(147 days)
METIC™ – Airway Balloon Catheter is intended to dilate strictures of the airway.
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.
The document describes the acceptance criteria and performance of the METIC™ Airway Balloon Catheter, but it does not involve a study based on artificial intelligence or machine learning. Instead, it describes laboratory and bench testing for a physical medical device. Therefore, several sections of your requested output, which are relevant to AI/ML studies, cannot be extracted from this document, as they are not applicable.
Here's the information that can be extracted relevant to the physical device's performance and testing:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Balloon Length | 24 mm and 40 ± 1mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Diameters | 5.00, 7.00, 9.00, 10.00, 12.00, 14.00 & 16.00 mm ± 10% at balloon Nominal pressure | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Profile | 5.0 X 24mm: 2.60 to 3.00 mm 7.0 X 24mm: 3.10 to 3.70 mm 10.0 X 40mm: 3.80 to 4.50 mm (Other sizes unspecified for profile) | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Catheter Usable Length | 425 ± 10 mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Catheter Overall Length | 450 ± 10 mm | Not explicitly reported as "Reported Device Performance" in a separate column, but implied to meet specification as part of "Technological Characteristics" and deemed "as safe and as effective as the predicate device" in the conclusion. |
| Balloon Burst Test | Actual Burst Pressure: 5.0 X 24mm: ≥ 22 ATM 7.0 X 24mm: ≥ 22 ATM 9.0 X 24mm: ≥ 22 ATM 10.0 X 40mm: ≥ 15 ATM 12.0 X 40mm: ≥ 15 ATM 14.0 X 40mm: ≥ 15 ATM 16.0 X 40mm: ≥ 15 ATM | "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 document then states in the conclusion: "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." Indicating these tests met the criteria. |
| Balloon Diameter @ Nominal Pressure | 5.0 X 24mm: 10 ATM 7.0 X 24mm: 10 ATM 9.0 X 24mm: 10 ATM 10.0 X 40mm: 7 ATM 12.0 X 40mm: 7 ATM 14.0 X 40mm: 7 ATM 16.0 X 40mm: 7 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Fatigue Test | Catheter shall withstand 10 cycles minimum to Rated Burst Pressure Rated Burst Pressure: 5.0 X 24mm: 17 ATM 7.0 X 24mm: 17 ATM 9.0 X 24mm: 17 ATM 10.0 X 40mm: 10 ATM 12.0 X 40mm: 10 ATM 14.0 X 40mm: 10 ATM 16.0 X 40mm: 10 ATM | (See above for general statement on performance evaluation and conclusion) |
| Balloon Inflation Time | ≤ 25 seconds | (See above for general statement on performance evaluation and conclusion) |
| Balloon Deflation Time | < 10 seconds | (See above for general statement on performance evaluation and conclusion) |
| Balloon Refoldability Test | Minimum 3 pleats should appear when looked from the tip after balloon inflation & Deflation up to 10 cycles at Nominal Pressure. | (See above for general statement on performance evaluation and conclusion) |
| Biocompatibility | Complies with ISO 10993 | The document states: "Biological evaluation of Metic™ Airway Balloon Catheter as per Use of International Standard ISO 10993-1..." and the conclusion states "biocompatibility...demonstrated the device is as safe and as effective as the predicate device." |
| Sterilization | Sterilized by Ethylene Oxide, SAL = 10^-6, EO residuals < 4mg/device, Ethylene Chlorhydrin < 9mg/device | The document states: "Metic™ Airway Balloon Catheter is sterilized by traditional Ethylene Oxide sterilization methods... The Ethylene Oxide sterilization process is validated as per ANSI /AAMI/ ISO 11135-1...SAL = 10^-6", and lists the residual levels. The conclusion states "sterilization...demonstrated the device is as safe and as effective as the predicate device." |
| Shelf-life | Proposed shelf life of 5 years (supported by accelerated and 2-year real-time study) | "The real time shelf time study for 2 years has been completed. The result of elevated temperature and real-time study has not shown any significant changes in product characteristics." The conclusion states "shelf life study...demonstrated the device is as safe and as effective as the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify exact sample sizes for each mechanical or physical test (e.g., how many balloons were tested for burst pressure). It generally states that "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." This implies that industry-standard sampling methods for medical devices were followed.
Data Provenance: The testing was performed by M/s. Meril Life Sciences Private Limited, located in Vapi, Gujarat, India. This is retrospective data from internal testing of the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is applicable to studies where human expert judgment is used to label data for an AI/ML system. Since this document describes the testing of a physical medical device (a balloon catheter), not an AI/ML system, this information is not applicable. Ground truth for the device's performance is established by metrological measurements, physical and mechanical tests, and compliance with material and biological standards, not by expert consensus on clinical data.
