Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical medical device (tympanostomy tube) and does not mention any software, algorithms, or AI/ML capabilities.

Therapeutic

Yes
The device is a tympanostomy tube intended to provide ventilation and drainage to the middle ear, thereby addressing chronic Eustachian tube dysfunction. This function directly aims to treat a medical condition.

Diagnostic

No
The device, a tympanostomy tube, is indicated for therapeutic purposes (providing ventilation and drainage to the middle ear for chronic Eustachian tube dysfunction), not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "silicone tube," which is a physical hardware component, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Description: The description clearly states the device is a "tympanostomy tube" intended to be placed in the middle ear for ventilation and drainage. This is a physical implantable device, not a test performed on a sample outside the body.
Intended Use: The intended use is to treat chronic Eustachian tube dysfunction by providing ventilation and drainage, which is a therapeutic intervention, not a diagnostic test.

Therefore, the Biowy Tym Tube is a medical device, but it falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

ETD

Device Description

The tympanostomy tube is a silicone tube that is intended to provide ventilation and drainage to the middle ear.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

middle ear, tympanic membrane

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)

Biocompatibility testing, according to ISO 10993, has been performed and the devices have been shown to be safe, non-toxic, and biocompatible.
Sterility: This submission is supported by appropriate sterilization and shelf-life validation.
Pyrogenicity: The device is labeled non-pyrogenic. Three production lots of the test article identified as Biowy Tym Tube, were validated for LAL Endotoxin testing using the Kinetic-Chromogenic test method.
Bench Testing results are summarized on the table below:
Visual Inspection: No visual defects. Met requirements.
Compression: Comparable to predicate. Met requirements.
Tensile: Higher than that needed for placement and removal. Met requirements.

The Biowy Tym Tube devices were tested successfully to fully characterize performance. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

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.

K830228

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

Regulation Number and Section

§ 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.

Summary

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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).

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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
NUMBER:	21 CFR 874.3880
PREDICATE DEVICE:	Otological Ventilation Tubes (K830228)
SPONSOR:	Biowy Corporation
27031/27002 Vista Terrace
Lake Forest, CA 92630 – USA
CONTACT PERSON:	Arthur Lu	Telephone No. 1-(949) 305-8211
Fax Number: 1-(866) 506-5094
STATEMENT OF
INTENDED USE:	Indicated where chronic Eustachian tube dysfunction does not respond to
conventional therapy.
DEVICE DESCRIPTION:	The tympanostomy tube is a silicone tube that is intended to provide
ventilation and drainage to the middle ear.
SAFETY AND
EFFECTIVENESS
INFORMATION:	Biocompatibility testing, according to ISO 10993, has been performed and
the devices have been shown to be safe, non-toxic, and biocompatible.
		Subject Device	Predicate
	Name	Biowy Tym Tube
(K233658)	Otological Ventilation Tubes
(K830228)
SUMMARY OF
TECHNOLOGICAL
SIMILARITIES and
DIFFERENCE (BETWEEN
THE BIOWY TYM TUBE	Use	Silicone vent tube to be
placed across the tympanic
membrane to allow for middle
ear ventilation and fluid
drainage.	Silicone vent tube to be placed
across the tympanic membrane
to allow for middle ear ventilation
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
performance.

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| Below is a tabulated list of all the performance testing that was provided in

support of the substantial equivalence of the subject device:
	Sterility: This submission is supported by appropriate sterilization and

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.