(139 days)
Not Found
No
The device description and performance information do not mention any AI, DNN, or ML components. It is a simple mechanical catheter.
Yes
The device is used for medical interventions such as injection, lavage, and hemostasis (tamponade) in the bronchi, which are direct treatments or diagnostic aids for medical conditions.
No
This device is designed for therapeutic interventions (injection of fluids, bronchial hemostasis) rather than for diagnosing a medical condition.
No
The device is a physical medical device (catheter) with a balloon component designed for injection into bronchi, saline injection, and bronchial hemostasis. It is described with physical components (natural rubber latex inflatable balloon, polyethylene tube, etc.) and undergoes biocompatibility and bench performance testing, which are characteristic of hardware medical devices, not software-only devices.
No.
The device is a catheter used for injection and hemostasis within the bronchi, which are medical procedures performed directly on a patient's body for diagnostic or therapeutic purposes, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).
Product codes
EOQ
Device Description
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). The Balloon Catheter is inserted into the instrument channel of compatible bronchoscopes and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). When the procedure is completed, the balloon is deflated, and the catheter is removed from the patient.
The Balloon Catheter is provided sterile and is constructed of a natural rubber latex inflatable balloon, polyethylene tube, branch, irrigation port, air feed cap, and stopcock. The inflatable balloon has a maximum diameter of Ø 11 mm after inflation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bronchi
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)
The following performance testing was conducted in support of substantial equivalence determination.
-
Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:- Cytotoxicity Study using the ISO Elution method (ISO 10993-5)
- Intracutaneous Irritation Study (ISO 10993-23)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10)
- Material-mediated Pyrogen Testing (USP )
- Acute Systemic Toxicity Study in Mice (ISO 10993-11)
All tests passed Biocompatibility.
-
Performance Testing – Bench (Non-Clinical)
Bench tests as listed below were conducted to ensure that the subject device performs as intended and meets design specifications.- Insertion of the Subject Device into the Endoscope
- Withdrawal of the Subject Device from the Endoscope
- Balloon Diameter after Inflation
- Performance of Infusion
- Strength of Junction
- Safety Evaluation
- Balloon Burst
All Bench Testing passed.
-
Performance testing – Animal
No animal study was performed. -
Performance testing – Clinical
No clinical study was performed. -
Risk Management
Risk management was performed in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were performed and identified as a result of this risk management.
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
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.
FDA 510(k) Clearance Letter - Disposable Balloon Catheter B5-2C
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 4, 2025
Olympus Medical Systems Corporation
Eve Smith
Regulatory Affairs Specialist II
2951 Ishikawa-cho
Hachioji-shi, Tokyo 192-8507
Japan
Re: K250118
Trade/Device Name: Disposable Balloon Catheter B5-2C
Regulation Number: 21 CFR 874.4680
Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories
Regulatory Class: Class II
Product Code: EOQ
Dated: May 1, 2025
Received: May 1, 2025
Dear Eve Smith:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K250118 - Eve Smith Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K250118 - Eve Smith Page 3
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250118
Device Name
Disposable Balloon Catheter B5-2C
Indications for Use (Describe)
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).
Type of Use (Select one or both, as applicable)
☒ 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."
Page 5
TRADITIONAL 510(K) NOTIFICATION
Disposable Balloon Catheter B5-2C
510(k) Summary
Page 1 of 4
510(k) Summary
For
Disposable Balloon Catheter B5-2C
General Information
Applicant: OLYMPUS MEDICAL SYSTEMS CORP.
2951 Ishikawa-cho, Hachioji-shi, Tokyo, Japan 192-8507
Phone: (+81) 42-642-2111
Fax: (+81) 42-642-2307
Establishment Registration Number: 8010047
Manufacturer: Shirakawa Olympus Co., Ltd.
3-1 Okamiyama, Odakura, Nishigo-mura, Nishishirakawa-gun,
Fukushima 961-8061, Japan
510(k) Submitter: Olympus Corporation of the Americas
3500 Corporate Parkway
Center Valley, PA 18034
Contact Person: Eve Smith
Regulatory Specialist II
Mobile: (267) 373-7633
Email: eve.smith@olympus.com
Date Prepared: May 1, 2025
Device Description
Device Name: Disposable Balloon Catheter B5-2C
Generic/Common Name: Disposable Balloon Catheter
Regulation Number: 874.4689
Regulatory Class: Class II
Classification Name: Bronchoscope (Flexible or Rigid)
Product Codes: EOQ
Review Panel: Ear, Nose and Throat
Predicate Device
| Device Name | 510(k) Submitter | 510(k) No. |
|---|---|---|
| Olympus B5/B7 Series Balloon Catheters | Olympus America, Inc. | K962901 |
Indications for Use
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade).
Page 6
TRADITIONAL 510(K) NOTIFICATION
Disposable Balloon Catheter B5-2C
510(k) Summary
Page 2 of 4
Device Description
The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). The Balloon Catheter is inserted into the instrument channel of compatible bronchoscopes and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). When the procedure is completed, the balloon is deflated, and the catheter is removed from the patient.
The Balloon Catheter is provided sterile and is constructed of a natural rubber latex inflatable balloon, polyethylene tube, branch, irrigation port, air feed cap, and stopcock. The inflatable balloon has a maximum diameter of Ø 11 mm after inflation.
