(268 days)
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.
Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.
This is a 510(k) premarket notification for breathing system heaters, not an AI/ML device. Therefore, the requested information about acceptance criteria for AI performance, sample sizes for test/training sets, ground truth establishment, expert consensus, MRMC studies, or standalone algorithm performance is not applicable.
The document discusses the substantial equivalence of the VentStar Helix Dual Heated N Exten. Kit (MP02280) and VentStar Helix Heated (N) Plus (MP02608) to previously cleared predicate devices. Substantial equivalence is determined by demonstrating that the new devices are as safe and effective as the predicate devices, despite some technological differences.
Here's the relevant information about the device's technical specifications and the non-clinical studies performed to demonstrate its safety and effectiveness:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides extensive comparison tables (Table 1 and Table 2) between the new devices and their predicate devices. These tables list various technical characteristics and performance parameters, indicating whether they are "Same," "Similar," or "Different" compared to the predicate. For characteristics marked "Different," numerical values are provided for both the subject device and the predicate device. These differences were evaluated through non-clinical testing to ensure they do not raise new questions of safety or effectiveness.
Due to the extensive nature of the comparison, which lists numerous parameters like hose diameter, length, resistance, compliance, leakage, volume, warm-up time, humidification output, and electrical data, a comprehensive reproduction of all "acceptance criteria" (which are implicitly the performance of the predicate device or established standards) and "reported device performance" in a single table format is beyond the scope of a short answer. However, the tables clearly highlight these comparisons.
For example, for VentStar Helix Dual Heated N Exten. Kit (MP02280) compared to predicate RT265 (K103767):
| Characteristic | Subject Device Performance | Predicate Device Performance | Comment |
|---|---|---|---|
| Hose diameter (ID) | 11 mm ID | 10 mm ID | Different |
| Resistance | Inspiratory: at 2.5 L/min < 0.1 mbar, at 5 L/min < 0.2 mbar, at 15 L/min < 1.0 mbar, at 30 L/min < 3.0 mbar. Expiratory: at 2.5 L/min < 0.1 mbar, at 5 L/min < 0.2 mbar, at 15 L/min < 0.7 mbar, at 30 L/min < 2.4 mbar | Inspiratory: at 2.5 L/min < 0.1 mbar, at 5 L/min < 0.4 mbar, at 15 L/min < 1.3 mbar, at 30 L/min < 9.6 mbar. Expiratory: at 2.5 L/min < 0.1 mbar, at 5 L/min < 0.2 mbar, at 15 L/min < 1.4 mbar, at 30 L/min < 5.3 mbar | Different |
| Humidification Output | Invasive ventilation at 2 to 60 L/min > 33 mg/L. Non-invasive ventilation at 2 to 60 L/min > 12 mg/L. | Invasive ventilation up to 60 L/min > 33 mg/L. Non-invasive ventilation up to 120 L/min > 10 mg/L. | Same / Different |
The document states that "Performance data related to each proposed modification has been tested and evaluated" and "High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device." This implies that the acceptance criteria are met if these differences do not negatively impact safety and effectiveness, as determined by the non-clinical testing against relevant standards.
2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device that uses test sets of data in the common understanding for AI performance evaluation. The "test set" here refers to the physical devices and materials subjected to non-clinical laboratory testing. The provenance of these physical samples is from the manufacturer, Drägerwerk AG & Co. KGaA (Germany). The studies are prospective in the sense that they are conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation (e.g., expert annotations on medical images) is not relevant for this type of device submission, which relies on engineering and biocompatibility testing against established standards.
4. Adjudication method for the test set: Not applicable. This concept is not relevant for the type of non-clinical testing performed for this device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used: For this device, "ground truth" refers to the established requirements and performance limits defined by international consensus standards and the performance characteristics of the predicate devices. For example, specific thresholds for electrical safety, biocompatibility, resistance, and humidification output are defined by standards like IEC 60601-1, ISO 5367, and ISO 18562. The device's performance is measured against these objective, quantifiable benchmarks.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
Summary of Non-Clinical Studies and Standards:
The study that proves the device meets the acceptance criteria is a series of non-clinical tests covering various aspects:
- Mechanical Performance: Demonstrated conformance to ISO 5367 (Breathing sets and connectors) and ISO 80601-2-12 (Critical care ventilators).
