PRECEPTIS TYMPANOSTOMY TUBE INSERTER

K133921 · Preceptis Medical · ETD · Aug 22, 2014 · Ear, Nose, Throat

Device Facts

• Record ID: K133921
• Device Name: PRECEPTIS TYMPANOSTOMY TUBE INSERTER
• Applicant: Preceptis Medical
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Aug 22, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.

Device Story

Manual, single-use surgical instrument for myringotomy and tympanostomy tube placement; comprises handle with removable tip assemblies containing preloaded ventilation tube and sharpened sheath. User manually advances sheath to create myringotomy; positions tube; retracts sheath via handle actuator to release tube into tympanic membrane. Used by surgeons under direct visualization; enables myringotomy and tube placement in single surgical pass; reduces surgical trauma. Suitable for bilateral procedures via interchangeable tip assemblies.

Clinical Evidence

Prospective, multicenter clinical study of 50 ears in 25 pediatric patients (mean age 2.6 years). 100% success rate in tube delivery. 80% of procedures performed using only the device; 20% required minor adjustment with auxiliary tools. 100% tube retention at 15-60 days post-surgery. No safety issues identified.

Technological Characteristics

Manual surgical instrument; single-use; sterile. Combines myringotomy, tube positioning, and suction functions. Features handle with removable tip assemblies, positioning rod, and sharpened sheath. Mechanical actuation via manual scroll on handle. No electronic components or software.

Indications for Use

Indicated for patients undergoing tympanostomy tube insertion procedures.

Regulatory Classification

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.

Predicate Devices

• Heinz Kurz Trocar Ventilation Tube (K071150)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2014

Preceptis Medical % Mr. Keith Leland VP of Research and Development 505 Highwav 169 North, #365 Plymouth, MN 55441

Re: K133921

> Trade/Device Name: Preceptis Tympanostomy Tube System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: II Product Code: ETD Dated: July 21, 2014 Received: July 22, 2014

Dear Mr. Leland,

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 (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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Tina Kiang -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): K133921

Device Name: Preceptis Tympanostomy Tube System

Indications For Use:

The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.

X___ 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Srinivas Nandkumar - S Sriniyas Nandkumar -S 2014.0

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## Table 1. Updated 510(k) Summary

| Submitter<br>Information: | Preceptis Medical, Inc.<br>505 Highway 169 North, #365<br>Plymouth, MN 55441<br>763.568.7819 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Keith Leland, VP of R&D |
| Date Prepared: | 21 July 2014 |
| Trade Name | Hummingbird TTS |
| Product Code | ETD (21 CFR Part 874.3880) |
| Common Name | Preceptis Tympanostomy Tube System |
| Predicate Device | Heinz Kurz Trocar Ventilation Tube, 510(k) K071150 |
| Device<br>Description | The Preceptis Tympanostomy Tube System (TTS) which includes a<br>tympanostomy tube inserter (TTI) with a preloaded ventilation tube, is a<br>single-use, sterile manual surgical instrument which is used to create a<br>myringotomy in the tympanic membrane and place a ventilation tube.<br>The TTI comprises a handle with one or more tip assemblies which<br>contain a sterile tympanostomy tube.<br><br>Each tip assembly can be removably attached to the handle and includes<br>a positioning rod and a ventilation tube pre-loaded inside the distal end<br>of a sharpened sheath. Attaching the tip assembly to the handle also<br>connects the sheath and actuator, allowing the user to retract the sheath<br>by manually scrolling an actuator located on the handle.<br><br>The user manually advances the sharpened sheath to create a<br>myringotomy and simultaneously positions the ventilation tube within<br>the myringotomy, always under direct visualization. The user then<br>manually retracts the sharpened sheath away from the myringotomy<br>using the manual actuator located on the handle. The retraction of the<br>sheath releases the tube within the myringotomy.<br><br>A first tip assembly can then be removed from the handle and replaced<br>with a second preloaded tip assembly for bilateral procedures. |
| Indications For<br>Use | The Tympanostomy Tube System is intended to deliver a<br>tympanostomy tube in tympanostomy procedures in which the patient is<br>receiving a tympanostomy tube. |
| Technological<br>Characteristics | The TTS is intended to deliver a tympanostomy tube (also referred to as<br>a ventilation tube) through the tympanic membrane (TM) of the patient.<br>It combines the separate functions of creating a myringotomy,<br>positioning and placing a ventilation tube across the TM, and<br>suctioning.<br><br>The TTI is a manual surgical instrument. The actions of creating the<br>myringotomy, positioning the ventilation tube, and retracting the sheath<br>surrounding the ventilation tube are all performed manually by the user.<br><br>A comparison between the TTS and the predicate device shows that the<br>technological characteristics as confirmed through dimensional<br>attributes and the indications for use are substantially equivalent |
| Performance<br>Data | The Preceptis Tympanostomy Tube System (TTS) includes a disposable<br>tool designed to create a myringotomy incision and place a<br>tympanostomy tube across the tympanic membrane in one surgical pass,<br>thereby reducing surgical trauma for the patient. Preceptis Medical, Inc.<br>conducted a prospective, treatment-only multicenter clinical study to<br>evaluate the performance and the safety of the TTS. A total of 50 ears<br>indicated for tympanostomy tube insertion were treated in 25 pediatric<br>patients (mean age of 2.6 years, ranging from 6 months to 7.8 years) by<br>6 investigators at 3 study sites. All procedures were performed under<br>general anesthesia.<br><br>The success rate in performing the tympanostomy procedures was<br>100%. Tympanostomy tubes were successfully delivered in all 25<br>patients (50 ears). In 40/50 ears (80%), only the TTI was used for the<br>tympanostomy procedure. In 10/50 ears (20%), either a pick or alligator<br>clip was used for additional adjustment of the tympanostomy tube. In all<br>cases, only a single TTI was used for each ear. At follow-up, between<br>15 and 60 days post-surgery, tube retention was 100%. There was one<br>case of recurrent infection not associated with the TTS and three<br>occluded tubes. An independent otolaryngologist reviewed the results<br>of the trial and determined that there were no safety issues associated<br>with the TTS. The Preceptis TTS met the study safety and performance<br>criteria |

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