The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.

Device Description

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes. Identical to the predicate device, the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.

AI/ML Overview

The provided document is a 510(k) summary for the Olympus Single Use Cytology Brush BC-205D, demonstrating its substantial equivalence to a predicate device. It focuses on the device's design, materials, and non-clinical performance, rather than a clinical study involving human patients or complex algorithms requiring extensive performance criteria.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone algorithm performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission because the demonstrated substantial equivalence is primarily based on bench testing and material characteristics, not clinical performance against a complex diagnostic ground truth.

Here's a breakdown of what can be extracted and why other parts are not applicable:

1. A table of acceptance criteria and the reported device performance:

The document mentions several tests and standards applied, along with the statement "The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device." However, it does not provide a specific table of quantitative acceptance criteria or detailed numerical results for each test. Instead, it lists the types of tests performed.

Acceptance Criteria Category	Reported Device Performance (Summary)
Risk Analysis	In accordance with ISO 14971:2007; Design verification tests and acceptance criteria identified and performed based on risk analysis assessment.
Biocompatibility	Performed in accordance with FDA Guidance (ISO-10993 Part 1); Passed ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Skin Sensitization), ISO 10993-7 (Ethylene Oxide Residuals), ISO 10993-11 (Systemic Toxicity), ASTM F756 (Hemolytic Properties), ISO 10993-4 (Interactions with blood), USP <151> (Pyrogen Test), USP 42, NF 37, Gen Chapters <85> & <161> (Kinetic-Chromogenic Limulus Amebocyte Lysate). Implies successful meeting of biocompatibility standards.
Sterilization Validation	Half-cycle approach in accordance with ISO 11135:2014. Validated.
Shelf-life Testing	Validated for three years by accelerated testing according to ASTM F1980-16. Validated.
Packaging Requirements	Per AAMI/ANSI/ISO 11607-1/2. Validated.
Performance Testing	Bench tests carried out to demonstrate performance, including: 1. Brush operation with compatible endoscope 2. Dimension of each part of the brush 3. General durability 4. Joint/tensile strength 5. Package integrity. Implies successful meeting of performance criteria.

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample sizes (number of units) used for each individual bench test (e.g., durability, tensile strength). It only states that tests were performed.
Data Provenance: The tests are "non-clinical testing" conducted by or for Olympus Medical Systems Corp. and Aomori Olympus Co., Ltd. (Japan). The specific location where the testing was physically conducted (e.g., country of origin of the data/testing) is not explicitly stated beyond the manufacturing location. These are laboratory/bench tests, not patient data.
Retrospective or Prospective: Not applicable, as these are bench tests, not involving patient data or clinical follow-up.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the context of diagnostic device performance based on expert consensus, is not relevant here. The "ground truth" for the engineering and material tests is defined by the physical or chemical properties being measured (e.g., tensile strength, biocompatibility standards, dimensions).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. Adjudication methods are used in clinical studies with human readers/interpreters to establish a consensus ground truth. Here, the "truth" is determined by engineering test methods and established standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device (cytology brush), not an AI/software algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device; there is no "algorithm only" performance to evaluate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is established by engineering and material standards, physical measurements, and biological compatibility tests. For example:
- Dimensions: Met specified dimensions.
- Strength/Durability: Passed defined stress tests (e.g., joint/tensile strength, general durability).
- Biocompatibility: Demonstrated non-toxicity, non-irritation, non-hemolysis, etc., as per ISO 10993 series and USP standards.
- Sterilization: Demonstrated effective sterilization and maintenance of sterility over shelf-life per ISO 11135 and ASTM F1980.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. (See #8)

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 2, 2019

Olympus Medical Systems Corp. % Jonathan Gilbert Regulatory Affairs Consultant to OCA Olympus Corporation of the Americas 3500 Corporate Parkway PO Box 610 Center Valley, Pennsylvania 18034-0610

Re: K190293

Trade/Device Name: Single Use Cytology Brush BC-205D Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: BTG Dated: July 2, 2019 Received: July 3, 2019

Dear Jonathan Gilbert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James Lee, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K190293

Device Name Single Use Cytology Brush BC-205D

Indications for Use (Describe)

Single Use Cytology Brush BC-205D

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger .

