The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.

Device Description

The subject device is a sterile, single use, disposable medical device. It is designed to be attached to the suction port of a bronchoscope during a pulmonary procedure to help the user engage in the suction function of the bronchoscope by depressing/activating the valve. The activation of the suction valve allows the user to control the suction flow of fluids from the patient to a suction pump/waste canister.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the DEFENDO Disposable Suction Valve. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a comparative effectiveness study with AI.

Therefore, many of the requested details, such as those related to AI performance, sample sizes for test/training sets for an algorithm, ground truth establishment, or human reader performance with/without AI assistance, are not applicable or not present in this type of regulatory submission.

However, I can extract the relevant information from the document regarding the non-clinical performance data used to support substantial equivalence.

Here's a breakdown of the available information:

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

The document doesn't provide a table of precise numerical acceptance criteria and reported performance values in the way you might expect for an AI algorithm. Instead, it lists the types of non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The implied "acceptance criterion" for these tests is that the new device performs similarly or equivalently to the predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Equivalent Valve Connection	Passed "Valve Connection Test"
Equivalent Valve Depression Force	Passed "Valve Depression Force Test"
Equivalent Suction Flow	Passed "Suction Flow Test"
Maintained Functionality over Shelf-life	Passed "Functional Testing" over shelf-life
Integrity of Sterile Barrier	Passed "Dye Penetration Testing", "Peel Strength Testing", "Visual Seal Inspection"
Effective Sterilization	Passed "Sterilization Validation"

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

This information is not provided in the document. The 510(k) summary only generically states that "Medivators has conducted the following testing." It does not detail specific sample sizes for these non-clinical mechanical and functional tests. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of non-clinical device testing.

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 as this is not a study involving human interpretation of data where ground truth needs to be established by experts. The tests are focused on the mechanical and functional properties of the device.

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

This information is not applicable for the same reasons as above.

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:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a disposable suction valve for bronchoscopes, not an AI-powered diagnostic tool. Therefore, there's no "human readers improve with AI vs without AI assistance" to report.

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

No, a standalone algorithm performance study was not done. This device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests would be defined by the engineering specifications and performance characteristics necessary for a functional and safe suction valve. This is typically established through established engineering standards, predicate device performance, and internal design requirements. It's not "expert consensus, pathology, or outcomes data" in the medical sense, but rather adherence to functional and safety benchmarks.

8. The sample size for the training set:

This information is not applicable as this device does not involve a training set for an algorithm.

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

This information is not applicable for the same reasons as above.

Summary of the study conducted (Non-Clinical Performance Data):

The study conducted was a series of non-clinical design verification tests and validation tests to demonstrate that the DEFENDO Disposable Suction Valve is substantially equivalent to its predicate devices (Olympus Disposable Suction Valve (K920025) and Defendo Disposable Suction Valve (K102581)).

The specific tests performed include:

Design Verification Comparison Tests to Predicate Device:
- Valve Connection Test
- Valve Depression Force Test
- Suction Flow Test
Shelf-life validation:
- Functional Testing
- Dye Penetration Testing
- Peel Strength Testing
- Visual Seal Inspection
Sterilization validation

The purpose of these tests was to show that the new device performs safely and effectively in a manner comparable to the legally marketed predicate devices, thereby supporting the claim of substantial equivalence for regulatory clearance. The document concludes that "The information and performance data provided indicates that the subject device is as safe and as effective as its predicate devices for its intended use when used in accordance with the device labeling."

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 17, 2015

Medivators, Inc. % Ms. Kinnari Shah Sr. Regulatory Affairs Specialist 14605 28th Ave N Minneapolis, MN 55447

Re: K151522

Trade/Device Name: DEFENDO Disposable Suction Valve Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: KTI Dated: "August 21, 2015" Received: August 20, 2015

Dear Ms. Kinnari Shah:

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.

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

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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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151522

Device Name DEFENDO Disposable Suction Valve

Indications for Use (Describe)

The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.

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 Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, followed by the word "MEDIVATORS" in blue capital letters. Below the company name is the text "A Cantel Medical Company" in a smaller font size, also in blue. The logo is clean and professional, with a focus on the company name and affiliation.

Indications for Use

510(k) number (if known): K151522

Device Name: DEFENDO Disposable Suction Valve

Indications for Use:

The DEFENDO Disposable Suction Valve is intended to control the suction function of a compatible bronchoscope during a pulmonary procedure.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/4/Picture/0 description: The image contains the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic on the left, which has several curved lines inside of it. To the right of the graphic is the word "MEDIVATORS" in a large, sans-serif, blue font. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif, blue font.

