Hummingbird Tympanostomy Tube System

K221254 · Preceptis Medical, Inc. · ETD · Jul 27, 2022 · Ear, Nose, Throat

Device Facts

• Record ID: K221254
• Device Name: Hummingbird Tympanostomy Tube System
• Applicant: Preceptis Medical, Inc.
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Jul 27, 2022
• 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 membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older.

Device Story

The Hummingbird Tympanostomy Tube System (HTTS) is a single-use, sterile manual surgical instrument designed for in-office myringotomy and ventilation tube placement. The device features a pre-loaded ventilation tube within a sharpened sheath. The surgeon manually advances the sheath to create a myringotomy in the tympanic membrane while simultaneously positioning the ventilation tube. A manual actuator on the handle is then used to retract the sheath, releasing the tube into the myringotomy. The procedure is performed under direct visualization by an otolaryngologist. The device eliminates the need for general anesthesia in pediatric patients, potentially reducing risks and recovery time associated with traditional operating room procedures. Clinical use involves patient immobilization (e.g., papoose/swaddling) and topical anesthesia.

Clinical Evidence

Multi-site prospective study in 48 children (2-17 years old, 74 ears) undergoing in-office tympanostomy. Primary endpoints: procedure success, tube delivery efficacy, and safety (adverse events). Results: 95.8% success rate for in-office completion; 97.3% efficacy for tube delivery; 0% adverse event rate. 100% of children were calm post-procedure. Data compared favorably to predicate (K200952) study results in 6-24 month olds.

Technological Characteristics

Single-use, sterile manual surgical instrument. Combines myringotomy creation and ventilation tube placement. Identical to predicate device in design, materials, and functionality. No electronic components or software.

Indications for Use

Indicated for pediatric patients 6 months and older requiring tympanostomy tube placement in an office setting.

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 (K200952)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 27, 2022

Preceptis Medical, Inc. Steve Anderson Chief Executive Officer 10900 89th Avenue North, Suite 4 Maple Grove. Minnesota 55369

Re: K221254

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: July 8, 2022 Received: July 11, 2022

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 w arranties. 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

{1}------------------------------------------------

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 (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, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K221254

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 membrane of the patient and is indicated to be used in office settings for pediatric patients 6 months and older.

| 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)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| 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: | 23 July 2022 |
| Trade Name | Hummingbird® Tympanostomy Tube System (HTTS) |
| 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, K200952 |
| Device<br>Description | The Hummingbird® Tympanostomy Tube System (HTTS), which includes a<br>preloaded ventilation tube, is a single-use, sterile manual surgical instrument<br>which is used to create a myringotomy in the tympanic membrane and place a<br>ventilation tube.<br><br>The surgeon manually advances the sharpened sheath to create a<br>myringotomy and simultaneously positions the ventilation tube within the<br>myringotomy, always under direct visualization. The user then manually<br>retracts the sharpened sheath away from the myringotomy using the manual<br>actuator located on the handle. The retraction of the sheath releases the tube<br>within the myringotomy. |
| Indications<br>For Use | The Hummingbird® Tympanostomy Tube System (HTTS) is intended to<br>deliver a tympanostomy tube (also referred to as a ventilation tube) through the<br>tympanic membrane of the patient and is indicated to be used in office settings<br>in pediatric patients 6 months and older. |
| Technical<br>Characteristics | The HTTS is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient. It combines the separate functions of creating a myringotomy, positioning, and placing a ventilation tube across the tympanic membrane.<br><br>The HTTS is the identical device as the predicate. Therefore, all technological characteristics (e.g., design, material, chemical composition, functionality) are identical and non-clinical performance data tests were not repeated. |
| Performance<br>Data | Office setting: 2 years and older<br>In a multi-site study in children 2-17 years old using the identical device as the predicate, a total of 48 children (74 ears) underwent tympanostomy procedures in an ENT office using the HTTS. Immobilization safety (papoose and/or swaddling with a nurse or MA holding the child's head) was used on all patients, and Phenol was used as a topical anesthetic on all patients. Results:<br>46/48 (95.8%) children received ventilation tubes in the office as planned (success). There were zero adverse events (safety). The median bi-lateral procedure time was 4'20" (range of 1'54"–18'06"). In 72/74 ears (97.3%), tube delivery was successfully delivered using the HTTS (efficacy). The recovery of the child was evaluated by the ENT and staff, and 48/48 (100.0%) children were judged as calm and/or no inappropriate crying before leaving the clinic. In 36 parent surveys collected at follow-up, 97.2% of parents strongly agree or agree that it was important to have an alternative to general anesthesia and 94.4% strongly agreed or agreed that they would recommend the HTTS office procedure to other parents. 87.5% of ears were completed in one surgical pass; 95.8% were completed in two passes or less; and 4.2% required more than 2 passes. In 7/72 ears (9.7%), additional instruments were used for tympanostomy tube adjustment. Precautions for in-office use in pediatric patients 6 months and older<br>When using the HTTS for tympanostomy tube placement in children 6 months and older in an otolaryngology office setting:<br>Assess suitability of the H-TTS procedure using shared decision making between the parents and the physician. |

{4}------------------------------------------------

{5}------------------------------------------------

## 510k Summary

| | Local anesthesia should be used on the tympanic membrane to increase<br>the child's comfort.<br>The head should be gently restrained by a nurse or medical assistant.<br>For children under three years old, immobilization with a papoose and/or<br>swaddling should be used to mitigate the child's body movement.<br>For children three years and older, discuss with the parents and child<br>whether to use papoosing to mitigate the child's body movement. | | | | |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------|--|--|
| Conclusion | The clinical data described above demonstrates that in-office HTTS pediatric<br>use in children 2 years and older is as safe, as effective and performs as well as<br>in children 6-24 months (the predicate device, K200952). A table comparing<br>study endpoint results with K200952 is shown below. These clinical results<br>using the identical device as the predicate demonstrate substantial equivalence. | | | | |
| | Clinical Outcome | Pediatric Office Study,<br>2-17 years old | Pediatric Office Study,<br>6-24 months<br>(K200952) | | |
| | Successful procedure<br>completion in-office | 95.8% | 98.9% | | |
| | Efficacy endpoint<br>(HTTS delivery of tube) | 97.3% | 96.9% | | |
| | Safety endpoint<br>(procedural AE rate) | 0.0% | 0.56% | | |