Type of Use (Select one or both, as applicable) |X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff

PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered horizontally. There is a thin, horizontal, yellow line below the word. The registered trademark symbol is located to the right of the word.

510(k) SUMMARY

Single Use Cytology Brush BC-205D

July 30, 2019

5.1 General Information

■ Applicant:	OLYMPUS MEDICAL SYSTEMS CORP.2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan192-8507Establishment Registration No: 8010047
■ Official Correspondent:	Jon Gilbert fbo Daphney Germain-KolawoleOlympus Corporation of the Americas3500 Corporate ParkwayPO Box 610 Center Valley, PA 18034-0610, USAPhone: 484-896-5691FAX: 484-896-7128Email: daphney.germain-kolawole@olympus.com
■ Manufacturer:	Aomori Olympus Co., Ltd.248-1 Okkonoki 2-chome Kuroishi-shi,Aomori, Japan 036-0357Establishment Registration No.: 9614641
5.2 Device Identification
■Device Trade Name andModel number (ifapplicable):	Single Use Cytology Brush BC-205D(Model number: BC-205D-2010)
■ Common Name:	Single Use Cytology Brush
■ Regulation Number:	874.4680
■ Regulation Name:	Bronchoscope (flexible or rigid) and accessories
■ Regulatory Class:	II
■ Classification Panel:	Ear Nose & Throat

Section 5 510(k) Summary Page 1 of 5

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image features the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced, creating a strong visual impact. A thin, horizontal yellow line is visible beneath the word, adding a subtle contrast to the overall design. The registered trademark symbol is present to the right of the word.

	K number	Product name	Manufacturer
Predicate device	K780872	CYTOLOGY BRUSH	COOPERVISION, INC.
Reference device	K171607	Bronchi andGastrointestinalCytology Brush	Wilson-Cook Medical,Inc. / Cook Endoscopy

5.3 Predicate Device/Reference Device Information

5.4 Device Description

The single use cytology brush BC-205D has been designed to collect specimens or cells endoscopically for cytologic examination in conjunction with bronchoscopes.

Identical to the predicate device, the subject device is inserted into bronchoscope channel to collect specimens with the brush which is equipped at the distal end of the subject device. Then users withdraw the subject device from bronchoscope channel and collect samples for cytology examination.

5.5 Indications for Use

The cytology brush has been specifically designed to collect specimens or cells endoscopically for cytologic examination in conjunction with Olympus bronchoscopes with channel φ1.7mm or larger.

5.6 Comparison of Technological Characteristics

Compared to the predicate device, our subject device, Single Use Cytology Brush BC-205D, mainly has the following technical differences:

Configuration of the device 2) Compatible endoscope 3) Material of the device

Validation from the non-clinical testing supported the substantial equivalence of the

subject device with the predicate device

A side by side comparison of the subject device and the predicate device is provided below.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The font is sans-serif and the letters are closely spaced. A registered trademark symbol is located to the right of the letter "S".

Features	Subject deviceSingle Use Cytology BrushBC-205D	Predicate device (PD)Cytology Brush
Administrative information
510(k)	Not yet known	K780872
Regulation number	Same as PD	874.4680
Device class	Same as PD	II
Product code	Same as PD	BTG
Indications for use
Indications for use	The cytology brush has beenspecifically designed tocollect specimens or cellsendoscopically for cytologicexamination in conjunctionwith Olympus bronchoscopeswith channel φ1.7mm orlarger.	The device is intended to be usedthrough endoscopes for thepurpose of collecting sterile,non-contaminated specimens formicrobiological analysis.
Technology features
Compatibleendoscopes	Olympus bronchoscopes withchannel φ1.7mm or larger.	Bronchoscope
Sterile status	Same as PD	Sterile product
Maximum insertionportion diameter	φ 1.4 mm	φ 1.8 mm
Working length	1150mm	900mm
Brush diameter	φ 2 mm	φ 1 mm
Brush length	10mm	N/A
Material	Tube: single-layer highdensity polymerPlug: noneDistal tip/Wire: stainless steelBrush: nylon	Tube: two-layer Teflon catheterPlug: non-toxic water soluble waxDistal tip/Wire: N/ABrush: N/A

