OXICHECK

K023565 · Caradyne, Ltd. · CCL · Mar 28, 2003 · Anesthesiology

Device Facts

• Record ID: K023565
• Device Name: OXICHECK
• Applicant: Caradyne, Ltd.
• Product Code: CCL · Anesthesiology
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.1720
• Device Class: Class 2

Intended Use

The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture. The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient. The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care. The OxiCheck is not intended for use in a MRI environment.

Device Story

OxiCheck is a disposable oxygen analyzer measuring fractional inspired oxygen (FiO2) in air/oxygen mixtures. Operated by qualified personnel in hospitals, sub-acute institutions, transport, or home settings; device provides spot-check measurements rather than continuous monitoring. Input is gas mixture; output is oxygen concentration percentage displayed to user. Integral NTC compensation adjusts for temperature. Device is not for use in breathing circuits or MRI environments. Benefits include portable, disposable verification of oxygen delivery concentrations.

Clinical Evidence

Bench testing only. Device performance validated against ASTM F1462-93 and ISO 7767:1997 standards. Metrics include measurement range (0-100% O2), response time (<10s), linearity error (<3%), and drift (<1% over 8 hours).

Technological Characteristics

Disposable oxygen analyzer; 90g weight. Sensing principle: oxygen concentration measurement with integral NTC temperature compensation. Materials: PVC in-line tee. Connectivity: None. Standards: ASTM F1462-93, ISO 7767:1997, ISO 5356 (15/22 mm conical fittings).

Indications for Use

Indicated for use by qualified personnel to check or measure oxygen concentration of delivered air/oxygen mixtures in hospitals, sub-acute institutions, transport, and home care settings. Not for use in breathing systems, patient monitoring, or MRI environments.

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 - Handi (K973282)
• Caradyne - Criterion 60 (K000959)

Submission Summary (Full Text)

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KO23565

MAR 2 8 2003

# 510(k) Summary of Safety and Effectiveness

### Non-Confidential Summary of Safety and Effectiveness Page 1 of 2

January 22, 2003

| Caradyne, Ltd. | Tel [phone] |
|----------------------------|------------------------------------|
| Parkmore Business Park | Fax [phone] |
| Parkmore West | |
| Galway, Ireland | |
| Official Contact: | John, O'Dea, PhD - General Manager |
| Proprietary or Trade Name: | OxiCheck |

Proprietary or Trade Name: Common/Usual Name: Classification Name: Predicate Devices:

OxiCheck Oxygen analyzer Analyzer, Gas, Oxygen, gaseous phase Ceramatec - Handi - K973282 Caradyne - Criterion 60 - K000959

#### Device Description:

The OxiCheck is a disposable oxygen analyzer that checks the oxygen concentration (also called fractional inspired oxygen, FiO2) of a delivered air/oxygen mixture.

#### Intended Use:

The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture.

The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient.

#### Environment of Use:

Intended for use in Hospitals, Sub-acute Institutions, Transport, and Home care settings. The OxiCheck is not intended for use in a MRI environment.

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## Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 January 22, 2003

| General Technical Characteristics | |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Attribute | Caradyne - OxiCheck - Proposed device |
| Indications for use | The OxiCheck is intended as a tool for use by qualified personnel to<br>check or measure oxygen concentration of a delivered air / oxygen<br>mixture. The OxiCheck is not intended for use in breathing systems<br>and is not intended for patient monitoring. It is not intended to be<br>used to continuously monitor or confirm oxygen delivery to a<br>patient. |
| Disposable | Yes |
| Prescription | Yes |
| Intended Environment of Use | Hospitals, Sub-acute Institutions, Transport, Home care.<br>The OxiCheck is not intended for use in a MRI environment. |
| Design and Specifications | |
| Measurement range | 0 to 100% O₂. |
| Display resolution | 1% O₂. |
| Response time | < 10 seconds to 90% of final value. |
| Linearity error | < 3% of reading. |
| Drift | < 1% O₂ over 8 hours. |
| Humidity influence | < 1% O₂ between 0 and 95% RH at 25°C. |
| Pressure influence | Proportional to changes in atmospheric pressure. |
| Operating temperature | 0 to 50°C. |
| Temperature compensation | Integral NTC compensation. |
| Operating humidity | 0 to 95% RH. |
| Storage temperature | -20 to 60°C in supplied shipping container. |
| Recommended storage temperature | 5 to 15°C. |
| Battery power indicator | Device powers off when battery is depleted. |
| Analyzer life | 500,000 oxygen hours (15 months continuous use at 45% O₂ or 5000<br>hour at 100% O₂). |
| Weight | ~ 90 gram |
| Materials | |
| In-line tee - PVC | Yes - Same material as Criterion 60 – K000959 |
| Performance Standards | |
| None under Section 514 | Yes |
| ASTM F1462-93 - Specification for<br>Oxygen Analyzers | Complies to applicable sections |
| ISO 7767:1997 - Oxygen Monitors for<br>Monitoring Patient Breathing Mixtures –<br>Safety Requirements | Complies to applicable sections |
| ISO 5356 – 15 / 22 mm Conical fittings | Complies |

### Differences between Other Legally Marketed Predicate Devices

The data within the submission demonstrates that the proposed devices when compared to the predicate devices are safe and effective and are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of three wavy lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Caradyne Limited C/O Mr. Paul Dryden ProMedic, Incorporated 6329 West Waterview Court McCordsville, Indiana 46055-9501

Re: K023565

Trade/Device Name: OxiCheck Regulation Number: 868.1720 Regulation Name: Oxygen Gas Analyzer Regulatory Class: II Product Code: CCL Dated: January 22, 2003 Received: January 23, 2003

Dear Mr. Dryden:

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. Dryden

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 (OS) 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.

Susan Renner

Susan Runner, DDS, MA 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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Indications for Use

| | Page 1 of 1 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K023565 (To be assigned) |
| Device Name: | OxiCheck |
| Intended Use: | The OxiCheck is intended as a tool for use by qualified personnel to check or measure oxygen concentration of a delivered air / oxygen mixture.<br>The OxiCheck is not intended for use in breathing systems and is not intended for patient monitoring. It is not intended to be used to continuously monitor or confirm oxygen delivery to a patient.<br>The OxiCheck is intended to be used in hospitals, Sub-acute Institutions, Transport, and Home care.<br>The OxiCheck is not intended for use in a MRI environment. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per CFR 801.109) or Over-the-counter use __

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K023565