B7 2C Occlusion Balloon

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 20, 2017 Spiration, Inc. Cheryl Frederick Executive Director, Regulatory Affairs 6675 185th Avenue N.E. Redmond, Washington 98052 Re: K171492 Trade/Device Name: B7 2C Occlusion Balloon Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOO Dated: August 22, 2017 Received: August 24, 2017 Dear Cheryl Frederick: 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, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Michael J. Ryan -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171492 Device Name B7-2C Occlusion Balloon #### Indications for Use (Describe) The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;">☑</span> 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}------------------------------------------------ ## 5 510(k) Summary – K171492 #### Submitter Information | Date of 510(k) Summary Preparation: | May 19, 2017 | |--------------------------------------|-----------------------------------------------------------------------------------------------| | Name and Address of Private Labeler: | Spiration, Inc.<br>6675 185th Avenue NE<br>Redmond, WA 98052 | | Name and Address of Manufacturer: | Aomori Olympus Co., LTD<br>2-248-1 Okkonoki<br>Kuroishi-shi Aomori<br>Japan 036-0357 | | Contact Person: | Cheryl Frederick<br>Executive Director, RA/QA<br>Phone: (425) 636-5470<br>Fax: (425) 497-8802 | | Subject Device | | Device Trade Name: B7 2C Occlusion Balloon Common Name: Bronchoscope and Accessories Classification Regulation: Product Code: Review Panel: #### Predicate Device Trade Name: 510(k) Number: Manufacturer: BP-25 Occlusion Balloon Bronchoscope and Accessories Bronchoscope (flexible or rigid) and Accessories 21 CFR 874.4680 EOQ 77- Ear, Nose and Throat Olympus B7-2C K962901 Aomori Olympus Co., LTD #### Device Description Olympus Respiratory America (ORA) dba Spiration, Inc. is submitting this Traditional 510(k) premarket notification to add a modified name and modified Indication for use to for the already cleared Olympus B7-2C Balloon Catheter (K962901, August 20, 1996). The current cleared Indication for Use for the B7-2C Balloon Catheter is as follows (the 510(k) was submitted with 2 model #'s with identical indications): Olympus B5-2C/B7-2C Balloon Catheters are to be used for selective endoscopic bronchography, medicine injection to bronchi, saline injection {4}------------------------------------------------ associated with bronchoalveolar lavage, foreign body removal from bronchi and bronchial hemostasis. The device design and materials are completely unchanged. it will be provided packaged and sterilized to ORA, and we will private label it. The only difference will be the package labeling and Instructions for Use indicating that the device is the B7-2C Occlusion Balloon, and the modified Indication for Use. In the modified indication for use, the B7-2C Occlusion Balloon will also be available for localizing air leaks. We proposed the following modified indication: The B7-2C Occlusion Balloons is to be used for selective endoscopic bronchography. saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks. The proposed modified Indication for Use removes medicine injection to bronchi, foreign body removal from bronchi and adds airway occlusion to localize air leaks. Both the predicate and proposed device, which is identical, are an accessory to Olympus bronchoscopes. Spiration will be private labeling the device with a modified name and Indications for use, which fall within the current Intended Use. The device is introduced through the instrument channel of the bronchoscope. The device is constructed of the inflatable balloon, catheter, bifurcation, irrigation port, air feed cap and stopcock. The B7-2C device is 1050 mm in working length, with a pre-inflation diameter of 2.55 mm and a post-inflation diameter of 13 mm, with a max volume of 1.7 cc. ## Device Materials (Patient Contacting) The B7-2C Occlusion Balloon is manufactured with materials commonly used in medical device applications. The patient contacting materials are included in Table 5-1 below: #### Table 5-1 B7-2C Patient Contacting Materials | Patient Contacting Materials | |----------------------------------------------| | Latex rubber | | Polyethylene impregnated with barium sulfate | Biocompatibility testing was repeated on the subject device to support this 510(k) submission, to confirm that it meets current biocompatibility requirements. #### How Provided The