(242 days)
Not Found
No
The device description and performance studies indicate a manual surgical instrument with no mention of AI or ML capabilities.
No
The device is described as a surgical instrument used to create a myringotomy and place a ventilation tube, rather than directly treating a disease or condition. The "Tympanostomy Tube System" delivers a "tympanostomy tube", which itself would be the therapeutic device.
No
The device is described as a surgical instrument used to create a myringotomy and place a ventilation tube, which are therapeutic actions, not diagnostic ones. Its intended use is to deliver a tympanostomy tube in tympanostomy procedures.
No
The device description clearly states it is a "single-use, sterile manual surgical instrument" which includes a handle, tip assemblies, a positioning rod, a sharpened sheath, and a manual actuator. These are all physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver a tympanostomy tube in tympanostomy procedures." 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 is a physical intervention on the patient.
- Anatomical Site: The anatomical site is the "tympanic membrane," which is part of the patient's body.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not examine specimens; it performs a surgical procedure.
The device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ETD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanostomy tube in tympanostomy procedures
Indicated Patient Age Range
pediatric patients (mean age of 2.6 years, ranging from 6 months to 7.8 years)
Intended User / Care Setting
Not Found
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)
The Preceptis Tympanostomy Tube System (TTS) includes a disposable tool designed to create a myringotomy incision and place a tympanostomy 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 to evaluate the performance and the safety of the TTS. A total of 50 ears indicated for tympanostomy tube insertion were treated in 25 pediatric patients (mean age of 2.6 years, ranging from 6 months to 7.8 years) by 6 investigators at 3 study sites. All procedures were performed under general anesthesia.
The success rate in performing the tympanostomy procedures was 100%. Tympanostomy tubes were successfully delivered in all 25 patients (50 ears). 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. At follow-up, between 15 and 60 days post-surgery, tube retention was 100%. There was one case of recurrent infection not associated with the TTS and three occluded tubes. An independent otolaryngologist reviewed the results of the trial and determined that there were no safety issues associated with the TTS. The Preceptis TTS met the study safety and performance criteria
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The success rate in performing the tympanostomy procedures was 100%.
Tympanostomy tubes were successfully delivered in all 25 patients (50 ears).
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.
At follow-up, between 15 and 60 days post-surgery, tube retention was 100%.
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.
Heinz Kurz Trocar Ventilation Tube, 510(k) K071150
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus-like symbol with three human profiles facing right, representing health and human services.
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
| Submitter
Information: | Preceptis Medical, Inc.
505 Highway 169 North, #365
Plymouth, MN 55441
763.568.7819 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 |
| Device
Description | 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. |
| 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. |
| Technological
Characteristics | The TTS is intended to deliver a tympanostomy tube (also referred to as
a 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.
The TTI is a manual surgical instrument. The actions of creating the
myringotomy, positioning the ventilation tube, and retracting the sheath
surrounding the ventilation tube are all performed manually by the user.
A comparison between the TTS and the predicate device shows that the
technological characteristics as confirmed through dimensional
attributes and the indications for use are substantially equivalent |
| Performance
Data | The Preceptis Tympanostomy Tube System (TTS) includes a disposable
tool designed to create a myringotomy incision and place a
tympanostomy 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 to
evaluate the performance and the safety of the TTS. A total of 50 ears
indicated for tympanostomy tube insertion were treated in 25 pediatric
patients (mean age of 2.6 years, ranging from 6 months to 7.8 years) by
6 investigators at 3 study sites. All procedures were performed under
general anesthesia.
The success rate in performing the tympanostomy procedures was
100%. Tympanostomy tubes were successfully delivered in all 25
patients (50 ears). 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. At follow-up, between
15 and 60 days post-surgery, tube retention was 100%. There was one
case of recurrent infection not associated with the TTS and three
occluded tubes. An independent otolaryngologist reviewed the results
of the trial and determined that there were no safety issues associated
with the TTS. The Preceptis TTS met the study safety and performance
criteria |
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