(212 days)
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.
The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).
The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.
The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.
The provided text is a 510(k) summary for the "Gas Module 3" device (K180788). This document primarily focuses on establishing substantial equivalence to a predicate device (Gas Module SE, K062754) based on non-clinical testing. It does not describe an acceptance criteria study in the conventional sense of establishing performance against a predefined clinical or statistical threshold.
Instead, the study outlined is a series of non-clinical bench tests and EMC/Electrical Safety tests designed to demonstrate that modifications to the predicate device still meet existing specifications and standards, and that its performance is equivalent to the predicate. There is no mention of a human-in-the-loop study, expert ground truth establishment, or specific sample sizes for clinical data because this is a non-clinical performance evaluation for a monitoring spirometer, not an AI/software-as-a-medical-device (SaMD) study involving ground truth or human reader performance.
Therefore, many of the requested fields cannot be directly populated from the provided text as they are not applicable to the type of device and study described.
Here's the information that can be extracted or deduced from the provided document:
1. A table of acceptance criteria and the reported device performance
The document details performance changes and states they meet relevant standards. It frames the "acceptance criteria" not as novel thresholds, but as continued adherence to existing specifications and consensus standards.
| Feature / Parameter | Predicate Device (Gas Module SE, K062754) Specification | Subject Device (Gas Module 3) Reported Performance / Specification | Comparison Analysis / "Acceptance Criteria Met" |
|---|---|---|---|
| Warm-up Time | 2 minutes (CO2, O2, N2O); 5 minutes (anesthetic agents); 30 minutes (full specification) | 45 seconds (CO2, O2, N2O, anesthetic agents); 10 minutes (full specification) | Acceptance: "Similar, warm-up time improved in Gas Module 3." Implied acceptance is faster warm-up is better. |
| Sampling Rate | 200 $\pm$ 20ml/min | 200 $\pm$ 20ml/min (larger water trap); 120 $\pm$ 12ml/min (smaller water trap) | Acceptance: "Same - The flow rate for larger size water trap is the same. The option to use a new smaller size water trap is introduced which support a flow rate of 120ml/min, which may provide enhanced gas management for smaller sized patients." Implied acceptance for 120ml/min is meeting clinical needs for smaller patients. |
| CO2 Measurement Range | 0 to 15% | 0 to 10% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| DES Measurement Range | 0 to 20% | 0 to 18% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| SEV Measurement Range | 0 to 8% | 0 to 8% | Acceptance: No change, same. |
| ENF Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| ISO Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| HAL Measurement Range | 0 to 6% | 0 to 5% | Acceptance: "Although the measurement range... for subject device is small than the predicate device, the difference... is insignificant in for the clinical use." |
| awRR Measurement Range | 4 to 60 rpm | 2 to 100 rpm | Acceptance: "The awRR measurement range for the subject device is wider than the predicate device. The awRR measurement range of the subject device has been tested using the test apparatus in figure 201.101 of ISO80601-2-55, and the test result meets the specification." Implied acceptance is broader range is beneficial and meets standards. |
| CO2 Accuracy | $\pm$ (0.2% + 2% of reading) | $\pm$ 0.1% @ 0-1%, $\pm$ 0.2% @ 1-5%, $\pm$ 0.3% @ 5-7%, $\pm$ 0.5% @ 7-10%, Unspecified @ >10% | Acceptance: "The CO2 measurement accuracy is now specified in different ranges. These accuracies in different ranges meet the requirements of ISO 80601-2-55." |
