(242 days)
The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
The Preceptis 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 TTI comprises 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 procedures.
Here's a breakdown of the acceptance criteria and study details for the Preceptis Tympanostomy Tube System (TTS), based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: No safety issues associated with the TTS. | An independent otolaryngologist reviewed the results of the trial and determined that there were no safety issues associated with the TTS. There was one case of recurrent infection not associated with the TTS and three occluded tubes, but these were not deemed safety issues directly attributable to the device. |
| Performance (Success Rate): 100% success rate in performing tympanostomy procedures. | The success rate in performing the tympanostomy procedures was 100%. Tympanostomy tubes were successfully delivered in all 25 patients (50 ears). |
| Performance (Use of TTI): TTI used as the sole instrument for the tympanostomy procedure. | In 40/50 ears (80%), only the TTI was used for the tympanostomy procedure. In 10/50 ears (20%), either a pick or alligator clip was used for additional adjustment of the tympanostomy tube. In all cases, only a single TTI was used for each ear. |
| Performance (Tube Retention): 100% tube retention at follow-up (15-60 days post-surgery). | At follow-up, between 15 and 60 days post-surgery, tube retention was 100%. |
The document explicitly states: "The Preceptis TTS met the study safety and performance criteria."
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 25 pediatric patients, involving a total of 50 ears.
- Data Provenance: Prospective, treatment-only multicenter clinical study. The document does not explicitly state the country of origin, but given the FDA submission and the language used, it's highly likely to be the United States.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: 1
- Qualifications of Experts: An independent otolaryngologist. No specific years of experience are provided, but the title suggests a qualified medical professional specializing in ear, nose, and throat.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The evaluation appears to be based on direct observation during the procedures by the 6 investigators, and the post-procedure safety review by a single independent otolaryngologist.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study solely evaluated the performance and safety of the TTS device in a treatment-only context. It did not compare the device's performance against human readers or assess improvement with AI assistance (as the device itself is a manual surgical instrument, not an AI diagnostic tool).
6. Standalone (Algorithm Only) Performance
No, a standalone (algorithm only) performance study was not done. The device is a manual surgical instrument, not an algorithm, and its performance is inherently tied to its use by a human surgeon.
7. Type of Ground Truth Used
The ground truth used was primarily clinical observation and outcomes data:
- Procedure Success: Directly observed by the 6 investigators during the surgery (whether the tympanostomy tube was successfully delivered and positioned).
- Safety: Evaluated by an independent otolaryngologist based on clinical results and adverse events.
- Tube Retention: Assessed at follow-up clinical visits.
8. Sample Size for the Training Set
The document does not mention a training set as this is a clinical study for a medical device (surgical instrument), not an AI/machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/machine learning model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
Preceptis Medical % Mr. Keith Leland VP of Research and Development 505 Highwav 169 North, #365 Plymouth, MN 55441
Re: K133921
Trade/Device Name: Preceptis Tympanostomy Tube System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: II Product Code: ETD Dated: July 21, 2014 Received: July 22, 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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set 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" (21 CFR 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.
Tina Kiang -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K133921
Device Name: Preceptis Tympanostomy Tube System
Indications For Use:
The Tympanostomy Tube System is intended to deliver a tympanostomy tube in tympanostomy procedures in which the patient is receiving a tympanostomy tube.
X___ Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Srinivas Nandkumar - S Sriniyas Nandkumar -S 2014.0
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Table 1. Updated 510(k) Summary
| SubmitterInformation: | Preceptis Medical, Inc.505 Highway 169 North, #365Plymouth, MN 55441763.568.7819 |
|---|---|
| Contact: | Keith Leland, VP of R&D |
| Date Prepared: | 21 July 2014 |
| Trade Name | Hummingbird TTS |
| Product Code | ETD (21 CFR Part 874.3880) |
| Common Name | Preceptis Tympanostomy Tube System |
| Predicate Device | Heinz Kurz Trocar Ventilation Tube, 510(k) K071150 |
| DeviceDescription | The Preceptis Tympanostomy Tube System (TTS) which includes atympanostomy 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 TTI comprises a handle with one or more tip assemblies whichcontain a 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 and replacedwith a second preloaded tip assembly for bilateral procedures. |
| Indications ForUse | The Tympanostomy Tube System is intended to deliver atympanostomy tube in tympanostomy procedures in which the patient isreceiving a tympanostomy tube. |
| TechnologicalCharacteristics | 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, andsuctioning.The TTI is a manual surgical instrument. The actions of creating themyringotomy, positioning the ventilation tube, and retracting the sheathsurrounding the ventilation tube are all performed manually by the user.A comparison between the TTS and the predicate device shows that thetechnological characteristics as confirmed through dimensionalattributes and the indications for use are substantially equivalent |
| PerformanceData | The Preceptis Tympanostomy Tube System (TTS) includes a disposabletool designed to create a myringotomy incision and place atympanostomy tube across the tympanic membrane in one surgical pass,thereby reducing surgical trauma for the patient. Preceptis Medical, Inc.conducted a prospective, treatment-only multicenter clinical study toevaluate the performance and the safety of the TTS. A total of 50 earsindicated for tympanostomy tube insertion were treated in 25 pediatricpatients (mean age of 2.6 years, ranging from 6 months to 7.8 years) by6 investigators at 3 study sites. All procedures were performed undergeneral anesthesia.The success rate in performing the tympanostomy procedures was100%. Tympanostomy tubes were successfully delivered in all 25patients (50 ears). In 40/50 ears (80%), only the TTI was used for thetympanostomy procedure. In 10/50 ears (20%), either a pick or alligatorclip was used for additional adjustment of the tympanostomy tube. In allcases, only a single TTI was used for each ear. At follow-up, between15 and 60 days post-surgery, tube retention was 100%. There was onecase of recurrent infection not associated with the TTS and threeoccluded tubes. An independent otolaryngologist reviewed the resultsof the trial and determined that there were no safety issues associatedwith the TTS. The Preceptis TTS met the study safety and performancecriteria |
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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.