(114 days)
Not Found
No
The description focuses on the mechanical function of the device and does not mention any AI or ML components.
Yes
The device is intended to be used for creating a myringotomy and inserting a tympanostomy tube, which is indicated for treating conditions like chronic otitis media with effusion, recurrent otitis media, and persistent high negative middle ear pressure, all of which are therapeutic interventions for ear conditions.
No
Explanation: The device is designed to create a myringotomy and insert a tympanostomy tube, which are therapeutic procedures, not diagnostic ones. Its purpose is to treat conditions like chronic otitis media with effusion, not to diagnose them.
No
The device description explicitly states it is a "mechanical device" that "penetrates the tympanic membrane and inserts the Acclarent Tympanostomy Tube." This indicates a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Tympanostomy Tube Delivery System is a surgical device used to create an opening in the eardrum and insert a tube directly into the middle ear. It is a physical intervention on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating conditions of the middle ear.
- Device Description: The description details a mechanical device for penetrating the tympanic membrane and inserting a tube.
- Anatomical Site: The device is used on the tympanic membrane and middle ear, which are parts of the patient's body.
The device is a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube.
Conditions for which tympanostomy tubes are indicated include:
- Chronic otitis media with effusion (serous, mucoid, or purulent)
- Recurrent otitis media that fails to respond to conventional medical treatment
- A history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.
- Retraction pocket of the tympanic membrane.
Product codes (comma separated list FDA assigned to the subject device)
ETD
Device Description
The Tympanostomy Tube Delivery System is a device that penetrates the tympanic membrane and inserts the Acclarent Tympanostomy Tube with a button controlled activation.
The Tympanostomy Tube Delivery System is a mechanical device that can create a myringotomy and deliver the Acclarent Tympanostomy Tube. The Acclarent Tympanostomy Tube is provided pre-loaded in the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane, middle ear
Indicated Patient Age Range
Not Found
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)
Acclarent conducted a prospective, multi-center, single arm clinical study to evaluate the performance and safety of the Acclarent TTDS device for the placement of the Acclarent Tympanostomy Tube in subject ears indicated for such treatment for chronic OME or recurrent AOM.
A total of 101 ears were enrolled in 53 pediatric subjects by 4 investigators at 4 study sites. All study procedures were performed under general anesthesia in the operating room. The overall Device Success rate of the TTDS device was 94% (95/101). The 6% device non-success rate was attributable to failure of the devices to fully deploy the tubes across the tympanic membranes. This anticipated failure mode can occur if the device tip is not fully registered against the tympanic membrane. This mode was not associated with any adverse sequelae and in each case, standard otologic tools were used to manually place a tympanostomy tube. 100% (101/101) of enrolled ears received their indicated treatment.
At the one-week post-procedure follow-up visit, retention of the Acclarent Tympanostomy Tube was observed at a rate of 98.95% (94/95). Consistent with the rates reported in the clinical literature, tube occlusion was observed in 5% of tubes at follow-up: the incidence of non-functional tympanostomy tubes caused by occlusion is relatively common, ranging from 7% to 37% (Tsao, BA et al. Otolaryngol Head Neck Surg, 128(6):870-874, 2001) and has been known to occur in a wide variety of tubes (Weigel, MT et al. Laryngoscope, 99:252-256, 1989).
