(172 days)
No
The device description and performance studies focus on the mechanical and material properties of a cytology brush, with no mention of AI or ML.
No
The device is described as a cytology brush designed to collect specimens for examination, not to treat a condition or restore a function.
No
The device is designed to collect specimens for cytology examination, not to perform the examination or interpret results themselves. It is a tool for sample collection, which is a step preceding diagnosis.
No
The device description clearly states it is a "single use cytology brush" which is a physical instrument used to collect specimens. The performance studies also describe testing related to physical properties like dimension, durability, and tensile strength, further indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "cytology brush" designed to "collect specimens or cells endoscopically for cytologic examination." This means the device is a tool for collecting the sample, not for analyzing it or performing a diagnostic test on it.
- Intended Use: The intended use is to "collect specimens or cells... for cytologic examination." Cytologic examination is the process of examining cells under a microscope, which is a separate step performed after the sample is collected.
The device is a medical device used in a procedure to obtain a sample that will then be used for an in vitro diagnostic test (cytologic examination). However, the brush itself is not the diagnostic test.
N/A
Intended Use / 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.
Product codes
BTG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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.
•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.
-
- Brush operation with the compatible endoscope
-
- Dimension of each part of the brush
-
- General durability
-
- Joint/tensile strength
-
- Package integrity
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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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)
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."
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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, Japan
192-8507
Establishment Registration No: 8010047 |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ■ Official Correspondent: | Jon Gilbert fbo Daphney Germain-Kolawole
Olympus Corporation of the Americas
3500 Corporate Parkway
PO Box 610 Center Valley, PA 18034-0610, USA
Phone: 484-896-5691
FAX: 484-896-7128
Email: daphney.germain-kolawole@olympus.com |
| ■ Manufacturer: | Aomori Olympus Co., Ltd.
248-1 Okkonoki 2-chome Kuroishi-shi,
Aomori, Japan 036-0357
Establishment Registration No.: 9614641 |
| 5.2 Device Identification | |
| ■Device Trade Name and
Model number (if
applicable): | 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
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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 and | |
| Gastrointestinal | |||
| Cytology 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.
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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 device
Single Use Cytology Brush
BC-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 been
specifically designed to
collect specimens or cells
endoscopically for cytologic
examination in conjunction
with Olympus bronchoscopes
with channel φ1.7mm or
larger. | The device is intended to be used
through endoscopes for the
purpose of collecting sterile,
non-contaminated specimens for
microbiological analysis. |
| Technology features | | |
| Compatible
endoscopes | Olympus bronchoscopes with
channel φ1.7mm or larger. | Bronchoscope |
| Sterile status | Same as PD | Sterile product |
| Maximum insertion
portion 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 high
density polymer
Plug: none
Distal tip/Wire: stainless steel
Brush: nylon | Tube: two-layer Teflon catheter
Plug: non-toxic water soluble wax
Distal tip/Wire: N/A
Brush: 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.
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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.
-
- Brush operation with the compatible endoscope
-
- Dimension of each part of the brush
-
- General durability
-
- Joint/tensile strength
-
- Package integrity
The following standards have been applied to the subject devices.
| Standard No. | Standard Title |
|---|---|
| ISO 14971 Second | |
| Edition: 2007-03-01 | Medical Devices - Application Of Risk Management To |
| Medical Devices | |
| ISO 10993-1 Fourth | |
| Edition:2009-10-15 | Biological Evaluation Of Medical Devices - Part1: |
| Evaluation And Testing Within A Risk Management Process | |
| [Including: Technical Corrigendum 1 (2010)] | |
| ISO10993-5 Third | |
| Edition: 2009-06-01 | Biological Evaluation Of Medical Devices – Part5: Tests For |
| In Vitro Cytotoxicity | |
| ISO 10993-10 Third | |
| Edition: 2010-08-01 | Biological Evaluation Of Medical Devices - Part 10: Tests |
| For Irritation And Skin Sensitization | |
| ISO 10993-7:2008 | |
| (R)2012 | Biological evaluation of medical devices - Part 7: Ethylene |
| oxide sterilization residuals |
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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 | |
| -USP 42, NF 37, General | |
| Chapters & | -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 for | |
| interactions with blood | |
| -Pyrogen Test | |
| -Kinetic-Chromogenic Limulus Amebocyte Lysate test method based on | |
| standards | |
| ISO 11135 Second | |
| Edition 2014 | Sterilization Of Health-Care Products: Ethylene Oxide - |
| Requirements For The Development, Validation And Routine | |
| Control Of A Sterilization Process For Medical Devices. | |
| ASTM F1980-16 | Standard Guide For Accelerated Aging Of Sterile Barrier |
| Systems For Medical Devices | |
| AAMI/ANSI/ISO | |
| 11607-1 | Packaging for terminally sterilized medical devices - Part 1: |
| Requirements for materials, sterile barrier systems and | |
| packaging systems [Including: Amendment 1 (2014)] | |
| AAMI/ANSI/ISO | |
| 11607-2 | Packaging for terminally sterilized medical devices - Part 2: |
| Validation requirements for forming, sealing and assembly | |
| processes [Including: Amendment 1 (2014)] |
5.8 Conclusion
The Single Use Cytology Brush BC-205D is substantially equivalent to the predicate device.