(57 days)
Not Found
No
The device description and performance studies indicate a manual surgical instrument with no mention of AI/ML capabilities.
Yes
The device is intended to deliver a tympanostomy tube to treat conditions requiring ventilation of the middle ear. The placement of a ventilation tube is a therapeutic intervention for conditions like recurrent acute otitis media or otitis media with effusion.
No
Explanation: The device is a surgical instrument designed to create a myringotomy and place a tympanostomy tube, which is a therapeutic intervention, not a diagnostic one. Its purpose is to treat an existing condition rather than identify or characterize one.
No
The device is described as a "single-use, sterile manual surgical instrument" that includes a preloaded ventilation tube and is used to create a myringotomy and place a tube. This clearly indicates a physical hardware device, not software.
Based on the provided information, the Hummingbird® Tympanostomy Tube System (HTTS) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The HTTS is intended to deliver a tympanostomy tube through the tympanic membrane. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a "single-use, sterile manual surgical instrument" used to "create a myringotomy in the tympanic membrane and place a ventilation tube." This clearly indicates a surgical tool for intervention.
- Anatomical Site: The device acts on the "tympanic membrane," which is a part of the patient's body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. The HTTS is a surgical instrument used inside the body to perform a therapeutic procedure.
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 of the patient and is indicated to be used in office settings for children 6-24 months old.
Product codes (comma separated list FDA assigned to the subject device)
ETD
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.
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
children 6-24 months old
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)
In order to evaluate the pediatric-specific performance of the HTTS in an office setting, a multi-site clinical study in children 6-24 months old was performed. A total of 180 children (360 ears) underwent tympanostomy procedures in an ENT office using the HTTS. The mean age of the patients was 13 months (range of 6-24 months). Immobilization (papoose and/or swaddling with a nurse or MA holding the child's head) was used on all patients, and Phenol was used on 173 out 180 patients. Results: 178/180 (98.9%) children received ventilation tubes in the office as planned. The rate of procedural adverse events was 2/360 ears (0.56%), and there were no serious or unanticipated adverse events reported. The median bi-lateral procedure time was 5:00 (range of 2:00-15:32). The recovery of the child was evaluated by the ENT and staff, and 177/180 (98.3%) children were judged as calm and/or no inappropriate crying before leaving the clinic. In 7 ears, tube delivery was completed using additional instruments 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% required more than 2 passes.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successful rate in office or under sedation: 98.9%
Efficacy endpoint (HTTS delivery of tube): 96.9%
Safety endpoint (procedural AE rate): 0.56%
% ears completed in one surgical pass: 84.5%
Early extrusion rate: 3.0%
Plugging rate: 11.3%
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.
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
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
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 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
2
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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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: | 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
Name | Tympanostomy Tube Inserter with pre-loaded ventilation tube |
| Predicate
Devices | Preceptis Tympanostomy Tube System, K142282 |
| 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. |
| 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 children 6-24 months
old. |
| 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. |
| Comparison to
the predicate | The HTTS is identical to the predicate (except the removal of the
suction feature), including the Intended Use. All other technological
characteristics (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 subject
device indications are expanded to include in-office use in children 6-
24 months old. |
| Performance
Data | In order to evaluate the pediatric-specific performance of the HTTS in
an office setting, a multi-site clinical study in children 6-24 months old
was performed. A total of 180 children (360 ears) underwent
tympanostomy procedures in an ENT office using the HTTS. The
mean age of the patients was 13 months (range of 6-24 months).
Immobilization (papoose and/or swaddling with a nurse or MA holding
the child's head) was used on all patients, and Phenol was used on 173
out 180 patients. Results:
178/180 (98.9%) children received ventilation tubes in the
office as planned. The rate of procedural adverse events was 2/360 ears
(0.56%), and there were no serious or unanticipated
adverse events reported. The median bi-lateral procedure time was 5:00 (range of
2:00-15:32). The recovery of the child was evaluated by the ENT and
staff, and 177/180 (98.3%) children were judged as calm
and/or no inappropriate crying before leaving the clinic. In 7 ears, tube delivery was completed using additional
instruments 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% required
more than 2 passes. |
4
5
- 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.
6
| 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% |