B7-2C Occlusion Balloon is provided sterile and is disposable, intended for single patient use. #### Proposed Indication for Use The B7-2C Occlusion Balloon is to be used for selective endoscopic bronchography, saline injection associated with bronchoalveolar lavage, bronchial hemostasis and airway occlusion to localize air leaks. {5}------------------------------------------------ ## Comparison to Predicate A comparison table, Table 5-2, is included below, which illustrates the equivalence of the subject B7-2C device to the predicate device. ## Table 5-2: Comparison of Key Characteristics of Proposed Device to Predicate Device | Device Name→<br>Device Characteristics ↓ | B7-2C Balloon Catheter<br>(K962901) | B7-2C Occlusion Balloon<br>(Proposed Device) | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification | II | II | | Code of Federal Regulations | 878.4680 | 878.4680 | | Prescription | Yes | Yes | | Indication for Use | Olympus B5-2C/B7-2C Balloon<br>Catheters are to be used for<br>selective endoscopic<br>bronchography, medicine<br>injection to bronchi, saline<br>injection associated with<br>bronchoalveolar lavage,<br>foreign body removal from<br>bronchi and bronchial<br>hemostasis. | The Olympus B7-2C Occlusion<br>Balloon is to be used for selective<br>endoscopic bronchography,<br>medicine injection to bronchi,<br>saline injection associated with<br>bronchoalveolar lavage, foreign<br>body removal from bronchi,<br>bronchial hemostasis and airway<br>occlusion to localize air leaks. | | Materials | Latex rubber Polyethylene<br>impregnated with<br>barium sulfate | Identical | | Minimum Endoscope<br>Channel Size | 2.8 mm | Identical | | Diameter | 7 French | Identical | | Length | 1050 mm | Identical | | Sterilization | Ethylene Oxide, Single Use | Identical | {6}------------------------------------------------ The intended use of the subject device is virtually identical to that of the predicate device with respect to bronchial hemostasis. Whereas the predicate device uses pressure aqainst the airway walls to support hemostasis, the proposed device uses pressure against the airway to localize air leaks within the lung. #### Performance Data Performance testing has been completed on both the predicate device as well as the subject device, which is identical to the subject device. The B7-2C Occlusion Balloon was subjected to the following verification and validation tests, as applicable: #### Biocompatibility Repeat biocompatibility testing was conducted on the subject device to confirm that it meets current biocompatibility requirements. The tests included cytotoxity, intracutaneous irritation, materials mediated pyrogen, sensitization and systemic toxicity. All tests were successfully passed. #### Sterilization/Shelf-Life The device was validated to achieve a sterility assurance level of 10°. #### Performance Testing Testing was completed for the subject device to evaluate the ability of the B7-2C to successfully occlude airways. All tests (N=30) showed complete occlusion of the airway. Based on the statistical plan, this shows that the B7-2C balloon is capable of occluding airways at 90% conformance and 95% confidence. All acceptance criteria defined in the protocol was met. Verification and burst testing bench was completed on the predicate device to confirm that the performance of the device conforms to mechanical and functional specifications. The testing included: - Verification ● - . Burst testing ## Conclusion (Statement of Equivalence) As confirmed in the prior 510(k) for the predicate device, which is identical to the subject device, the device successfully passed all performance testing. For the subject device, biocompatibility testing was successfully passed, as well as bench testing to verify the ability of the device to successfully occlude airways. As stated above, the intended use of the subject device is virtually identical to that of the predicate device with respect to bronchial hemostasis. Whereas the predicate device uses pressure against the airway walls to support hemostasis, the proposed device uses pressure against the airway to allow the physician to localize air leaks within the lung. Since the modified device name and Indication for Use are the only changes, and the proposed Indication for Use is within the original Intended Use, we believe that the information provided supports a determination of substantial equivalence to the predicate device, and market clearance of the B7-2C Occlusion Balloon.