MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C

K022446 · Aomori Olympus Co., Ltd. · EOQ · Mar 28, 2003 · Ear, Nose, Throat

Device Facts

• Record ID: K022446
• Device Name: MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C
• Applicant: Aomori Olympus Co., Ltd.
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

Device Story

Mucus Collection Probe (BC-401C, BC-402C) is a single-use bronchoscope accessory. Device consists of a tube and an extendable fiber rod with an absorbent tip. Operation: clinician inserts device through the working channel of an Olympus bronchoscope; advances distal end to target area; extends fiber rod to contact mucosa; absorbs bronchial secretions onto the fiber tip. The probe is then withdrawn for subsequent biochemical analysis of the collected fluid. Used in clinical settings by physicians to facilitate diagnostic sampling of bronchial secretions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Single-use bronchoscope accessory. Consists of a tube and extendable fiber rod. Dimensions: 1.8mm/2.5mm max diameter; 1050mm working length. Compatible with endoscope channels 2mm or larger. Mechanical operation; no energy source or software.

Indications for Use

Indicated for the collection of bronchial secretions in the tracheobronchial tree for patients undergoing bronchoscopy.

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

• BC-14C/15C/16C Cytology Brush (K931154)

Submission Summary (Full Text)

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KO22446

MAR 2 8 2003

### SMDA 510(k) SUMMARY

#### A. Submitter's Name, Address, Phone and Fax Numbers

Name & Address of manufacturer:

Registration No .: Address, Phone and Fax Numbers: of R&D Department, Endoscope Division

Olympus Opto-Electronics Co., Ltd. Aomori Plant 248-1 Okkonoki 2-chome Kuroishi-shi Aomori, Japan, 036-0367 9614641 2951 Ishikawa-Cho, Hachioji-shi, Tokyo 192-8507 Japan TEL [phone] FAX [phone]

#### B. Name of Contact Person

Name: . Address, Phone and Fax Numbers: Ms. Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747-3157 TEL: [phone] FAX: [phone]

#### C. Device Name, Common Name, Classification Name and Predicate Devices

| Trade Name: | Mucus Collection Probe BC-401C, BC-402C, |
|-----------------|-------------------------------------------------|
| Common Name: | Bronchoscope accessory |
| Classification: | Bronchoscope and accessories<br>21 CFR 874.4680 |

Predicate Device:

BC-14C/15C/16C Cytology Brush, manufactured by 01ympus (K931154 EVIS-200 System Olympus Videobronchoscope & Accessories )

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### COMPARISON TABLE

| | | -Subject Devices:<br>BC-401C/402C | Predicate Device:<br>BC-14C/15C/16C<br>(# K931154) |
|--------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Labeling-<br><br>Intended<br>Use | The subject devices are designed to be used with<br>an Olympus bronchoscope for the collection of<br>bronchial secretions in the tracheobronchial tree.<br>Bronchial fluids absorbed onto the fiber tip of<br>the collection probe are subsequently analyzed<br>for biochemical constituents. | This instrument has been designed to be<br>used with Olympus endoscopes to<br>collect tissue specimens in the Tracheo<br>bronchial Tree. |
| | Operation | Bronchoscopic Microsampling.<br>Insert the instrument in the endoscope with<br>the fiber rod retracted into the tube.<br>Advance the distal end of the insertion<br>portion toward target area. Extend the fiber<br>rod from the tube, and contact the target<br>area to collect bronchial secretions. | Insert the instrument into the endoscope<br>with the brush retracted in the tube.<br>Advance the distal end of the insertion<br>portion toward target area. Extend the<br>brush from the tube, and brush the<br>target area to collect tissue specimen. |
| Design | Maximum<br>diameter | 1.8mm, 2.5mm | 1.8mm |
| | Insertion<br>portion<br>diameter | 1.7mm, 2.4mm | 1.7mm |
| | Brush<br>diameter | 1mm | 2.4mm, 3mm |
| | Brush<br>length | 5mm | 6mm, 10mm |
| | Fiber rod<br>diameter | 1.1mm, 1.9mm | |
| | Fiber rod<br>length | 30mm, 20mm | |
| | Working<br>length | 1050mm | 1050mm, 1050mm |
| | Applicable<br>endoscope<br>channel | 2mm or more | 2mm or more |

#### D. Description of the Device(s) &

Mucus Collection Probes, BC-401C and BC-402C, have been designed to be used with an Olympus endoscope to collect bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents. Single use.

#### E. Intended Use of the Device(s)

The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the brocheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

F. Summary including Conclusions drawn from Non-clinical Tests

When compared to the predicate device, the subject device does not add any significant changes in the intended use, method of operation, material, or design that could affect the safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Aomori Olympus Co., Ltd. c/o Laura Storms-Tyler Olympus America, Inc. 2 Corporate Center Drive Melville, NY 11747-3157

Re: K022446

Trade/Device Name: Olympus Mucous Collection Probe BC-401C, BC-402C Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope and accessories Regulatory Class: Class II Product Code: EOQ Dated: December 23, 2002 Received: March 13, 2003

Dear Ms. Storms-Tyler:

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. Iisting 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.

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.

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Page 2 - Laura Storms-Tyler

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 yours,

A. Kalgi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

V222446 510(k) Number(if known): Not assigned yet. Device Name: Mucus Collection Probe

## Indications for Use :

The subject devices are designed to be used with an Olympus bronchoscope for the collection of bronchial secretions in the tracheobronchial tree. Bronchial fluids absorbed onto the fiber tip of the collection probe are subsequently analyzed for biochemical constituents.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Prescription 21 CFR 801.109) Over-The-Counter Use

(Optional Format 1-2-96)

Karen t brker

(Division S Nose and

510(k) Number K022446

Prescription Use (Per 21 CFR 801.109)