(114 days)
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.
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.
The Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System is a mechanical device designed to create a myringotomy and deliver a preloaded tympanostomy tube.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Success Rate | 94% (95/101 ears) |
| Tube Retention (1 week post-procedure) | 98.95% (94/95 ears) |
| Patient received indicated treatment | 100% (101/101 ears) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 101 ears enrolled from 53 pediatric subjects.
- Data Provenance: The study was a prospective, multi-center, single-arm clinical study conducted across 4 study sites. The country of origin is not specified but implied to be the US given the FDA submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on evaluating the device's technical performance and patient outcomes, rather than diagnostic accuracy requiring expert consensus on a ground truth label. Procedures were performed by 4 investigators (presumably surgeons).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for establishing a ground truth for the test set, as the study primarily evaluated objective device performance metrics (success rate, tube retention) directly observed during or after surgical procedures.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The study was a single-arm clinical study evaluating the device's performance directly.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The clinical study evaluated the performance and safety of the Acclarent TTDS device for the placement of the Acclarent Tympanostomy Tube. The success rates and retention rates are standalone performance metrics.
7. Type of Ground Truth Used
The "ground truth" in this context refers to directly observed clinical outcomes and device functionality.
- Device Success: Based on the observed ability of the device to fully deploy tubes across the tympanic membranes. Failures were directly observed (e.g., device not fully deploying the tube).
- Tube Retention: Observed during the one-week post-procedure follow-up.
- Indicated Treatment Received: Direct observation that all enrolled ears received the intended tympanostomy tube placement, even if manual intervention was required after device failure.
8. Sample Size for the Training Set
The document does not mention any "training set" in the context of an algorithm or AI model development. The study described is a clinical performance study of a mechanical device, not an AI/ML-based device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML model was utilized.
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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 DriveMenlo Park, California 94025 | |
| Contact Person: | Gurvinder Singh NandaRegulatory Affairs ManagerPhone: (650) 687-5414Fax: (650) 687-4449 | |
| Date of Submission: | January 25, 2011 | |
| Device Trade Name: | TBD | |
| Common Name: | Acclarent Tympanostomy Tube and Tympanostomy Tube DeliverySystem | |
| 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 penetratesthe tympanic membrane and inserts the Acclarent Tympanostomy Tubewith a button controlled activation. | |
| Indications for Use: | The Tympanostomy Tube Delivery System is intended to provide ameans to create a myringotomy with insertion of a preloaded Paparellatype 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. |
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Aclarent
Traditional 510(k)
Acclarent Tympanostomy Tube and Tympanostomy Tube Delivery System
| TechnologicalCharacteristics: | The Tympanostomy Tube Delivery System is a mechanical device thatcan create a myringotomy and deliver the Acclarent TympanostomyTube. The Acclarent Tympanostomy Tube is provided pre-loaded inthe subject device. |
|---|---|
| Performance Data: | Acclarent conducted a prospective, multi-center, single arm clinicalstudy to evaluate the performance and safety of the Acclarent TTDSdevice for the placement of the Acclarent Tympanostomy Tube insubject ears indicated for such treatment for chronic OME or recurrentAOM. |
| A total of 101 ears were enrolled in 53 pediatric subjects by 4investigators at 4 study sites. All study procedures were performedunder general anesthesia in the operating room. The overall DeviceSuccess rate of the TTDS device was 94% (95/101). The 6% devicenon-success rate was attributable to failure of the devices to fullydeploy the tubes across the tympanic membranes. This anticipatedfailure mode can occur if the device tip is not fully registered againstthe tympanic membrane. This mode was not associated with anyadverse sequelae and in each case, standard otologic tools were used tomanually place a tympanostomy tube. 100% (101/101) of enrolled earsreceived their indicated treatment. | |
| At the one-week post-procedure follow-up visit, retention of theAcclarent Tympanostomy Tube was observed at a rate of 98.95%(94/95). Consistent with the rates reported in the clinical literature, tubeocclusion was observed in 5% of tubes at follow-up: the incidence ofnon-functional tympanostomy tubes caused by occlusion is relativelycommon, ranging from 7% to 37% (Tsao, BA et al. Otolaryngol HeadNeck Surg, 128(6):870-874, 2001) and has been known to occur in awide variety of tubes (Weigel, MT et al. Laryngoscope, 99:252-256,1989). | |
| The Tympanostomy Tube Delivery System met all the studyperformance acceptance criteria. | |
| Summary of SubstantialEquivalence: | The Acclarent Tympanostomy Tube and Tympanostomy Tube DeliverySystem is substantially equivalent to the predicate devices as confirmedthrough dimensional attributes. |
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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.
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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
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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 UseX(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)
§ 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.