- Thermal Safety: Implied by testing against the aforementioned standards and the device's function as a heated breathing circuit.
- Environmental Conditions: Not explicitly detailed beyond compliance with relevant standards.
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to IEC 60601-1 (basic safety and performance) and IEC 60601-1-2 (EMC).
- Functional Verification and Performance Capacity and Accuracy: Demonstrated through compliance with ISO 5367, ISO 80601-2-12, ISO 5356-1 (Conical connectors), and ISO 80601-2-74 (Respiratory humidifying equipment).
- Biocompatibility Testing: Materials and completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 ("Biological Evaluation of Medical Devices") and ISO 18562 series ("Biocompatibility evaluation of breathing gas pathways in healthcare"). Specific tests included:
- Emissions of particulate matter (ISO 18562-2)
- Emission of VOC with additional humidity (ISO 18562-3)
- Leachables in condensate (ISO 18562-4)
- Extraction (ISO 10993-18)
- Material characterization (ISO 10993-18)
- Cytotoxicity (ISO 10993-5)
- Sensitization (ISO 10993-10)
- Irritation (ISO 10993-10)
The "acceptance criteria" are implicitly defined by the requirements of these recognized consensus standards and the performance characteristics of the predicate devices, which the subject devices "meet all applicable requirements of" and are found to be "substantially equivalent" to. The testing demonstrates that despite some technological differences, no new safety or effectiveness concerns are raised compared to the predicate devices.
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June 14, 2023
Dräegerwerk AG & Co. KGaA Jan Upmeier Regulatory Affairs Manager Moislinger Allee 53-55 Luebeck, Schleswig-Holstein 23542 Germany
Re: K222822
Trade/Device Name: VentStar Helix dual heated N Exten. Kit (MP02280), VentStar Helix heated (N) Plus (MP02608) Regulation Number: 21 CFR 868.5270 Regulation Name: Breathing system heater Regulatory Class: Class II Product Code: BZE Dated: May 17, 2023 Received: May 17, 2023
Dear Jan Upmeier:
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 J. Lee. Ph.D. 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) K22822
Device Name
VentStar Helix Dual heated N Exten. Kit / VentStar Helix heated (N) Plus
Indications for Use (Describe)
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Premarket Notification Summary
| Submitter: | Drägerwerk AG & Co. KGaAMoislinger Allee 53-5523542 Lübeck, GermanyEstablishment's registration number: 9611500 |
|---|---|
| Contact Person: | Jan UpmeierRegulatory Affairs ManagerE-Mail: jan.upmeier@draeger.comTelephone: +49 451 882 8474 |
| Applicant's US Contact Person: | Darlene ThibodeauHead of Quality Assurance and ComplianceE-Mail: darlene.thibodeau@draeger.comTelephone: 978 773-1060 |
| Date prepared: | June 14th, 2023 |
| Device Name: | Trade Name: VentStar Helix DualHeated N Exten. Kit / VentStar Helix Heated (N) PlusClassification Name: Breathing system heaterRegulation Number: 21 CFR 868.5270Product Code: BZEClass: II |
| Predicate Device: | Primary predicate for VentStar Helix Dual Heated NExten. Kit: RT265 Dual Heated Infant Breathing Circuit,Fisher & Paykel HealthCare, cleared via K103767;Secondary predicate for VentStar Helix Heated (N) PlusMP00308 VentStar heated (N), Drägerwerk AG & Co.KGaA, cleared via K103618 |
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510(k) Summary
Device Description
The subject devices (VentStar Helix Dual Heated N Exten. Kit and VentStar Helix Heated (N) Plus), two inspiratory (and expiratory) heated disposable breathing circuits with humidifier chamber are designed for neonatal patients with a tidal volume of up to 100 mL, for conduction of humidified breathing gas from the humidifier to the patient. VentStar Helix Dual Heated N Exten. Kit is a dual heated breathing circuit and VentStar Helix Heated (N) Plus is a single heated breathing circuit to be connected to a humidifier MR850 by Fisher and Paykel, both tested for system compatibility and released for use with Dräger Babylog VN-Series ventilators.
Additionally, this submission comprises a neonatal humidifier chamber and a double connector for connection to the ventilators as accessories to the above mentioned medical devices.
