VENTILAIR II MEDICAL AIR COMPRESSOR by HAMILTON MEDICAL AG

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.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Hamilton Medical VENTILAIR II Medical Air Compressor:

The provided text is a 510(k) summary for the Hamilton Medical VENTILAIR II Medical Air Compressor. The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to an already legally marketed device (predicate device). This typically involves comparing characteristics and performance data. The document does not describe acceptance criteria in the sense of predefined thresholds for a study to pass, but rather presents performance characteristics of the VENTILAIR II and compares them to predicate devices to establish substantial equivalence.

It's important to note that a 510(k) summary often summarizes testing, and a detailed study protocol with explicit acceptance criteria might be in the full submission, but not fully reproduced here.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a substantial equivalence submission, the "acceptance criteria" are implicitly the performance characteristics of the predicate devices, and the "reported device performance" is that of the VENTILAIR II. The goal is to show the VENTILAIR II performs as well as or better than the predicates for the relevant characteristics.

Characteristic	Predicate Device Performance Examples (Range across predicates)	VENTILAIR II Performance	Implicit Acceptance Criteria (Substantial Equivalence)
Intended Use	Source of compressed air for various medical devices, including ventilators	Independent/backup 30 psi compressed air source for GALILEO and RAPHAEL ventilators	Comparable intended use (providing compressed air for medical ventilators).
Filtering	Unspecified to $\le$ 1 micron (Pre-compression HEPA, water trap filter)	$\le$ 5 microns at output; 0.5 micron filter in ventilator input	Effective filtration to ensure clean air supply, comparable to or better than predicates. The 5 micron output, coupled with the ventilator's 0.5 micron filter, likely deemed equivalent or superior.
Water Trap	Yes, with automatic vaporization	Yes, with automatic vaporization	Presence and function of water trap for removing moisture, comparable to predicates.
Pressure Relief Valve	Set to 59 PSIG - 85 PSIG	Set to 32 PSIG	Presence and functionality of a pressure relief valve for safety. The set point differs, but is appropriate for its intended output pressure.
Auto Backup Pressure (On)	Not available, 40.5 PSIG, or optional at 45 PSIG	On at 30 PSIG	Functionality for automatic backup. Set point appropriately aligned with intended operating pressure (30 psi nominal).
Auto Backup Pressure (Off)	50 PSIG or 55 PSIG	Off at 38 PSIG	Functionality for automatic backup. Set point appropriately aligned with intended operating pressure (30 psi nominal).
Electrical Rating (Voltage)	102 V - 132 V	115 V $\pm$ 10 %	Compatibility with standard electrical outlets for medical equipment.
Electrical Rating (Hertz)	60 Hertz	60 Hertz	Compatibility with standard electrical frequencies.
Electrical Rating (Power)	Unspecified to 500 W	466 W	Reasonable power consumption for the device's function.
Overcurrent Protection	Unspecified, Fuse, or Circuit breaker	Fuse	Presence of safety measures for electrical overcurrents.
Output	30 l/min at 44 PSIG; 45 l/min at 50 PSIG; 55 l/min at 50 PSIG	40 l/min at 30 PSIG	Sufficient air output capacity for its intended use (driving Hamilton ventilators). The pressure output (30 PSIG) is specific to the stated operating pressure of GALILEO and RAPHAEL ventilators.
Dew Point Depression	Unspecified, 5 °C below room temperature at 30 l/min, > 3 °F below room temperature at 55 l/min	3.3 °C below room temperature at 40 l/min	Effective drying capability to prevent condensation and ensure quality medical air.
Input/Output Interface	Various DISS fittings	¾" - 16 male DISS fitting with internal check valve (1 input, 1 output)	Standardized and safe connection for air supply.
Ambient Environment (Temp)	20 to 104 °F	50 to 104 °F	Operability within typical clinical environmental conditions.
Ambient Environment (RH)	30 to 99 % non-condensing RH	< 85 % RH	Operability within typical clinical environmental conditions regarding humidity.
Ambient Environment (Altitude)	Unspecified to 13,000 ft max. altitude	7,200 ft maximum altitude	Operability across a reasonable range of altitudes.
Noise Level	46 to < 55 dB(A)	< 50 dB(A)	Noise levels acceptable for a clinical environment.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state a "sample size" in the context of patients or individual devices tested in a clinical trial. The testing described is "laboratory performance verification and validation test data," which implies engineering and functional testing on units of the device.

