VENTILAIR II MEDICAL AIR COMPRESSOR

• K Number: K041781
• Device Name: VENTILAIR II MEDICAL AIR COMPRESSOR
• Manufacturer: HAMILTON MEDICAL AG
• Date Cleared: 2005-03-14 ( 256 days)
• Product Code: BTI
• Regulation Number: 868.6250

Intended Use

The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.

Device Description

The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts. Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure). The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure. The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals. The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.

Predicate Devices

K982789, K920954

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description explicitly states that the device is "electromechanical and preumatic device only and has no software-based components."

Therapeutic

No.
The VEN TILAIR II is a medical air supply device that provides compressed air to ventilators, it does not directly treat or diagnose a disease or condition.

Diagnostic

No

The device is described as an electromechanical and pneumatic device that supplies medical air to ventilators. It specifically states it "has no software-based components" and is for supplying air, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the VENTILAIR II is an "electromechanical and pneumatic device only and has no software-based components."

IVD (In Vitro Diagnostic)

Based on the provided information, the Hamilton Medical VENTILAIR II is not an In Vitro Diagnostic (IVD) device.

Here's why:

• Intended Use: The intended use is to supply medical air to ventilators. This is a life support function, not a diagnostic test performed on samples taken from the human body.
• Device Description: The device is described as an electromechanical and pneumatic device that generates and conditions air. It does not involve the analysis of biological samples.
• Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens (like blood, urine, tissue, etc.) for diagnostic purposes.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The VENTILAIR II's function is to provide a necessary resource (medical air) for the operation of a life support device (ventilator).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.

Product codes

BTI

Device Description

The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts.

Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure).

The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure.

The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals.

The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals and other institutions

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K982789, K920954, Bennett MC-2 Mobile Air Compresor (Pre-Amendment)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.6250 Portable air compressor.

(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.

Summary

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510(K) SUMMARY 9

• 1. Summary Preparation Date: January 18, 2005
• 2. Applicant Information: Name: Hamilton Medical AG Via Nova CH-7403 Rhäzüns Switzerland FDA Establishmen Registration Number: 3001421318 Contact Person:J.. David Thompson, General Manager Hamilton Medical Inc. P.O.Box 30008 Reno, NV 89502 Phone [phone] Fax [phone] Email: [e-mail]
• 3. Device Proprietary Name: VENTILAIR II Medical Air Compressor

Common/Usual Name: Air Compressor Classification Name: Compressor. Air. Portable Classification Panel: Anesthesiology Classification Code: BTI

• 4. BTI Device Identification Code (per 21 SFR Part 868.6250): A portable air compressor is a device to provide comopressed air for medical purposes, e.g. to drive ventilators and other respiratory devices.
• 5. Regulatory Status: Portable air compressors and their accessories (FDA product code BTI) have been classified by the FDA as class II. There are currently no mandatory performance standards or special control requirements for these devices.
• 6. Intended Use: The Hamilton Medical VENTILAIR II is intended for use in hospitals and other institutions as an alternative to central air or cylinder air to supply medical air at 30 psi nominal to the GALILEO and the RAPHAEL models of Hamilton Medical ventilators which are intended to be operated with 30 psi nominal medical air supply. It can also be used as a backup medical air supply for these ventilators in case of failure of their normal air supply.
• 7. General Device Description: The VENTILAIR II is an electromechanical and preumatic device only and has no software-based components. The device is rated at 115 V ± 10 %, 60 Hertz. It requires 466 Watts to power. The enclosure is designed to be mounted either on the GALILEO model or RAPHAEL model ventilator carts.

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Only one control is accessed during normal device operation, a power switch. The Power switch is switched ON both when the VENTILAIR II is configured and operated as a permanent air supply and when it is used as an emergency backup air supply. An indicator is provided to inform the user of the device performance status. This "Performance Gauge" is a pressure gauge calibrated for three zones of operation: Green (Normal Dry Operation), Yellow (Poor Drying Effect), and Red (Wet with Low Output Pressure).

The VENTILAIR II has two air movements. The first is the cool, clean, dry compressed air movement that provides condensation-free compressed air to the ventilator. The second is the ambient air movement - an S-pattern that cools the entire drying system and compressor within the enclosure.

The VENTILAIR II has been designed for easy maintenance. The compressor air intake filter element must be checked weekly. The 5 micron filter in the water trap must be replaced annually. Two internal pressure requlators and two other internal components must be checked annually and adjusted if necessary. Compressor overhaul is required periodically using the compressor manufacturer's overhaul kit. If the VENTILAIR II is used as an independent or continuous air source, an annual overhaul is recommended. If the compressor is used only as a backup in case of failure of the main air supply, overhaul is recommended every five years. All maintenance and overhaul procedures are described in the VENTILAIR II Operator's and Service Manuals.

The VENTILAIR II is in full compliance with all required safety aspects of the current edition of IEC 60601-1. Several specific safety mechanisms have been incorporated into the VENTILAIR 11.