| O2 Accuracy | $\pm$ (1% + 2% of reading) | $\pm$ 1% @ 0-25%, $\pm$ 2% @ 25-80%, $\pm$ 3% @ 80-100% | Acceptance: "The O2 measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| N2O Accuracy | $\pm$ (1% + 2% of reading) | $\pm$ 2% @ 0-20%, $\pm$ 3% @ 20-100% | Acceptance: "The N2O measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| DES Accuracy | $\pm$ (0.15% + 5% of reading) | $\pm$ 0.1% @ 0-1%, $\pm$ 0.2% @ 1-5%, $\pm$ 0.4% @ 5-10%, $\pm$ 0.6% @ 10-15%, $\pm$ 1% @ 15-18%, Unspecified @ >18% | Acceptance: "The DES measurement accuracy is now specified in different ranges. These accuracies in different ranges still meet the requirements of ISO 80601-2-55." |
| SEV Accuracy | $\pm$ (0.15% + 5% of reading) | $\pm$ 0.15% @ 0-1%, $\pm$ 0.2% @ 1-5%, $\pm$ 0.4% @ 5-8%, Unspecified @ >8% | Acceptance: "The SEV measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| ENF Accuracy | $\pm$ (0.15% + 5% of reading) | $\pm$ 0.15% @ 0-1%, $\pm$ 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The ENF measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| ISO Accuracy | $\pm$ (0.15% + 5% of reading) | $\pm$ 0.15% @ 0-1%, $\pm$ 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The ISO measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| HAL Accuracy | $\pm$ (0.15% + 5% of reading) | $\pm$ 0.15% @ 0-1%, $\pm$ 0.2% @ 1-5%, Unspecified @ >5% | Acceptance: "The HAL measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55." |
| CO2 Rise Time | < 400ms | < 250 ms (200ml/min); < 250 ms (120ml/min) | Acceptance: "The CO2 rise time for subject device is smaller than the predicate device. The smaller rise time means the device can detect the variety of the concentration of the gas with greater sensitively." (Improved performance, meets implied criteria). |
| O2 Rise Time | < 400ms | < 400 ms (200ml/min); < 450 ms (120ml/min) | Acceptance: "The difference of rise time between the subject device and the predicate device is insignificant in clinical use. So no clinical risks or safety issue introduced." (Meets required clinical insignificance). |
| N2O Rise Time | < 400ms | < 250 ms (200ml/min); < 250 ms (120ml/min) | Acceptance: "The N2O rise time for subject device is smaller than the predicate device." (Improved performance). |
| DES Rise Time | < 600ms | < 300ms (200ml/min); < 300ms (120ml/min) | Acceptance: "The DES rise time for subject device is smaller than the predicate device." (Improved performance). |
| SEV Rise Time | < 600ms | < 300ms (200ml/min); < 300ms (120ml/min) | Acceptance: "The SEV rise time for subject device is smaller than the predicate device." (Improved performance). |
| ENF Rise Time | < 600ms | < 350ms (200ml/min); < 350ms (120ml/min) | Acceptance: "The ENF rise time for subject device is smaller than the predicate device." (Improved performance). |
| ISO Rise Time | < 600ms | < 300ms (200ml/min); < 300ms (120ml/min) | Acceptance: "The ISO rise time for subject device is smaller than the predicate device." (Improved performance). |
| HAL Rise Time | < 1000ms | < 300ms (200ml/min); < 300ms (120ml/min) | Acceptance: "The HAL rise time for subject device is smaller than the predicate device." (Improved performance). |
| All Gases Delay Time | < 2.5 s | < 4 s (200ml/min); < 4 s (120ml/min) | Acceptance: "The difference of delay time between the subject device and the predicate device is insignificant in clinical use. So no clinical risks or safety issue introduced." (Meets required clinical insignificance). |
| EMC/Electrical Safety | Compliance with AAMI ANSI ES 60601-1 and IEC 60601-1-2 (predicate) | Compliance with AAMI ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012* and IEC 60601-1-2:2014 | Acceptance: "The testing provides an evaluation of the EMC and electrical safety of the subject devices relevant to each of the modifications... shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device." |
| General Performance | Meets specifications (predicate) | Meets specifications (subject) | Acceptance: "The functional and system level testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device." Also, conformance to ISO 80601-2-55:2011. |
| Software V&V | Not explicitly detailed for predicate | Verification and Validation conducted | Acceptance: "Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff... Verification... conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The testing appears to be bench testing of the device itself, likely involving controlled gas mixtures and simulated breathing patterns rather than human or animal subjects.
