesthetic agents Halothane, Enflurane, Isoflurance, Sevoflurance and Desflurane | Respiration rate and breathing gases CO2 | Compared with Predicate device: Breath rate monitoring capability is not incorporated in the subject device. (Different Note 01) Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to |
Page 12
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||||
| Measurement method | Infrared absorption method | Infrared absorption method | Infrared absorption method | Substantially Equivalent. |
| Measure mode | Mainstream | Mainstream | Mainstream | Substantially Equivalent. |
| Airway adapters | Disposable adult/pediatric: - Adds less than 6 ml deadspace Disposable infant: - Adds less than 1 ml deadspace | Disposable adult/pediatric: - Adds less than 6 ml deadspace Disposable infant: - Adds less than 1 ml deadspace | Disposable adult/pediatric: - Adds less than 5 ml deadspace Disposable infant: - Adds less than 1 ml deadspace | Substantially Equivalent. |
| Respiration rate / | 0 to 150 ±1breaths/min. The respiration rate is displayed after three breaths and the average value is updated every breath | Range: 2 - 150 breaths per minute Accuracy: ±1breaths/min | Compared with Predicate device: Breath rate monitoring capability is not incorporated in the subject device. (Different Note 01) Compared with Reference device: The reference |
Page 13
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||||
| Fi and Et | CO2, N2O, Agents (HAL, ISO, ENF, SEV, DES） Fi and Et are displayed after one breath and have a continually updated breath average. The following methods are used to calculate end-tidal(Et) values: - - CO2: The highest concentration of CO2 during one breathing cycle - - N2O and anesthetic agents: The momentary gas concentration at the time point where ETCO2 is detected. Et-values for anaesthetic | Measured gas: CO2, N2O, primary and secondary agents (HAL, ISO, ENF, SEV, DES) Fi and Et are displayed after one breath and have a continuously updated breath average. The following method is used to calculate end-tidal (Et) values: - CO2: The highest concentration of CO2 during one breathing cycle with a weight function applied to favor values closer to the end of the cycle. | Not specified | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and |
Page 14
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| agents and N2O will typically decrease below nominal value when respiration rate exceeds 80 bpm. EtCO2 will be within specification for all respiration rates up to 150 bpm. | - N2O primary and secondary agents (HAL, ISO, ENF, SEV, DES): The momentary gas concentration at the time point where EtCO2 is detected. Et-values for anaesthetic agents and N2O will typically decrease below nominal value when respiratory rate exceeds 80 bpm. EtCO2 will be within specification for all respiratory rates up to 150 bpm. | "Warm-up time". | ||
| Accuracy (for dry single gases at 22±5℃ and 1013±40hPa.) | CO2: range 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | CO2: range 0 to 15 vol%, ±(0.2 vol% + 2% of reading) | 0 - 40 mmHg, ±2 mmHg 41 - 70 mmHg, ±5% of actual 71 - 100 mmHg, ±8% of actual 101 - 150 mmHg, ±10% of reading (At respiration rates > 80 breaths per minute, all ranges are ±12% of actual.) | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: Different Note 02 |
Page 15
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| N2O: range 0 to 100 vol%, ±(2 vol% + 2% of reading) | N2O: range 0 to 100 vol%, ±(2 vol% + 2% of reading) | The reference device does not support N2O, HAL, ISO, ENF, SEV, or DES monitoring. | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | |
| HAL, ISO, ENF: range 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | HAL, ISO, ENF: range 0 to 8 vol%, ±(0.15 vol% + 5% of reading) | |||
| SEV: range 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | SEV: range 0 to 10 vol%, ±(0.15 vol% + 5% of reading) | |||
| DES: range 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | DES: range 0 to 22 vol%, ±(0.15 vol% + 5% of reading) | |||
| Accuracy (all conditions) | CO2: ±(0.3 vol% + 4% of reading) | CO2: ±(0.3 vol% + 4% of reading) | Not specified | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: The reference device is exclusively |
| N2O: ±(2 vol% + 5% of reading) | N2O: ±(2 vol% + 5% of reading) | The reference device does not support N2O, HAL, ISO, ENF, SEV, or DES monitoring. | ||
| Agents: ±(0.2 vol% + 10% of reading) | Agents: ±(0.2 vol% + 10% of reading) |
Page 16
| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||||
| Anaesthetic agents threshold | 0.2 vol% | 0.15 vol%. When an agent is identified, concentrations will be reported even below 0.15% as long as apnea is not detected; 0.2 vol% + 10% of total agent concentration | The reference device does not support N2O, HAL, ISO, ENF, SEV, or DES monitoring. | Compared with Predicate device: Different Note 03 Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". |
| Anaesthetic agents identification | Manual selection | Automatic identification | The reference device does not support N2O, HAL, | Compared with Predicate device: |
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| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| ISO, ENF, SEV, or DES monitoring. | Different Note 04 Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | |||
| Prevent the impact of water vapor condensation | Heater-based | Optional HME (Heat Moisture Exchanger) | Heater-based | Compared with Predicate device: Different Note 05 Compared with Reference device: Substantially Equivalent. |
| Warm-up time | 10-180 seconds | < 20 seconds (agent identification enabled and full accuracy) Full specifications within 2 minutes at an ambient temperature of 25º C | Different Note 06 | |
| Data update frequency | 20Hz | 20Hz | Not specified | Compared with Predicate device: |
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| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". | ||||
| Total system response time | <1 second | <1 second | Not specified | Compared with Predicate device: Substantially Equivalent. Compared with Reference device: The reference device is exclusively equipped for CO2 monitoring, |
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| Characteristics | Subject device | Predicate device (K123043) | Reference device (K042601) | Remark |
|---|---|---|---|---|
| employed solely to verify the equivalence in "Prevent the impact of water vapor condensation" and "Warm-up time". Compared with Predicate device: Substantially Equivalent. | ||||
| Performance | Complied with ISO 80601-2-55 | Complied with ISO 80601-2-55 | Complied with ISO 80601-2-55 | Substantially Equivalent. |
Note 01:
The subject device does not support breath rate monitoring, and the predicate device supports breath rate monitoring. The CO2, N2O and the anesthetic agents of subject device have been verified by the bench test, and the subject device complies with ISO 80601-2-55. The difference does not raise any safety and effectiveness issues based on tests in this submission.