Test Set Sample Size: Not specified as a number of devices or subjects. It is implied that at least one Ventilair II unit was subjected to the listed performance tests.
Data Provenance: The testing appears to be retrospective in the sense that it evaluates the performance of a manufactured device according to established engineering standards and comparisons. The location of the testing is not explicitly stated but is implicitly associated with Hamilton Medical AG (Switzerland) or its US subsidiary (Reno, NV). It is laboratory-based testing, not clinical data from patients in a specific country.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable as the described testing involves objective engineering and performance verification against known specifications and predicate device characteristics, not expert interpretation of medical images or patient data to establish "ground truth." There is no mention of human experts defining outcomes for test data in this context.

4. Adjudication Method for the Test Set

This section is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. The testing described here is objective measurement of physical and electrical properties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers evaluating cases, often with and without AI assistance, to measure diagnostic performance. The VENTILAIR II is a medical air compressor, not a diagnostic imaging device or an AI-powered analytical tool, so such a study would not be relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

No, a standalone algorithm performance study was not done. The VENTILAIR II is an electromechanical and pneumatic device with no software-based components, let alone an AI algorithm. Its performance is evaluated through direct measurement of its physical output and adherence to safety standards.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the VENTILAIR II is based on:

Engineering specifications and standards: Compliance with IEC 60601-1 and other relevant safety and performance standards.
Physical measurements: Direct measurements of output pressure, flow rate, dew point, noise level, electrical ratings, etc.
Comparison to predicate device characteristics: The performance data of the legally marketed predicate devices (Draeger Medical Air Compressor, Infrasonics Air Star Portable Compressor, Bennett MC-2 Mobile Air Compresor) serve as the benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

This section is not applicable. The VENTILAIR II is an electromechanical device with no AI or machine learning components requiring a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This section is not applicable for the same reason as point 8.

Summary

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510(K) SUMMARY 9

1. Summary Preparation Date: January 18, 2005
1. 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 775-858-3200 Fax 775-856-5621 Email: thompson@hammed1.com
1. Device Proprietary Name: VENTILAIR II Medical Air Compressor

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

1. 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.
1. 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.
1. 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.
1. 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.

1. 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.
1. 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.

1. 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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#	Characteristic	Bennett MC-2 Air Compressor (Pre-Amendment)	PREDICATE DEVICESDraeger Medical Air Compressor (K982789)	Infrasonics Air Star Compressor (K920954)	VENTILAIR IISimilar 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 AirCompressor (Pre-Amendment)	PREDICATE DEVICESDraeger Medical AirCompressor (K982789)	Infrasonics Air StarCompressor (K920954)	VENTILAIR IISimilar or Different(From All OtherPredicates Combined)
Characteristic
Electrical ratings	115 V; 60 Hertz; powerconsumption unspecifiedin available labeling	110 V; 60 Hertz; 500 W	102 to 132 V; 60 Hertz;power consumptionunspecified in availablelabeling	115 ± 10 %; 60 Hertz;466 W
Overcurrentprotection	Unspecified in availablelabeling	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 pointdepression	Unspecified in availablelabeling	5 °C below roomtemperature at 30 l/min	> 3 °F below roomtemperature at 55 l/min	3.3 °C below roomtemperture at 40 l/min
Input/outputinterface	Two DISS 9/16" - 18threaded outlets (onecapped when not in use)	Quick connect DISScoupling with internalcheck valve (1 input, 1output)	¾" - 16 male DISSfitting with internal checkvalve (optional input, 1output)	¾" - 16 male DISS fittingwith internal check valve(1 input, 1 output)
Ambientenvironment	Unspecified in availablelabeling	50 to 104 °F; 30 to 95 %RH, 13,000 ft max.altitude	20 to 95 °F; ≤ 99 %noncondensing RH;altitude unspecified inavailable labeling	50 to 104 °F; < 85 % RH;7,200 ft maximum altitude
Noise level	Unspecified in availablelabeling	46 to 49 dB(A)	< 55 dB(A)	< 50 dB(A)

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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.

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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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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

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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:

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

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.