(258 days)
No
The description focuses on a mechanical surgical instrument for placing tympanostomy tubes and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "surgical instrument" that "rapidly places a tympanostomy tube across the tympanic membrane of a patient" to provide "ventilation to the middle ear space". This function of placing a medical device to treat a condition (middle ear ventilation) constitutes a therapeutic purpose.
No
This device is a surgical instrument intended to deliver a tympanostomy tube, combining the functions of creating a myringotomy and placing the tube. It is a therapeutic device, not a diagnostic one.
No
The device description clearly outlines a physical, single-use surgical instrument with a myringotomy knife, cartridge, handpiece, and activation button, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Solo+ Tympanostomy Tube Device Function: The Solo+ device is a surgical instrument used to physically place a tube through the tympanic membrane. It is a procedural device, not a device that analyzes biological samples.
- Intended Use: The intended use is to deliver a tympanostomy tube, which is a surgical intervention, not a diagnostic test.
- Device Description: The description details a mechanical device for creating an incision and placing a tube, not for analyzing biological specimens.
Therefore, the Solo+ Tympanostomy Tube Device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.
Product codes (comma separated list FDA assigned to the subject device)
ETD
Device Description
The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.
To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tympanic membrane
Indicated Patient Age Range
pediatric patients 6-24 months old.
Intended User / Care Setting
office settings
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)
A clinical study using the Solo+ TTD has demonstrated substantial equivalence to the predicate device, Preceptis Hummingbird TTS intra-operatively and through 1st post-operative follow-up in an in-office setting.
In a multi-site study, a total of 20 patients (40 ears), underwent tympanostomy procedures using the Solo+ TTD across 2 sites in an in-office setting with topical anesthesia and protective stabilization. The mean age of the patients is 12.5 months (range 6 to 19 months) and a median age of 12.5 months.
Results:
- 20/20 (100%) children received tympanostomy tubes as planned (success) .
- There were no device or procedure related serious adverse events. .
- 87.5% (35/40) of ears were completed using only the Solo+ TTD without the need for . additional instruments to aid in the placement.
The clinical data described above demonstrates that in an in-office setting, the Solo+ TTD is as safe and as effective as the Hummingbird TTS in pediatric patients 6-24 months old.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Successful Placement of the Device without need for an operating room procedure: 100 % (20/20 patients)
Delivery Success (placed without the need for additional instruments to aid in placement of the device): 87.5% (35/40 ears)
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 20, 2024
AventaMed DAC Keith Jansen President and CEO Rubicon Centre, Rossa Avenue, Bishopstown, Cork T12 Y275 Ireland
Re: K232702
Trade/Device Name: Solo+ Tympanostomy Tube Device (TTD) Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: April 19, 2024 Received: April 19, 2024
Dear Keith Jansen:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shuchen Peng -S
Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232702
Device Name Solo+ Tympanostomy Tube Device (TTD)
Indications for Use (Describe)
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.
| 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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Image /page/3/Picture/0 description: The image shows the logo for AventaMed, a medical company specializing in ENT surgery. The logo features the company name in a combination of blue and gray lettering, with the word "Aventa" in blue and "Med" in gray. Below the name is the tagline "Advancing ENT Surgery" in smaller, gray font. To the right of the name is a stylized blue image of an ear.
510(k) Summary
General Information
| Date Prepared: | 20th May 2024 |
|---|---|
| Classification: | Class II, 21 CFR 874.3880 Tympanostomy Tube |
| Product Code: | ETD |
| Trade Name: | Solo+ Tympanostomy Tube Device (TTD) |
| Common Name: | Tympanostomy Tube |
| Model Numbers: | Solo+ Tympanostomy Tube Handpiece (Catalogue#: 12115-100-000) |
| Solo+ Tympanostomy Tube Cartridge (Catalogue#: 12115-200-000) | |
| Owners Name | AventaMed DAC |
| Rubicon Centre | |
| Rossa Avenue | |
| Bishopstown Cork | |
| T12 Y275 | |
| Ireland | |
| Contact Person: | Keith Jansen, President and CEO |
| AventaMed DAC: | Rubicon Centre |
| Rossa Avenue | |
| Bishopstown | |
| Cork | |
| T12 Y275 | |
| Ireland | |
| Tel: +353 21 492 8980 | |
| Email: keith.jansen@aventamed.com |
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Image /page/4/Picture/0 description: The image shows the logo for AventaMed, a company that specializes in advancing ENT surgery. The logo features the company name in a combination of blue and gray lettering, with the word "Aventa" in blue and "Med" in gray. Below the name is the tagline "Advancing ENT Surgery" in smaller, gray font. To the right of the name is a stylized blue image of an ear.