Note 02:
The subject device exhibits different CO2 range and accuracy compared to the reference device. These parameters, however, are identical to those of the predicate device. The CO2 range and accuracy of subject device have been verified by the bench test, and the subject device complies with ISO 80601-2-55. The difference does not raise any safety and effectiveness issues based on tests in this submission.
Note 03:
The anaesthetic agents threshold of the subject device is different from the predicate device. But the anaesthetic agents threshold of the subject device has been verified by the bench test, and the subject device complies with ISO 80601-2-55. The difference does not raise any safety and effectiveness issues based on tests in this submission.
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Note 04:
The predicate device incorporates automated anesthetic gas identification, whereas the subject device requires manual selection of the anesthetic agent by qualified clinicians via key operation. Software validation testing confirmed the efficacy of the gas selection function on the subject device. Manual selection by clinicians demonstrated higher reliability compared to automated gas identification. The difference does not raise any safety and effectiveness issues based on tests in this submission.
Note 05:
Both the subject device and the reference device (K042601) don't incorporate an HME (Heat and Moisture Exchanger). Both the subject device and the reference device (K042601) utilize a heater for preventing the impact of water vapor condensation. The predicate device offers HME as an optional feature. The reference device has a commercial distribution history of over 15 years in the market, which substantiates that the use of a heater is effective in preventing the impact of water vapor condensation. Consequently, the difference in "preventing the impact of water vapor condensation" between the subject device and predicate device are not clinically significant with regard to safety or effectiveness.
Note 06:
Neither the subject device nor the reference device incorporates an HME (Heat and Moisture Exchanger), whereas the predicate device offers HME as an optional feature. As with the reference device, the subject device exhibits an extended warm-up duration relative to the predicate device. The warm-up time of the subject device (range: 10-180 seconds) corresponds to its operational performance within the specified operating temperature range of 10℃ to 40℃, demonstrating minor variations compared to the reference device. And the warm-up time of the subject device has been verified by the bench test. The software system level test report in this submission under defined conditions demonstrated a nominal surface heating
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temperature of 38℃ (±2°C accuracy) for the subject device, with a maximum recorded value of 43.6℃ at an ambient temperature of 40º C. The airway adapter has a relatively short profile. Since the gas is in a continuous flow state within the breathing circuit, the surface temperature of the airway adapter has a minimal effect on the temperature of the gas itself. And the surface heating temperature is safe for patients, clinicians and subject device. The difference in warm-up time does not raise any safety and effectiveness issues.
Based on the aforementioned substantial equivalence comparison table, the subject device is as same as predicate device. The Breath rate (refer to Note 01), CO2 range and accuracy (refer to Note 02), Anaesthetic agents threshold (refer to Note 03), Anaesthetic agents identification (refer to Note 04), Prevent the impact of water vapor condensation (refer to Note 05), Warm-up time (refer to Note 06) are different which had been validated. However, the differences would not raise any safety and effectiveness issue based on tests in this submission. Thus, the subject device is substantially equivalent to the predicate device which is legally marketed in US.
7. Brief discussions of the non-clinical tests
The following tests were conducted to demonstrate substantial equivalence to the predicate device:
| Test Standard | Description | Result |
|---|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)] | Pass |
| IEC 60601-1-2 Edition 4.1 2020-09 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential | Pass |
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| Test Standard | Description | Result |
|---|---|---|
| CONSOLIDATED VERSION | performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| ISO 80601-2-55 Second edition 2018-02 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | Pass |
| ISO 10993-1 Fifth edition 2018-08 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Pass |
| ISO 10993-5 Third edition 2009-06-01 | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| ISO 10993-10 Fourth edition 2021-11 | Biological evaluation of medical devices - Part 10: Tests for skin sensitization | Pass |
| ISO 10993-23 First edition 2021-01 | Biological evaluation of medical devices - Part 23: Tests for irritation | Pass |
| ISO 18562-1 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process | Pass |
| ISO 18562-2 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter | Pass |
| ISO 18562-3 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds | Pass |
| ISO 18562-4 First edition 2017-03 | Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: | Pass |
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| Test Standard | Description | Result |
|---|---|---|
| Tests for leachables in condensate | ||
| ISO 14971 Third edition 2019-12 | Medical devices - Application of risk management to medical devices | Pass |
It is concluded that the subject devices are in compliance with the requirements of the aforementioned tests.
8. Brief discussions of the clinical tests
Not applicable, the subject device does not require clinical test data to support substantial equivalence.
9. Software information
The software documentation level of the Medical Gas Analyzer should be of the Basic Documentation. According to FDA Guidance document "Content of Premarket Submissions for Device Software Functions", the software validation documentation summarizes the required information for a Basic Documentation level.
10. Conclusions
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Prior Care Science Technology LTD concludes that the subject device is as safe and as effective, and thus substantially equivalent, to the predicate device, IMRA AX+ Infrared Mainstream Gas Analyzer (K123043).
§ 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).