510(k) Summary

Manufacturer:	Medivators Inc., a Cantel Medical Company
Address:	3150 Pollock Drive,Conroe, TX 77303(800) 328-3345
Official Contact:	Kinnari ShahSr. Regulatory Affairs Specialist, Medivators Inc.
Date Prepared:	August 21, 2015
Trade Name:	DEFENDO Disposable Suction Valve
Common Name:	Bronchoscope Accessory
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	KTI
Device Class:	II
Regulation No:	874.4680

Medivators Inc. has supplied the following information to support substantial equivalence of the DEFENDO Disposable Suction Valve to other Suction Valves currently cleared for sale in the United States of America.

1. Intended Use

The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.

2. Device Description

3. Comparison to Other Devices in Commercial Distribution Within the United States

DEFENDO Disposable Suction Valve is equivalent in function, intended use and scientific technology to its predicate devices - Olympus Disposable Suction Valve cleared under 510(k) – K920025 and Defendo Disposable Suction Valve cleared under 510(k) – K102581.

Similarities between Subject and Predicate Devices - Subject and predicate devices have similar intended use, principle of operation and scientific technology. They are provided sterile and must be disposed after a single use. The subject device and the predicate device –

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Image /page/5/Picture/0 description: The image shows the logo for "MEDIVATORS A Cantel Medical Company". The logo consists of a blue circular icon with several curved lines inside, followed by the word "MEDIVATORS" in blue, and the text "A Cantel Medical Company" in a smaller font size below it. The logo is simple and professional, and the blue color gives it a clean and modern look.

Olympus Disposable Suction Valve have the same valve body (subcomponent of valve that mates with the endoscope) geometry and thus are compatible with the same bronchoscope models.

Difference between Subject and Predicate Devices - The only critical difference between the subject device and the predicate device - Olympus Disposable Suction Valve is the material of construction. However subject device has the same material of composition as its other predicate - Defendo Disposable Suction Valve cleared under 510(k) - K102581. When used as indicated, the subject device will not contact the patient either directly.

A device comparison table which supports substantial equivalence of the subject device is provided below:

DeviceParameters	Subject Device –DEFENDO DisposableSuction Valve	Predicate Device –Olympus Disposable SuctionValve (K920025)	Predicate Device –DEFENDO DisposableValve (K102581)
Trade Name	DEFENDO DisposableSuction Valve	Olympus Disposable SuctionValve	DEFENDO DisposableSuction Valve
RegulationNumber	874.4680	874.4680	876.1500
Device Class	Class II	Class II	Class II
CertificationPanel	Ear, Nose & Throat	Ear, Nose & Throat	Gastroenterology/Urology
Product Code	KTI	EOQ	ODC
Indication ofUse	The DEFENDO DisposableSuction Valve is intended tobe used to control the suctionfunction of a compatiblebronchoscope during apulmonary procedure.	The OLYMPUSDISPOSABLE SUCTIONVALVE is an attachment forOlympus bronchoscopes. Thedevice is designed to fit intothe suction port of theendoscope to insure thecontrol and proper flow ofliquids (body fluids) throughthe scope without leakage.	The DEFENDO DisposableSuction Valve is intendedto be used to control thesuction function of anendoscope during a GIendoscopic procedure.
CompatibleEndoscopes	Compatible bronchoscopes	OLYMPUS® bronchoscopes	GI Endoscopes
Single Use	Yes	Yes	Yes
Suppliedsterile	Yes	Yes	Yes

Table 2 – Device Comparison Table

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Image /page/6/Picture/0 description: The image shows the logo for Medivators, a Cantel Medical Company. The logo consists of a blue circular graphic with several curved lines inside, followed by the word "MEDIVATORS" in blue, block letters. Below the company name is the text "A Cantel Medical Company" in a smaller, sans-serif font, also in blue.

4. Summary of Non-Clinical Performance Data

Medivators has conducted the following testing to demonstrate substantial equivalence of DEFENDO Disposable Suction Valve-

Design Verification Comparison Tests to Predicate Device ●
- o Valve Connection Test
- Valve Depression Force Test o
- o Suction Flow Test
Shelf-life validation ●
- o Functional Testing
- Dye Penetration Testing o
- Peel Strength Testing о
- O Visual Seal Inspection
Sterilization validation ●

5. Conclusion

Medivators Inc. has provided appropriate premarket notification information in the form of this 510(k) to support the substantial equivalence of the subject device to legally marketed predicate devices. The information and performance data provided indicates that the subject device is as safe and as effective as its predicate devices for its intended use when used in accordance with the device labeling.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.