VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)

K222822 · Draegerwerk AG & CO Kgaa · BZE · Jun 14, 2023 · Anesthesiology

Device Facts

• Record ID: K222822
• Device Name: VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
• Applicant: Draegerwerk AG & CO Kgaa
• Product Code: BZE · Anesthesiology
• Decision Date: Jun 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5270
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

VentStar Helix devices are disposable, heated breathing circuits designed for neonatal patients (tidal volume ≤100 mL). The system connects to a Fisher & Paykel MR850 humidifier to deliver humidified gas to the patient. The VentStar Helix Dual Heated N Exten. Kit provides inspiratory and expiratory heating, while the VentStar Helix Heated (N) Plus provides inspiratory heating. Used in hospital settings or during intrahospital transport, these circuits are compatible with Dräger Babylog VN-Series ventilators. The device functions as a conduit for breathing gas; heating wires integrated into the circuit walls maintain gas temperature and humidity levels to prevent condensation. Healthcare providers connect the circuit to the humidifier and ventilator; the system operates passively to maintain gas conditions. Benefits include consistent humidification and temperature control for neonates, reducing the risk of airway drying or thermal injury. The device is not for use during MRI or electrocautery.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including mechanical, thermal safety, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-1, ISO 18562).

Technological Characteristics

Disposable breathing circuits with integrated heating wires. Materials evaluated per ISO 10993-1 and ISO 18562. Connectors comply with ISO 5356-1. Electrical: 22V, 2.73A, 60W. Connectivity: Physical connection to MR850 humidifier and Dräger Babylog VN-Series ventilators. Sterilization: Not specified (disposable).

Indications for Use

Indicated for neonatal patients with tidal volume up to 100 mL requiring humidified breathing gas delivery via connection to a Fisher & Paykel MR850 humidifier. Contraindicated for use during MRI or electrocautery.

Regulatory Classification

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.

Predicate Devices

• RT265 Dual Heated Infant Breathing Circuit, Fisher & Paykel HealthCare (K103767)
• VentStar heated (N) (MP00308), Drägerwerk AG & Co. KGaA (K102618)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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. KGaA<br>Moislinger Allee 53-55<br>23542 Lübeck, Germany<br>Establishment's registration number: 9611500 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jan Upmeier<br>Regulatory Affairs Manager<br>E-Mail: [e-mail]<br>Telephone: [phone] |
| Applicant's US Contact Person: | Darlene Thibodeau<br>Head of Quality Assurance and Compliance<br>E-Mail: [e-mail]<br>Telephone: [phone] |
| Date prepared: | June 14th, 2023 |
| Device Name: | Trade Name: VentStar Helix Dual<br>Heated N Exten. Kit / VentStar Helix Heated (N) Plus<br>Classification Name: Breathing system heater<br>Regulation Number: 21 CFR 868.5270<br>Product Code: BZE<br>Class: II |
| Predicate Device: | Primary predicate for VentStar Helix Dual Heated N<br>Exten. Kit: RT265 Dual Heated Infant Breathing Circuit,<br>Fisher & Paykel HealthCare, cleared via K103767;<br>Secondary predicate for VentStar Helix Heated (N) Plus<br>MP00308 VentStar heated (N), Drägerwerk AG & Co.<br>KGaA, cleared via K103618 |