- Data Provenance: Not specified, but given the manufacturer (Shenzhen Mindray Bio-medical Electronics Co., Ltd.) it's likely conducted in China. The testing is non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not a study requiring expert-established ground truth for performance evaluation of classification or diagnosis. It's a non-clinical engineering and performance validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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
- No. This is a non-clinical device performance study, not an AI/SaMD study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a hardware gas module that measures gases. While it has software, the performance evaluation described pertains to the measurement accuracy and response times of the physical sensing system, not an "algorithm only" performance in the context of AI/SaMD. The performance metrics are direct measurements, not algorithmic outputs from complex data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance would be established by reference laboratory standards and calibrated gas mixtures for accuracy and precision measurements, as per relevant ISO standards (e.g., ISO 80601-2-55). It is not based on expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable. This is a monitoring device, not a machine learning/AI algorithm that requires a "training set" in the conventional sense. Software verification and validation were performed, but this is distinct from training an AI model.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set."
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October 24, 2018
Shenzhen Mindray Bio-medical Electronics Co., Ltd Yanhong Bai Manager Regulatory Affairs Mindray Building, Keji 12th Road South High-tech Industrial Park, Nanshan Shenzhen, 518057 CN
Re: K180788
Trade/Device Name: Gas Module 3 Regulation Number: 21 CFR 868.1850 Regulation Name: Monitoring Spirometer Regulatory Class: Class II Product Code: BZK Dated: September 19, 2018 Received: September 24, 2018
Dear Yanhong Bai:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. 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) K180788
Device Name Gas Module 3
Indications for Use (Describe)
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
| 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) |
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510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Gas Module 3 is provided below.
| Device Common Name: | Spirometer, Monitoring (W/wo Alarm) |
|---|---|
| Device Proprietary Name: | Gas Module 3 |
| Submitter: | Shenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,Hi-tech Industrial Park, Nanshan,Shenzhen, 518057, P. R. ChinaTel: +86 755 8188 8998Fax: +86 755 2658 2680 |
| Contact: | Ms. Yanhong BaiManager Regulatory AffairsShenzhen Mindray Bio-medical Electronics Co., LTD.Mindray Building, Keji 12th Road South,High-tech Industrial Park, Nanshan, Shenzhen518057, P.R. ChinaTel: +86 755 81885635Fax: +86 755 26582680E-mail: baiyanhong@mindray.com |
| Date Prepared: | October 23, 2018 |
| Classification Regulation: | 21 CFR 868.1850, Class II, Monitoring spirometer |
| Panel: | Anesthesiology |
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| Primary | ||||
|---|---|---|---|---|
| Product Code | Regulation Number | Panel | Regulation description | Device Common Name |
| BZK | 21 CFR 868.1850 | Anesthesiology | Monitoring spirometer | Spirometer, Monitoring (W/wo Alarm) |
Classification Regulation, Classification Name and Product Codes:
Primary Predicate Device: K062754 - GAS MODULE SE; DATASCOPE CORP.
Indications for Use:
The indications for use for the Gas Module 3 include monitoring of airway gases during anesthesia and/or assisted respiration. The intended environment of use is the anesthesia department, including the Operating Room (OR) and post anesthesia care units (PACU), etc.
Device Description:
The Gas Module 3 is an independently powered unit capable of interfacing with Mindray DS USA, Inc. (hereafter MRDS) Patient Monitors using a proprietary communications protocol. The system connects to the patient monitor via a RS232 connector. All Gas Module 3 data display on the monitor screen. And all user commands are entered on the monitor and then electronically transmitted to the Gas Module 3.
The Gas Module 3 measures in real-time, breath-by-breath CO2, O2, N2O gases. Additionally, the Gas Module 3 monitors the anesthetic agents Halothane (HAL), Isoflurane (ISO), Sevoflurane (SEV), Desflurane (DES) and Enflurane (ENF).