The Tympanostomy Tube Delivery System met all the study performance acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall Device Success rate: 94% (95/101)
Retention of the Acclarent Tympanostomy Tube at one-week post-procedure: 98.95% (94/95)
Tube occlusion at follow-up: 5%
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
Aclarent
Traditional 510(k)
Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
APR - 1 2011
| APPENDIX A: 510(k) SUMMARY | ||
|---|---|---|
| Sponsor/Submitter: | Acclarent, Inc. | |
| 1525-B O'Brien Drive | ||
| Menlo Park, California 94025 | ||
| Contact Person: | Gurvinder Singh Nanda | |
| Regulatory Affairs Manager | ||
| Phone: (650) 687-5414 | ||
| Fax: (650) 687-4449 | ||
| Date of Submission: | January 25, 2011 | |
| Device Trade Name: | TBD | |
| Common Name: | Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery | |
| System | ||
| Device Classification: | Class II | |
| Regulation Number: | 21 CFR 874.3880 | |
| Classification Name: | Tube, Tympanostomy | |
| Product Code: | ETD | |
| Predicate Devices: | Heinz Kurz GmbH Medizintechnik Trocar Ventilation Tube (K830228) | |
| Acclarent Tympanostomy Tube (K082188) | ||
| Exmoor Plastics Ltd. Myringotomy Kit (K980828) | ||
| Device Description: | The Tympanostomy Tube Delivery System is a device that penetrates | |
| the tympanic membrane and inserts the Acclarent Tympanostomy Tube | ||
| with a button controlled activation. | ||
| Indications for Use: | The Tympanostomy Tube Delivery System is intended to provide a | |
| means to create a myringotomy with insertion of a preloaded Paparella | ||
| type tympanostomy tube. |
Conditions for which tympanostomy tubes are indicated include:
Chronic otitis media with effusion (serous, mucoid, or purulent)Recurrent otitis media that fails to respond to conventional medical treatmentA history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.Retraction pocket of the tympanic membrane. | |
1
Aclarent
Traditional 510(k)
Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
| Technological
Characteristics: | The Tympanostomy Tube Delivery System is a mechanical device that
can create a myringotomy and deliver the Acclarent Tympanostomy
Tube. The Acclarent Tympanostomy Tube is provided pre-loaded in
the subject device. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Acclarent conducted a prospective, multi-center, single arm clinical
study to evaluate the performance and safety of the Acclarent TTDS
device for the placement of the Acclarent Tympanostomy Tube in
subject ears indicated for such treatment for chronic OME or recurrent
AOM. |
| | A total of 101 ears were enrolled in 53 pediatric subjects by 4
investigators at 4 study sites. All study procedures were performed
under general anesthesia in the operating room. The overall Device
Success rate of the TTDS device was 94% (95/101). The 6% device
non-success rate was attributable to failure of the devices to fully
deploy the tubes across the tympanic membranes. This anticipated
failure mode can occur if the device tip is not fully registered against
the tympanic membrane. This mode was not associated with any
adverse sequelae and in each case, standard otologic tools were used to
manually place a tympanostomy tube. 100% (101/101) of enrolled ears
received their indicated treatment. |
| | At the one-week post-procedure follow-up visit, retention of the
Acclarent Tympanostomy Tube was observed at a rate of 98.95%
(94/95). Consistent with the rates reported in the clinical literature, tube
occlusion was observed in 5% of tubes at follow-up: the incidence of
non-functional tympanostomy tubes caused by occlusion is relatively
common, ranging from 7% to 37% (Tsao, BA et al. Otolaryngol Head
Neck Surg, 128(6):870-874, 2001) and has been known to occur in a
wide variety of tubes (Weigel, MT et al. Laryngoscope, 99:252-256,
1989). |
| | The Tympanostomy Tube Delivery System met all the study
performance acceptance criteria. |
| Summary of Substantial
Equivalence: | The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery
System is substantially equivalent to the predicate devices as confirmed
through dimensional attributes. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Acclarent, Inc. c/o Gurvinder Singh Nanda, Ph.D. Regulatory Affairs Manager 1525-B O'Brien Drive Menlo Park, CA 94025
- 1 2911 APR
Re: K103595
Trade/Device Name: Tympanostomy Tube Delivery System Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: February 24, 2011 Received: February 28, 2011
Dear Dr. Nanda:
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.
3
Page 2 - Gurvinder Singh Nanda, Ph.D.
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Euth Rinn for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Acclarent
Traditional 510(k) Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
| 510(k) Number (if known): | K103595 | |
|---|---|---|
| Trade Name: | TBD | |
| Common Name: | Tympanostomy Tube Delivery System | |
| Indications For Use: | The Tympanostomy Tube Delivery System is intended to provide a means to create a myringotomy with insertion of a preloaded Paparella type tympanostomy tube. | |
| Conditions for which tympanostomy tubes are indicated include: | ||
| Chronic otitis media with effusion (serous, mucoid, or purulent)Recurrent otitis media that fails to respond to conventional medical treatmentA history of persistent high negative middle ear pressure which may be associated with conductive hearing loss, otalgia, vertigo and/or tinnitus.Retraction pocket of the tympanic membrane. | ||
| Prescription Use | ||
| X | ||
| (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C. Clumpp
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
KID3595 510(k) Number_
(Posted November 13, 2003)