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510(k) Summary

K222822

# 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

K222822

| Table 1: Comparison Table VentStar Helix Dual Heated N Exten. Kit (MP02280) | | | |
|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Substantial Equivalence<br>Discussion | 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<br>(MP02280): Inspiratory and expiratory heated<br>disposable breathing circuit with humidifier<br>chamber for connection to a humidifier MR850 by<br>Fisher & Paykel, for neonatal patients with a tidal<br>volume of up to 100 mL, for conducting humidified<br>breathing gas from humidifier to patient. | The dual-heated breathing circuits are<br>intended as conduits of breathing gas for<br>ventilation of infant patients, and to maintain<br>the temperature of humidified inspired gas.<br>The RT265 is used for flow rates greater than<br>4 L/min, and the RT266 is for flow rates<br>between 0.3 and 4 L/min. | Similar |
| Description | Dual-heated breathing circuits with humidifier<br>chamber | Dual-heated breathing circuits with humidifier<br>chamber | Same |
| Heater | for connection to a Fisher & Paykel humidifier<br>MR850 | for connection to a Fisher & Paykel humidifier<br>MR850 | Same |
| Patient Population | Neonatal patients with a tidal volume of up to 100<br>mL and a weight up to 8 kg. | Infants, tidal volume <185 mL | Similar |
| Application | Disposable | disposable | Same |
| Hose diameter<br>ID = Inner Diameter<br>OD = Outer Diameter | 11 mm ID | 10 mm ID | Different |
| Color | Inspiratory limb: blue spiral on colorless hose<br>Expiratory limb: white spiral on colorless hose | Inspiratory limb: blue-transparent<br>Expiratory limb: white | Similar |
| Heating Wire | Inspiratory limb: in the wall of the circuit<br>Expiratory limb: in the wall of the circuit | Inspiratory limb: Spiral wire inside the circuit<br>Expiratory 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 according<br>to ISO 5356-1 | Y-piece with ISO cone 15 mm female<br>according to ISO 5356-1 | Same |
| Device Connector | 11.5 mm female connector (ID) according to ISO<br>5356-1 | 15 mm male (OD)/11.5 mm (ID) female<br>connector according to ISO 5356-1 | Same |
| Traditional 510(k) | 510(k) Summary | | K22282 |
| Substantial Equivalence<br>Discussion | Subject of Submission | Primary Predicate Device | Comments |
| Product Name | MP02280 | REF RT265 | - |
| Length<br>Inspiratory Line | 1.70 m ±10% (66,9 inch ±10%), including 40 cm<br>(15.74 in) hose extension | 1.60 m (59 inch), including 40 cm (15.74 in)<br>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 |
| Resistance<br>Inspiratory: | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 1.0 mbar<br>at 30 L/min < 3.0 mbar | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.4 mbar<br>at 15 L/min < 1.3 mbar<br>at 30 L/min < 9.6 mbar | Different |
| Expiratory: | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 0.7 mbar<br>at 30 L/min < 2.4 mbar | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 1.4 mbar<br>at 30 L/min < 5.3 mbar | Different |
| Compliance | at 60 mbar (breathing circuit: inspiration and<br>expiration) < 0.8 mL/hPa (mL/mbar) | 1.27 mL/mbar (1.3 cmH2O) | Different |
| Leakage | at 20 mbar < 15 mL/min<br>at 40 mbar < 30 mL/min<br>at 60 mbar < 30 mL/min | @ 60 mbar ≤ 75 mL/min | Different |
| Volume of breathing<br>circuit/ humidifier chamber | Inspiratory volume of the breathing circuit with<br>incubator extension 360 ml ±10%<br>Volume (air) of humidifier chamber with water 210<br>ml ±10%<br>Volume (air) of humidifier chamber without water<br>300 ml ±10% | Inspiratory volume of the breathing circuit<br>with incubator extension 450 ml<br>Volume (air) of humidifier chamber with water<br>190 ml<br>Volume (air) of humidifier chamber without<br>water 350 ml | Different |
| Warm up Time | 30 min | 30 min | Same |
| Substantial Equivalence<br>Discussion | 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 > 12<br>mg/L | Non-invasive ventilation up to 120 L/min > 10<br>mg/L | Different |
| Breathing gas temperature<br>at Y-Piece | Adjusted and controlled by Fisher & Paykel<br>MR850 humidifier | Adjusted and controlled by Fisher & Paykel<br>MR850 humidifier | Same |
| Electrical Connection Data | 22 V, 2,73 A, 60 W<br>14 Ω inspiratory<br>12 Ω expiratory (MP02650) | 22 V, 2.73 A, 60 W, 50/60 Hz | Same |
| Ventilation modes | VentStar Helix dual heated (N) Plus is suitable for<br>standard ventilation modes, such as<br>Synchronized Intermittend Mandatory Ventilation<br>(SIMV), Mandatory Minute Ventilation (MMV), and<br>Continuous Positive Airway Pressure (CPAP) as<br>well as for High Frequency Oscillation (HFO) | No information is provided in the IFU, suitable<br>for delivery of breathing gas. | Similar |