Intended Use
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM.
Indications for Use
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for pediatric patients 6-24 months old.
Predicate Device
- Hummingbird Tympanostomy Tube System (HTTS), Preceptis Medical Inc. (K200952) .
Reference Device
- . Otological Ventilation Tube - Sheehy Design, Micromedics, Inc. (K830228)
Device Description
The Solo+ Tympanostomy Tube Device TTD (Solo+ TTD) is a single use, sterile, "all-in-one" surgical instrument that rapidly places a tympanostomy tube across the tympanic membrane of a patient. It combines the traditionally separate functions of creating a myringotomy, and positioning and placing a tympanostomy tube across the tympanic membrane. Placement of the tube provides ventilation to the middle ear space through the tympanic membrane.
To use the device, the user creates a myringotomy with the device's myringotomy knife, which is located at its distal tip of the Cartridge. The user advances the device until the tympanostomy tube outer flange reaches the tympanic membrane. The user then actuates the device by pressing the activation button on the Handpiece. This retracts the myringotomy knife construct and deploys the tube across the tympanic membrane.
5
Image /page/5/Picture/0 description: The image shows the logo for AventaMed, a company that specializes in advancing ENT surgery. The logo features the company name in a combination of blue and gray lettering, with the word "Aventa" in blue and "Med" in gray. Below the name is the tagline "Advancing ENT Surgery" in smaller, gray font. To the right of the name is a stylized blue image of an ear.
Materials
The Solo+ TTD is comprised of materials that are commonly used in medical device applications. The biological safety tests were performed in accordance with ISO 10993-1 (Biological evaluation of medical devices -- Part 1: Evaluation and testing). For testing the device has been categorized in two parts, the Solo+ Delivery System which has a category of a surface device contacting breached or compromised surfaces and the Solo+ Tympanostomy Tube which has a category of Implant Device contacting tissue/bone.
The tests performed to demonstrate the biocompatibility of the device were:
- Physical and Chemical Characterization
- . Cytotoxicity
- Sensitization ●
- Irritation / Intracutaneous Reactivity ●
- Acute Systemic Toxicity
- Subchronic Toxicity
- Subacute Toxicity ●
- Implantation Short-Term and Long Term ●
- Material- Mediated Pyrogenicity ●
Comparison of Technological Characteristics of Solo+ TTD compared to the Predicate Device (Preceptis, Hummingbird TTS) and Reference Device (Micromedics, Otological Ventilation Tube - Sheehy Design)
The Solo+ TTD and the equivalent commercialized predicate device Preceptis Hummingbird TTS were evaluated for substantial equivalence. No significant difference in clinical, and biological parameters was identified between the devices have the same intended patient and user populations and intended use; to deliver a tympanostomy tube through the tympanic membrane of the patient. Both devices combine the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the tympanic membrane. Technological equivalence is demonstrated via comparative test data and assessment of the
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Image /page/6/Picture/0 description: The image shows the logo for AventaMed, a company specializing in advancing ENT surgery. The logo features the company name in a combination of blue and gray lettering, with the word "Aventa" in blue and "Med" in gray. Below the name is the tagline "Advancing ENT Surgery" in smaller, gray font. To the right of the name is a stylized blue drawing of an ear.
primary technological characteristics. Biological equivalence is demonstrated via reference to the material used in each device and the biocompatibility testing which demonstrates that the devices are biologically safe for their intended use.
