COMBICATH CATHETER

K974642 · Plastimed Laboratoire Pharmaceutique · EOQ · Mar 13, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K974642
• Device Name: COMBICATH CATHETER
• Applicant: Plastimed Laboratoire Pharmaceutique
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalveolar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis. The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.

Device Story

COMBICATH is a radiopaque, double-plugged, telescoping catheter; used to collect bronchoalveolar secretion samples in mechanically ventilated patients. Device inserted into airway to capture protected distal samples; prevents contamination during transit. Used in clinical settings by healthcare providers. Output is a biological sample for laboratory analysis; facilitates diagnosis of respiratory conditions in ventilated patients.

Clinical Evidence

Bench testing only. Functional and safety testing performed under conditions simulating normal usage to ensure conformance to product specifications.

Technological Characteristics

Radiopaque, double-plugged, telescoping catheter design. Materials and dimensions consistent with predicate devices. No electronic components, software, or energy sources.

Indications for Use

Indicated for mechanically ventilated patients requiring bronchoalveolar lavage or protected distal bronchoalveolar sampling for laboratory testing and diagnosis.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

• BAL Cath (K923487)

Reference Devices

• Rigid Suction Tip (K822255)
• Argyle Taussig Culture Catheter (K791327)
• Argyle DeLee Suction Catheter (K820572)

Submission Summary (Full Text)

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K974642

MAR 1 3 1998 510(k) Summary A. 510(K) SUMMARY Plastimed Laboratoire Pharmaceutique SUBMITTER: Mr. Mike McCormick CONTACT PERSON: Plastimed, LLC 212 3rd Avenue North, #446, Minneapolis, MN 55401 Phone: [phone] Fax: [phone] December 12, 1997 DATE PREPARED: COMBICATH Double Plugged Telescoping Catheter TRADE NAME: CLASSIFICATION NAME Bronchoscope (flexible or rigid) and Accessories and NUMBER: Class II, 21 CFR 874.4680 PRODUCT CODE: KTR The COMBICATH Catheter is substantially equivalent to the BAL PREDICATE DEVICE(S): Cath (K923487), manufactured by Ballard Medical. Other similar devices include the Rigid Suction Tip (K822255), the Argyle Taussig Culture Catheter (K791327), and the Argyle DeLee Suction Catheter (K820572), made by other manufacturers. DEVICE DESCRIPTION: The COMBICATH Catheter, is a radiopaque, double plugged, telescoping catheter designed to capture bronchoalveolar secretion samples in mechanically ventilated patients. INTENDED USE: The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalveolar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis. The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis. FUNCTIONAL & Functional and safety testing of the COMBICATH Catheter SAFETY TESTING: consisted of examination of the function of the device under conditions similar to those found in normal usage and testing to ensure conformance to product specifications. The results of the examination and testing were successful, and did not raise any issues of safety and effectiveness of the device.

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## CONCLUSION:

The COMBICATH Catheter is substantially equivalent to the BAL Cath (K923487), manufactured by Ballard Medical, based upon the devices' similarities in functional design, materials and indications for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mike McCormick Plastimed L.L.C. 212 3rd Ave. North Suite 446 Minneapolis, MN 55401 Re:

K974642 Plastimed COMBICATH Catheter Dated: December 12, 1997 Received: December 15, 1997 Regulatory class: II 21 CFR 874.4680/Procode: 77 EOO

Dear Mr. McCormick:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/odrh/dsmaldsmam.html".

Sincerely yours,

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

MAR 1 3 1998

Enclosure

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## Indications for Use Page

The COMBICATH Catheter Model 58216.27 is intended for use as a sampling tool by performing mini bronchoalvestar lavage in mechanically ventilated patients to obtain bronchoalveolar samples for laboratory testing and diagnosis.

The COMBICATH Catheter Models 58223.19, 58228.19, and 58229.19 are intended for use as sampling tools to capture protected distal bronchoalveolar samples from mechanically ventilated patients for laboratory testing and diagnosis.

| (Division Sign-Off) | |
|------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, | |
| and Neurological Devices | |
| 510(k) Number | K974642 |

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