(147 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 intended to dilate strictures of the airway, which is a therapeutic action.
No
The device is described as a treatment device, intended to "dilate strictures of the airway." There is no mention of it being used for diagnosis.
No
The device description clearly outlines a physical catheter with a balloon, stylet, and Luer connector, indicating it is a hardware medical device, not software-only.
No, 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 Description and Intended Use: The METIC™ – Airway Balloon Catheter is a physical device designed to be inserted into the airway to dilate strictures. It is a therapeutic device used directly on the patient's anatomy.
- Lack of Biological Sample Analysis: The description and intended use do not involve the analysis of any biological samples.
Therefore, based on the provided information, the METIC™ – Airway Balloon Catheter is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.
Product codes (comma separated list FDA assigned to the subject device)
KTI
Device Description
The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 safety and effectiveness of METIC™ – Airway Balloon Catheter has been evaluated for the following performance and safety requirements:
- Visual Inspection
- Dimensional Measurement
- Balloon Burst and Balloon Compliance
- Inflation and Deflation Time
- Catheter Bond Strength
- Flexibility and Kink
- Torquability
- Catheter Fatigue
- Balloon Hub Measurement
- Proximal Luer fitting
- Balloon Preparation, Deployment and Retraction
The performance, biocompatibility, sterilization, packaging and shelf life study conducted on METIC™ – Airway Balloon Catheter demonstrated the device is as safe and as effective as the predicate device.
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
Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 15, 2023
M/s Meril Life Sciences Pvt. Ltd. Bhavin Choradiya Senior Manager- Regulatory Affairs Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi Vapi, Gujarat 396191 India
Re: K231818
Trade/Device Name: METIC™ Airway Balloon Catheter Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: KTI Dated: June 20, 2023 Received: June 21, 2023
Dear Bhavin Choradiya:
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"
1
(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 OS 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 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-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 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.
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-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.
Joyce C. Lin -S
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231818
Device Name METICTM - Airway Balloon Catheter
Indications for Use (Describe)
METIC™ - Airway Balloon Catheter is intended to dilate strictures of the airway.
| 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)
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510(k) Summary
Type of 510(k)
Traditional
Submitter
M/s. Meril Life Sciences Private Limited Survey No. 135/139, Bilakhia House, Muktanand Marg, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 Web site: www.merillife.com
Establishment Registration No.
3009613036
Contact Person
Dr. Bhavin Choradiya
E-mail: bhavin.choradiya@merillife.com
Device details
| Trade Name/ Proprietary Name | METIC™ – Airway Balloon Catheter |
|---|---|
| Panel | Airway Dilation Balloon Catheter |
| Common/ Usual Name | Balloon Dilation Catheter |
| Classification Name | Bronchoscope (Flexible or Rigid)and Accessories |
| Regulation Number | 21 CFR 874.4680 |
| Classification | Class II |
| Product Code | KTI |
Predicate Device
| Predicate device | |||
|---|---|---|---|
| Subject device | Trade Name | Manufacturer | 510 (k) No. |
| METIC™ – Airway | |||
| Balloon Catheter | Inspira Air® Balloon | ||
| Dilation System | |||
| (Primary Predicate) | Acclarent Inc. | K090660 | |
| Aeris® Balloon Dilation | |||
| Catheter | |||
| (Second Predicate) | Bryan Medical Inc. | K150951 |
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Indications for Use
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.
Federal law (USA) restricts this device to sale by or on the order of a physician or licensed healthcare practitioner.
Device Description
The METIC™ – Airway Balloon Catheter is comprised of a single lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A Luer at the proximal end is used for the placement of the stylet and injecting sterile water into the balloon.
Image /page/5/Figure/6 description: This image is a technical drawing of a medical device, specifically a balloon catheter. The drawing includes labels pointing to key components such as the "BALLOON", "INFLATION PORT", "STYLET", "HUB", and "LUER CAP". The drawing also includes measurements, such as "425±10" and "450±10", indicating the length of certain parts of the device, and "$\$2.40" which indicates the diameter of a part of the device.
Mechanism of Action
Airway structures, also called airway stenosis, are an obstruction of the trachea (airway or windpipe) due to constriction or narrowing of the passageway. Airway strictures affect an individual's ability to breathe and cough up secretions in the lungs. METIC™ - Airway Balloon Catheter goes into the airway via mouth under visualization of endoscope. Balloon is deployed at the stenosis area. Once placed to the right location balloon is than inflated using saline to desired atmospheric pressure to dilate the airway. After certain second it balloon is deflated. If required multiple dilation is performed in order to achieve desired dilation of airway.
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PRINCIPLE OF OPERATION
Metic™ Airway Balloon catheter operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end. It has a single lumen shaft. The catheter features a balloon of appropriate compliance for the clinical application, constructed from a polymer. The balloon is designed to uniformly expand to a specified diameter and length at a specific pressure as labeled, with well characterized rates of inflation and deflation and a defined burst pressure. The device generally features a type of endoscopic marker to indicate catheter position relative to the tip of quiding catheter during use.
Since the operating principles of Airway Balloon catheter and PTCA catheter are similar, the Guidance for industry & FDA staff class II special control guidance document for certain Percutaneous Transluminal coronary angioplasty (PTCA) catheters, September 8, 2010 was used for test methodology and sampling. However, the acceptance criteria are based on intended use specifications for an airway balloon and as per the predicate devices.
Technological Characteristics
Metic™ Airway Balloon Catheter Specification
| Characteristics | Specification | |
|---|---|---|
| Balloon Length (mm) | 24 mm and 40 ± 1mm | |
| Balloon Diameters (mm) | 5.00, 7.00, 9.00, 10.00, 12.00, 14.00 & 16.00 mm ± 10% at balloon Nominal pressure | |
| Balloon profile | Balloon Size | Profile |
| 5.0 X 24mm | 2.60 to 3.00 mm | |
| 7.0 X 24mm | 3.10 to 3.70 mm | |
| 9.0 X 24mm | ||
| 10.0 X 40mm | 3.80 to 4.50 mm | |
| 12.0 X 40mm | ||
| 14.0 X 40mm | ||
| 16.0 X 40mm |
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| Characteristics | Specification | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Catheter Usable Length | 425 ± 10 mm | ||||||||||||||
| Catheter Overall Length | 450 ± 10 mm | ||||||||||||||
| Balloon burst test | Actual Burst Pressure: | ||||||||||||||
| Balloon Size Burst Pressure 5.0 X 24mm ≥ 22 ATM 7.0 X 24mm 9.0 X 24mm 10.0 X 40mm 12.0 X 40mm 14.0 X 40mm 16.0 X 40mm ≥ 15 ATM | |||||||||||||||
| Balloon Diameter @ | |||||||||||||||
| Nominal Pressure (mm) | Balloon Size Nominal Pressure 5.0 X 24mm 10 ATM 7.0 X 24mm 9.0 X 24mm 10.0 X 40mm 12.0 X 40mm 14.0 X 40mm 7 ATM 16.0 X 40mm | ||||||||||||||
| Balloon Fatigue Test | Catheter shall withstand 10 cycles minimum to | ||||||||||||||
| Rated Burst Pressure | |||||||||||||||
| Balloon Size Rated Burst Pressure 5.0 X 24mm 17 ATM 7.0 X 24mm 9.0 X 24mm 10.0 X 40mm 12.0 X 40mm 10 ATM 14.0 X 40mm 16.0 X 40mm | |||||||||||||||
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| Characteristics | Specification |
|---|---|
| Balloon inflation Time | |
| (Medium – Water) | $≤$ 25 seconds |
| Balloon Deflation |