VENTILAIR II MEDICAL AIR COMPRESSOR

K041781 · Hamilton Medical AG · BTI · Mar 14, 2005 · Anesthesiology

Device Facts

• Record ID: K041781
• Device Name: VENTILAIR II MEDICAL AIR COMPRESSOR
• Applicant: Hamilton Medical AG
• Product Code: BTI · Anesthesiology
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2

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 Story

Electromechanical/pneumatic portable air compressor; provides 30 psi nominal medical air to GALILEO and RAPHAEL ventilators. Used in hospitals/institutions as alternative to central/cylinder air or as emergency backup. Device features two air movements: compressed air path for ventilator supply and ambient air path for cooling. User operates via power switch; performance monitored via pressure gauge (Green/Yellow/Red zones). No software components. Maintenance includes weekly intake filter checks and annual internal component/regulator inspections. Benefits include continuous, condensation-free air supply for critical respiratory support.

Clinical Evidence

Bench testing only. No clinical data presented. Performance verification included laboratory testing of output pressure, flow rate, dew point depression, and safety compliance with IEC 60601-1.

Technological Characteristics

Electromechanical/pneumatic portable compressor; 115V/60Hz; 466W power consumption. Output: 40 l/min at 30 psi. Features 5-micron output filter and water trap with automatic vaporization. Materials selected to prevent contamination of gas flow. No software/firmware. Dimensions/form factor designed for mounting on ventilator carts. Safety mechanisms include pressure relief valve (32 PSIG) and overcurrent protection (fuse).

Indications for Use

Indicated for use in hospitals and institutions as a primary or backup 30 psi medical air supply for Hamilton Medical GALILEO and RAPHAEL ventilators.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Draeger Medical Air Compressor (K982789)
• Infrasonics Air Star Portable Compressor (K920954)
• Bennett MC-2 Mobile Air Compressor (Pre-Amendment)

Submission Summary (Full Text)

{0}------------------------------------------------

K041781

| | Comments of the contribution of the comments of the minimal concerner of the contraction of the consistence of the consistence of the consistence of the consistence in the co<br>12.00 15.00 | からいつけられるということです。 そして、そこではないというというというというというということです。<br>.<br>AND STATE CALLERY | |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Doc .- Title | ------------------------------------------<br>Ventilair II Section | Joc .- Version .<br>"White the different to the research futured in the first to be the first to<br>Called College Complete Comments of Children Company Controlled Collection Controller Company of Concello Come of Concerner of Concerner of Concerner of Concerner of Concerne | |

## 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.

| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A AN AND A LIES & LINE & LEASE OF<br>AND AND COLLEGE & Access of | Carling of Children College of the |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 44 5 611.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | 800 7 | 2004-03-11 |
| attribution Cadder Party<br><br>CALL Co., Co., Canada Co., LEAN<br>HOUSE A. F. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. | 10.00<br><br>THE COLLECTION CALL CALL CALL CALL<br>4 7 4 8 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 | |
| | .<br>a new den looked for logically in religion m infrastrial program information of the interest of the interest of the interest of the states of the story of the complete of the<br>client of BaNds, ac n I (" in a "if("\(" ) " = "("("\\["+")")")")")")")")")")")")")")")")")")")")")")")")")")")")")")")")")""(""""""""""""""""""""""""""""""""""""""""""""""""<br><br>----------------------------------------------------------------------------------------------<br>A F E MALL PR . 19 AS, PAR 15 PAR 15 Comment<br>1<br>Acres Courts A. B | Carles Carder Problem Company Comparison<br>. In In Intelligence and a viames Children I stampen below<br>. |
| | I<br> | <br>September 19, 2017 11:40 PM |

{1}------------------------------------------------

| | Pinters Manne - Mentilation - HAMLTON MEDCALAG - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -<br>AMILTON MEDICAEA<br>Ventilair IF 510 Kr Sur<br>-1130.000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 | a consult of the last to | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|--|
| Doc .- Title<br>Callery of Concession | --- " xaction 9: 510(k) Summarv<br>Vontilair II . | Onc.-Varsion | |

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).

| Unio | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>SUFFFFFFULLS |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 0000 0000 0000 0000 0000000000000000000000000000000000000000000000000000000000000<br>4.60<br><br>STANKS AL I SELECT | Comments of the country of the results of the production of the comments of the production of the<br>----------------------------------------------------------------------<br>.<br><br>Machel ad 1 1 1 momen a 10 to as 6 a 1 1 2 . 1 .<br>a contract and a season that man and an a magazine rates ab-<br>Contraction of the many would be the love the 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10,<br>. | -------------------------------------------------------------------------------------------------------------------------------- |

