MESIRE™ - Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Device Description

The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components.

MESIRE™ Sinus Balloon Catheter
MESIRE™ Guide - Sinus Guide Catheter
MESIRE™ Illuminus Sinus Light Wire
MESIRE™ Latch Catheter Holding System

AI/ML Overview

The MESIRE™ - Balloon Sinus Dilatation System is a Class I device and the provided documentation is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study results with specific performance metrics against acceptance criteria that are typically seen for higher-risk devices or software.

Based on the provided text, the acceptance criteria and the study demonstrating the device meets them can be summarized as follows:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or reported device performance in a comparative table format. Instead, it states that "The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." It then lists various mechanical tests, biocompatibility tests, sterilization validation, and packaging/shelf life studies. The results are generally described as "demonstrated" or "complies with/meets requirements", implying successful achievement of pre-defined criteria for each test.

Category	Acceptance Criteria (Implicit from testing)	Reported Device Performance
Mechanical Tests	The device should effectively dilate the sinus and maintain structural integrity and functionality under simulated use conditions. Specific criteria for each test (e.g., maximum pressure, inflation/deflation times, bond strength, flexibility, kink resistance, absence of leakage, visual inspection standards, dimensional tolerances, burst pressure, fatigue resistance, refoldability).	"The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus." All listed mechanical tests were performed, and the device presumably met the internal specifications.
Biocompatibility	The device materials in contact with mucous membrane for < 24 hours must be safe and not cause adverse biological reactions. (Per ISO 10993-1, specific limits for cytotoxicity, sensitization, irritation/intracutaneous reactivity).	Evaluation conducted per FDA Bluebook Memorandum #G95-1 and ISO 10993-1. Cytotoxicity, Sensitization, and Irritation/Intracutaneous reactivity tests were conducted, and the device "complies with ISO 10993".
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶ and Ethylene Oxide (EtO) residuals meeting ISO 10993-7 requirements.	Validated per AAMI/ANSI/ISO 11135 with an SAL of 10⁻⁶ using the overkill (half-cycle) approach. EtO residuals met ISO 10993-7 requirements.
Packaging & Shelf Life	Package integrity maintained throughout the shelf life; product stability and functionality maintained over time. (Specific standards: ISO 11607, ASTM 1980, ASTM D 999, ASTM D 5276).	Packaging validation per ISO 11607. Shelf life validation per ASTM 1980 & ISO 11607. Transportation Study per ASTM D 999 & ASTM D 5276. Studies were conducted to ensure package integrity throughout shelf life.

2. Sample sized used for the test set and the data provenance

The document does not specify the sample sizes used for the mechanical tests, biocompatibility tests, sterilization validation, or packaging/shelf life studies. It mentions "Simulated use testing was performed" for mechanical tests, implying lab-based testing. There is no information provided regarding the provenance (country of origin, retrospective or prospective) of any data beyond what's implied by the tests being conducted by Meril Life Sciences Private Limited in India.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and therefore not provided in the document. The device is a physical surgical instrument, not an AI/ML-driven diagnostic or image analysis tool that would require expert-established ground truth for its performance evaluation. The "ground truth" here would be established by physical measurements and compliance with engineering and biological standards.

4. Adjudication method for the test set

This information is not applicable and therefore not provided in the document for the reasons stated in point 3.

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

No such study was done or reported. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and therefore not provided in the document, as the device is a physical surgical instrument and does not involve AI algorithms.

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily based on:

Engineering specifications and standards: For mechanical tests (e.g., measurements, burst pressure, material properties).
Biological standards: For biocompatibility (e.g., ISO 10993 series).
Sterilization standards: For sterility assurance (e.g., AAMI/ANSI/ISO 11135).
Packaging and shelf-life standards: For integrity and stability (e.g., ISO 11607).

These are established scientific and regulatory benchmarks, rather than expert consensus, pathology, or outcomes data in the context of clinical decision-making.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this traditional manual surgical instrument.

9. How the ground truth for the training set was established

This information is not applicable as there is no "training set" for this device.

Summary

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December 12, 2017

M/s. Meril Life Sciences Private Limited Umesh Sharma General Manager - Quality Assurance/Regulatory Affairs Survey No. 135/139, Bilakhia House, Muktanand Marg Chala, Vapi, 396191 Gujarat India

Re: K172737

Trade/Device Name: MESIRE™ - Balloon Sinus Dilatation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: September 7, 2017 Received: September 11, 2017

Dear Umesh Sharma:

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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 medical devices and radiation-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 yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172737

Device Name

MESIRE(TM) - Balloon Sinus Dilatation System

Indications for Use (Describe)

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) Summary

Submitter l.