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510(k) Summary

K222822

#### Table 2: Comparison Table VentStar Helix heated (N) Plus (MP02608)

| Substantial Equivalence<br>Discussion | 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):<br>Inspiratory heated disposable breathing circuit<br>with humidifier chamber for connection to a<br>humidifier MR850 by Fisher & Paykel, for<br>neonatal patients with a tidal volume of up to 100<br>mL, for conducting humidified breathing gas from<br>humidifier to patient. | VentStar heated (N) (MP00308): Disposable<br>inspiratory heated breathing circuit for<br>connection to a Fisher & Paykel MR850<br>humidifier, for conveying moistened breathing<br>gas between the humidifier and neonatal<br>patients with a body weight of up to 5 kg (11<br>lbs). | Similar |
| Substantial Equivalence<br>Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Description | Single-heated breathing circuits with humidifier<br>chamber | Single-heated breathing circuits with<br>humidifier chamber | Same |
| Heater | For connection to a Fisher & Paykel humidifier<br>MR850 | For connection to a Fisher & Paykel<br>humidifier MR850 | Same |
| Patient Population | Neonatal patients | Neonatal patients | Same |
| Application | Disposable | Disposable | Same |
| Hose diameter (Inner<br>Diameter) | 11 mm ID | Heated hose: 14 mm ID<br>Non-heated hose: 10 mm ID | Different |
| Color | Inspiratory limb: blue spiral on colorless hose<br>Expiratory limb: white spiral on colorless hose<br>with water trap | Inspiratory limb: transparent with white<br>heating wire inside the limp<br>Expiratory limb: transparent | Different |
| Heating Wire | Inspiratory limb: in the wall of the circuit<br>Expiratory limb: none | Inspiratory limb: white heating wire inside the<br>limp<br>Expiratory 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 according<br>to ISO 5356-1 | Y-piece with ISO cone 15 mm female<br>according to ISO 5356-1 | Same |
| Device Connector | 11.5 mm female (ID) connector according to ISO<br>5356-1 | 15 mm male (OD)/11.5 mm female (ID)<br>connector according to ISO 5356-1 | Same |
| Length | Inspiratory Limb 1.70 m ±10% (66,9 inch ±10%), including 40 cm<br>(15.74 in) hose extension | 1.2 m ±10% (47 inch ±10%) including 30 cm<br>(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 Equivalence<br>Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Resistance | Inspiratory:<br>at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 1.0 mbar<br>at 30 L/min < 3.0 mbar | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.4 mbar<br>at 15 L/min < 2 mbar<br>at 30 L/min < 7 mbar | Different |
| | Expiratory:<br>at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 1.0 mbar<br>at 30 L/min < 3.3 mbar | at 2.5 L/min < 0.1 mbar<br>at 5 L/min < 0.2 mbar<br>at 15 L/min < 1.5 mbar<br>at 30 L/min < 5 mbar | |
| Compliance | at 60 mbar (breathing circuit: inspiration and<br>expiration) < 1.0 mL/hPa | at 60 mbar <0.9 mL/mbar | Similar |
| Leakage | at 20 mbar < 15 mL/min<br>at 40 mbar < 30 mL/min<br>at 60 mbar < 30 mL/min | at 60 mbar <50 mL/min | Different |
| Volume of breathing<br>circuit/ humidifier chamber | Inspiratory volume of the breathing circuit with<br>incubator extension 360 ml ±10%<br>Volume (air) of humidifier chamber with water 210<br>ml ±10%<br>Volume (air) of humidifier chamber without water<br>300 ml ±10% | Inspiratory volume of the breathing circuit<br>with incubator extension 350 ml<br>Volume (air) of humidifier chamber with water<br>190 ml<br>Volume (air) of humidifier chamber without<br>water 300 ml | Similar |
| Warm up Time | 30 min | 30 min | Same |
| Humidification Output | Invasive ventilation at 2 to 60 L/min > 33 mg/L<br>Non-invasive ventilation at 2 to 60 L/min > 12<br>mg/L | Invasive ventilation at 4 to 30 L/min >33 mg/L<br>Non-invasive ventilation at 4 to 30 L/min > 12<br>mg/L | Different |
| Breathing gas temperature<br>at Y-Piece | Adjusted and controlled by Fisher & Paykel<br>MR850 humidifier | Adjusted and controlled by Fisher & Paykel<br>MR850 humidifier | Same |
| Substantial Equivalence<br>Discussion | Subject of Submission | Reference Predicate Device | Comments |
| Product Name | MP02608 | MP00308 | - |
| Electrical Connection Data | 22 V, 2.73 A, 60 W<br>$14 \Omega$ inspiratory | 22 V, 2,73 A, 60 W,<br>$16 \Omega$ 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