Indications for Use
VentStar Helix dual heated N Exten. Kit (MP02280): Inspiratory and expiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
VentStar Helix heated (N) Plus (MP02608): Inspiratory heated disposable breathing circuit with humidifier chamber for connection to a humidifier MR850 by Fisher & Paykel, for neonatal patients with a tidal volume of up to 100 mL, for conducting humidified breathing gas from humidifier to patient.
Environments of use
The device is intended for stationary use in hospitals and medical rooms or for intrahospital patient transport.
Do not use the device in the following environments of use:
- -Magnetic resonance imaging
- -During electrocautery
Comparison to Predicate
Drägerwerk AG & Co KGaA concludes that VentStar Helix Dual Heated N Exten. Kit (MP02280) in Table 1 is substantial equivalent to the Fisher & Paykel's product REF RT265 (K103767) and VentStar Helix heated (N) Plus (MP02608) in Table 2 is substantial equivalent to the Drägerwerk AG & Co KGaA's VentStar heated (N) REF MP00308 (K102618).
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510(k) Summary
| Table 1: Comparison Table VentStar Helix Dual Heated N Exten. Kit (MP02280) | |||
|---|---|---|---|
| Substantial EquivalenceDiscussion | Subject of Submission | Primary Predicate Device | Comments |
| Product Name | MP02280 | REF RT265 | |
| 510(k) Number | K222822 | K103767 | |
| Indications for use | VentStar Helix dual heated N Exten. Kit(MP02280): Inspiratory and expiratory heateddisposable breathing circuit with humidifierchamber for connection to a humidifier MR850 byFisher & Paykel, for neonatal patients with a tidalvolume of up to 100 mL, for conducting humidifiedbreathing gas from humidifier to patient. | The dual-heated breathing circuits areintended as conduits of breathing gas forventilation of infant patients, and to maintainthe temperature of humidified inspired gas.The RT265 is used for flow rates greater than4 L/min, and the RT266 is for flow ratesbetween 0.3 and 4 L/min. | Similar |
| Description | Dual-heated breathing circuits with humidifierchamber | Dual-heated breathing circuits with humidifierchamber | Same |
| Heater | for connection to a Fisher & Paykel humidifierMR850 | for connection to a Fisher & Paykel humidifierMR850 | Same |
| Patient Population | Neonatal patients with a tidal volume of up to 100mL and a weight up to 8 kg. | Infants, tidal volume <185 mL | Similar |
| Application | Disposable | disposable | Same |
| Hose diameterID = Inner DiameterOD = Outer Diameter | 11 mm ID | 10 mm ID | Different |
| Color | Inspiratory limb: blue spiral on colorless hoseExpiratory limb: white spiral on colorless hose | Inspiratory limb: blue-transparentExpiratory limb: white | Similar |
| Heating Wire | Inspiratory limb: in the wall of the circuitExpiratory limb: in the wall of the circuit | Inspiratory limb: Spiral wire inside the circuitExpiratory limb: Spiral wire inside the circuit | Different |
| Connectors | ISO 5356-1 Conical Connectors | ISO 5356-1 Conical Connectors | Same |
| Patient Connector | Y-piece with ISO cone 15 mm female accordingto ISO 5356-1 | Y-piece with ISO cone 15 mm femaleaccording to ISO 5356-1 | Same |
| Device Connector | 11.5 mm female connector (ID) according to ISO5356-1 | 15 mm male (OD)/11.5 mm (ID) femaleconnector according to ISO 5356-1 | Same |
| Traditional 510(k) | 510(k) Summary | K22282 | |
| Substantial EquivalenceDiscussion | Subject of Submission | Primary Predicate Device | Comments |
| Product Name | MP02280 | REF RT265 | - |
| LengthInspiratory Line | 1.70 m ±10% (66,9 inch ±10%), including 40 cm(15.74 in) hose extension | 1.60 m (59 inch), including 40 cm (15.74 in)hose extension | Different |
| Expiratory Limb | 1.63 m ± 80 mm (64.17 ±3.15 inch) | 1.60 m (63 inch) | Different |
| Humidifier Connection | 0.50 m ± 40 mm (19.7 ±1.58 inch) | 0.70 m (27.6 inch) | Different |
| ResistanceInspiratory: | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 1.0 mbarat 30 L/min < 3.0 mbar | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.4 mbarat 15 L/min < 1.3 mbarat 30 L/min < 9.6 mbar | Different |