The Gas Module 3 consists of AION Multigas Analyzer, Servomex Paramagnetic Oxygen sensor, Power supply Board and Communication Board.
The subject device is a modified version of a previously cleared model, the Gas Module SE. The Gas Module SE was cleared under K062754, on September 13, 2006.
Non-clinical testing:
EMC and Electrical Safety - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754), Mindray conducted additional Electromagnetic Compatibility and Electrical Safety testing on the subject device. The testing provides an evaluation of the EMC and electrical safety of the subject devices relevant to each of the modifications since clearance of the predicate Gas Module SE. The Electromagnetic Compatibility and Electrical Safety testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
AAMI ANSI ES 60601-1: 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and ●
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A2:2010/(R)2012* Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
Performance Testing - Bench - To establish the substantial equivalence of the subject Gas Module 3 to the previously cleared Gas Module SE (K062754). Mindray conducted functional and system level testing on the subject devices. The testing provides an evaluation of the performance of the subject devices relevant to each of the modifications since clearance of the Gas Module SE. The functional and system level testing shows that the subject device continues to meet the specifications and the performance of the subject device is equivalent to the predicate device.
In addition, Mindray has conducted testing to ensure the subject device meets following consensus standards.
- ISO 80601-2-55: 2011 Medical electrical equipment - part 2-55: particular requirements for the basic safety and essential performance of respiratory gas monitors
Software Verification and Validation Testing
Software verification and validation testing was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Verification of the subject Gas Module 3 was conducted to ensure that the product works as designed. Validation was conducted to check the design and performance of the product.
Substantial Equivalence:
Comparison of Indications - The indication for use of the subject device (Gas Module 3) is identical to that of the predicate device (Gas Module SE), with only the device name changed. The minor change to the indication for use does not change the fundamental intended use of the Gas Module 3.
Comparison of Technological Characteristics - The table below compares the key technological feature of the subject device to the primary predicate device (Gas Module SE, K062754). The features in gray are the main features that have been modified since their previous clearances.
Device Comparison Table
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| Feature | Predicate Device(K062754) | Subject Device | Comparison analysis |
|---|---|---|---|
| Gas Module SE | Gas Module 3 | ||
| Indications forUse | The indications for usefor the Gas Module SEinclude monitoring ofairway gases, duringanesthesia and/orassisted respiration. Theintended environment ofuse is the anesthesiadepartment, including theOperating Room (OR)and post anesthesia careunits (PACU), etc. | The indications for use forthe Gas Module 3 includemonitoring of airway gasesduring anesthesia and/orassisted respiration. Theintended environment ofuse is the anesthesiadepartment, including theOperating Room (OR) andpost anesthesia care units(PACU), etc. | SameThe indication for use ofthe subject device (GasModule 3) is identical tothat of the predicatedevice (Gas Module SE),with only the devicename changed. |
| Power supply | Multi-voltage powersupply, source 100-240VAC, 50-60Hz. | Multi-voltage powersupply, source 100-240VAC, 50-60Hz. | Same |
