GAS SAMPLING LINES

K023579 · Promedic, Inc. · CCK · Jan 28, 2003 · Anesthesiology

Device Facts

• Record ID: K023579
• Device Name: GAS SAMPLING LINES
• Applicant: Promedic, Inc.
• Product Code: CCK · Anesthesiology
• Decision Date: Jan 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1400
• Device Class: Class 2

Intended Use

The gas sampling lines are intended to connect to a port in the breathing circuit to the expired gas monitor. Disposable, single use.

Device Story

Gas sampling lines consist of small-bore tubing of varying lengths and diameters; connect to breathing circuit ports via luer fittings; transport expired gas samples to external monitors. May include in-line filters to prevent moisture ingress. Used in hospital and sub-acute institutional settings; operated by clinicians. Device facilitates continuous gas monitoring by providing a pathway for gas analysis; enables clinical assessment of patient respiratory status.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Tubing constructed of PVC or PVC/PE; luer connectors of PVC or PC. Conforms to ISO 594-2 for conical fittings. Single-use, disposable. No electronic components or software.

Indications for Use

Indicated for connection between a breathing circuit port and an expired gas monitor for gas sampling. No specific patient population defined.

Regulatory Classification

Identification

A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

Predicate Devices

• Catheter Research, Inc. - Disposable gas sampling lines (K946044)

Submission Summary (Full Text)

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K0235-79

# JAN 2 8 2003

Gas Sampling Lines

#### Premarket Notification 510(k)

#### 2.1 510(k) Summary of Safety and Effectiveness

### Non-Confidential Summary of Safety and Effectiveness

Page 1 of 2 October 23, 2002

ProMedic, Inc. 6329 W. Waterview Ct. McCordsville, IN 46055-9501 Tel [phone] Fax [phone]

| Official Contact: | Paul Dryden - President |
|----------------------------|--------------------------------------------------------------------|
| Proprietary or Trade Name: | Gas Sampling Lines |
| Common/Usual Name: | Gas sampling accessories |
| Classification Name: | Analyzer, Gas, Carbon dioxide, gaseous phase - accessory |
| Predicate Devices: | Catheter Research, Inc. - K946044<br>Disposable gas sampling lines |

#### Device Description:

Environment of Use:

Small bore tubing of various internal diameters and lengths, commonly referred to as gas-sampling lines. These connect to a port in the breathing circuit. May incorporate standard luer connector fittings and / or in-line filter at monitor end.

Intended Use: The gas sampling lines are intended to connect from a port in the breathing circit to the expired gas monitor. Disposable, single use.

Hospital, Sub-acute Institutions

Page 11

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### Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 October 23, 2002

### General Technical Characteristics

| Attribute | ProMedic - Proposed device |
|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Indications for use | The gas sampling lines are intended to connect<br>from a port in the breathing circuit to the expired<br>gas monitor |
| Intended for single use | Yes |
| Prescription | Yes |
| Intended population | Not applicable |
| Intended Environment of Use | Hospital, Sub-acute Institutions |
| Design | |
| Connects to a luer port in the breathing circuit and<br>then sampling the gas, which is then transferred<br>via the small bore tubing to the monitor | Yes |
| Of various lengths and diameters | Yes |
| May incorporate an in-line filter intended to<br>prevent water from entering the monitor | Yes |
| Materials | |
| Tubing - PVC or PVC / PE | Yes |
| Luer connectors - PVC, PC | Yes |
| Sampling line - not in gas path | Yes |
| Performance Standards | |
| None under Section 514 | Yes |
| ISO 594-2 - Conical fittings for luer tapers | Yes |

### 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles incorporated into the design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 28 2003

Mr. Paul Dryden President ProMedic, Incorporated 6329 W. Waterview Court McCordsville, Indiana 46055-9501

Re: K023579

Trade/Device Name: Gas Sampling Lines Regulation Number: 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCK Dated: November 14, 2002 Received: November 19, 2002

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 Runres

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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## 2.3 Indications for Use

Page 1 of 1

| 510(k) Number: | <span style="text-decoration:underline;">14023579</span> (To be assigned) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Gas Sampling Lines |
| Intended Use: | The gas sampling lines are intended to connect to a port in<br>the breathing circuit to the expired gas monitor.<br><br>Disposable, single use. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per CFR 801.109)
✓

or

Over-the-counter use ________________________________________________________________________________________________________________________________________________________

HWesterlin

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

510(k) Number: K023374