4. Adjudication Method for the Test Set
This question is applicable to studies involving human reviewers or evaluators, often in AI/ML performance assessment. Since this document is about the physical testing of a medical device, this information is not applicable. Device performance is measured against predefined specifications and standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is specifically for AI/ML studies assessing changes in human performance with AI assistance. This document describes the physical testing of a medical device, not an AI/ML system. Therefore, this information is not applicable. The device's safety and effectiveness were established through bench testing and comparison to predicate devices, not through a clinical study involving human readers or AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question refers to the performance of an AI algorithm without human interaction. Since this document is about the physical testing of a medical device, this information is not applicable. The device itself is a physical tool, not an algorithm.
7. The Type of Ground Truth Used
For the physical device, the "ground truth" for its performance is established by:
- Direct measurements: Dimensional measurements, inflation/deflation times.
- Physical and mechanical tests: Balloon burst pressure, fatigue resistance, bond strength, flexibility, kink resistance, torquability.
- Chemical and biological tests: Biocompatibility (cytotoxicity, irritation, sensitization), ethylene oxide residuals.
- Compliance with established standards: ISO and AAMI standards for manufacturing, sterilization, and biocompatibility.
There is no "expert consensus," "pathology," or "outcomes data" specifically used as ground truth for these engineering performance tests.
8. The Sample Size for the Training Set
This question is applicable to AI/ML studies. Since this document describes the physical testing of a medical device, this information is not applicable. There is no "training set" in the context of this device's development and testing.
9. How the Ground Truth for the Training Set Was Established
This question is applicable to AI/ML studies. Since this document describes the physical testing of a medical device, this information is not applicable. There is no "training set" or "ground truth for a training set" in the context of this device's development and testing.
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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"
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(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
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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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™ – AirwayBalloon Catheter | Inspira Air® BalloonDilation System(Primary Predicate) | Acclarent Inc. | K090660 |
| Aeris® Balloon DilationCatheter(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 toRated 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 | < 10 seconds |
| Balloon Refoldability Test | Minimum 3 pleats should appear when lookedfrom the tip after balloon inflation & Deflationup to 10 cycles at Nominal Pressure. |
Patient contacting material
| Component name | Material ofConstruction | Unique materialIdentifier | PatientContact |
|---|---|---|---|
| METIC™ Airway Balloon Catheter | |||
| Balloon | Nylon 12 | Vestamid care ML21 | Yes |
| Catheter tubing | Polyether blockamide | Pebax 72 D | Yes |
| Stylet | Stainless Steel | SS304V | No |
| Catheter Hub | Polycarbonate | - | No |
Contact classification as per ISO 10993-1
| Device Name | Category | Contact | Contact Duration |
|---|---|---|---|
| METIC™ AirwayBalloon Catheter | Surfacecontacting | Mucosalmembranes | A – Limited Exposure< 24 H |
Clinical Study Results
Not applicable. Based on the substantial equivalence discussion and the testing results from bench tests, it was determined that a clinical study was not required to demonstrate substantial equivalence with the predicate devices.
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Substantial Equivalence
The Metic™ Airway Balloon Catheter is substantially equivalent with the predicate devices contained in the following table.
| Characteristics | Subject Device | Predicate Device | Safety /Effectiveness | |
|---|---|---|---|---|
| Device Name | Metic™ AirwayBalloon Catheter | Inspira Air® BalloonDilation System(510K no. K090660)Primary Predicate | Aeris® Balloon DilationCatheter(510K no. K150951)Second Predicate | - |
| Manufacturer | Meril Life SciencesPvt. Ltd., India | Acclarent Inc. | Bryan Medical Inc. | - |
| Common Name | Airway BalloonCatheter | Airway BalloonCatheter | Balloon DilationCatheter | Same |
| Class | II | II | II | Same |
| Product Code | KTI | KTI | KTI | Same |
| Regulation Number | 21 CFR 874.4680 | 21 CFR 874.4680 | 21 CFR 874.4680 | Same |
| Single Patient Use | Yes | Yes | Yes | Same |
| Direct Patient Contact | Yes | Yes | Yes | Same |
| Balloon Diameter (mm) | 5.0,7.0, 9.0,10.0,12.0,14.0,16.0 | 5.0,7.0, 8.5,10.0,12.0,14.0,16.0 | 5.0,7.0, 8.0, 9.0,10.0,12.0,14.0,16.0 | Same |
| Balloon Length (mm) | 24 ± 1 mm | 24 ± 1 mm | 30 ± 1 mm | Same |
| 40 ± 1 mm | 40 ± 1 mm | 40 ± 1 mm | Same | |
| Characteristics | Subject Device | Predicate Device | Predicate Device | Safety /Effectiveness |
| Maximum InflationPressure | 10-17 ATM | 8 – 16 ATM | 10 & 17 ATM | Inflation pressurerange is within therange of predicatedevice. |
| Flexible Shaft | Yes | Yes | Yes | Same |
| Indications for Use | The MeticTM AirwayBalloon Catheter is aninstrument intended todilate strictures of theairway. | The Inspira AIR®Balloon DilationSystem is aninstrument intended todilate strictures of theairway tree. | Aeris® Airway BalloonDilation Catheter isintended for use inadult and pediatricpopulations to dilatestrictures of the airwaytree. | Same |
| TechnologicalCharacteristics | Enables dilation ofairway Strictures | Enables dilation ofairway Strictures | Enables dilation ofairway strictures | Same |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Same |
| Packaging | Thermoformed tray inpouch | Thermoformed tray inpouch | Thermoformed tray inpouch | Same |
| Labelled as non-pyrogenic? | No | No | No | Same |
| Principles of Operation | Hydraulic pressurizationapplied through aninflatable balloon | Hydraulic pressurizationapplied through aninflatable balloon | Hydraulic pressurizationapplied through aninflatable balloon | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Complies with ISO10993 | Same |
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Labelling
The Labels and IFUs of Metic™ Airway Balloon Catheter are in accordance with complies with requirements of 21 CFR 801.109 and ISO 15223 - 1: Medical Devices -Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
Sterilization
Metic™ Airway Balloon Catheter is sterilized by traditional Ethylene Oxide sterilization methods as described in Sterility Review Guidance K90-1.
