(86 days)
Not Found
No
The device description and performance studies indicate a manual surgical instrument with no mention of AI or ML capabilities.
Yes
The device is a surgical instrument used to create a myringotomy and place a ventilation tube, which is a medical intervention for a health condition (recurrent ear infections). This aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a surgical instrument used to create a myringotomy and place a tympanostomy tube; it does not diagnose a condition.
No
The device description clearly states it is a "single-use, sterile manual surgical instrument" which includes a "preloaded ventilation tube." This indicates it is a physical hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Hummingbird® Tympanostomy Tube System (HTTS) Function: The HTTS is a surgical instrument used to physically insert a tube into the tympanic membrane. It does not analyze or test any bodily fluids or tissues. Its purpose is a direct surgical intervention.
The provided information clearly describes a surgical device used for a procedure, not a diagnostic test performed on a specimen.
N/A
Intended Use / Indications for 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.
Product codes
ETD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane
Indicated Patient Age Range
pediatric patients 6 months and older.
Intended User / Care Setting
office settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Office setting: 2 years and older
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:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successful procedure completion in-office: 95.8%
Efficacy endpoint (HTTS delivery of tube): 97.3%
Safety endpoint (procedural AE rate): 0.0%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Preceptis Tympanostomy Tube System, K200952
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
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 (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
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)
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3
| Submitter
Information: | Preceptis Medical, Inc.
10900 89th Avenue North, Suite 4
Maple Grove, MN 55369
763.568.7819 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Steve Anderson, CEO |
| Date
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
Name | Tympanostomy Tube Inserter with pre-loaded ventilation tube |
| Predicate
Devices | Preceptis Tympanostomy Tube System, K200952 |
| Device
Description | 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. |
| Indications
For 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
in pediatric patients 6 months and older. |
| Technical
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.
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
Data | Office setting: 2 years and older
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:
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
When 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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5
510k Summary
| | Local anesthesia should be used on the tympanic membrane to increase
the 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/or
swaddling should be used to mitigate the child's body movement.
For children three years and older, discuss with the parents and child
whether to use papoosing to mitigate the child's body movement. | | | | |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------------------------|--|--|
| Conclusion | The clinical data described above demonstrates that in-office HTTS pediatric
use in children 2 years and older is as safe, as effective and performs as well as
in children 6-24 months (the predicate device, K200952). A table comparing
study endpoint results with K200952 is shown below. These clinical results
using 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 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% | | |