{2}------------------------------------------------

| www.rangement.com/sport/supply/supply.com/sport/ | Project Name | | |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--|
| MALERIAN & AN AND AND AND AND A FE<br>ﻟ | <br><br>Minin It Cantler Or E<br>ાં ની રહ્યપાય | A MARK MANAGER A BRANCH A BREASE A BREASE AND A BALL BALL BE BE BERESS AND | |
| LOC .- Patri<br>B B B B B B | .<br>D:\FDA KORRESPONDENZIVENTILAIR 510(K) RESPONSELE37209<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Called of Children and Children and Children and Children and Children of | |

## omparison to Legally Marketed Predicate Devices

| # | Characteristic | Bennett MC-2 Air Compressor (Pre-Amendment) | PREDICATE DEVICES<br>Draeger Medical Air Compressor (K982789) | Infrasonics Air Star Compressor (K920954) | VENTILAIR II<br>Similar or Different<br>(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 |

H. Pohl
© Copylgitty Hamliton MEDICALAGAGA CARACTER CARACHER CONFECTION - CONFERTRAULICHICONFIDENTAL

{3}------------------------------------------------

| | Bennett MC-2 Air<br>Compressor (Pre-Amendment) | PREDICATE DEVICES<br>Draeger Medical Air<br>Compressor (K982789) | Infrasonics Air Star<br>Compressor (K920954) | VENTILAIR II<br>Similar or Different<br>(From All Other<br>Predicates Combined) |
|---------------------------|----------------------------------------------------------------------------|------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Characteristic | | | | |
| Electrical ratings | 115 V; 60 Hertz; power<br>consumption unspecified<br>in available labeling | 110 V; 60 Hertz; 500 W | 102 to 132 V; 60 Hertz;<br>power consumption<br>unspecified in available<br>labeling | 115 ± 10 %; 60 Hertz;<br>466 W |
| Overcurrent<br>protection | Unspecified in available<br>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<br>depression | Unspecified in available<br>labeling | 5 °C below room<br>temperature at 30 l/min | > 3 °F below room<br>temperature at 55 l/min | 3.3 °C below room<br>temperture at 40 l/min |
| Input/output<br>interface | Two DISS 9/16" - 18<br>threaded outlets (one<br>capped when not in use) | Quick connect DISS<br>coupling with internal<br>check valve (1 input, 1<br>output) | ¾" - 16 male DISS<br>fitting with internal check<br>valve (optional input, 1<br>output) | ¾" - 16 male DISS fitting<br>with internal check valve<br>(1 input, 1 output) |
| Ambient<br>environment | Unspecified in available<br>labeling | 50 to 104 °F; 30 to 95 %<br>RH, 13,000 ft max.<br>altitude | 20 to 95 °F; ≤ 99 %<br>noncondensing RH;<br>altitude unspecified in<br>available labeling | 50 to 104 °F; < 85 % RH;<br>7,200 ft maximum altitude |
| Noise level | Unspecified in available<br>labeling | 46 to 49 dB(A) | < 55 dB(A) | < 50 dB(A) |

| Call Concess and Carder of Children | . A fi fi fine for a finance and a minister a a comments of a province and comments of the more and |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | A Property A LEA CONSULT CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSULTION CONSUL |
| | |
| | |
| | - American American American Comments of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Childre |
| | |
| | |
| | |
| | Commender of Acres of Acres of Canadian Company |
| | |
| | |
| | |
| | |
| | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | A Children Art |
| | |
| | |
| | © Copyright by Hamliton MEDICAL AG A CHARLE CONSULTION CONSULTION VERTRAULICH CONFIDENTAL |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |

l

.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

...... .. ...

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three figures representing health, services, and human aspects. The seal is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Hamilton Medical AG C/O Mr. J. David Thompson General Manager Hamilton Medical, Incorporated P.O. Box 30008 Reno, Nevada 89502

Re: K041781

Trade/Device Name: Hamilton Medical VENTILAIR II Medical Air Compressor Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: January 27, 2005 Received: January 28, 2005

Dear Mr. Thompson:

We have reviewed your Scction 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 Fedcral 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Ecderal Register.

{5}------------------------------------------------

Page 2 - Mr. Thompson

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

| Project Name | Ventilair II 510(k) Submission |
|---------------|---------------------------------------------|
| | HAMILTON MEDICAL AG |
| Doc.-Title: | Ventilair II Section 4: Indications for Use |
| Doc.-Version: | 1.1 |
| | Doc.-No: E372047 |

## INDICATION FOR USE STATEMENT 1

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Hamilton Medical VENTILAIR II Medical Air Compressor Device Name:

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.

Prescription Use: × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aury Sukum

Sign-Off
of Anesthesiology. General Hospi

tiony. General Hospital, on Control, Dental Devices

Number: K041781

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

| H. Pohl |
|----------------------------------|
| Page 2 of 2 |
| 2004-03-02 |
| Copyright by HAMILTON MEDICAL AG |
| CONFIDENTIAL |