Hummingbird Tympanostomy Tube System

K200952 · Preceptis Medical, Inc. · ETD · Jun 5, 2020 · Ear, Nose, Throat

Device Facts

• Record ID: K200952
• Device Name: Hummingbird Tympanostomy Tube System
• Applicant: Preceptis Medical, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Jun 5, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic of the patient and is indicated to be used in office settings for children 6-24 months old.

Device Story

Hummingbird Tympanostomy Tube System (HTTS) is a single-use, sterile manual surgical instrument for myringotomy and ventilation tube placement. Device features a preloaded ventilation tube within a sharpened sheath. Surgeon manually advances sheath to create myringotomy and position tube under direct visualization; manual actuator on handle retracts sheath to release tube. Used in ENT office settings by physicians; requires patient immobilization (papoose/swaddling) and local anesthesia. Eliminates need for general anesthesia in pediatric patients. Benefits include reduced procedural risk and avoidance of general anesthesia for children 6-24 months old.

Clinical Evidence

Multi-site clinical study in 180 children (360 ears, mean age 13 months) undergoing office-based tympanostomy. 98.9% (178/180) success rate for tube delivery. Procedural adverse event rate 0.56% (2/360 ears). 84.5% of ears completed in one surgical pass; 97.7% in two or fewer. 98.3% of children judged calm post-procedure. Independent video review by clinicians confirmed acceptable tolerance in all 18 cases reviewed. Parent surveys indicated 93.1% support for the alternative to general anesthesia.

Technological Characteristics

Single-use, sterile manual surgical instrument. Combines myringotomy creation and ventilation tube placement. Features a sharpened sheath and manual actuator for tube release. Identical design and materials to predicate K142282, excluding the suction feature. Shelf life: 27 months.

Indications for Use

Indicated for delivery of tympanostomy tubes through the tympanic membrane in children 6-24 months old in office settings.

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

• Preceptis Tympanostomy Tube System (K142282)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters 'FDA' in white. Next to the blue square, the words 'U.S. FOOD & DRUG' are written in blue, with 'ADMINISTRATION' written in a smaller font size below it.

June 5, 2020

Preceptis Medical, Inc Steve Anderson Chief Executive Officer 10900 89th Ave N Suite 4 Maple Grove, Minnesota 55369

Re: K200952

Trade/Device Name: Hummingbird Tympanostomy Tube System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: April 4, 2020 Received: April 9, 2020

### Dear Steve Anderson:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shu-Chen Peng

for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200952

Device Name

Hummingbird® Tympanostomy Tube System

Indications for Use (Describe)