Method followed for Ethylene Oxide sterilization is as per ANSI /AAMI/ISO 11135 (Sterilization of health care products – Ethylene Oxide - Part 1 (Requirements for development, validation and routine control of a sterilization process for medical devices).
The Ethylene Oxide sterilization process is validated as per ANSI /AAMI/ ISO 11135-1 Sterilization of health care products – Ethylene Oxide - Part 1 (Requirements for development, validation and routine control of a sterilization process for medical devices), Method C (Overkill Method: This method is based on demonstrating that the sterilization of a microbial challenge (biological indicator) exceeds the challenge posed by the bioburden of the product. This method is commonly used to demonstrate total inactivation of a 106 Bl at a half-cycle exposure time. When exposure time is doubled, a minimum 12 SLR is delivered during EO exposure).
SAL = 10-6
Ethylene Oxide residuals remaining on the device is in accordance with ISO 10993-7: Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals" for ethylene oxide and ethylene chlorohydrin
The maximum residual levels after EO sterilization are as under.
-
- Ethylene Oxide < 4mg/device
-
- Ethylene Chlorhydrin < 9mg/device
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Packaging
Metic™ Airway Balloon Catheter is supplied sterile. The components are packed in below packaging configuration. The Sterile barrier packaging is designed to maintain sterility and permit fast and easy opening in a single peel.
Metic™ Airway Balloon Catheter is available as an integrated System.
Packaging Confiquration
| S. N. | Component | Sterile barrier | Secondary Packaging |
|---|---|---|---|
| 1. | MeticTM AirwayBalloon Catheter | Thermoformed traysealed with Tyvek lid | Cardboard carton alongwith “Instruction for use” |
Shelf-life
The proposed shelf life of Metic™ Airway Balloon Catheter is 5 years. The shelf life study for Metic™ Airway Balloon Catheter was planned as per ASTM 1980 recommended conditions. The study was conducted with elevated temperature condition and with real time conditions. As per ASTM 1980 following conditions were used to establish the shelf life of the Metic™ Airway Balloon Catheter.
The real time shelf time study for 2 years has been completed. The result of elevated temperature and real-time study has not shown any significant changes in product characteristics.
Test Conditions
| Study | Storage Conditions | Time period |
|---|---|---|
| Metic™ Airway Balloon Catheter | ||
| Accelerated | 40 ± 2°C / 75 ± 5 % RH | 457 days |
| Long term | 30 ± 2°C / 65 ± 5 % RH | 60 months |
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Biocompatibility study
Biological evaluation of Metic™ Airway Balloon Catheter as per Use of International Standard ISO 10993-1 ("Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". (September 8, 2023). Guidance for Industry and Food and Drug Administration Staff)
Performance
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 were based on the intended use specifications for an airway balloon and as per the predicate devices.
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
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Conclusion
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.
Hence, METIC™ - Airway Balloon Catheter is substantially equivalent to currently marketed devices having the same intended use and similar materials and performance and will perform as intended in the specified use conditions.
Compliance with Voluntary Standards
The Metic™ Airway Balloon Catheter comply with the following standards:
- ISO 14971: 2019, Medical devices Application of risk management to medical devices.
- ISO 11607-1:2020, Packaging for terminally Sterilized Medical Devices Part 1: . Packaging For Terminally Sterilized Medical Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
- · ISO 11135: 2014, Sterilization of Health-Care Products Ethylene Oxide -Requirements for the Development, Validation and Routine Control of Sterilization Process for Medical Devices. Second Edition, 2014-07-09
- · ISO 10993-1: 2018, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process. 2014-07-09
- . ISO 10993-7 Second Edition 2008-10-15. Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals
- AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical . Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Fifth Edition 2021, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And Skin Sensitization.
§ 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.