The Pulmonary Balloon Catheters are multi-lumen catheters with a dilation balloon on the distal tip. The catheters have two extension legs with luer connectors on the proximal end. The catheter is designed to pass through the working channel of a bronchoscope and accept a 0.035 in (0.89 mm) X 260 cm guidewire lumen. Two redundant inflation lumens are used to inflate and deflate the dilation balloon.

The dilation balloon will be available in a 7.5F catheter with a length of 1.5 cm and in one additional balloon diameter of 4mm range that will be added to the current range from to 20 mm. Each balloon size will inflate to three different diameters for the specified inflation pressures. The balloon will be identifiable with both endoscopic and radiopague marker bands. A glow-in-the-dark tag that can be read in low light conditions is attached to the catheter shaft. The tag indicates diameter and corresponding pressure of the balloon.

AI/ML Overview

The provided text is a 510(k) summary for the Elation™ Pulmonary Balloon Dilation Catheter. It outlines the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device. However, it does not contain a study that explicitly establishes acceptance criteria and then proves the device meets those criteria through a detailed performance study as would be seen in a clinical trial.

Instead, the document details a series of non-clinical, bench-top tests designed to show that the modified device (with a smaller balloon diameter and shorter length) performs equivalently to its predicate. The text states "All tests passed the predetermined acceptance criteria," but it does not list these specific criteria or provide detailed results from a study proving this. It also mentions a "design validation study... with porcine lungs to demonstrate the safety of dilation of smaller (6mm diameter or below) bronchi," but no specific data or acceptance criteria for this study are provided.

Therefore, many of the requested items cannot be fully answered from the provided text.

Here's an attempt to answer based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Not Explicitly Stated in Document)	Reported Device Performance (Summary)
Balloon Length	(Implied: Within design specifications)	Tests passed predetermined acceptance criteria.
Balloon Diameter	(Implied: Within design specifications)	Tests passed predetermined acceptance criteria.
Burst Pressure	(Implied: Withstand specified pressure without bursting)	Tests passed predetermined acceptance criteria.
Pressure Cycling	(Implied: Maintain integrity over 10 cycles)	Tests passed predetermined acceptance criteria.
Leak Testing	(Implied: No leaks detected)	Tests passed predetermined acceptance criteria.
Material Attachment	(Implied: Secure attachment)	Tests passed predetermined acceptance criteria.
Tip Tensile	(Implied: Withstand specified tensile force)	Tests passed predetermined acceptance criteria.
Proximal Tensile	(Implied: Withstand specified tensile force)	Tests passed predetermined acceptance criteria.
Wire Tensile	(Implied: Withstand specified tensile force)	Tests passed predetermined acceptance criteria.
Design Validation (Porcine)	(Implied: Demonstrate safety of dilation in <6mm bronchi)	Safety of dilation of smaller bronchi demonstrated.

2. Sample Size and Data Provenance for Test Set

Sample Size: Not specified for any of the non-clinical tests or the porcine lung study.
Data Provenance: The tests are described as "non-clinical tests" and a "design validation study... with porcine lungs," indicating bench-top and ex-vivo (animal) testing rather than human clinical data. No country of origin for the data is specified, but the applicant address is in the United States. The data is retrospective in the sense that it was collected as part of the device development and submission process.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable as this was a non-clinical/pre-clinical study. Ground truth was established by device specifications and technical standards for the bench tests, and likely by veterinary observations/measurements for the porcine study.

4. Adjudication Method for Test Set

Not applicable as this was a non-clinical/pre-clinical study. Results would have been measured against predetermined technical specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This device is a physical medical device (catheter), not an AI diagnostic or assistive technology that would typically be evaluated with MRMC studies.

6. Standalone Performance Study

The non-clinical tests listed (Balloon length, diameter, burst pressure, etc.) can be considered standalone performance evaluations of the device's physical properties. The design validation study in porcine lungs also falls into this category, evaluating the device's functional performance in a relevant biological model without human intervention as part of the primary outcome assessment.

7. Type of Ground Truth Used

Non-clinical tests: Engineering specifications, material properties, and relevant industry standards.
Porcine lung study: Direct observation, measurement, and potentially histological analysis of the porcine lung tissue post-dilation, guided by pre-defined safety endpoints.

8. Sample Size for Training Set

Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning or AI models. The design and manufacturing process would be informed by engineering principles, material science, and prior device knowledge.

9. How Ground Truth for Training Set was Established

Not applicable (see #8).

Summary

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March 8, 2022

Merit Medical Systems, Inc. David Thomas Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K213434

Trade/Device Name: Elation Pulmonary Balloon Dilation Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: January 14, 2022 Received: January 18, 2022

Dear David Thomas:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K213434

Device Name

Elation™ Pulmonary Balloon Dilation Catheter

Indications for Use (Describe)

The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.

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)

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510(k) #: K213434	510(k) Summary	Prepared on: 2022-01-13
-------------------	----------------	-------------------------

Contact Details	21 CFR 807.92(a)(1)
-----------------	---------------------

Applicant Name	Merit Medical Systems, Inc.
Applicant Address	1600 West Merit Parkway South Jordan UT 84095 United States
Applicant Contact Telephone	8013164956
Applicant Contact	Mr. David Thomas
Applicant Contact Email	david.thomas@merit.com

Device Name	21 CFR 807.92(a)(2)
-------------	---------------------

Device Trade Name	Elation™ Pulmonary Balloon Dilation Catheter
Common Name	Bronchoscope (flexible or rigid) and accessories
Classification Name	Bronchoscope Accessory
Regulation Number	874.4680
Product Code	KTI

Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
------------------------------------	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K161392	Elation™ Pulmonary Balloon Dilation Catheter	KTI

Device Description Summary

Intended Use/Indications for Use

The Elation™ Pulmonary Balloon Dilation Catheter is intended to endoscopically dilate strictures of the trachea and bronchi.

Indications for Use Comparison

The indications for use has not changed from the predicate device.

21 CFR 807.92(a)(4)

ures of the trachea and bronchi.

21 CFR 807.92(a)(5)

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Technological Comparison

The Elation® Pulmonary Balloon Dilation Catheter (4mm) size is the same as the currently marketed Elation Pulmonary Balloon Dilation Catheter except for the smaller diameter range for the balloon of (4-5-6) mm diameter ranges offered and the shorter length of 15mm. The currently marketed Elation® Pulmonary Balloon Dilation Catheter is offered in lengths of 20, 30 and 55mm. There are no changes to the materials, principal of operation or indications for uses the same 7.5F catheter size with a working length of 100 cm as the current Elation® Pulmonary Balloon Dilation Catheter.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

The following non-clinical tests were performed to support the substantial equivalence for this product:

· Balloon length
· Balloon diameter
· Burst pressure
- o Pressure cycling and leak testing (10 cycles at largest diameter/pressure)
- o Leak testing
- o Material attachment
· Tip Tensile
· Proximal Tensile
· Wire Tensile

In addition, a design validation study was performed with porcine lungs to demonstrate the safety of diation of smaller (6mm diameter or below) bronchi.

All tests passed the predetermined acceptance criteria.

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.