(62 days)
Not Found
No
The summary describes a mechanical device for tube insertion and does not mention any AI/ML components or image processing.
No
A therapeutic device is one that treats or heals a disease or condition. This device is a delivery system for a tympanostomy tube and creates a myringotomy, which are procedural steps, but the device itself does not provide therapy. The therapy would be provided by the tympanostomy tube itself in functioning to ventilate the middle ear.
No
The device is described as a "Delivery System" that "penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube." Its purpose is to create a myringotomy and insert a tube, which are interventional procedures, not diagnostic ones.
No
The device description explicitly states it is a "device that penetrates the tympanic membrane and inserts the Grommet type tympanostomy tube with a button controlled activation," indicating a physical, hardware-based device. Performance studies also mention bench verification testing and sterilization validation, which are typical for hardware medical devices.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Tula Tube Delivery System is a surgical device used to physically penetrate the tympanic membrane and insert a tube. It directly interacts with the patient's body during a procedure.
- Intended Use: The intended use clearly describes a surgical procedure (creating a myringotomy and inserting a tube), not a diagnostic test performed on a sample.
The information provided describes a surgical instrument, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The Tula Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Grommet type tympanostomy tube.
Product codes
ETD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane
Indicated Patient Age Range
Not Found
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)
Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance characteristics. The testing 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 per ISO 11135:2014 - "Sterilization of Health Care Products-Ethylene Oxide: Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The method used for sterilization validation is the overkill (half-cycle approach) in a fixed chamber method per Annex B of ISO 11135:2014.
Biocompatibility evaluation and testing conducted gave acceptable results per ISO 10993-1 and FDA Bluebook Memorandum G95-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other to form a single, abstract figure.
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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Image /page/2/Picture/0 description: The image shows the logo for Tusker Medical. The logo features a stylized origami elephant in brown and white, followed by the word "TUSKER" in bold, black letters. Below "TUSKER" is the word "MEDICAL" in a smaller, gray font. Underneath the logo is the text "TULA Tube Delivery System".
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 a |
| myringotomy with insertion of a preloaded Grommet type tympanostomy | |
| tube. |
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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Image /page/3/Picture/0 description: The image shows the text "Special 510(k) Premarket Notification". The text is written in a simple, sans-serif font and is centered on the image. The text is likely a title or heading for a document or presentation related to medical device regulation.
510(k) SUMMARY
| Sponsor/Submitter: | Tusker Medical
155 Jefferson Drive, Suite 200
Menlo Park, California 94025 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Pavan Sethi, Ph.D.
Director, Regulatory Affairs
Phone: (408) 513-7529
Fax: (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 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. |
| Indications for Use: | The Tula Tube Delivery System is intended to provide a means to create a
myringotomy with insertion of a preloaded Grommet type tympanostomy
tube. |
| Technological
Characteristics: | Tula Tube Delivery System is composed of four concentric components that
cut, dilate, shield and stabilize. The cutter creates the myringotomy. The
dilator opens the incision while the shield introduces the tympanostomy tube
through the myringotomy. The subject device is identical to the predicate
device in method of operation, materials and intended use. The aspects of the
device that control the tympanostomy tube delivery (Cutter, Dilator, Shield,
Plunger, Clear Tip, Outer Tube) are unchanged between the subject and
predicate device. |
| | The main differences in technological characteristics are: the modified device
will be pre-loaded with a Grommet style tympanostomy tube instead of a
Paparella style tympanostomy tube, and the Tube Delivery System is slightly
modified to accommodate and implant a Grommet type tympanostomy tube.
These differences in technological characteristics do not raise different
questions of safety and effectiveness than the predicate and do not render this
device Not Substantially Equivalent (NSE). |
| Performance Data: | Bench verification testing was conducted to verify that the modified device
meets the design inputs and intended performance characteristics. The
testing 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 per
ISO 11135:2014 - "Sterilization of Health Care Products-Ethylene Oxide:
Requirements for Development, Validation, and Routine Control of a
Sterilization Process for Medical Devices". The method used for sterilization
validation is the overkill (half-cycle approach) in a fixed chamber method per
Annex B of ISO 11135:2014. |
| | Biocompatibility evaluation and testing conducted gave acceptable
results per ISO 10993-1 and FDA Bluebook Memorandum G95-1. |
| Summary of
Substantial
Equivalence: | The subject device TULA Tube Delivery System is substantially equivalent
to the predicate device in indication for use, performance, fundamental
scientific technology, safety and effectiveness. |
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Image /page/4/Picture/1 description: The image contains the logo for Tusker Medical. The logo features a stylized origami elephant in shades of gray, followed by the text "TUSKER" in bold, black letters. Below "TUSKER" is the word "MEDICAL" in a smaller, gray font. Underneath the logo is the text "TULA Tube Delivery System" in a serif font.