| User interface | Operation is controlledby a connected patientmonitor via Mindray DSUSA proprietarycommunication protocolby a RS232 connector. | Operation is controlled by aconnected patient monitorvia Mindray DS USAproprietary communicationprotocol by a RS232connector. | Same |
| Measuredgases | CO2, O2, N2O andAnesthetic agents(Halothane, Isoflurane,Sevoflurane, Desfluraneand Enflurane). | CO2, O2, N2O andAnesthetic agents(Halothane, Isoflurane,Sevoflurane, Desfluraneand Enflurane). | Same |
| Measuredparameters | Patient inspired/expiredgas concentration andrespiration rate. | Patient inspired/expired gasconcentration andrespiration rate. | Same |
| Warm-up time | 2 minutes to operationwith CO2, O2 and N2O. 5minutes to operation ofanesthetic agents. 30minutes for fullspecification. | 45 seconds to operationwith CO2, O2, N2O andanesthetic agents. 10minutes for fullspecification. | Similar, warm-up timeimproved in Gas Module 3. |
| Sampling rate | The sampling systemtakes care of drawing agas sample to analyzersat a fixed rate(200 $\pm$ 20ml/min). | 200 $\pm$ 20ml/min with largersize water trap.120 $\pm$ 12ml/min with smallersizewater trap. | Same - The flow rate forlarger size water trap is thesame. The option to use anew smaller size water trapis introduced which supporta flow rate of 120ml/min,which may provideenhanced gas managementfor smaller sized patients. |
| Gas samplingaccessories | Water trapSampling line | Adult/Pediatric Water trapNeonate Water trapAdult/Pediatric SamplinglineNeonate Sampling line | The water trap andsampling line is changedfrom Datex-Ohmeda toArtema Technology. |
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| Adapter, StraightAdapter, Elbow | Adapter, StraightAdapter, Elbow | In Gas Module SE, there isone water trap (PN: 0202-00-0129) and one sampleline (PN: 0683-00-0451-10)for all patient types (Adult,Pediatric and Neonate) withthe sample line flow ratesetting 200ml/min.In Gas Module 3, there isone water trap (PN: 0202-00-0182-10) and sampleline (PN: 0683-00-0525-25)for adult and pediatricpatient with the samplingflow rate setting200ml/min. And a smallsize water trap (PN: 0202-00-0181-10) and sampleline (PN: 0683-00-0524-25)is introduced for the flowrate 120ml/min, which is anenhancement for neonatepatients.The adapter is the same. |
|---|---|---|
| ------------------------------------- | ------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Measurementrange | CO2:O2:100%N2O:DES:SEV:ENF:ISO:HAL:awRR:rpm | 0 to 15%0 to 100%0 to 100%0 to 20%0 to 8%0 to 6%0 to 6%0 to 6%4 to 60rpm | CO2:O2:N2O:DES:SEV:ENF:ISO:HAL:awRR:rpm | 0 to 10%0 to 100%0 to 100%0 to 18%0 to 8%0 to 5%0 to 5%0 to 5%2 to 100 | Although the measurement range of CO2, DES, ENF, ISO and HAL for subject device is small than the predicate device, the difference in the measurement range of these gases for the subject device is insignificant in for the clinical use.The awRR measurement range for the subject device is wider than the predicate device.The awRR measurement range of the subject device has been tested using the test apparatus in figure 201.101 of ISO80601-2-55, and the test result meets the specification. |
|---|---|---|---|---|---|
| Full accuracy | CO2 accuracy: | $\pm$ (0.2% + 2% of reading) | CO2 accuracy: | $\pm$ 0.1% @ 0 - 1%$\pm$ 0.2% @ 1 - 5%$\pm$ 0.3% @ 5 - 7%$\pm$ 0.5% @ 7 - 10%Unspecified @ > 10% | The CO2 measurement accuracy is now specified in different ranges. These accuracies in different ranges meet the requirements of ISO 80601-2-55. |
| O2 accuracy: | $\pm$ (1% + 2% of reading) | O2 accuracy: | $\pm$ 1% @ 0 - 25%$\pm$ 2% @ 25 - 80%$\pm$ 3% @ 80 - 100% | The O2 measurement accuracy is now specified in different ranges. These accuracies in different ranges continue to meet the requirements of ISO 80601-2-55 |
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| N2O accuracy: $\pm$ (1% +2% of reading) | N2O accuracy:$\pm$ 2% @ 0 – 20%$\pm$ 3% @ 20 – 100% | The N2O measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges continue to meet therequirements of ISO 80601-2-55. |