K222822

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510(k) Summary

K222822

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# 510(k) Summary

K222822

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

K222822

# 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

K222822

# List of Consensus Standards

| Standards Number | Standards Title | FDA Recognition<br>No. + date |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| ISO<br>10993-1<br>Fifth Edition<br>2018 | Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process | 2-258 01/14/2019 |
| ISO<br>18562-1<br>First Edition<br>2017 | Biocompatibility evaluation of breathing gas pathways in healthcare<br>applications - Part 1: Evaluation and testing within a risk<br>management process | 1-134<br>06/07/2018 |
| IEC<br>60601-1-2<br>Edition 4.0<br>2014 | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests | 19-8<br>09/17/2018 |
| ISO<br>18190<br>First Edition<br>2016 | Anaesthetic and respiratory equipment - General requirements for<br>airways and related equipment | 1-120<br>01/14/2019 |
| ANSI AAMI<br>ES60601-1<br>2005/(R)2012 | Medical electrical equipment - Part 1: General requirements for basic<br>safety and essential performance (IEC 60601-1:2005, MOD) and<br>A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) | 19-4<br>07/09/2014 |
| ISO<br>80601-2-12<br>First Edition<br>2011 | Medical electrical equipment - Part 2-12: Particular requirements for<br>the safety of lung ventilators - Critical care ventilators [Including:<br>Technical Corrigendum 1 (2011)] | 1-98<br>01/30/2014 |
| ISO<br>80601-2-74<br>First Edition<br>2017 | Medical electrical equipment - Part 2-74: Particular requirements for<br>basic safety and essential performance of respiratory humidifying<br>equipment | 1-138<br>01/14/2019 |
| IEC<br>60601-1-6<br>Edition 3.1<br>2013 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability | 5-89<br>06/27/2016 |
| IEC<br>62366-1<br>Edition 1.0<br>2015 | Medical devices - Part 1: Application of usability engineering to<br>medical devices [Including CORRIGENDUM 1 (2016)] | 5-114<br>12/23/2016 |
| ISO<br>5356-1<br>Third Edition<br>2004 | Anaesthetic and respiratory equipment - Conical connectors: Part 1:<br>Cones and sockets | 1-62<br>03/16/2012 |
| ISO<br>5367<br>Fifth Edition<br>2014 | Anaesthetic and respiratory equipment -- Breathing sets and<br>connectors | 1-103<br>08/14/2015 |
| ISO<br>14971<br>Third Edition<br>2019 | Medical devices - Application of risk management to medical devices | 5-125<br>12/23/2019 |

{14}------------------------------------------------

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.

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