(139 days)
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.
It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.
Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.
The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).
The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
The provided text describes a 510(k) premarket notification for a medical device, the "inspired™ VHB20 Heated Humidifier." This document focuses on demonstrating substantial equivalence to a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier. The information provided is primarily for regulatory clearance based on equivalence, not a clinical study proving specific performance metrics against acceptance criteria in the way one might see for a novel AI/ML device.
Therefore, many of the requested items related to Acceptance Criteria and Study Design (e.g., sample size for test sets, ground truth establishment by experts, MRMC studies, standalone performance with effect sizes) are not applicable to this type of regulatory submission for a respiratory gas humidifier. The "acceptance criteria" here are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through bench testing comparing its performance specifications.
However, I can extract the relevant "acceptance criteria" (which are performance specifications) and the "reported device performance" from the provided Table 1, and comment on other requested points based on the available information.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this type of device are generally its performance specifications that demonstrate it operates within safe and effective parameters, comparable to a predicate device. The "reported device performance" is the measured performance of the proposed device.
Here's a table comparing the subject device's reported performance against the predicate's, which implicitly serves as the "acceptance criteria" for substantial equivalence:
| Performance Characteristic | Acceptance Criteria (Predicate: Fisher & Paykel MR850) | Reported Device Performance (Subject: inspired™ VHB20) | Comment (from document) |
|---|---|---|---|
| Heater plate over temperature cutout (hardware) | $118 \pm 6°C$ | $118 \pm 7°C$ | Similar |
| Safety cutoff temperature (software control) | $110°C$ | $105°C$ | Similar |
| Heater Wires power supply | 22V~, 2.73A max, 60W, 50/60Hz | 24VDC, 80VA | Similar |
| Temperature control settings (Airway Invasive) | Default: $40°C$, Range: $35-40°C$ (Versions 7.22) | Default: $39°C$, Range: $35-40°C$ | Similar |
| Temperature control settings (Airway Non-invasive) | Default: $34°C$, Range: $28-34°C$ (Versions 7.22) | Default: $34°C$, Range: $30-37°C$ | Similar |
| Temperature control settings (Chamber outlet Invasive) | Default: N/A, Range: $35.5-42°C$ (Versions 7.22) | Default: $36°C$, Range: $35-43°C$ | Similar |
| Temperature control settings (Chamber outlet Non-invasive) | Default: N/A, Range: $31-36°C$ (Versions 7.22) | Default: $31°C$, Range: $30-32°C$ | Similar |
| Display Accuracy | $\pm 0.3°C$ (in 25 to $45°C$ range) | $\pm 2°C$ | Similar |
| High temperature alarm (Invasive mode) | Displayed temp exceeds $41°C$ or Airway temp exceeds $43°C$ | Patient-side temperature exceeds $41°C$ | Similar |
| High temperature alarm (Non-invasive mode) | Displayed temp exceeds $41°C$ or Airway temp exceeds $43°C$ | Patient-side temperature exceeds $38°C$ | Similar |
| Low temperature alarm (Invasive mode) | After 10 min @ $29.5°C$ or 60 min @ $34.5°C$ | Patient-side temp < $34°C$ for 22 minutes | Similar |
| Low temperature alarm (Non-invasive mode) | After 10 min @ $29.5°C$ or 60 min @ $34.5°C$ | Patient-side temp < $29°C$ for 22 minutes | Similar |
| Sound Pressure Level (Alarms) | Exceed 50 dBA @ 1m | Exceed 50 dBA @ 1m | Similar |
| Recommended ambient Temperature range | 18 - 26°C | 18 - 28°C | Similar |
| Recommended flow range (Invasive) | Up to 60 Lpm | 5 to 60 Lpm | Similar |
| Recommended flow range (Non-invasive) | Up to 120 Lpm | 5 to 120 Lpm | Similar |
| Humidity Performance (Invasive) | > 33mg/L | $\geq 33mg/L$ | Similar |
| Humidity Performance (Non-Invasive) | > 10 mg/L | $\geq 12 mg/L$ | Similar |
| Warm-up time | Less than 30 minutes | <25 minutes | Similar |
Study Details (Based on provided text)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of patient or clinical samples, as this is a bench test for a physical device. Electrical safety, EMC, and software verification/validation are typically performed on a limited number of manufactured units.
