(92 days)
Not Found
No
The 510(k) summary describes a mechanical balloon dilation system and does not mention any AI/ML components or capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device 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," directly indicating its therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "diagnostic and therapeutic procedures."
No
The device description explicitly lists multiple hardware components (Balloon Catheter, Guide Catheter, Light Wire, Catheter Holding System) and the performance studies focus on mechanical, biocompatibility, sterilization, packaging, and shelf life testing of these physical components.
Based on the provided information, the MESIRE™ - Balloon Sinus Dilatation System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "access the sinus space and to dilate the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The components listed are all instruments used for a surgical or interventional procedure (catheters, light wire, holding system). These are not reagents, analyzers, or other components typically associated with IVD testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MESIRE™ system is a medical device used for a procedural intervention within the body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LRC
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sinus space, paranasal sinus cavities, maxillary sinus
Indicated Patient Age Range
all ages, specifically mentioning "For children aged 17 and under"
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)
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
§ 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.
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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)
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.
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
| Trade
Proprietary
Name | / Regulatory
Class | Product Code | Regulation
Number | Review Panel |
|--------------------------------------------------|-----------------------|--------------|----------------------|-----------------------------------------------------------|
| MESIRE™
Balloon Sinus
Dilatation
System | I | LRC | 21 CFR
874.4420 | Ear, Nose, and
Throat Manual
Surgical
Instrument |
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.
-
- 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™ Balloon | ||
| Sinus dilatation | |||
| System | Relieva Solo | ||
| Elite™ Sinus | |||
| Balloon Catheter | Relieva Ultirra™ | ||
| Nav Sinus | |||
| Balloon Catheter | |||
| 510 (K) Number | K172737 | K111254 | K161698 |
| Manufacturer | Meril Life | ||
| Sciences Pvt. | |||
| Ltd., India | Acclarent Inc. | Acclarent Inc. | |
| Common Name | Sinus Balloon | ||
| Dilation System | Sinus Balloon | ||
| Dilation System | Sinus Balloon | ||
| Dilation System | |||
| Class | I | I | I |
| Product Code | LRC | LRC | LRC |
| Regulation | |||
| Number | 21 CFR | ||
| 874.4420 | 21 CFR | ||
| 874.4420 | 21 CFR | ||
| 874.4420 | |||
| Single Patient | |||
| Use | Yes | Yes | Yes |
| Direct Patient | |||
| Contact | Yes | Yes | Yes |
| Principles of | |||
| Operation | Hydraulic | ||
| pressurization | |||
| applied through | |||
| an inflatable | Hydraulic | ||
| pressurization | |||
| applied through | |||
| an inflatable | Hydraulic | ||
| pressurization | |||
| applied through | |||
| an 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 Inflation | |||
| Pressure | 13-14 ATM | 12 ATM | 12 ATM |
| Flexible Shaft | Yes | Yes | Yes |
| Indications for | |||
| Use | Dilation of Sinus | ||
| Tissue | Dilation of Sinus | ||
| Tissue | Dilation of Sinus | ||
| Tissue | |||
| Technological | |||
| Characteristics | Enables dilation | ||
| of sinus ostia | Enables dilation | ||
| of sinus ostia | |||
| with added | |||
| capability of | |||
| irrigating the | |||
| sinuses. | Allows for | ||
| dilation of sinus | |||
| ostia and EM | |||
| Navigation | |||
| Use a Sinus | |||
| Guide for Access | |||
| into Targeted | |||
| Anatomy | Yes | Yes | Yes |
| Guidewire | |||
| Compatibility with | |||
| Sinus Illumination | |||
| System | Yes | ||
| 0.89 mm (0.035") | Yes | ||
| 0.035" | Yes | ||
| 0.035" | |||
| Sterilisation | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Biocompatibility | Complies with | ||
| ISO 10993 | Complies with | ||
| ISO 10993 | Complies with | ||
| ISO 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