(251 days)
The Hummingbird™ Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
The Hummingbird™ Tympanostomy Tube System (TTS) which includes a tympanostomy tube inserter (TTI) with 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 TTS includes a handle with one or more tip assemblies which contain a sterile tympanostomy tube. Each tip assembly can be removably attached to the handle and includes a positioning rod and a ventilation tube pre-loaded inside the distal end of a sharpened sheath. Attaching the tip assembly to the handle also connects the sheath and actuator, allowing the user to retract the sheath by manually scrolling an actuator located on the handle. The user 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. A first tip assembly can then be removed from the handle and replaced with a second preloaded tip assembly for bilateral
The provided document describes the Preceptis Medical, Inc. Hummingbird™ Tympanostomy Tube System (TTS) and its regulatory review (K142282), but it does not contain a table of acceptance criteria or a study that specifically addresses acceptance criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures typically associated with AI/algorithm-based devices.
The document details the device's function as a surgical instrument and predominantly focuses on its safety and successful delivery of tympanostomy tubes in a clinical setting. It also makes a statement about a "comparison between the TTS and predicate device shows that the devices are identical." This suggests the primary "acceptance criterion" for this 510(k) submission and the study conducted was likely demonstrating substantial equivalence to a predicate device, particularly regarding safety and the successful placement of tubes.
However, based on the information provided, here's an attempt to answer your questions by interpreting what could be considered "acceptance criteria" and "reported device performance" for this type of medical device, and then addressing the other points:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit quantitative acceptance criteria (e.g., "Sensitivity > X%") are not present in the document. For a surgical instrument like the Hummingbird™ TTS, acceptance criteria would typically revolve around its ability to perform its intended function safely and effectively. Based on the "Performance Data" section, the key performance indicator was the successful placement of ventilation tubes and the absence of certain adverse events.
| Acceptance Criterion (Inferred from study findings) | Reported Device Performance |
|---|---|
| 1. Successful placement of ventilation tubes as planned. | 100% of children received ventilation tubes as planned. |
| 2. Absence of intra-operative adverse events. | No intra-operative adverse events. |
| 3. Absence of unanticipated adverse events. | No unanticipated adverse events. |
| 4. Adverse event rates to be within peer-reviewed literature rates. | Adverse event rates were well within peer-reviewed literature reported rates. |
| 5. Ability to complete procedure under moderate sedation. | Procedure performed under moderate sedation with local anesthetic. (Note: Some conversions to general anesthesia occurred, but overall aim was moderate sedation completion.) |
2. Sample Size and Data Provenance
- Test set sample size: A total of 69 children (136 ears) across two studies (an initial feasibility study followed by a multi-site study).
- Data provenance: The document does not explicitly state the country of origin, but given the FDA submission context, it is highly likely the studies were conducted in the USA. The studies were prospective clinical studies involving human subjects undergoing tympanostomy procedures.
3. Number of Experts and Qualifications for Ground Truth
- Number of experts: Not explicitly stated how many surgeons or anesthesiologists participated, but the studies involved multiple sites, implying multiple medical professionals.
- Qualifications of experts: The document refers to "surgeons" and "anesthesiologists" who determined the moderate sedation regimen and performed the procedures. It can be inferred they are qualified medical professionals in their respective fields, likely board-certified or similarly qualified, with experience in pediatric ENT procedures and anesthesia. No specific years of experience or sub-specialty details are provided.
4. Adjudication Method for the Test Set
- Adjudication method: Not explicitly mentioned. For a surgical procedure, the "ground truth" (successful tube placement, adverse events) is typically determined and documented by the operating surgeon and/or the attending medical staff at the time of the procedure, possibly reviewed by an independent clinical monitor or study coordinator. There's no indication of a formal 2+1 or 3+1 adjudication process as would be common for subjective image interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC study: No. This device is a surgical instrument, not an AI/imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with AI assistance is not applicable and was not performed.
6. Standalone (Algorithm Only) Performance Study
- Standalone study: No. This device is a manual surgical instrument and does not incorporate an algorithm or AI component. Therefore, no standalone algorithm performance study was done.
7. Type of Ground Truth Used
- Type of ground truth: The ground truth was based on clinical outcomes and observations during surgical procedures. This includes:
- Direct observation of successful tube placement.
- Documentation of intra-operative and unanticipated adverse events by medical personnel.
- Assessment of sedation levels and conversions.
8. Sample Size for the Training Set
- Training set sample size: Not applicable. As a manual surgical instrument, there is no "training set" in the context of machine learning or AI algorithms. The development of the device would involve engineering, bench testing, potentially cadaver studies, and iterative design improvements, but not a data-driven training set in the AI sense.