- Data Provenance: The origin of the data is from "Bench testing" and "Non-Clinical Testing Summary" performed by the manufacturer, Vincent Healthcare Products Limited. It is a retrospective submission based on completed testing. There is no mention of country of origin for the testing data specifically, but the manufacturer is based in Hong Kong and the submission is to the US FDA.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical device with measurable performance specifications (temperature, humidity, flow, electrical safety). "Ground truth" is established by direct measurement using calibrated equipment and standard test methods (e.g., ISO, IEC standards mentioned) and comparison to the predicate's known specifications. This does not involve human expert interpretation of clinical data to establish a "ground truth."
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human review processes (e.g., clinicians interpret images and a tie-breaker resolves discrepancies). For bench testing of a device's physical performance, the results are quantitative and directly measured against specifications.
-
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. An MRMC study is relevant for AI/ML-driven diagnostic devices where human reader performance is being evaluated with or without AI assistance. This document is for a heated humidifier, which is not an AI/ML diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes (conceptually). The device's performance specifications (temperature control, humidity output, etc.) were verified independently through bench testing (
Non-Clinical Testing Summary: Bench testing). This is analogous to a standalone performance evaluation for a physical device, though the term "algorithm only" doesn't directly apply as it's not a purely software-based diagnostic algorithm. The software verification and validation are for the embedded system controlling the humidifier.
- Yes (conceptually). The device's performance specifications (temperature control, humidity output, etc.) were verified independently through bench testing (
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance is established by direct physical measurement against predefined engineering specifications and international standards (e.g., IEC 60601-1, ISO 80601-2-74) and comparison to the well-established performance of a predicate device. This is primarily a technical/engineering ground truth, not a clinical one derived from patient outcomes or expert consensus on medical images/diagnoses.
-
The sample size for the training set:
- Not Applicable. This is a hardware medical device with embedded software, not a machine learning model that requires a training set.
-
How the ground truth for the training set was established:
- Not Applicable. As there is no machine learning model or training set, this question is not relevant.
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December 21, 2022
Vincent Healthcare Products Limited % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, Florida 33704
Re: K222351
Trade/Device Name: inspired™ VHB20 Heated Humidifier Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: August 3, 2022 Received: August 4, 2022
Dear Paul Dryden:
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.
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.
Ethan L. Nyberg -S
for James Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222351
Device Name inspired™ VHB20 Heated Humidifier
Indications for Use (Describe)
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
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) Summarv Page 1 of 6
| Date Prepared: | 19-Dec-22 |
|---|---|
| Vincent Healthcare Products LimitedFlat/RM B2, 7/F., Hang Fung Industrial Building, Phase 2, 2G Hok Yuen StreetHung Hom, Kowloon Hong Kong | |
| Official Contact: | Patrick Dennis, QA/RA Supervisor |
| Submission Correspondent: | Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704 |
| Proprietary or Trade Name: | inspired™ VHB20 Heated Humidifier |
| Common/Usual Name: | Respiratory gas humidifier |
| Classification Name: | 21CFR 868.5450 |
| Product Code: | BTT |
| Predicate Device: | K073706 - Fisher & Paykel MR850 RespiratoryHumidifier |
| Common/Usual Name: | Respiratory gas humidifier |
| Classification Name: | 21CFR 868.5450 |
| Product Code: | BTT |
Device Description:
The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.
It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.
Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.
The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).
The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
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Principle of Operation:
The inspired™ VHB20 Heated Humidifier is a respiratory humidifier that provides a heat source and temperature control to warm a water container, referred as a water chamber, to heat and humidify dry respiratory gases.
Indications for Use:
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired™ VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
Patient Population:
Infant to adult patients.
Environments of use:
Hospital/institutional environment
We present the proposed device vs. the predicate in Table 1.
As part of the comparison we will present and discuss the:
- Indications for Use ●
- . Technology and Principle of Operation
- Performance and Specifications .