Where there is a difference in geometry of the tympanostomy tube to the Preceptis Hummingbird TTS tympanostomy tube, equivalence is demonstrated to the reference device; the Micromedics Otological Ventilation Tube - Sheehy Design via review of the appropriate technological characteristics.
Via the comparative analysis and the test data generated and reviewed, the Solo+ TTD Device has been shown to be substantially equivalent to the commercialized Hummingbird TTS.
Non-Clinical Information
The determination of substantial equivalence is also based on an assessment of non-clinical engineering tests, as listed in Table 1 and Table 2.
Table 1: List of Design Verification Tests
| Design Verification Tests | |
|---|---|
| Device Visual and Dimensional Checks | Packaging testing |
| Device Puncture Measurement | Biocompatibility Testing |
| Simulated Use Testing | MRI safety testing |
| Cartridge Functional Tests | Sterilization Validation |
| Handpiece Functional Tests | Residuals testing |
| Aging Testing | Bioburden & Endotoxin Validation |
| Transportation Testing |
Table 2: List of Design Validation Tests
| Design Validation Tests | |
|---|---|
| IFU/Label comprehension | Device placement |
| Package suitability | Device ease of use |
| Device functionality testing | Device Disposal |
| Visualization assessment |
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Image /page/7/Picture/0 description: The image shows the logo for AventaMed. The logo features the name "AventaMed" in a combination of blue and gray colors, with the "Aventa" portion in blue and the "Med" portion in gray. Below the name, there is a tagline that reads "Advancing ENT Surgery." To the right of the name, there is a stylized blue image of an ear.
The test results demonstrate that the Solo+ TTD Device meets the requirements in the applicable standards and specifications and is substantially equivalent to a legally marketed predicate device.
Clinical Information
A clinical study using the Solo+ TTD has demonstrated substantial equivalence to the predicate device, Preceptis Hummingbird TTS intra-operatively and through 1st post-operative follow-up in an in-office setting.
In-office setting: 6-24 months old.
In a multi-site study, a total of 20 patients (40 ears), underwent tympanostomy procedures using the Solo+ TTD across 2 sites in an in-office setting with topical anesthesia and protective stabilization. The mean age of the patients is 12.5 months (range 6 to 19 months) and a median age of 12.5 months.
Results:
- 20/20 (100%) children received tympanostomy tubes as planned (success) .
- There were no device or procedure related serious adverse events. .
- 87.5% (35/40) of ears were completed using only the Solo+ TTD without the need for . additional instruments to aid in the placement.
The clinical data described above demonstrates that in an in-office setting, the Solo+ TTD is as safe and as effective as the Hummingbird TTS in pediatric patients 6-24 months old. A table comparing study endpoint results with the comparative study for the Hummingbird TTS (K200952) is shown in Table 3.
| Table 3: Study endpoints compared between Solo+ TTD and Hummingbird TTS | ||
|---|---|---|
| ------------------------------------------------------------------------- | -- | -- |
| Clinical Outcome | AventaMed DAC
Solo+ TTD | Preceptis Hummingbird TTS
(K200952) |
|---------------------------------------------------------------------------------------------------------------|----------------------------|----------------------------------------|
| Successful Placement of the Device
without need for an operating room
procedure | 100 % (20/20 patients) | 98.9% |
| Delivery Success (placed without
the need for additional instruments
to aid in placement of the device) | 87.5% (35/40 ears) | 96.9% |
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Image /page/8/Picture/0 description: The image shows the logo for AventaMed, a medical company. The logo features the company name in a combination of gray and teal colors, with the word "Aventa" in gray and "Med" in teal. Below the name is the tagline "Advancing ENT Surgery" in a smaller font. To the right of the company name is a stylized image of an ear in teal.
Conclusion
These clinical results, together with the comparison of technological and performance characteristics, demonstrate that there are no differences between the two devices that raise different questions of safety and effectiveness relevant to use of the Solo+ TTD in an office setting. The Solo+ TTD has been demonstrated to be substantially equivalent to the Hummingbird TTS.