5.7 Summary of non-clinical testing

The technological differences between the predicate device and the subject device have been verified and validated by means of the following tests and standards to endorse the claims of substantial equivalence to the predicate device.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a registered trademark symbol to the right of the word. The background is white.

·Risk analysis was carried out in accordance with established in-house acceptance criteria based on ISO 14971:2007. The design verification tests and their acceptance criteria were identified and performed as a result of this risk analysis assessment.

·Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16 2016.

·Sterilization validation and Shelf-life testing

Sterilization validation was carried out with the method of Half-cycle approach in accordance with ISO 11135:2014. The shelf-life for three years has been validated by accelerated testing according to ASTM F1980-16. The requirements on packaging for terminally sterilized medical device per AAMI/ANSI/ISO 11607-1/2 have also been validated.

•Performance testing

The following bench tests were also carried out to demonstrate the performance of the subject device.

1. Brush operation with the compatible endoscope
1. Dimension of each part of the brush
1. General durability
1. Joint/tensile strength
1. Package integrity

The following standards have been applied to the subject devices.

Standard No.	Standard Title
ISO 14971 SecondEdition: 2007-03-01	Medical Devices - Application Of Risk Management ToMedical Devices
ISO 10993-1 FourthEdition:2009-10-15	Biological Evaluation Of Medical Devices - Part1:Evaluation And Testing Within A Risk Management Process[Including: Technical Corrigendum 1 (2010)]
ISO10993-5 ThirdEdition: 2009-06-01	Biological Evaluation Of Medical Devices – Part5: Tests ForIn Vitro Cytotoxicity
ISO 10993-10 ThirdEdition: 2010-08-01	Biological Evaluation Of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization
ISO 10993-7:2008(R)2012	Biological evaluation of medical devices - Part 7: Ethyleneoxide sterilization residuals

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, blue letters. The letters are spaced closely together, and the word is centered in the image. There is a yellow line underneath the word. The registered trademark symbol is located to the right of the letter "S".

Standard No.	Standard Title
-ISO 10993-11-ASTM F756-ISO 10993-4-USP General Chapter <151>-USP 42, NF 37, GeneralChapters <85> & <161>	-Biological evaluation of medical devices - Part 11: Tests for systemic toxicity-Standard Practice for Assessment of Hemolytic Properties of Materials-Biological evaluation of medical devices - Part 4: Selection of tests forinteractions with blood-Pyrogen Test-Kinetic-Chromogenic Limulus Amebocyte Lysate test method based onstandards
ISO 11135 SecondEdition 2014	Sterilization Of Health-Care Products: Ethylene Oxide -Requirements For The Development, Validation And RoutineControl Of A Sterilization Process For Medical Devices.
ASTM F1980-16	Standard Guide For Accelerated Aging Of Sterile BarrierSystems For Medical Devices
AAMI/ANSI/ISO11607-1	Packaging for terminally sterilized medical devices - Part 1:Requirements for materials, sterile barrier systems andpackaging systems [Including: Amendment 1 (2014)]
AAMI/ANSI/ISO11607-2	Packaging for terminally sterilized medical devices - Part 2:Validation requirements for forming, sealing and assemblyprocesses [Including: Amendment 1 (2014)]

5.8 Conclusion

The Single Use Cytology Brush BC-205D is substantially equivalent to the predicate device.

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.