| Expiratory: | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 0.7 mbarat 30 L/min < 2.4 mbar | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 1.4 mbarat 30 L/min < 5.3 mbar | Different |
| Compliance | at 60 mbar (breathing circuit: inspiration andexpiration) < 0.8 mL/hPa (mL/mbar) | 1.27 mL/mbar (1.3 cmH2O) | Different |
| Leakage | at 20 mbar < 15 mL/minat 40 mbar < 30 mL/minat 60 mbar < 30 mL/min | @ 60 mbar ≤ 75 mL/min | Different |
| Volume of breathingcircuit/ humidifier chamber | Inspiratory volume of the breathing circuit withincubator extension 360 ml ±10%Volume (air) of humidifier chamber with water 210ml ±10%Volume (air) of humidifier chamber without water300 ml ±10% | Inspiratory volume of the breathing circuitwith incubator extension 450 mlVolume (air) of humidifier chamber with water190 mlVolume (air) of humidifier chamber withoutwater 350 ml | Different |
| Warm up Time | 30 min | 30 min | Same |
| Substantial EquivalenceDiscussion | Subject of Submission | Primary Predicate Device | Comment |
| Product Name | MP02280 | REF RT265 | - |
| Humidification Output | Invasive ventilation at 2 to 60 L/min > 33 mg/L | Invasive ventilation up to 60 L/min > 33 mg/L | Same |
| Non-invasive ventilation at 2 to 60 L/min > 12mg/L | Non-invasive ventilation up to 120 L/min > 10mg/L | Different | |
| Breathing gas temperatureat Y-Piece | Adjusted and controlled by Fisher & PaykelMR850 humidifier | Adjusted and controlled by Fisher & PaykelMR850 humidifier | Same |
| Electrical Connection Data | 22 V, 2,73 A, 60 W14 Ω inspiratory12 Ω expiratory (MP02650) | 22 V, 2.73 A, 60 W, 50/60 Hz | Same |
| Ventilation modes | VentStar Helix dual heated (N) Plus is suitable forstandard ventilation modes, such asSynchronized Intermittend Mandatory Ventilation(SIMV), Mandatory Minute Ventilation (MMV), andContinuous Positive Airway Pressure (CPAP) aswell as for High Frequency Oscillation (HFO) | No information is provided in the IFU, suitablefor delivery of breathing gas. | Similar |
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510(k) Summary
Table 2: Comparison Table VentStar Helix heated (N) Plus (MP02608)
| Substantial EquivalenceDiscussion | Subject of Submission | Reference Predicate Device | Comments |
|---|---|---|---|
| Product Name | MP02608 | MP00308 | - |
| 510(k) Number | K222822 | K102618 | - |
| Indications for use | VentStar Helix heated (N) Plus (MP02608):Inspiratory heated disposable breathing circuitwith humidifier chamber for connection to ahumidifier MR850 by Fisher & Paykel, forneonatal patients with a tidal volume of up to 100mL, for conducting humidified breathing gas fromhumidifier to patient. | VentStar heated (N) (MP00308): Disposableinspiratory heated breathing circuit forconnection to a Fisher & Paykel MR850humidifier, for conveying moistened breathinggas between the humidifier and neonatalpatients with a body weight of up to 5 kg (11lbs). | Similar |
| Substantial EquivalenceDiscussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Description | Single-heated breathing circuits with humidifierchamber | Single-heated breathing circuits withhumidifier chamber | Same |
| Heater | For connection to a Fisher & Paykel humidifierMR850 | For connection to a Fisher & Paykelhumidifier MR850 | Same |
| Patient Population | Neonatal patients | Neonatal patients | Same |
| Application | Disposable | Disposable | Same |
| Hose diameter (InnerDiameter) | 11 mm ID | Heated hose: 14 mm IDNon-heated hose: 10 mm ID | Different |
| Color | Inspiratory limb: blue spiral on colorless hoseExpiratory limb: white spiral on colorless hosewith water trap | Inspiratory limb: transparent with whiteheating wire inside the limpExpiratory limb: transparent | Different |
| Heating Wire | Inspiratory limb: in the wall of the circuitExpiratory limb: none | Inspiratory limb: white heating wire inside thelimpExpiratory limb: none | Different |
| Connectors | ISO 5356-1 Conical Connectors | ISO 5356-1 Conical Connectors | Same |
| Patient Connector | Y-piece with ISO cone 15 mm female accordingto ISO 5356-1 | Y-piece with ISO cone 15 mm femaleaccording to ISO 5356-1 | Same |
| Device Connector | 11.5 mm female (ID) connector according to ISO5356-1 | 15 mm male (OD)/11.5 mm female (ID)connector according to ISO 5356-1 | Same |
