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 Description

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.

AI/ML Overview

This response is based on the provided text.

The information provided describes a 510(k) premarket notification for the Olympus Mucus Collection Probe BC-401C, BC-402C. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and a detailed study design as might be seen for novel devices. Therefore, much of the requested information (e.g., specific acceptance criteria for performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone algorithm performance) is not typically included or required in a 510(k) premarket notification for a device of this nature.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific quantitative acceptance criteria or reported device performance metrics are provided in the document. The submission asserts substantial equivalence based on the intended use, method of operation, materials, and design being similar to the predicate device.

Acceptance Criteria	Reported Device Performance
Not specified	Not specified

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable. The document does not describe a clinical performance study with a test set. The review is based on a comparison to a predicate device, focusing on design, intended use, and operational similarities.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable, as no test set requiring expert-established ground truth is described.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or is mentioned in the provided text.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable, as this is a physical medical device (mucus collection probe), not an AI algorithm.

7. Type of Ground Truth Used:

Not applicable, as no performance study requiring ground truth is described.

8. Sample Size for the Training Set:

Not applicable, as this is a physical medical device and there is no mention of an algorithm or training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Study Proving Acceptance Criteria:

The "study" or justification for meeting acceptance criteria in this 510(k) submission is primarily a comparison to a predicate device. The key statement from the document is:

"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."

This statement serves as the basis for FDA's determination of substantial equivalence, which is the "acceptance criteria" for a 510(k) clearance in this context. The detailed comparison table in section {1} highlights the similarities and minor differences (e.g., maximum diameter, brush diameter, fiber rod presence) between the subject devices (BC-401C/402C) and the predicate device (BC-14C/15C/16C). The argument is that these differences do not raise new questions of safety or effectiveness.

Summary

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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 426-42-2891 FAX 426-42-2291

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: (631) 844-5688 FAX: (631) 844-5554

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 accessories21 CFR 874.4680

Predicate Device:

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

{1}------------------------------------------------

COMPARISON TABLE

		-Subject Devices:BC-401C/402C	Predicate Device:BC-14C/15C/16C(# K931154)
	Labeling-IntendedUse	The subject devices are designed to be used withan Olympus bronchoscope for the collection ofbronchial secretions in the tracheobronchial tree.Bronchial fluids absorbed onto the fiber tip ofthe collection probe are subsequently analyzedfor biochemical constituents.	This instrument has been designed to beused with Olympus endoscopes tocollect tissue specimens in the Tracheobronchial Tree.
	Operation	Bronchoscopic Microsampling.Insert the instrument in the endoscope withthe fiber rod retracted into the tube.Advance the distal end of the insertionportion toward target area. Extend the fiberrod from the tube, and contact the targetarea to collect bronchial secretions.	Insert the instrument into the endoscopewith the brush retracted in the tube.Advance the distal end of the insertionportion toward target area. Extend thebrush from the tube, and brush thetarget area to collect tissue specimen.
Design	Maximumdiameter	1.8mm, 2.5mm	1.8mm
	Insertionportiondiameter	1.7mm, 2.4mm	1.7mm
	Brushdiameter	1mm	2.4mm, 3mm
	Brushlength	5mm	6mm, 10mm
	Fiber roddiameter	1.1mm, 1.9mm
	Fiber rodlength	30mm, 20mm
	Workinglength	1050mm	1050mm, 1050mm
	Applicableendoscopechannel	2mm or more	2mm or more

D. Description of the Device(s) &

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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three lines representing the head, body, and legs. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle.

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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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 :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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)

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.