Comparison of Technological Characteristics
Table 1 compares the DISPOSABLE BALLOON CATHETER B5-2C to the predicate device with respect to Intended use/indications for use, and technological characteristics, providing detailed information regarding the basis for the determination of substantial equivalence.
Table 1. Subject and Predicate Device Comparison Table
| Feature / Characteristic | Subject Device (SD) | Predicate Device (PD) |
|---|---|---|
| Disposable Balloon Catheter B5-2C | Olympus B5/B7 Series Balloon Catheters (K962901) | |
| Intended Use/Indications for Use | The DISPOSABLE BALLOON CATHETER B5-2C has been designed to be used for injection into bronchi, saline injection associated with bronchoalveolar lavage, and bronchial hemostasis (tamponade). | Olympus B5-2C Balloon Catheter is to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection associated with bronchoalveolar lavage, foreign body removal from bronchi, and bronchial hemostasis (tamponade). |
| Regulation Number | 874.4680 | 874.4680 |
| Regulation Name | Bronchoscope (flexible or rigid) | Bronchoscope (flexible or rigid) |
| Regulatory Class | Class II | Class II |
| Product Code | EOQ | EOQ |
| Classification Panel | Ear, Nose, & Throat | Ear, Nose, & Throat |
| Basic principle | The Balloon Catheter is inserted into the instrument channel of the bronchoscope and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for hemostasis (tamponade). | The Balloon Catheter is inserted into the instrument channel of the bronchoscope and advanced to the target area, where medical fluid or saline solution are injected, or the balloon is inflated to allow for removal of a foreign object and hemostasis (tamponade). |
| Shape of the Balloon | ||
| Balloon Material | Natural Rubber Latex (manufactured by Okamoto Corp) | Natural Rubber Latex (manufactured by Regitex Corp) |
| Maximum Insertion Portion Diameter (mm) | ø 1.95 | ø 1.95 |
Page 7
TRADITIONAL 510(K) NOTIFICATION
Disposable Balloon Catheter B5-2C
510(k) Summary
Page 3 of 4
| Feature / Characteristic | Subject Device (SD) | Predicate Device (PD) |
|---|---|---|
| Disposable Balloon Catheter B5-2C | Olympus B5/B7 Series Balloon Catheters (K962901) | |
| Working Length (mm) | 1050 | 1050 |
| Diameter after inflation (mm) | ø 11.0 | ø 11.0 |
| Maximum Air Volume (ml [cc]) | 2.1 | 1.5 |
| Compatible Guidewire | ø 0.53mm (0.021 in) | ø 0.53mm (0.021 in) |
| Compatible Bronchoscope | BF endoscopes; Working length less than 600 mm; Working Channel diameter (mm) :ø 2, ø 2.2: ø 2.8, ø 3.2 | BF endoscopes; Working length less than 600 mm Working Channel diameter (mm) :ø 2, ø 2.2: ø 2.8, ø 3.2 |
| Reprocessing | Single Use | Single Use |
| Sterilization Method | EO | EO |
| Primary Packaging | Film: polyethylene terephthalate Sheet: high-density polyethylene (Tyvek) | Film: polyethelene terephthalate and polyethelene Sheet: S-Vellum-NF (95g/m²) equivalent material |
The Disposable Balloon Catheter B5-2C is substantially equivalent to the legally marketed predicate device based on similar intended use/indications for use and technological features with the predicate device.
There are slight differences in the subject device and predicate device intended use/indications for use statements; however, these differences do not create a new intended use for the subject device when compared to the predicate device.
Due to a change in the manufacturer of Natural Rubber Latex (balloon material), the subject device will hold an increased amount (volume) of air in the balloon. Although this is different between Subject Device and Predicate Device, Olympus conducted Balloon Burst, Safety Verification, and Balloon Diameter measurements/testing to demonstrate substantial equivalence of the subject device to the predicate device. The results of these tests indicate that the material change and increased volume do not affect substantial equivalence between Subject and Predicate devices.
Summary of Performance Testing
The following performance testing was conducted in support of substantial equivalence determination.
- Biocompatibility Testing
Biocompatibility testing was conducted in accordance with the FDA's Guidance for Industry and Food and Drug Administration Staff, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The biocompatibility testing included the following tests:
- Cytotoxicity Study using the ISO Elution method (ISO 10993-5)
- Intracutaneous Irritation Study (ISO 10993-23)
- Guinea Pig Maximization Sensitization Test (ISO 10993-10)
Page 8
TRADITIONAL 510(K) NOTIFICATION
Disposable Balloon Catheter B5-2C
510(k) Summary
Page 4 of 4
- Material-mediated Pyrogen Testing (USP )
- Acute Systemic Toxicity Study in Mice (ISO 10993-11)
All tests passed Biocompatibility.
- Performance Testing – Bench (Non-Clinical)
Bench tests as listed below were conducted to ensure that the subject device performs as intended and meets design specifications.
- Insertion of the Subject Device into the Endoscope
- Withdrawal of the Subject Device from the Endoscope
- Balloon Diameter after Inflation
- Performance of Infusion
- Strength of Junction
- Safety Evaluation
- Balloon Burst
All Bench Testing passed.
- Performance testing – Animal
No animal study was performed.
- Performance testing – Clinical
No clinical study was performed.
- Risk Management
Risk management was performed in accordance with ISO 14971:2019. The design verification tests and their acceptance criteria were performed and identified as a result of this risk management.
Conclusion
In summary, the DISPOSABLE BALLOON CATHETER B5-2C is substantially equivalent to the predicate device.