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 Description

The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument. The HTTS is used to create a myringotomy in the tympanic membrane and place a ventilation tube. The surgeon manually advances the sharpened sheath to create a myringotomy and simultaneously positions the ventilation tube within the myringotomy, always under direct visualization. The surgeon then manually retracts the sharpened sheath away from the myringotomy using the manual actuator located on the handle. The retraction of the sheath releases the tube within the myringotomy.

AI/ML Overview

The provided text describes the Hummingbird® Tympanostomy Tube System (HTTS) and its performance data, particularly in an office setting for children. Here's a breakdown based on the categories you provided:

1. A table of acceptance criteria and the reported device performance

While the document doesn't explicitly list "acceptance criteria" in a separate table, it presents several performance metrics from a clinical study, implicitly serving as the basis for evaluating the device's acceptability for its intended use. The comparison to a predicate device's performance also highlights what might be considered acceptable thresholds.

Clinical Metric	Reported Device Performance (HTTS Pediatric Office Study)	Implicit Acceptance Criteria (based on predicate or good clinical outcome)
Successful rate in office or under sedation	98.9%	High success rate (e.g., >88.3% of predicate)
Efficacy endpoint (HTTS delivery of tube)	96.9%	High efficacy (e.g., >92% of predicate)
Safety endpoint (procedural Adverse Event rate)	0.56% (2/360 ears)	Low procedural AE rate (ideally comparable to or lower than predicate, though predicate reported 0.0%)
% ears completed in one surgical pass	84.5%	High percentage of single-pass completion (e.g., >82% of predicate)
Child's tolerance of procedure (clinician review)	"In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably."	Acceptable tolerance by child in office setting.
Parent satisfaction (alternative to GA)	93.1% strongly agree/agree	High parent satisfaction.
Parent recommendation	93.1% strongly agree/agree	High parent recommendation.
Bi-lateral procedure time	Median 5:00 (range 2:00-15:32)	Efficient procedure time for office setting.
Recovery (calm/no inappropriate crying before leaving)	98.3% (177/180 children)	High rate of calm recovery.
Tube delivery using additional instruments	7 ears	Minimal need for additional instruments.
Passes required: >2 passes	2.3%	Low rate of multiple passes.
Early extrusion rate	3.0%	Comparable to or lower than predicate (predicate 3.2%).
Plugging rate	11.3%	Comparable to or lower than predicate (predicate 12.3%).

2. Sample size used for the test set and the data provenance

Sample Size: 180 children (360 ears) underwent tympanostomy procedures in an ENT office using the HTTS.
Data Provenance: The study was a "multi-site clinical study." While specific countries are not mentioned, the FDA clearance suggests it was likely
conducted, at least in part, within the United States. The data is prospective, collected specifically for this clinical evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: The document states "A committee of clinicians with ENT and/or pediatric specialty independently reviewed 18 procedure videos". The exact number of clinicians on this committee is not specified, but it was more than one due to the phrasing "each of the reviewers".
Qualifications of Experts: Clinicians with "ENT and/or pediatric specialty". No specific years of experience are mentioned.

4. Adjudication method for the test set

For the video review of child tolerance, it appears experts reviewed independently, and the aggregated results (bar graph tabulation) indicate a consensus was reached, as "In all 18 cases, each of the reviewers deemed that the child tolerated the procedure acceptably." This suggests either unanimous agreement or a very strong majority for acceptability. No specific formal adjudication such as 2+1 or 3+1 is detailed for the video review, but the reported outcome implies a high level of agreement.
For the core clinical endpoints (success rate, AE rate), these are typically based on observed events and objective measures, not multi-reader adjudication of images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study involving AI assistance for human readers was not done. The device is a surgical instrument (Tympanostomy Tube System), not an AI-powered diagnostic or assistive tool for human interpretation of data. The study focuses on the device's performance outcomes (efficacy, safety, procedural characteristics) during its use.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical surgical instrument, not an algorithm. Its performance is inherently tied to its use by a human operator (surgeon) in real-world clinical settings, making "standalone" algorithm-only performance irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's performance relies on several types of data:

Clinical Outcomes Data: This includes direct measurements of success rates (tube delivery, completion in office), adverse event rates, procedure times, early extrusion rates, and plugging rates.
Expert Observational Consensus: For the child's tolerance during the procedure, a committee of ENT/pediatric clinicians reviewed videos and made judgments (see point 3 & 4).
Patient/Parent Reported Outcomes: Parent surveys provided data on satisfaction and willingness to recommend.