9. How Ground Truth for the Training Set Was Established
- How ground truth for the training set was established: Not applicable. Since there is no training set for an AI algorithm, there is no method for establishing its ground truth. Device development would rely on engineering specifications, preclinical testing results, and established surgical principles.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 23, 2015
Preceptis Medical, Inc. Mr. Keith Leland Vice President of Research and Development 505 Highway 169 North, #365 Plymouth, MN 55441
Re: K142282
Trade/Device Name: Hummingbird™ Tympanostomy Tube System (TTS) Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: November 13, 2014 Received: November 14, 2014
Dear Mr. Leland:
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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Keith Leland
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
William H. Maisel -S
William H. Maisel, MD, MPH Director, Office of Device Evaluation (Acting) Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142282
Device Name
Hummingbird™ Tympanostomy Tube System
Indications for Use (Describe)
The Hummingbird™ Tympanostomy Tube System is intended to deliver a tympanostomy procedures in which the patient is receiving a tympanostomy tube.
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.505 Highway 169 North, #365Plymouth, MN 55441763.568.7819 |
|---|---|
| Contact: | Keith Leland, VP of R&D |
| DatePrepared: | 23 April 2015 |
| Trade Name | Hummingbird™ Tympanostomy Tube System (TTS) |
| Product Code | ETD (21 CFR Part 874.3880) |
| CommonName | Tympanostomy Tube Inserter with pre-loaded ventilation tube |
| PredicateDevices | Preceptis Tympanostomy Tube System, 510(k) K133921 |
| DeviceDescription | The Hummingbird™ Tympanostomy Tube System (TTS) which includesa tympanostomy tube inserter (TTI) with a preloaded ventilation tube, is asingle-use, sterile manual surgical instrument which is used to create amyringotomy in the tympanic membrane and place a ventilation tube.The TTS includes a handle with one or more tip assemblies which containa sterile tympanostomy tube.Each tip assembly can be removably attached to the handle and includesa positioning rod and a ventilation tube pre-loaded inside the distal endof a sharpened sheath. Attaching the tip assembly to the handle alsoconnects the sheath and actuator, allowing the user to retract the sheathby manually scrolling an actuator located on the handle.The user manually advances the sharpened sheath to create amyringotomy and simultaneously positions the ventilation tube withinthe myringotomy, always under direct visualization. The user thenmanually retracts the sharpened sheath away from the myringotomyusing the manual actuator located on the handle. The retraction of thesheath releases the tube within the myringotomy.A first tip assembly can then be removed from the handle andreplaced with a second preloaded tip assembly for bilateral |
| IndicationsFor Use | The Hummingbird™ Tympanostomy Tube System is intended to delivera tympanostomy tube in tympanostomy procedures in which thepatient is receiving a tympanostomy tube. |
| TechnicalCharacteristics | The TTS is intended to deliver a tympanostomy tube (also referred to asa ventilation tube) through the tympanic membrane (TM) of the patient.It combines the separate functions of creating a myringotomy,positioning and placing a ventilation tube across the TM, and suctioning.A comparison between the TTS and predicate device shows that thedevices are identical. |
| PerformanceData | Clinical performance data was submitted to assess the performance of thedevice when placed under moderate sedation with local anesthetic. In twostudies (an initial feasibility study followed by a multi-site study), a total of69 children (136 ears) underwent tympanostomy procedures undermoderate sedation using the Preceptis TTS. The mean age of the patientswas 2.4 years (range of 8 months to 8.9 years). Results: |
| 100% of the children received ventilation tubes as planned. There were no intra-operative adverse events, no unanticipated adverse events, and adverse event rates were well within peer-reviewed literature reported rates. Moderate sedation was per definition from the ASA guidelines, Continuum of Depth of Sedation: Definition of General Anesthesia and Levels of Sedation/Analgesia. The moderate sedation regimen was determined by the surgeon and anesthesiologist. In these two studies, the surgeon and anesthesiologist chose to use nitrous oxide (50-70%) in all cases. In the 1st study, there were 12 conversions (30%) from moderate sedation to general anesthesia due to surgical challenges. In the 2nd study, 2 cases (7%) were converted. The reduction in the conversion rate was likely due to increased surgical experience and design improvements to the TTS to improve visibility and repeatability. In most cases during the study, the surgeon chose to use a local anesthetic on the tympanic membrane to reduce discomfort for the patient. Under moderate sedation, local anesthesia of the tympanic membrane should be used to reduce the risk of head movement and increase patient comfort. |
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§ 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.