(62 days)
The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.
The Tula Tube Delivery System (TDS) is a device that penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube with a button controlled activation. It is intended to provide a means to create a myringotomy with insertion of a preloaded grommet type tympanostomy tube.
This document describes the TULA Tube Delivery System, a medical device intended to create a myringotomy and insert a tympanostomy tube. The document is primarily a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to a predicate device. As such, it does not contain information related to software performance, AI algorithms, or clinical study results with acceptance criteria typical for AI/ML devices.
The provided text focuses on the device's mechanical functions, sterilization, and biocompatibility, which are assessed through bench verification testing. Therefore, I cannot generate the requested table and information about acceptance criteria, study design, and AI performance from the given text.
The information provided pertains to the regulatory clearance of a physical medical device, not a diagnostic AI system.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993 - 0002
June 28, 2017
Tusker Medical Pavan Sethi Director. Regulatory Affairs 155 Jefferson Drive Suite 200 Menlo Park, California 94025
Re: K171239
Trade/Device Name: TULA Tube Delivery System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: June 1. 2017 Received: June 2, 2017
Dear Pavan Sethi:
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.
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
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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Eric A. Mann -S
for Malvina 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): | K171239 |
|---|---|
| Trade Name: | TULA® Tube Delivery System |
| Common Name: | Tympanostomy Tube and Tympanostomy Tube Delivery System |
| Indications For Use: | The Tula Tube Delivery System is intended to provide a means to create amyringotomy with insertion of a preloaded Grommet type tympanostomytube. |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) SUMMARY
| Sponsor/Submitter: | Tusker Medical155 Jefferson Drive, Suite 200Menlo Park, California 94025 |
|---|---|
| Contact Person: | Pavan Sethi, Ph.D.Director, Regulatory AffairsPhone: (408) 513-7529Fax: (650) 223-6769 |
| Date of Submission: | April 26, 2017 |
| Device Trade Name: | TULA® Tube Delivery System |
| Common Name: | Tympanostomy Tube and Tympanostomy Tube Delivery System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 874.3880 |
| Classification Name: | Tube, Tympanostomy |
| Product Code: | ETD |
| Predicate Device: | Tympanostomy Tube Delivery System (K103595) |
| Device Description: | The Tula Tube Delivery System (TDS) is a device that penetrates thetympanic membrane and inserts the Grommet type tympanostomy tube witha button controlled activation. It is intended to provide a means to create amyringotomy with insertion of a preloaded grommet type tympanostomytube. |
| Indications for Use: | The Tula Tube Delivery System is intended to provide a means to create amyringotomy with insertion of a preloaded Grommet type tympanostomytube. |
| TechnologicalCharacteristics: | Tula Tube Delivery System is composed of four concentric components thatcut, dilate, shield and stabilize. The cutter creates the myringotomy. Thedilator opens the incision while the shield introduces the tympanostomy tubethrough the myringotomy. The subject device is identical to the predicatedevice in method of operation, materials and intended use. The aspects of thedevice that control the tympanostomy tube delivery (Cutter, Dilator, Shield,Plunger, Clear Tip, Outer Tube) are unchanged between the subject andpredicate device. |
| The main differences in technological characteristics are: the modified devicewill be pre-loaded with a Grommet style tympanostomy tube instead of aPaparella style tympanostomy tube, and the Tube Delivery System is slightlymodified to accommodate and implant a Grommet type tympanostomy tube.These differences in technological characteristics do not raise differentquestions of safety and effectiveness than the predicate and do not render thisdevice Not Substantially Equivalent (NSE). | |
| Performance Data: | Bench verification testing was conducted to verify that the modified devicemeets the design inputs and intended performance characteristics. Thetesting included tube deployment test, tube deployment time upon actuation,hearing safety test, loudness discomfort level and diameteral interference. |
| Sterilization of the modified TULA Tube Delivery System is validated perISO 11135:2014 - "Sterilization of Health Care Products-Ethylene Oxide:Requirements for Development, Validation, and Routine Control of aSterilization Process for Medical Devices". The method used for sterilizationvalidation is the overkill (half-cycle approach) in a fixed chamber method perAnnex B of ISO 11135:2014. | |
| Biocompatibility evaluation and testing conducted gave acceptableresults per ISO 10993-1 and FDA Bluebook Memorandum G95-1. | |
| Summary ofSubstantialEquivalence: | The subject device TULA Tube Delivery System is substantially equivalentto the predicate device in indication for use, performance, fundamentalscientific technology, safety and effectiveness. |
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§ 874.3880 Tympanostomy tube.
(a)
Identification. A tympanostomy tube is a device that is intended to be implanted for ventilation or drainage of the middle ear. The device is inserted through the tympanic membrane to permit a free exchange of air between the outer ear and middle ear. A type of tympanostomy tube known as the malleous clip tube attaches to the malleous to provide middle ear ventilation. The device is made of materials such as polytetrafluoroethylene, polyethylene, silicon elastomer, or porous polyethylene.(b)
Classification. Class II.