|---|---|---|
| DES accuracy: $\pm$ (0.15% + 5% ofreading) | DES accuracy:$\pm$ 0.1% @ 0 - 1%$\pm$ 0.2% @ 1 - 5%$\pm$ 0.4% @ 5 - 10%$\pm$ 0.6% @ 10 - 15%$\pm$ 1% @ 15 - 18%Unspecified @ > 18% | The DES measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges still meet therequirements of ISO 80601-2-55. |
| SEV accuracy: $\pm$ (0.15%+ 5% of reading) | SEV accuracy:$\pm$ 0.15% @ 0 - 1%$\pm$ 0.2% @ 1 - 5%$\pm$ 0.4% @ 5 - 8%Unspecified @ > 8% | The SEV measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges continue to meet therequirements of ISO 80601-2-55. |
| ENF accuracy: $\pm$ (0.15%+ 5% of reading) | ENF accuracy:$\pm$ 0.15% @ 0 - 1%$\pm$ 0.2% @ 1 - 5%Unspecified @ > 5% | The ENF measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges continue to meet therequirements of ISO 80601-2-55. |
| ISO accuracy: $\pm$ (0.15% +5% of reading) | ISO accuracy:$\pm$ 0.15% @ 0 - 1%$\pm$ 0.2% @ 1 - 5%Unspecified @ > 5% | The ISO measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges continue to meet therequirements of ISO 80601-2-55. |
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| HAL accuracy: ±(0.15% + 5% of reading) | HAL accuracy:±0.15 % @ 0 - 1%±0.2 % @ 1 - 5%Unspecified @ > 5% | The Hal measurementaccuracy is now specified indifferent ranges. Theseaccuracies in differentranges continue to meet therequirements of ISO 80601-2-55. | |
|---|---|---|---|
| Rise time | CO2 rise time: < 400ms | CO2 rise time: < 250 msfor 200ml/minCO2 rise time: < 250 msfor 120ml/min | The CO2 rise time forsubject device is smallerthan the predicate device.The smaller rise time meansthe device can detect thevariety of the concentrationof the gas with greatersensitively. |
| O2 rise time : < 400ms | O2 rise time: < 400 msfor 200ml/minO2 rise time: < 450 ms for120ml/min | The difference of rise timebetween the subject deviceand the predicate device isinsignificant in clinical use.So no clinical risks orsafety issue introduced. | |
| N2O rise time: < 400ms | N2O rise time: < 250 msfor 200ml/minN2O rise time: < 250 msfor 120ml/min | The N2O rise time forsubject device is smallerthan the predicate device. | |
| DES rise time: <600ms | DES rise time: <300msfor 200ml/min.DES rise time: <300msfor 120ml/min. | The DES rise time forsubject device is smallerthan the predicate device. | |
| SEV rise time: <600ms | SEV rise time: <300ms for200ml/min.SEV rise time: <300ms for120ml/min. | The SEV rise time forsubject device is smallerthan the predicate device. | |
| ENF rise time: <600ms | ENF rise time: <350ms for200ml/min.ENF rise time: <350ms for120ml/min | The ENF rise time forsubject device is smallerthan the predicate device. | |
| ISO rise time: <600ms | ISO rise time: <300ms for 200ml/min.ISO rise time: <300ms for 120ml/min. | The ISO rise time for subject device is smaller than the predicate device. | |
| HAL rise time: <1000ms | HAL rise time: <300ms for 200ml/min.HAL rise time: <300ms for 120ml/min. | The HAL rise time for subject device is smaller than the predicate device. | |
| Delay time | All gases delay time: <2.5 s | All gases delay time: <4 s for 200ml/minAll gases delay time: <4 s for 120ml/min | The difference of delay time between the subject device and the predicate device is insignificant in clinical use.So no clinical risks or safety issue introduced. |
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Substantial Equivalence Conclusion:
Based on the detailed comparison of specifications and modifications to the subject device (Gas Module 3), predicted device (Gas Module SE, K062754), the performance testing results and conformance with applicable standards the Gas Module 3 can be found substantially equivalent to the predicate device.
§ 868.1850 Monitoring spirometer.
(a)
Identification. A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status.(b)
Classification. Class II (performance standards).