| Length | Inspiratory Limb 1.70 m ±10% (66,9 inch ±10%), including 40 cm(15.74 in) hose extension | 1.2 m ±10% (47 inch ±10%) including 30 cm(11.81 inch ±10%) hose extension | Different |
| Expiratory Limb 1.40 m ± 90 mm (55 ±3.54 inch) | 1.1 m ± 60 mm (43,30 ±2.36 inch) | ||
| Humidifier Connection 0.50 m ± 40 mm (19.7 ±1.58 inch) | 0.3 m ± 10 mm (11.81 ±0.39 inch) | ||
| Substantial EquivalenceDiscussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Resistance | Inspiratory:at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 1.0 mbarat 30 L/min < 3.0 mbar | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.4 mbarat 15 L/min < 2 mbarat 30 L/min < 7 mbar | Different |
| Expiratory:at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 1.0 mbarat 30 L/min < 3.3 mbar | at 2.5 L/min < 0.1 mbarat 5 L/min < 0.2 mbarat 15 L/min < 1.5 mbarat 30 L/min < 5 mbar | ||
| Compliance | at 60 mbar (breathing circuit: inspiration andexpiration) < 1.0 mL/hPa | at 60 mbar <0.9 mL/mbar | Similar |
| Leakage | at 20 mbar < 15 mL/minat 40 mbar < 30 mL/minat 60 mbar < 30 mL/min | at 60 mbar <50 mL/min | Different |
| Volume of breathingcircuit/ humidifier chamber | Inspiratory volume of the breathing circuit withincubator extension 360 ml ±10%Volume (air) of humidifier chamber with water 210ml ±10%Volume (air) of humidifier chamber without water300 ml ±10% | Inspiratory volume of the breathing circuitwith incubator extension 350 mlVolume (air) of humidifier chamber with water190 mlVolume (air) of humidifier chamber withoutwater 300 ml | Similar |
| Warm up Time | 30 min | 30 min | Same |
| Humidification Output | Invasive ventilation at 2 to 60 L/min > 33 mg/LNon-invasive ventilation at 2 to 60 L/min > 12mg/L | Invasive ventilation at 4 to 30 L/min >33 mg/LNon-invasive ventilation at 4 to 30 L/min > 12mg/L | Different |
| Breathing gas temperatureat Y-Piece | Adjusted and controlled by Fisher & PaykelMR850 humidifier | Adjusted and controlled by Fisher & PaykelMR850 humidifier | Same |
| Substantial EquivalenceDiscussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Electrical Connection Data | 22 V, 2.73 A, 60 W$14 \Omega$ inspiratory | 22 V, 2,73 A, 60 W,$16 \Omega$ inspiratory | Same |
| Ventilation modes | VentStar Helix dual heated (N) Plus is suitable for standard ventilation modes, such as Synchronized Intermittend Mandatory Ventilation (SIMV), Mandatory Minute Ventilation (MMV), and Continuous Positive Airway Pressure (CPAP) as well as for High Frequency Oscillation (HFO). | Suitable for standard ventilation modes, such as Synchronized Intermittend Mandatory Ventilation (SIMV), Mandatory Minute Ventilation (MMV), and Continuous Positive Airway Pressure (CPAP) as well as for High Frequency Oscillation (HFO). | Same |
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510(k) Summary
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510(k) Summary
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510(k) Summary
The indications for use and fundamental scientific technology are the same for both proposed and predicate devices.
As demonstrated in the nonclinical testing the different technological characteristics do not raise any new questions of safety and effectiveness when compared to the predicate devices.
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510(k) Summary
Performance Data
Non-clinical testing of the breathing circuits has been performed covering mechanical, thermal safety, environmental conditions, electrical safety and electromagnetic compatibility, functional verification, and performance capacity and accuracy. Verification and validation testing was conducted in conformance to the FDA recognized standards as listed below. Performance data related to each proposed modification has been tested and evaluated. High level summary reports included in this 510(k) demonstrate that the subject devices are substantially equivalent to the predicate device.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted for VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus. The devices comply with the IEC 60601-1 for basic safety and performance and the IEC 60601-1-2 standard for EMC.