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510(k) Summary Page 3 of 6
Table 1 - Comparison - Subject vs. Predicate
| 510(k) Number | Subject Device | K073706 Predicate | Comment |
|---|---|---|---|
| Device Name | Vincent Medical inspiredTM VHB20 Heated Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
| Classification No. & Product code | 868.5450 / BTT | 868.5450 / BTT | Similar |
| Indications for Use | The inspiredTM VHB20 Heated Humidifier is intended to be usedto warm and add humidity to gases delivered to patients requiringmechanical ventilation or positive pressure breathing assistance orgeneral medical gases. | The Fisher & Paykel Healthcare MR850 humidifier is intendedto be used to warm and add humidity to gases delivered topatients requiring mechanical ventilation or positive pressurebreathing assistance or general medical gases. | Similar |
| The inspiredTM VHB20 Heated Humidifier is indicated for use bytrained personnel only within a hospital/institutional environment.It is compatible with the Fisher and Paykel MR290Humidification Chamber (Single Use), RT380 Dual HeatedBreathing Circuit and RT265 Dual Heated Infant BreathingCircuit. | |||
| Principle of operation | The device has two heating control units and two temperaturesensors respectively. Water within a humidification chamber isheated by the device's heating plate and this temperature iscontrolled by the device with the use of temperature probes. Drymedical gases passing through the chamber gain increased humidityand heat. The heater wire adaptor supplies current to heater wireswithin breathing tubes that maintain gas temperature travelling topatient. Temperature probes measurement temperature and devicecontrols chamber temperature to achieve desired gas warmth andhumidify for patient. | The device has two heating control units and two temperaturesensors respectively. Water within a humidification chamber isheated by the device's heating plate and this temperature iscontrolled by the device with the use of temperature probes. Drymedical gases passing through the chamber gain increasedhumidity and heat. The heater wire adaptor supplies current toheater wires within breathing tubes that maintain gas temperaturetravelling to patient. Temperature probes measurementtemperature and device controls chamber temperature to achievedesired gas warmth and humidify for patient. | Similar |
| Components | The device consists of VHB20 Heated Humidifier, Heater wireadaptor and Temperature-humidity data/sensor cable. | The device consists of MR850 Respiratory Humidifier, Heaterwire adaptor and Temperature probe. | Similar |
| Electrical Protection Classification | Class I | Class I | Similar |
| Applied part | Type BF | Type BF | Similar |
| Drip proof | IPX1 | IPX1 | Similar |
| Target population | Infant to adult | Any patient requiring active humidification | Similar |
| Heating Method | Pass over | Pass over | Similar |
| Dimensions (H x D x W) | 159mm x 204mm x 150mm | 140mm × 173mm × 135mm | Similar |
| Weight (without humidificationchamber) | 1.9kg | 2.8kg | Similar |
| Supply voltage | 110 - 127V | 115V | Similar |
| 510(k) Number | Subject Device | K073706 Predicate | Comment |
| Device Name | Vincent Medical inspired™ VHB20 Heated Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
| Supply frequency | 50/60 Hz | 50/60 Hz | Similar |
| Supply current | 3.0A max at 110V | 2.0 A max at 115V | Similar |
| Heater plate power | 150W | 150 W | Similar |
| Heater plate over temperaturecutout (hardware) | $118 ± 7°C$ | $118 ± 6°C$ | Similar |
| Safety cutoff temperature(software control) | $105°C$ | $110°C$ | Similar |
| Heater Wires power supply | 24VDC, 80VA | 22V~, 2.73A max, 60W, 50/60Hz | Similar |
| Temperature control settings | |||
| Airway | |||
| Invasive | Default: $39°C$ | Default: $40°C$ | Similar |
| Range: $35-40°C$ | Range: $35-40°C$ , (Versions 7.22) | ||
| Non-invasive | Default: $34°C$ | Default: $34°C$ | Similar |
| Range: $30-37°C$ | Range: $28-34°C$ , (Versions 7.22) | ||
| Chamber outlet | |||
| Invasive | Default: $36°C$ | Default: | Similar |
| Range: $35-43°C$ | Range: $35.5-42°C$ , (Versions 7.22) | ||
| Non-Invasive | Default: $31°C$ | Default: | Similar |
| Range: $30-32°C$ | Range: $31-36°C$ , (Versions 7.22) | ||
| Display | 2.8-inch - LCD display | 3 digit 14 mm - 7 segment LED | Similar |
| Display Range | 10 - 70°C | 10 - 70°C | Similar |
| Accuracy | $± 2°C$ | $± 0.3°C$ | Similar |
| (in 25 to $45°C$ temperature range) | |||
| Alarms | |||
| High temperature alarm | Invasive mode: Patient-side temperature exceeds $41°C$ | Invasive and Non-invasive mode: | Similar |
