(137 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a balloon catheter, with no mention of AI or ML.
Yes
The device is described with an "Intended Use" to "endoscopically dilate strictures of the trachea and bronchi," which are therapeutic actions directed at treating a medical condition.
No
Explanation: The device description clearly states its intended use is to "endoscopically dilate strictures of the trachea and bronchi", which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly details a physical catheter with a balloon, lumens, connectors, and marker bands, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "endoscopically dilate strictures of the trachea and bronchi." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon designed for mechanical dilation within the airway. It does not describe a device used to examine specimens derived from the human body for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to obtaining diagnostic information from in vitro testing.
IVD devices are used to perform tests on samples taken from the body to diagnose diseases or conditions. This device is used within the body to treat a condition.
N/A
Intended Use / Indications for Use
The Elation™ Pulmonary Balloon Dilation Catheter is intended to be used to endoscopically dilate strictures of the trachea and bronchi.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Trachea and 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 non-clinical tests were performed to support the substantial equivalence for this product:
- Balloon length
- Balloon diameter
- Burst pressure
- Pressure cycling and leak testing (10 cycles at largest diameter/pressure)
- Leak testing
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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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
1
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
2
Indications for Use
Submission Number (if known)
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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3
| 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
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.
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)
21 CFR 807.92(a)(5)
4
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.