Biowy Tym Tube (TT)

K233658 · Biowy Corporation · ETD · Feb 16, 2024 · Ear, Nose, Throat

Device Facts

• Record ID: K233658
• Device Name: Biowy Tym Tube (TT)
• Applicant: Biowy Corporation
• Product Code: ETD · Ear, Nose, Throat
• Decision Date: Feb 16, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3880
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.

Device Story

Biowy Tym Tube is a silicone ventilation tube designed for placement across the tympanic membrane. It provides ventilation and fluid drainage to the middle ear. The device is intended for use by clinicians in a medical setting to treat chronic Eustachian tube dysfunction. By maintaining an open pathway through the eardrum, the tube facilitates pressure equalization and drainage, potentially preventing complications associated with chronic middle ear fluid accumulation.

Clinical Evidence

Bench testing only. Testing included visual inspection, compression, and tensile strength, all of which met predetermined acceptance criteria. Biocompatibility was verified per ISO 10993. Pyrogenicity was validated using the Kinetic-Chromogenic LAL test method. No clinical data provided.

Technological Characteristics

Material: Silicone. Form factor: Tubular. Dimensions: 1.14mm ID, 1.6mm OD, 2.20mm length. Sterilization: Ethylene Oxide (EO). Non-pyrogenic.

Indications for Use

Indicated for patients with chronic Eustachian tube dysfunction unresponsive to conventional therapy.

Regulatory Classification

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.

Predicate Devices

• Otological Ventilation Tubes (K830228)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 16, 2024

Biowy Corporation Zhihua Lu President 27031 Vista Terrace Lake Forest. California 92630

## Re: K233658

Trade/Device Name: Biowy Tym Tube (TT) Regulation Number: 21 CFR 874.3880 Regulation Name: Tympanostomy Tube Regulatory Class: Class II Product Code: ETD Dated: January 15, 2024 Received: January 16, 2024

## Dear Zhihua Lu:

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).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joyce C. Lin -S

for 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) K233658

Device Name Biowy Tym Tube (TT)

#### Indications for Use (Describe)

The Biowy Tym Tube products are indicated for where chronic Eustachian tube dysfunction does not respond to conventional therapy.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# Biowy Corporation

# Biowy Tym Tube 510(k)

## Traditional 510(k)

## 510(k) Summary

| PROPRIETARY NAME: | Biowy Tym Tube | | | | | |
|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| COMMON NAME: | Tympanostomy Tube | | | | | |
| REGULATION NAME: | Tympanostomy Tube | | | | | |
| DEVICE CLASS: | II | | | | | |
| REGULATION NUMBER: | 21 CFR 874.3880 | | | | | |
| PRODUCT CODE: | ETD | | | | | |
| CLASSIFICATION<br>NUMBER: | 21 CFR 874.3880 | | | | | |
| PREDICATE DEVICE: | Otological Ventilation Tubes (K830228) | | | | | |
| SPONSOR: | Biowy Corporation<br>27031/27002 Vista Terrace<br>Lake Forest, CA 92630 – USA | | | | | |
| CONTACT PERSON: | Arthur Lu | Telephone No. 1-[phone]<br>Fax Number: 1-[phone] | | | | |
| STATEMENT OF<br>INTENDED USE: | Indicated where chronic Eustachian tube dysfunction does not respond to<br>conventional therapy. | | | | | |
| DEVICE DESCRIPTION: | The tympanostomy tube is a silicone tube that is intended to provide<br>ventilation and drainage to the middle ear. | | | | | |
| SAFETY AND<br>EFFECTIVENESS<br>INFORMATION: | Biocompatibility testing, according to ISO 10993, has been performed and<br>the devices have been shown to be safe, non-toxic, and biocompatible. | | | | | |
| | | Subject Device | Predicate | | | |
| | Name | Biowy Tym Tube<br>(K233658) | Otological Ventilation Tubes<br>(K830228) | | | |
| SUMMARY OF<br>TECHNOLOGICAL<br>SIMILARITIES and<br>DIFFERENCE (BETWEEN<br>THE BIOWY TYM TUBE | Use | Silicone vent tube to be<br>placed across the tympanic<br>membrane to allow for middle<br>ear ventilation and fluid<br>drainage. | Silicone vent tube to be placed<br>across the tympanic membrane<br>to allow for middle ear ventilation<br>and fluid drainage. | | | |
| AND THE PREDICATE) | Materials | Silicone | Silicone | | | |
| | Shape | Tube | Tube | | | |
| | ID | 1.14mm | 1mm | | | |
| | OD | 1.6mm | 1.4mm | | | |
| | Length | 2.20mm | various | | | |
| | Sterility | Sterile (by EO) | Sterile (by EO) | | | |
| PERFORMANCE: | The Biowy Tym Tube devices were tested successfully to fully characterize<br>performance. | | | | | |

{4}------------------------------------------------

| Below is a tabulated list of all the performance testing that was provided in<br>support of the substantial equivalence of the subject device: | | | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------|--|--|
| | Sterility: This submission is supported by appropriate sterilization and<br>1.<br>shelf-life validation.<br>Pyrogenicity: The device is labeled non-pyrogenic. Three production lots<br>2.<br>of the test article identified as Biowy Tym Tube, were validated for LAL<br>Endotoxin testing using the Kinetic-Chromogenic test method.<br>3.<br>Bench Testing results are summarized on the table below: | | | | |
| | Biowy Tym Tube | Standards/Requirements | | | |
| | | | Results | | |
| | Visual Inspection | No visual defects | Met requirements | | |
| | Compression | Comparable to predicate | Met requirements | | |
| | Tensile | Higher than that needed for<br>placement and removal | Met requirements | | |

## CONCLUSION:

The Biowy Tym Tube meets all the predetermined performance acceptance criteria of the testing performed and the performance data were determined to be comparable to the prodicate device. Therefore, the Biowy Tymp Tube is substantially equivalent to the Otological Ventilation Tubes (K830228), concurrence date February 28, 1983.

The predicate device has not been removed from the market at the initiative of the Commissioner of Food and Drugs or has not been determined to be misbranded or adulterated by a judicial order.