Further Performance Testing
To demonstrate performance and functionality, VentStar Helix Dual Heated N Exten. Kit and VentStar Helix heated (N) Plus were tested and meet all applicable requirements of the following standards:
- . ISO 5367: Anaesthetic and respiratory equipment -- Breathing sets and connectors
- . ISO 80601-2-12: Medical electrical equipment. Particular requirements for basic safety and essential performance of critical care ventilators
- . ISO 5356-1: Anaesthetic and respiratory equipment -- Conical connectors -- Part 1: Cones and sockets
- . ISO 80601-2-74: Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (Gap Analysis)
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Traditional 510(k) 510(k) Summary
K222822
Biocompatibility Testing
All materials used in the fabrication of the heated breathing systems and also the completed products were evaluated through biological qualification safety tests as outlined in ISO 10993-1 "Biological Evaluation of Medical Devices" and the international standard series of ISO 18562 "Biocompatibility evaluation of breathing gas pathways in healthcare". These materials were also tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. The following tests were performed:
- . Test for emissions of particulate matter (PM) according to ISO 18562-2
- Test for emission of VOC with additional humidity according to ISO 18562-3
- . Test for leachables in condensate according to ISO 18562-4
- . Extracting according to ISO 10993-18 (Exhaustive extraction in Water, Isopropanol; simulated use extraction with Isopropanol)
- . Material characterization according to ISO 10993-18 (2009-08) (organic and inorganic extractables/ leachables)
- . Cytotoxicity according to ISO 10993-5
- Sensitization according to ISO 10993-10 .
- . Irritation according to ISO 10993-10
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510(k) Summary
List of Consensus Standards
| Standards Number | Standards Title | FDA RecognitionNo. + date |
|---|---|---|
| ISO10993-1Fifth Edition2018 | Biological evaluation of medical devices - Part 1: Evaluation andtesting within a risk management process | 2-258 01/14/2019 |
| ISO18562-1First Edition2017 | Biocompatibility evaluation of breathing gas pathways in healthcareapplications - Part 1: Evaluation and testing within a riskmanagement process | 1-13406/07/2018 |
| IEC60601-1-2Edition 4.02014 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests | 19-809/17/2018 |
| ISO18190First Edition2016 | Anaesthetic and respiratory equipment - General requirements forairways and related equipment | 1-12001/14/2019 |
| ANSI AAMIES60601-12005/(R)2012 | Medical electrical equipment - Part 1: General requirements for basicsafety and essential performance (IEC 60601-1:2005, MOD) andA1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | 19-407/09/2014 |
| ISO80601-2-12First Edition2011 | Medical electrical equipment - Part 2-12: Particular requirements forthe safety of lung ventilators - Critical care ventilators [Including:Technical Corrigendum 1 (2011)] | 1-9801/30/2014 |
| ISO80601-2-74First Edition2017 | Medical electrical equipment - Part 2-74: Particular requirements forbasic safety and essential performance of respiratory humidifyingequipment | 1-13801/14/2019 |
| IEC60601-1-6Edition 3.12013 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability | 5-8906/27/2016 |
| IEC62366-1Edition 1.02015 | Medical devices - Part 1: Application of usability engineering tomedical devices [Including CORRIGENDUM 1 (2016)] | 5-11412/23/2016 |
| ISO5356-1Third Edition2004 | Anaesthetic and respiratory equipment - Conical connectors: Part 1:Cones and sockets | 1-6203/16/2012 |
| ISO5367Fifth Edition2014 | Anaesthetic and respiratory equipment -- Breathing sets andconnectors | 1-10308/14/2015 |
| ISO14971Third Edition2019 | Medical devices - Application of risk management to medical devices | 5-12512/23/2019 |
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Traditional 510(k) K222822 510(k) Summary
Conclusion
Based on the indications for use/intended use, technological characteristics, performance/nonclinical testing, and comparison to the predicate devices, the subject devices are substantially equivalent to the legally marketed predicate devices and raise no new safety and effectiveness questions compared to the predicate devices.
- END -
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).