M/s. Meril Life Sciences Private Limited Survey No. 135/139, Bilakhia House, Muktanand Marq, Chala, Vapi – 396191 Gujarat, India. Tel. No: +91-260-3052100, Fax: +91-260-3052125 E-mail: umesh.sharma@merillife.com Web site: www.merillife.com

Contact Person: Umesh Sharma Date Prepared: November 20th, 2017

II. Device

TradeProprietaryName	/ RegulatoryClass	Product Code	RegulationNumber	Review Panel
MESIRE™Balloon SinusDilatationSystem	I	LRC	21 CFR874.4420	Ear, Nose, andThroat ManualSurgicalInstrument

III. Predicate Device

Relieva Solo Elite™ Sinus Balloon Catheter (510k no. K111254) .
Relieva Ultirra™ Nav Sinus Balloon Catheter (510k no. K161698) .

IV. Device Description

The MESIRE™ - Balloon Sinus Dilatation System consists of following components. It is available as an integrated system or individual components.

MESIRE™ Sinus Balloon Catheter 1.
1. MESIRE™ Guide - Sinus Guide Catheter
MESIRE™ Illuminus Sinus Light Wire 3.
MESIRE™ Latch Catheter Holding System 4.

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1. MESIRE™ Sinus Balloon Catheter

MESIRE™ Sinus Balloon Catheter is an "Over the Wire" type catheter with an integrated shaft system and a low profile Pebax balloon (dilatation element) which is bonded distally to the inner lumen and proximally to outer lumen with distal shaft. The system has dual lumen one lumen is used for inflation of the balloon with saline, and second provides passage of sinus light wire to facilitated advancement of the sinus balloon catheter to the target.

The proximal end of inner lumen is assembled to a Luer hub at its proximal end. The distal shaft, hypo tube, strain relief (protect from bending and kinking) are bonded to the hub from the proximal end of the hub respectively. The main port of Hub permits the use of guide wire and Lateral port for balloon inflation / deflation. Three distal endoscopic markers present on the distal shaft of the Sinus balloon catheter helps in accurate positioning of the balloon under endoscopy.

Three proximal shaft markers present on the hypo tube helps in positioning the Sinus balloon catheter with respect to Sinus Guide catheter. The first proximal shaft marker at distal end on hypo tube indicated that the tip of the Sinus balloon catheter is in the straight section of the sinus guide catheter. Second and third proximal shaft markers on hypo tube correspond to the exit of the balloon from the sinus guide catheter.

2. MESIRE™ Guide - Sinus Guide Catheter

The MESIRE™ Guide - Sinus Guide Catheter consists of a distal angled tip, a SS shaft and a proximal luer hub. A blue marker tip allows endoscopic visualization. The shaft consists of a stainless steel tube and a lubricious PTFE inner liner. Tip angle is mentioned on color band. The Luer hub allows for flushing of the device before use.

The MESIRE™ Guide - Sinus Guide Catheter is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.

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3. MESIRE™ IIIuminus – Sinus Light Wire

The MESIRE™ Illuminus – Sinus Light Wire-is 0.83 mm compatible flexible light wire that transmits light from the proximal to distal tip. The MESIRE™ Illuminus - Sinus Light Wire consists of a light guide cable connector, Stainless steel coil wire, fiber optic cable and a distal and proximal light lens. The light guide cable connector is an universal connector and it is to be attached with light cable (Available with Health care facility) and light cable is further connected with light source (Available with Health care facility). When light source is put on the proximal light lens will pass the light through and distal light lens will illuminate.

The MESIRE™ Illuminus – Sinus Light Wire is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.

MESIRE™ Latch - Catheter Holding System 4.

The MESIRE™ Latch - Catheter Holding System is attached to the proximal end of sinus guide catheter. The projection of Catheter Holding System to the sinus guide catheter provides an augmentation to the users to sustain the position of Sinus quide catheter. MESIRE™ Latch - Catheter Holding System is compatible with minimum Sinus quide catheter ID 2.50mm

The MESIRE™ Latch - Catheter Holding System is intended to provide an augmentation to sinus guide catheter.

V. Intended Use

MESIRE™ – Balloon Sinus Dilatation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.

