The provided text describes the Biowy Tym Tube, a tympanostomy tube, and its 510(k) summary for substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets clinical acceptance criteria in the context of an AI/ML device.

The provided information focuses on engineering and biocompatibility testing for a physical medical device, not a software or AI/ML product. Therefore, I cannot extract the requested details relevant to AI/ML device performance or clinical studies using AI models.

To answer your request, here's an analysis based solely on the information provided, which is limited to the physical device's characteristics and safety testing:

Based on the provided document, the "device" in question is the Biowy Tym Tube, a physical tympanostomy tube, not an AI/ML software device. The acceptance criteria and "study" described pertain to the physical properties, sterility, and biocompatibility of this physical device.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria / Test	Reported Device Performance
Sterility: Appropriate sterilization and shelf-life validation.	Met requirements (submission supported by appropriate validation).
Pyrogenicity: Device labeled non-pyrogenic. Validated for LAL Endotoxin testing using the Kinetic-Chromogenic test method using three production lots.	Met requirements (labeled non-pyrogenic, tested successfully).
Bench Testing - Visual Inspection: No visual defects.	Met requirements
Bench Testing - Compression: Comparable to predicate.	Met requirements
Bench Testing - Tensile: Higher than that needed for placement and removal.	Met requirements
Biocompatibility: According to ISO 10993.	Shown to be safe, non-toxic, and biocompatible.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Sample Size for Test Set:
- Pyrogenicity: "Three production lots of the test article identified as Biowy Tym Tube" were validated.
- Bench Testing (Visual, Compression, Tensile): Not explicitly stated, but typically involves a sample size representative of production for such physical tests.
- Biocompatibility: Not explicitly stated, but ISO 10993 testing requires specific sample sizes depending on the test.
Data Provenance: Not specified. This type of testing is typically performed by internal or contract labs and is generally considered part of the manufacturing quality control and design verification process, not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable and not provided in the document. The tests performed are engineering, chemical, and biological safety tests, not clinical evaluations requiring expert interpretation (like a radiologist establishing ground truth for image analysis).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or expert reviews of complex data (e.g., medical images, clinical outcomes) to resolve discrepancies. The described tests are objective measurements against defined standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI/ML devices involving human readers. The Biowy Tym Tube is a physical medical device, not an AI/ML system.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This information is not applicable and not provided. This concept applies to standalone AI/ML algorithms. The described device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the tests mentioned are:

Sterility: Absence of microorganisms (verified through validated sterilization processes).
Pyrogenicity: Absence of pyrogens/endotoxins (quantified via LAL test).
Visual Inspection: Conformance to manufacturing specifications (e.g., no cracks, burrs, malformations).
Compression/Tensile: Objective physical measurements against defined engineering specifications and comparison to the predicate device.
Biocompatibility: Absence of adverse biological reactions (measured via ISO 10993 tests for cytotoxicity, sensitization, irritation, etc.).

These are objective, measurable standards for a physical product, not clinical "ground truth" derived from patient data or expert interpretation.

8. The sample size for the training set:

This information is not applicable and not provided. A "training set" is relevant for AI/ML models. This document describes a physical medical device.

9. How the ground truth for the training set was established:

This information is not applicable and not provided. This concept is for AI/ML models.

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
CLASSIFICATIONNUMBER:	21 CFR 874.3880
PREDICATE DEVICE:	Otological Ventilation Tubes (K830228)
SPONSOR:	Biowy Corporation27031/27002 Vista TerraceLake Forest, CA 92630 – USA
CONTACT PERSON:	Arthur Lu	Telephone No. 1-(949) 305-8211Fax Number: 1-(866) 506-5094
STATEMENT OFINTENDED USE:	Indicated where chronic Eustachian tube dysfunction does not respond toconventional therapy.
DEVICE DESCRIPTION:	The tympanostomy tube is a silicone tube that is intended to provideventilation and drainage to the middle ear.
SAFETY ANDEFFECTIVENESSINFORMATION:	Biocompatibility testing, according to ISO 10993, has been performed andthe devices have been shown to be safe, non-toxic, and biocompatible.
		Subject Device	Predicate
	Name	Biowy Tym Tube(K233658)	Otological Ventilation Tubes(K830228)
SUMMARY OFTECHNOLOGICALSIMILARITIES andDIFFERENCE (BETWEENTHE BIOWY TYM TUBE	Use	Silicone vent tube to beplaced across the tympanicmembrane to allow for middleear ventilation and fluiddrainage.	Silicone vent tube to be placedacross the tympanic membraneto allow for middle ear ventilationand 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 characterizeperformance.

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Sterility: This submission is supported by appropriate sterilization and1.shelf-life validation.Pyrogenicity: The device is labeled non-pyrogenic. Three production lots2.of the test article identified as Biowy Tym Tube, were validated for LALEndotoxin testing using the Kinetic-Chromogenic test method.3.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 forplacement 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.

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.