8. The sample size for the training set

This question is not applicable to the information provided. The "training set" concept is relevant for machine learning algorithms. This document describes the clinical evaluation of a medical device (surgical instrument), not an AI system. The study described is a clinical validation study, not a dataset for training.

9. How the ground truth for the training set was established

This question is not applicable for the same reasons as point 8.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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SubmitterInformation:	Preceptis Medical, Inc.10900 89th Avenue North, Suite 4Maple Grove, MN 55369763.568.7819
Contact:	Steve Anderson, CEO
DatePrepared:	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
CommonName	Tympanostomy Tube Inserter with pre-loaded ventilation tube
PredicateDevices	Preceptis Tympanostomy Tube System, K142282
DeviceDescription	The Hummingbird® Tympanostomy Tube System (HTTS), whichincludes a preloaded ventilation tube, is a single-use, sterile manualsurgical instrument. The HTTS is used to create a myringotomy inthe tympanic membrane and place a ventilation tube. The surgeonmanually advances the sharpened sheath to create a myringotomyand simultaneously positions the ventilation tube within themyringotomy, always under direct visualization. The surgeon thenmanually retracts the sharpened sheath away from the myringotomyusing the manual actuator located on the handle. The retraction ofthe sheath releases the tube within the myringotomy.
IndicationsFor Use	The Hummingbird® Tympanostomy Tube System (HTTS) isintended to deliver a tympanostomy tube (also referred to as aventilation tube) through the tympanic membrane of the patientand is indicated to be used in office settings for children 6-24 monthsold.
TechnicalCharacteristics	The HTTS is intended to deliver a tympanostomy tube (alsoreferred to as a ventilation tube) through the tympanic membraneof the patient. It combines the separate functions of creating amyringotomy, positioning and placing a ventilation tube across thetympanic membrane.
Comparison tothe predicate	The HTTS is identical to the predicate (except the removal of thesuction feature), including the Intended Use. All other technologicalcharacteristics (e.g., design, material, chemical composition,functionality) are identical and non-clinical performance data tests(except shelf life testing) were not repeated from K142282.Shelf life of the device is increased to 27 months (supported by non-clinical testing).Indications for use are different from the predicate device as the subjectdevice indications are expanded to include in-office use in children 6-24 months old.
PerformanceData	In order to evaluate the pediatric-specific performance of the HTTS inan office setting, a multi-site clinical study in children 6-24 months oldwas performed. A total of 180 children (360 ears) underwenttympanostomy procedures in an ENT office using the HTTS. Themean age of the patients was 13 months (range of 6-24 months).Immobilization (papoose and/or swaddling with a nurse or MA holdingthe child's head) was used on all patients, and Phenol was used on 173out 180 patients. Results:178/180 (98.9%) children received ventilation tubes in theoffice as planned. The rate of procedural adverse events was 2/360 ears(0.56%), and there were no serious or unanticipatedadverse events reported. The median bi-lateral procedure time was 5:00 (range of2:00-15:32). The recovery of the child was evaluated by the ENT andstaff, and 177/180 (98.3%) children were judged as calmand/or no inappropriate crying before leaving the clinic. In 7 ears, tube delivery was completed using additionalinstruments to the HTTS. 84.5% of ears were completed in one surgical pass; 97.7%were completed in two passes or less; and 2.3% requiredmore 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%

Regulation Number and Section

§ 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.