For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

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VI. Substantial Equivalence

The MESIRE™ – Balloon Sinus Dilatation System is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics. The MESIRE™ -Sinus Balloon catheter operates on the same principle as predicate devices i.e. hydraulic pressurization applied through an inflatable balloon attached to the distal end.

Comparison Chart of MESIRE™ – Balloon Sinus Dilatation System and Predicate devices

Characteristics	Subject Device	Predicate Device
Device Name	Mesire™ BalloonSinus dilatationSystem	Relieva SoloElite™ SinusBalloon Catheter	Relieva Ultirra™Nav SinusBalloon Catheter
510 (K) Number	K172737	K111254	K161698
Manufacturer	Meril LifeSciences Pvt.Ltd., India	Acclarent Inc.	Acclarent Inc.
Common Name	Sinus BalloonDilation System	Sinus BalloonDilation System	Sinus BalloonDilation System
Class	I	I	I
Product Code	LRC	LRC	LRC
RegulationNumber	21 CFR874.4420	21 CFR874.4420	21 CFR874.4420
Single PatientUse	Yes	Yes	Yes
Direct PatientContact	Yes	Yes	Yes
Principles ofOperation	Hydraulicpressurizationapplied throughan inflatable	Hydraulicpressurizationapplied throughan inflatable	Hydraulicpressurizationapplied throughan inflatable
	balloon	balloon	balloon
Balloon Diameter	5mm, , 6mm,7mm	3.5mm, 6mm,7mm	5mm
Balloon Length	17mm	16mm	16mm
Working Length	256mm	245 mm	245 mm
Maximum InflationPressure	13-14 ATM	12 ATM	12 ATM
Flexible Shaft	Yes	Yes	Yes
Indications forUse	Dilation of SinusTissue	Dilation of SinusTissue	Dilation of SinusTissue
TechnologicalCharacteristics	Enables dilationof sinus ostia	Enables dilationof sinus ostiawith addedcapability ofirrigating thesinuses.	Allows fordilation of sinusostia and EMNavigation
Use a SinusGuide for Accessinto TargetedAnatomy	Yes	Yes	Yes
GuidewireCompatibility withSinus IlluminationSystem	Yes0.89 mm (0.035")	Yes0.035"	Yes0.035"
Sterilisation	Ethylene Oxide	Ethylene Oxide	Ethylene Oxide
Biocompatibility	Complies withISO 10993	Complies withISO 10993	Complies withISO 10993

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510(k) K172737

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VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Mechanical Tests

Simulated use testing was performed utilizing the Mesire™ Balloon Sinus dilatation System components. The following testing demonstrated that Mesire™ Balloon Sinus dilatation System effectively dilated the sinus.

Visual Inspection .
Dimensional Measurement .
. Balloon Burst and Balloon Compliance
. Balloon Fatigue
. Inflation and Deflation Time
Refoldability ●
Catheter Bond Strength .
Flexibility and Kink .
Freedom from leakage

Biocompatibility

The biocompatibility evaluation for Mesire™ Balloon Sinus dilatation System was conducted in accordance with FDA Bluebook Memorandum #G95-1 "Use of International standard ISO 10993, under biological evaluation of medical devices Part 1: Evaluation and testing" May 1, 1995, and International Standards ISO 10993-1 "Biological evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process" as recognized by FDA.

As per ISO 10993-1, MESIRE™ Balloon Sinus Dilatation System is a surface contacting device having contact with mucous membrane for < 24 hours. Accordingly, following biological evaluation tests were conducted:

1. Cytotoxicity
1. Sensitization
1. Irritation / Intracutaneous reactivity

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Sterilisation

The sterilization process has been validated per AAMI/ANSI/ISO 11135 and demonstrated a sterility assurance level of 10°. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7 requirements.

Packaging & Shelf life

Following packaging and shelf life study was conducted to ensure package integrity throughout the shelf life.

. Packaging validation as per ISO 11607
. Shelf life validation as per ASTM 1980 & ISO 11607
. Transportation Study as per ASTM D 999 & ASTM D 5276

VIII. Conclusion

MESIRE™ – Balloon Sinus Dilatation System is substantially equivalent to currently marketed devices and presents no substantial differences in design, intended use, function and technological characteristics to predicate device. The Mechanical, Biocompatibility, Sterilisation, Packaging and Shelf life study conducted on MESIRE™ – Balloon Sinus Dilatation System demonstrated its safety, efficacy and equivalence with the predicate device.

Hence. MESIRE™ - Balloon Sinus Dilatation System will perform as intended and specified use conditions.

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.