(246 days)
No
The 510(k) summary describes a simple mucus collection probe and does not mention any AI or ML components or functionalities.
No
The device is described as a collection probe for diagnostic purposes (analysis of biochemical constituents), not for treating a condition or disease.
No
The device is for collection of bronchial secretions, which are then subsequently analyzed for biochemical constituents. The device itself is not performing the diagnostic analysis. It is a collection tool.
No
The device description clearly states it is a "Mucus Collection Probe" with a "fiber tip," indicating a physical hardware component for collecting bronchial secretions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: IVDs are devices intended for use in the collection, preparation, and examination of specimens taken from the human body for the purpose of providing information for the diagnosis, treatment, or prevention of disease. The key is that the device itself is involved in the analysis or examination of the specimen to provide diagnostic information.
- Device Function: The description clearly states that the device is used for the collection of bronchial secretions. The analysis of these secretions for biochemical constituents happens subsequently and is not performed by the collection probe itself.
- Intended Use: The intended use is for the collection of samples, not for the analysis or diagnosis based on those samples.
While the collected sample will be used for in vitro diagnostic testing, the collection probe itself is a specimen collection device, not an IVD.
N/A
Intended Use / 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.
Product codes
EOQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheobronchial tree.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
0
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 accessories |
| 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:
BC-401C/402C | Predicate Device:
BC-14C/15C/16C
(# K931154) |
|--------|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Labeling-
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. | This instrument has been designed to be
used with Olympus endoscopes to
collect tissue specimens in the Tracheo
bronchial Tree. |
| | Operation | Bronchoscopic Microsampling.
Insert the instrument in the endoscope with
the fiber rod retracted into the tube.
Advance the distal end of the insertion
portion toward target area. Extend the fiber
rod from the tube, and contact the target
area to collect bronchial secretions. | Insert the instrument into the endoscope
with the brush retracted in the tube.
Advance the distal end of the insertion
portion toward target area. Extend the
brush from the tube, and brush the
target area to collect tissue specimen. |
| Design | Maximum
diameter | 1.8mm, 2.5mm | 1.8mm |
| | Insertion
portion
diameter | 1.7mm, 2.4mm | 1.7mm |
| | Brush
diameter | 1mm | 2.4mm, 3mm |
| | Brush
length | 5mm | 6mm, 10mm |
| | Fiber rod
diameter | 1.1mm, 1.9mm | |
| | Fiber rod
length | 30mm, 20mm | |
| | Working
length | 1050mm | 1050mm, 1050mm |
| | Applicable
endoscope
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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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.
3
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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Image /page/4/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced together. The word is centered and takes up most of the frame.
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)
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)