| Non-invasive mode: Patient-side temperature exceeds $38°C$ | Displayed temperature exceeds $41°C$ | ||
| orAirway temperature exceeds $43°C$ | |||
| Invasive mode: Patient-side temperature < $34°C$ for 22 minutes | Invasive mode only: | Similar | |
| Low temperature alarm - | Non-invasive mode: Patient-side temperature < $29°C$ for 22 | After 10 minutes @ $29.5°C$ | |
| minutes | or | ||
| After 60 minutes @ $34.5°C$ | |||
| Sound Pressure Level | Alarms exceed 50 dBA @ 1m | Alarms exceed 50 dBA @ 1m | Similar |
| 510(k) Number | Subject Device | K073706 Predicate | Comment |
| Device Name | Vincent Medical inspiredTM VHB20 Heated Humidifier | Fisher & Paykel MR850 Respiratory Humidifier | |
| Performance | |||
| Recommended ambientTemperature range | 18 - 28°C | 18 - 26°C | Similar |
| Recommended flow range | Invasive - 5 to 60 LpmNon-invasive - 5 to 120 Lpm | Invasive - Up to 60 LpmNon-invasive - Up to 120 Lpm | Similar |
| Humidity Performance | Invasive - ≥ 33mg/LNon-Invasive - ≥12 mg/L | Invasive - > 33mg/LNon-Invasive - > 10 mg/L | Similar |
| Warm-up time | <25 minutes | Less than 30 minutes | Similar |
| Standards | ANSI AAMI ES60601-1IEC 60601-1-2ISO 80601-2-74AIM 7351731 | IEC 60601-1EN 60601-1IEC 60601-1-2EN 60601-1-2EN ISO 8185:2009 | Similar |
| Biocompatibility | Externally Communicating, Tissue, permanent Duration | Externally Communicating, Tissue, permanent Duration | Similar |
| Accessories | |||
| Heater Wire Adapter | |||
| Type/configuration | Utilizes F&P accessories - Dual limb | Dual limb | Similar |
| Circuit connector | Inspiratory limb / Expiratory Limb2 pin clover-type / 2 pin S-type | Inspiratory limb / Expiratory Limb2 pin clover-type / 2 pin S-type | Similar |
| Temperature Probe Lead | |||
| Number of probes | 2 | 2 | Similar |
| Probe location | Chamber outletPatient end | Chamber outletPatient end | Similar |
| Function | Airway temperature measurementChamber outlet temperature measurement | Airway temperature measurementChamber outlet temperature measurement | |
| Compatible Consumables | |||
| Humidification Chamber | |||
| Type/configuration | Autofeed | Autofeed | |
| Model | Fisher & Paykel MR290 | Fisher & Paykel MR290 | |
| Breathing Circuits | |||
| Type/configuration | Dual heated | Dual heated | |
| Model | Fisher & Paykel RT265Fisher & Paykel RT380 | Fisher & Paykel RT265Fisher & Paykel RT380 |
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510(k) Summary Page 4 of 6
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510(k) Summary Page 5 of 6
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Substantial Equivalence Discussion
Table 1 above compares the key features of the proposed with the identified predicate - Fisher & Paykel MR850, K073706. The comparison demonstrates that the proposed device can be found to be substantially equivalent.
Indications for Use
The indications for use are similar for the proposed device when compared to the predicate device.
Discussion - Both devices are indicated for use for humidification of gasses and heating of the gas going to the patient. The subject device have equivalent flow, humidification and heating ranges. Minor difference do not raise different concerns of risk than the predicate.
Technology and construction
The technology is identical heated plate, humidification chamber. Discussion - There are no differences that raise new concerns of safety or effectiveness.
Environment of Use
The environments of use are similar to predicate which are clinical settings. Discussion - The environments of use are the same.
Patient Population
The patient population of the subject device is infant to adult, which is more restrictive than the predicate which is neonate to adult
Discussion - The subject device is more restrictive than the predicate.
Non-Clinical Testing Summary
Bench testing
We performed tests related to demonstrate:
- Temperature and humidification performance at various flow and temperature settings .
- . Electrical safetv and EMC
- . Software verification and Validation
Discussion – The test results met the applicable standards and are similar to the reported performance of the predicate device.
Biocompatibility
Both devices are considered externally communicating, tissue with permanent duration of use (> 30 days). We performed the applicable ISO 10993 and ISO 18562.
Discussion - The subject materials were found to meet the applicable requirements for biocompatibility safety for the intended population.
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device predicate and reference have been found to substantially equivalent.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).