COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E

K023354 · Siemens Elema AB · BTI · Sep 5, 2003 · Anesthesiology

Device Facts

• Record ID: K023354
• Device Name: COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
• Applicant: Siemens Elema AB
• Product Code: BTI · Anesthesiology
• Decision Date: Sep 5, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2

Intended Use

The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is to be used only for bedside application within the hospital environment. Compressor Mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

Device Story

Compressor Mini provides dry, filtered compressed air to respiratory ventilators or anesthesia machines; capacity ~30 L/min at 50-64 psi. Device features compact, lightweight design for quiet bedside operation in hospitals. Operated by physicians, nurses, or technicians. Includes standby function for automatic activation during central gas supply failure. Integrated alarm system monitors temperature and pressure. Output used by clinicians to support mechanical ventilation or anesthesia delivery. Benefits include reliable, localized air supply for single-ventilator support.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Portable air compressor; provides 30 L/min at 50-64 psi. Features integrated pressure and temperature alarms. Compact, lightweight design with lower power consumption than predicate. Standby function for automatic gas supply switching. Intended for hospital bedside use. Not MRI compatible.

Indications for Use

Indicated for use by healthcare providers, physicians, nurses, and technicians to provide dry, filtered, compressed air (approx. 30 L/min at 50-64 psi) to medical respiratory ventilators or anesthesia machines in hospital bedside settings. Contraindicated for in-hospital patient transport, ambulance/air transport, and MRI environments.

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

• ALRECO 40400 Allan Rehnström AB (K951926)

Submission Summary (Full Text)

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K02354

SEP - 5 2003

| SIEMENS | | Document Type<br>510(k) Notification | Page<br>19 |
|----------------------------------------------------|--|--------------------------------------|-----------------|
| Obiect/Subiect<br>Compressor Mini - 510(k) Summary | | Doc-ID<br>EVU-113162 | Issue no.<br>01 |

# 510(K) Summary as required by section 807.92(c) 1 October 2002

# Subscribers Name & Address: F.1

Siemens-Elema AB Electromedical Systems Division, Life Support Systems Röntgenvägen 2 SE-171 95 Solna, Sweden Tel: [phone] Fax: [phone] Official Correspondent: Richard Flynn.

(Manager Regulatory Affairs/Quality Assurance, Siemens Medical Solutions USA, Inc. /S.S.G. -R.A. 16 Electronics Avenue Danvers, MA USA 01923) Veronica Ekström

Contact Person for this submission:

# F.2 Trade Name:

Device name: Compressor Mini

| Common Name | Classification Number | Class | Regulation Number |
|-----------------|-----------------------|-------|-------------------|
| Compressor Mini | BTI | II | 21.CFR.868.6250 |

#### F.3 Predicate Device Identification:

Compressor Mini is a first time application. Substantial equivalence to a predicate device, ALRECO 40400 Allan Rehnström AB K951926, is claimed.

#### F.4 Device Description:

Compressor Mini will provide a supply of dry and filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vimin at 50-64 psi (350 - 450 kPa).

The compressor is of light weight and compact design. It runs quietly, which makes it suitable for bedside use.

It may be employed as a primary or secondary source of compressed air. The Standby function assures that if the central gas supply fails the Compressor Mini will start to deliver compressed air.

The Compressor Mini is fitted with two alarm parameters, temperature and pressure. The Compressor Mini is designed with the similar materials and technology as the predicate device ALRECO 40400.

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| | Document Type<br>510(k) Notification | Page | |
|----------------------------------------------------|--------------------------------------|----------------------|-----------------|
| Object/Subject<br>Compressor Mini - 510(k) Summary | | 20 | |
| | | Doc-ID<br>EVU-113162 | Issue no.<br>01 |

### Intended Use of the Device: F.5

The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 - 450 kPa). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is to be used only for bedside application within the hospital environment. Compressor Mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI.

# F.6 Summary of technological characteristics of Device and Predicate Device

The functionality for the Compressor mini is equivalent to the ALRECO 40400. Compressor mini and ALRECO 40400 have the same technological characteristics, intended use, materials, method of operation, performance claims and energy source but the compressor mini is scaled down for smaller size.

The differences are:

- A more compact design and lighter weight. ●
- Less power consumption.
- Lower continuous flow and smaller built-in reservoir, since the Compressor Mini is . designed to supply only one ventilator with compressed air. The Compressor Compact could support multiple ventilators.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is written in a simple, sans-serif font.

SEP - 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Siemens-Elema AB C/O Mr. Timothy W. Capehart Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K023354

Trade Name: Compressor Mini, 115 V, Model 64 81 779 EH81E Regulation Number: 868.6250 Regulation Name: Compressor, Air, Portable Regulatory Class: II Product Code: BTI Dated: August 8, 2003 Received: August 15, 2003

Dear Mr. Capehart:

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. 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 Federal Register.

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Page 2 -Mr. Timothy W. Capehart

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/dsma/dsmamain.html

Sincerely vours

Qui- S. Lyon

Susan Runner, DDS, Interim 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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510(k) Number (if known): K023354

Device Name: Compressor Mini

Indications For Use:

The intended use of Compressor Mini is to provide a supply of dry, filtered, compressed air for a medical respiratory ventilator or anaesthesia machine that meets the specifications of the Compressor Mini. Its capacity is approximately 30 Vmin at 50-64 psi (350 -- 450 kPa, 3.5 - 4.5 bar). Compressor Mini is intended to be operated by healthcare providers, physicians, nurses and technicians. Compressor Mini is intended to be used for bedside application in a hospital environment. Compressor Mini is not intended to be used during in-hospital transportation or during ambulance or air transportation.

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

----------------Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(21 CFR 868.6250)

OR

Over-The-Counter Use

E. Antrach for JXH

General Hospital.

510(k) Number: K023354