• 8. Device Materials: All materials within the VENTILAIR II flow path have been carefully selected to avoid any contamination of the medical air flow path. There are no plastic mold release compounds and no outgassed toxic material present to contaminate the gas flow. A 5 micron filter has been built into the device to capture any particulate impurities. In addition all Hamilton Medical GALILEO and RAPHAEL ventilators have a 0.5 micron filter built into their air inputs to trap any particulate impurities.
• 9. Substanital Eqiuvalence: The Hamilton Medical VENTILAIR II Medical Air Compressor is substantially equivalent to the Draeger Medical Air Compressor (K982789), Infrasonics Air Star Portable Compressor (K920954), and the Bennett MC-2 Mobile Air Compresor (Pre-Amendment).

Among the information presented in the 510(k) submission to support the equivalency of the VENTILAIR II to these predicate devices is: (a.) device description, (b.) comparison to the legally marketed predicate devices, and (c.) laboratory performance verification and validation test data.

• 10. Comparison Table: The table that follows describes some Important characteristics of the VENTILAIR II Medical Air Compressor and its predicate devices: Draeger Medical Air Compressor (K982789), Infrasonics Air Star Portable Compressor (K920954), and Bennett MC-2 Mobile Air Compressor (Pre-Amendment).

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omparison to Legally Marketed Predicate Devices

| # | Characteristic | Bennett MC-2 Air Compressor (Pre-Amendment) | PREDICATE DEVICES
Draeger Medical Air Compressor (K982789) | Infrasonics Air Star Compressor (K920954) | VENTILAIR II
Similar or Different
(From All Other Predicates Combined) |
|---|---------------------------------|--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Intended use and applications | Source of compressed air for Bennet IPPB therapy units, respiration units and other devices requiring clean filtered air | Independent or backup compressed air source to power medical ICU ventilators | Independent or backup compressed air source to power Infrasonics Infant Star and other ventilators | Independent/backup 30 psi compressed air source to power GALILEO and RAPHAEL ventilators in hospitals and other institutions at 30 psi nominal operating pressure |
| 2 | User controls/visual indicators | Power switch / pressure gauge | Power switch / power LED, high air temperature LED | Power switch / pressure gauge, power LED, low pressure LED, compressor on LED and wall air on LED | Power switch / pressure performance gauge, power failure and low pressure indicators built into ventilator |
| 3 | Alarms | Audible and visual power failure and low pressure built into ventilator (respiration unit) | Audible and visual high output air temperature | Audible and visual power failure and low pressure | Audible and visual power failure and low pressure indicators built into ventilator |
| 4 | Filtering | Pre-compression HEPA filter; water trap filter (size unspecified in available labeling) | $≤$ 1 micron | Degree of filtering unspecified in available labeling | $≤$ 5 microns at output of device; 0.5 micron filter built into ventilator input |
| 5 | Water trap | Yes, with automatic vaporization | Yes, with automatic vaporization | Yes, with automatic vaporization | Yes, with automatic vaporization |
| 6 | Pressure relief valve | Yes, set to 60 PSIG | Yes, set to 59 PSIG | Yes, set to 85 PSIG | Yes, set to 32 PSIG |
| 7 | Auto backup pressure | Feature not available | On at 40.5 PSIG, off at 50 PSIG | Optional featue, on at 45 PSIG, off at 55 PSIG | On at 30 PSIG, off at 38 PSIG |

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| | Bennett MC-2 Air
Compressor (Pre-Amendment) | PREDICATE DEVICES
Draeger Medical Air
Compressor (K982789) | Infrasonics Air Star
Compressor (K920954) | VENTILAIR II
Similar or Different
(From All Other
Predicates Combined) |
|---------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Characteristic | | | | |
| Electrical ratings | 115 V; 60 Hertz; power
consumption unspecified
in available labeling | 110 V; 60 Hertz; 500 W | 102 to 132 V; 60 Hertz;
power consumption
unspecified in available
labeling | 115 ± 10 %; 60 Hertz;
466 W |
| Overcurrent
protection | Unspecified in available
labeling | Fuse | Circuit breaker | Fuse |
| Output | 45 l/min at 50 PSIG | 30 l/min at 44 PSIG | 55 l/min at 50 PSIG | 40 l/min at 30 PSIG |
| Dew point
depression | Unspecified in available
labeling | 5 °C below room
temperature at 30 l/min | > 3 °F below room
temperature at 55 l/min | 3.3 °C below room
temperture at 40 l/min |
| Input/output
interface | Two DISS 9/16" - 18
threaded outlets (one
capped when not in use) | Quick connect DISS
coupling with internal
check valve (1 input, 1
output) | ¾" - 16 male DISS
fitting with internal check
valve (optional input, 1
output) | ¾" - 16 male DISS fitting
with internal check valve
(1 input, 1 output) |
| Ambient
environment | Unspecified in available
labeling | 50 to 104 °F; 30 to 95 %
RH, 13,000 ft max.
altitude | 20 to 95 °F; ≤ 99 %
noncondensing RH;
altitude unspecified in
available labeling | 50 to 104 °F;