(86 days)
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.
The Hummingbird® Tympanostomy Tube System (HTTS), which includes a preloaded ventilation tube, is a single-use, sterile manual surgical instrument which 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 user 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.
The provided text does not describe an AI/ML device but rather a medical device called the "Hummingbird® Tympanostomy Tube System (HTTS)". Therefore, the information requested regarding acceptance criteria and study proving device meets acceptance criteria, specifically for an AI/ML device, cannot be extracted from this document.
However, I can extract the information relevant to the clinical performance of the HTTS device itself, based on the provided text, using the structure you've requested. Please note that terms like "test set," "training set," "experts," and "ground truth" are typical for AI/ML studies and may not perfectly align with how a traditional medical device's clinical study is described, but I will interpret them to the best of my ability based on the provided clinical data.
Device: Hummingbird® Tympanostomy Tube System (HTTS)
Device Type: Medical Device (Tympanostomy Tube Inserter with pre-loaded ventilation tube) - Not an AI/ML device.
Acceptance Criteria (Interpreted as Clinical Performance Endpoints) and Reported Device Performance:
| Acceptance Criteria (Clinical Endpoint) | Reported Device Performance (2-17 years old study) | Pediatric Office Study, 6-24 months (K200952, for comparison) |
|---|---|---|
| Successful procedure completion in-office | 95.8% | 98.9% |
| Efficacy endpoint (HTTS delivery of tube) | 97.3% | 96.9% |
| Safety endpoint (procedural AE rate) | 0.0% | 0.56% |
Study Proving Device Meets Acceptance Criteria:
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Sample Size and Data Provenance:
- Test Set (Clinical Study Population): A total of 48 children (74 ears) for the "2-17 years old" study.
- Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be a multi-site study in an ENT office setting.
- Retrospective or Prospective: Implied to be prospective, as it describes a multi-site study where procedures were performed and results collected.
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Number of Experts and Qualifications:
- The study involved ENT specialists performing the procedures and evaluating outcomes. Specific numbers or detailed qualifications (e.g., years of experience) beyond "ENT" are not provided. The recovery of the child was evaluated by the "ENT and staff."
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Adjudication Method for the Test Set:
- No formal adjudication method (like 2+1 or 3+1 used in imaging studies) is described. Clinical outcomes were presumably determined by the treating ENT and staff, and adverse events were recorded.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC study was not done, as this is not an AI/ML diagnostic or assistive device. The study evaluates the effectiveness and safety of a surgical device performed by human operators.
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Standalone Performance:
- This concept is not directly applicable. The device (HTTS) is a manual surgical instrument. Its "performance" is inherently tied to its use by a human operator. The study provides data on its performance when used in a clinical setting by an ENT.
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Type of Ground Truth Used:
- The "ground truth" for clinical outcomes (successful procedure completion, efficacy of tube delivery, safety/AEs) was established through direct observation, medical records, and clinical assessment by the treating physicians and staff during and after the procedure. Parent surveys were also collected for satisfaction.
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Sample Size for the Training Set:
- This is not an AI/ML device, so there is no "training set" in the context of machine learning. The device design and previous predicate device (K200952) serve as the foundation for this iteration.
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How Ground Truth for the Training Set Was Established:
- Not applicable, as there is no AI/ML training set. The device's design and previous version (K200952) are based on traditional engineering and medical device development processes, which include preclinical testing and clinical data from previous iterations. The present study for K221254 uses clinical data from the identical device (as the predicate) to demonstrate substantial equivalence for an expanded age group.
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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
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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 (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, 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
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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)
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| SubmitterInformation: | Preceptis Medical, Inc.10900 89th Avenue North, Suite 4Maple Grove, MN 55369763.568.7819 |
|---|---|
| Contact: | Steve Anderson, CEO |
| DatePrepared: | 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 |
| CommonName | Tympanostomy Tube Inserter with pre-loaded ventilation tube |
| PredicateDevices | Preceptis Tympanostomy Tube System, K200952 |
| DeviceDescription | The Hummingbird® Tympanostomy Tube System (HTTS), which includes apreloaded ventilation tube, is a single-use, sterile manual surgical instrumentwhich is used to create a myringotomy in the tympanic membrane and place aventilation tube.The surgeon manually advances the sharpened sheath to create amyringotomy and simultaneously positions the ventilation tube within themyringotomy, always under direct visualization. The user then manuallyretracts the sharpened sheath away from the myringotomy using the manualactuator located on the handle. The retraction of the sheath releases the tubewithin the myringotomy. |
| IndicationsFor Use | The Hummingbird® Tympanostomy Tube System (HTTS) is intended todeliver a tympanostomy tube (also referred to as a ventilation tube) through thetympanic membrane of the patient and is indicated to be used in office settingsin pediatric patients 6 months and older. |
| TechnicalCharacteristics | 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.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. |
| PerformanceData | Office setting: 2 years and olderIn 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: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 olderWhen using the HTTS for tympanostomy tube placement in children 6 months and older in an otolaryngology office setting:Assess suitability of the H-TTS procedure using shared decision making between the parents and the physician. |
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510k Summary
| Local anesthesia should be used on the tympanic membrane to increasethe child's comfort.The head should be gently restrained by a nurse or medical assistant.For children under three years old, immobilization with a papoose and/orswaddling should be used to mitigate the child's body movement.For children three years and older, discuss with the parents and childwhether to use papoosing to mitigate the child's body movement. | |||||
|---|---|---|---|---|---|
| Conclusion | The clinical data described above demonstrates that in-office HTTS pediatricuse in children 2 years and older is as safe, as effective and performs as well asin children 6-24 months (the predicate device, K200952). A table comparingstudy endpoint results with K200952 is shown below. These clinical resultsusing the identical device as the predicate demonstrate substantial equivalence. | ||||
| Clinical Outcome | Pediatric Office Study,2-17 years old | Pediatric Office Study,6-24 months(K200952) | |||
| Successful procedurecompletion in-office | 95.8% | 98.9% | |||
| Efficacy endpoint(HTTS delivery of tube) | 97.3% | 96.9% | |||
| Safety endpoint(procedural AE rate) | 0.0% | 0.56% |
§ 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.