(104 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a disposable suction valve, with no mention of AI or ML.
No.
The device controls the function of another device (bronchoscope) but does not directly provide therapy or interact therapeutically with the patient.
No
Explanation: The device description states its purpose is to control the suction function of a bronchoscope during pulmonary procedures to remove fluids. This is a functional role within a medical procedure, not a diagnostic one. There is no mention of it being used to identify or analyze a medical condition.
No
The device description explicitly states it is a "sterile, single use, disposable medical device" designed to be "attached to the suction port of a bronchoscope," indicating it is a physical hardware component. The performance studies also focus on physical characteristics like valve connection, depression force, suction flow, and sterilization.
Based on the provided information, the DEFENDO Disposable Suction Valve is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control suction during a pulmonary procedure using a bronchoscope. This is a direct interaction with the patient's body during a medical procedure, not an in vitro test performed on samples outside the body.
- Device Description: The device is described as being attached to a bronchoscope and controlling the flow of fluids from the patient. This confirms its use within the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical control of suction during a procedure.
Therefore, the DEFENDO Disposable Suction Valve falls under the category of a surgical or procedural device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The DEFENDO Disposable Suction Valve is intended to be used to control the suction function of a compatible bronchoscope during a pulmonary procedure.
Product codes (comma separated list FDA assigned to the subject device)
KTI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
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)
Medivators has conducted the following testing to demonstrate substantial equivalence of DEFENDO Disposable Suction Valve-
- 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 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.
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.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
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
1
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
2
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 Shah |
| Sr. 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
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.
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:
| Device
Parameters | Subject Device –
DEFENDO Disposable
Suction Valve | Predicate Device –
Olympus Disposable Suction
Valve (K920025) | Predicate Device –
DEFENDO Disposable
Valve (K102581) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | DEFENDO Disposable
Suction Valve | Olympus Disposable Suction
Valve | DEFENDO Disposable
Suction Valve |
| Regulation
Number | 874.4680 | 874.4680 | 876.1500 |
| Device Class | Class II | Class II | Class II |
| Certification
Panel | Ear, Nose & Throat | Ear, Nose & Throat | Gastroenterology/Urology |
| Product Code | KTI | EOQ | ODC |
| Indication of
Use | The DEFENDO Disposable
Suction Valve is intended to
be used to control the suction
function of a compatible
bronchoscope during a
pulmonary procedure. | The OLYMPUS
DISPOSABLE SUCTION
VALVE is an attachment for
Olympus bronchoscopes. The
device is designed to fit into
the suction port of the
endoscope to insure the
control and proper flow of
liquids (body fluids) through
the scope without leakage. | The DEFENDO Disposable
Suction Valve is intended
to be used to control the
suction function of an
endoscope during a GI
endoscopic procedure. |
| Compatible
Endoscopes | Compatible bronchoscopes | OLYMPUS® bronchoscopes | GI Endoscopes |
| Single Use | Yes | Yes | Yes |
| Supplied
sterile | 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.