The Hummingbird® Tympanostomy Tube System (HTTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic of the patient and is indicated to be used in office settings for children 6-24 months old.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| Submitter<br>Information: | Preceptis Medical, Inc.<br>10900 89th Avenue North, Suite 4<br>Maple Grove, MN 55369<br>763.568.7819 |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Steve Anderson, CEO |
| Date<br>Prepared: | 5 June 2020 |
| Trade Name | Hummingbird® Tympanostomy Tube System (TTS) |
| Product Code | Ear, Nose and Throat Devices: ETD (21 CFR Part 874.3880) |
| Classification | Class II |
| Common<br>Name | Tympanostomy Tube Inserter with pre-loaded ventilation tube |
| Predicate<br>Devices | Preceptis Tympanostomy Tube System, K142282 |
| Device<br>Description | The Hummingbird® Tympanostomy Tube System (HTTS), which<br>includes a preloaded ventilation tube, is a single-use, sterile manual<br>surgical instrument. The HTTS is used to create a myringotomy in<br>the tympanic membrane and place a ventilation tube. The surgeon<br>manually advances the sharpened sheath to create a myringotomy<br>and simultaneously positions the ventilation tube within the<br>myringotomy, always under direct visualization. The surgeon then<br>manually retracts the sharpened sheath away from the myringotomy<br>using the manual actuator located on the handle. The retraction of<br>the sheath releases the tube within the myringotomy. |
| Indications<br>For Use | The Hummingbird® Tympanostomy Tube System (HTTS) is<br>intended to deliver a tympanostomy tube (also referred to as a<br>ventilation tube) through the tympanic membrane of the patient<br>and is indicated to be used in office settings for children 6-24 months<br>old. |
| Technical<br>Characteristics | The HTTS is intended to deliver a tympanostomy tube (also<br>referred to as a ventilation tube) through the tympanic membrane<br>of the patient. It combines the separate functions of creating a<br>myringotomy, positioning and placing a ventilation tube across the<br>tympanic membrane. |
| Comparison to<br>the predicate | The HTTS is identical to the predicate (except the removal of the<br>suction feature), including the Intended Use. All other technological<br>characteristics (e.g., design, material, chemical composition,<br>functionality) are identical and non-clinical performance data tests<br>(except shelf life testing) were not repeated from K142282.<br><br>Shelf life of the device is increased to 27 months (supported by non-<br>clinical testing).<br><br>Indications for use are different from the predicate device as the subject<br>device indications are expanded to include in-office use in children 6-<br>24 months old. |
| Performance<br>Data | In order to evaluate the pediatric-specific performance of the HTTS in<br>an office setting, a multi-site clinical study in children 6-24 months old<br>was performed. A total of 180 children (360 ears) underwent<br>tympanostomy procedures in an ENT office using the HTTS. The<br>mean age of the patients was 13 months (range of 6-24 months).<br>Immobilization (papoose and/or swaddling with a nurse or MA holding<br>the child's head) was used on all patients, and Phenol was used on 173<br>out 180 patients. Results:<br>178/180 (98.9%) children received ventilation tubes in the<br>office as planned. The rate of procedural adverse events was 2/360 ears<br>(0.56%), and there were no serious or unanticipated<br>adverse events reported. The median bi-lateral procedure time was 5:00 (range of<br>2:00-15:32). The recovery of the child was evaluated by the ENT and<br>staff, and 177/180 (98.3%) children were judged as calm<br>and/or no inappropriate crying before leaving the clinic. In 7 ears, tube delivery was completed using additional<br>instruments to the HTTS. 84.5% of ears were completed in one surgical pass; 97.7%<br>were completed in two passes or less; and 2.3% required<br>more than 2 passes. |

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- In 130 parent surveys collected at follow-up, 93.1% of parents strongly agree or agree that it was important to have an alternative to general anesthesia and that they would recommend the HTTS office procedure to other parents.
- A committee of clinicians with ENT and/or pediatric . specialty independently reviewed 18 procedure videos to evaluate how the child tolerated the procedure. At each stage of the procedure, the clinician reviewers rated the response of the child in the following categories: no response, mild, moderate or significant. In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably. A bar graph tabulation of the committee video review is as follows:

Image /page/5/Figure/3 description: The image is a bar graph titled "Patient Response Observed by Procedure Phase". The graph shows the percentage of patients reviewed for different procedure phases, including patient entering the room, papoose/swaddling, ear wax removal, topical anesthetic application and tube insertion, and 3 minutes post procedure. The patient responses are categorized as no response, mild, moderate, and significant.

## Precautions for office use

When using the HTTS for tympanostomy tube placement in children in an otolaryngology office setting:

- Assess suitability of the HTTS procedure using shared ● decision making between the parents and the physician.
- . Local anesthesia should be used on the tympanic membrane to increase the child's comfort.
- . Immobilization with a papoose and/or swaddling should be used to mitigate the child's body movement, and the head should be gently restrained by a nurse or medical assistant.

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| Clinical Metric | Pediatric Office Study | Predicate Conscious Sedation Study (K142282) |
|---------------------------------------------|------------------------|----------------------------------------------|
| Median age of child | 12 months | 21 months |
| Successful rate in office or under sedation | 98.9% | 88.3% |
| Efficacy endpoint (HTTS delivery of tube) | 96.9% | 92% |
| Safety endpoint (procedural AE rate) | 0.56% | 0.0% |
| % ears completed in one surgical pass | 84.5% | 82% |
| Early extrusion rate | 3.0% | 3.2% |
| Plugging rate | 11.3% | 12.3% |