ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106

K082655 · Envitec-Wismar GmbH · CCL · Nov 25, 2008 · Anesthesiology

Device Facts

• Record ID: K082655
• Device Name: ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
• Applicant: Envitec-Wismar GmbH
• Product Code: CCL · Anesthesiology
• Decision Date: Nov 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Device Story

EnviteC Medical Oxygen Sensors function as replacement components for oxygen analyzers in anesthesia, critical care, and respiratory care equipment. Sensors utilize electro-galvanic technology; precious metal cathode and lead anode immersed in liquid electrolyte generate electrical voltage proportional to oxygen concentration. Some models include internal temperature-compensation components to adjust output voltage. Sensors are housed in plastic, can-shaped configurations with various mounting and electrical connection types to match industry standards. Device is installed by clinicians or technicians into existing monitoring systems. Output is an electrical signal representing oxygen concentration, used by the host analyzer to display oxygen levels for clinical decision-making regarding patient ventilation and oxygen delivery. Benefits include continued accurate monitoring of inspired oxygen gas delivered to patients.

Clinical Evidence

No clinical data. Bench testing only. Evaluated for basic safety, mechanical characteristics, and environmental operation/storage. Performance testing confirmed signal characteristics under varying temperature, pressure, humidity, and interfering gas conditions. All compliance and performance criteria met.

Technological Characteristics

Electro-galvanic measurement principle; precious metal cathode and lead anode in liquid electrolyte. Plastic can-shaped housing with varied mounting/electrical interfaces. Includes internal temperature-compensation components in specific models. Standalone sensor component.

Indications for Use

Indicated for use as replacement oxygen-sensing components in oxygen analyzers measuring oxygen concentration in breathing gas mixtures for patients requiring respiratory monitoring. Prescription use only.

Regulatory Classification

Identification

An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

Predicate Devices

• Ceramatec MAXCELL and Ceramatek (Maxtec, Inc.) CAG Galvanic Oxygen Sensors (K972992)

Submission Summary (Full Text)

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K082655
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# 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92

- (a) (1) Submitted by: EnviteC-Wismar GmbH by Honeywell Alter Holzhafen 18 Wismar 23966 Germanv NOV 2 5 2008 Tel.: [phone] Fax: [phone] [e-mail] Contact Person: Mr. Marcus Lindenlaub Position/Title: Managing Director Date of Preparation: September 8, 2008 (2) EnviteC Medical Oxygen Sensors Trade Name: Common/Classification Name: Oxygen Gas Analyzer CCL: 21 CFR §868.1720 Product Code(s): Class: Class II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K972992 Ceramatec MAXCELL and Ceramatek (Maxtec, Inc.) CAG Galvanic Oxygen Sensors Reason for Submission: New device
#### (4) Description of Device:

The subject of this 510(k) is a family of EnviteC Medical Oxygen Sensors which may be used as industry replacement types with various medical inspired-oxygen measuring devices.

The EnviteC Medical Oxygen Sensors all utilize the commonly accepted electro-galvanic operating principle with defined variations in the mounting configuration and electrical connections to correspond to common industry family replacement types.

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#### (5) Intended use:

Medical oxygen sensors have widespread use to sense the quantity of inspired oxygen gas delivered to a patient. Applications include anesthesia monitoring equipment, critical care monitors, and respiratory care including oxygen concentrators.

## Indications for Use:

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

#### (6) Technological Characteristics:

The EnviteC Medical Oxygen Sensors employ the same technological characteristics as the predicate device - the electro-galvanic measurement principle.

The sensors utilize two electrodes, a precious metal cathode and a lead anode immersed in a liquid electrolyte solution, to produce an electrical voltage in relation to the amount of oxygen present. Specific sensors include internal temperature-compensation components to adjust the output voltage in relation to temperature.

The sensors are housed in a plastic can-shaped configuration which can be screwed or mounted to the inspired air or gas supply. Across the family of sensors offered, variations in the mounting configuration and electrical connections correspond to common industry replacement types.

#### (1) Non-Clinical Tests Submitted: (b)

The sensors were evaluated in accordance with the applicable elements of standards for respiratory gas monitors. Compliance tests included evaluation of basic safety, mechanical characteristics, and environmental operation and storage conditions. The devices passed all of the compliance tests.

The sensors were evaluated for device performance characteristics including signal characteristics in the presence of temperature, pressure, humidity, and interfering gases. The devices met all of the performance criteria.

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### Clinical Tests Submitted: (2)

(none / none required)

#### (3) Conclusions from Tests:

As described above, the EnviteC Medical Oxygen Sensors meet the applicable requirements for respiratory gas sensors as substantiated by parameter and compliance testing. Equivalence to the predicate device(s) is substantiated by detailed comparison of specifications and intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EnviteC-Wismar GmbH C/O Mr. Stephen Gorski Imagenix, Incorporated S65 W35739 Piper Road Eagle, Wisconsin 53119

NOV 2 5 2008

Re: K082655

Trade/Device Name: EnviteC Medical Oxygen Sensors Types OOM101; OOM102 /-1; OOM103 /-1/-1M; OOM104:OOM105;OOM106;OOM107 /-2; OOM110;OOM111;OOM201;OOM202 /-1/-2/-2S;OOM204

Regulation Number: 21 CFR 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: August 14, 2008 Received: September 12, 2008

Dear Mr. Gorski:

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. Gorski

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 yours,

Suite Y. Michie Oms

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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# Indications for Use

### 510(k) Number (if known):

### Device Name: EnviteC Medical Oxygen Sensors types OOM101; OOM102 /-1; OOM103 /-1 /-1M; OOM104; OOM105; OOM106; OOM107 /-2; OOM110; OOM111; OOM201; OOM202 /-1 /-2 /-2S; OOM204

## Indications for use:

The EnviteC Medical Oxygen Sensors are intended to replace the original oxygen-sensing component of an oxygen analyzer that measures oxygen concentration in breathing gas mixtures.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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)

Suitty Y. Michael Duns.

(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control, Dental Devices

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510(k) Number: K082655