(30 days)
No
The device description and performance studies focus on mechanical function and fluid dynamics, with no mention of AI or ML.
No
The device is described as a "cleaning adapter" used to pre-clean endoscopes post-procedure. It is explicitly stated that it is "not intended to be used with patients" and its materials are "non-patient contacting." Therapeutic devices are generally intended for direct medical treatment or diagnosis on a patient.
No
The device is described as a "Single Use Cleaning Adapter" intended for "pre-clean[ing] the endoscope's air/water channel post-procedure." Its purpose is to facilitate the cleaning of medical equipment, not to diagnose medical conditions or diseases.
No
The device description clearly states it is a "single use, non-sterile disposable valve" and lists multiple physical components like a cap, spring, and valve stem, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is explicitly for pre-cleaning the endoscope's air/water channel post-procedure. This is a cleaning and maintenance function for a medical device (the endoscope), not a diagnostic test performed on a biological sample from a patient.
- Device Description: The description reinforces that the device is a cleaning adapter used to flush air and water through the endoscope channels. It is specifically stated as not intended to be used with patients and the materials are non-patient contacting.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or condition.
IVD devices are defined as those intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This cleaning adapter does not fit this definition.
N/A
Intended Use / Indications for Use
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
Product codes
ODC
Device Description
The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are non-patient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes thru high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Olympus Single-Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The purpose of this Special 510(k) is to obtain clearance for a non-sterile version of the Defendo Fujifilm 700 Single Use Cleaning Adapter that is used on Olympus endoscopes. The non-clinical testing involved the following:
| Testing Conducted | Acceptance Criteria | Results |
|---|---|---|
| Button cycling/external leak | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
| Force to depress | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Force to Attach | Meet acceptance criteria | Pass |
The above testing is similar to testing conducted for the predicate device under 510(k), K232329.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 6. 2024
STERIS Corporation Carroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060
Re: K240352
Trade/Device Name: Defendo Single Use Cleaning Adapter for Olympus Endoscopes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 5, 2024 Received: February 5, 2024
Dear Carroll Martin:
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 (QS) 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,
Sivakami Venkatachalam -S
for
Shanil P. Haugen. Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K240352
Device Name
Defendo Single Use Cleaning Adapter for Olympus Endoscopes
Indications for Use (Describe)
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel postprocedure, and not to be used during a patient procedure.
Type of Use (Select one or both, as applicable)X 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 STERIS logo. The logo consists of the word "STERIS" in large, bold, sans-serif font, with the registered trademark symbol to the right of the word. Below the word is an image of several horizontal wavy lines stacked on top of each other. At the top right of the image is the text "K240352 Page 1 of 4".
510(k) Summary For Defendo Single Use Cleaning Adapter for Olympus Endoscopes
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact:
Carroll Martin Regulatory Affairs Director Tel: 440-358-6259 Email: Carroll_Martin@steris.com
Submission Date: February 5, 2024
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
4
1. Device Name
| Trade Name: | Defendo Single Use Cleaning Adapter for Olympus
Endoscopes |
|--------------------|---------------------------------------------------------------|
| Device Class: | Class II |
| Regulation Name: | Endoscope and Accessories |
| Common/usual Name: | Cleaning Adapter |
| Regulation Number: | 21 CFR 876.1500 |
| Product Code: | ODC |
2. Predicate Device
Defendo Fujifilm 700 Single Use Cleaning Adapter, K232329
3. Device Description
This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.
The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are non-patient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes thru high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Olympus Single-Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.
4. Indications for Use
The Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.
5
5. Technological Characteristics Comparison Table
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | Defendo Fujifilm 700 Single
Use Cleaning Adapter,
K232329 – Predicate Device | Defendo Cleaning
Adapter for Olympus
Endoscopes- Modified
Device | Comparison |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | The Single Use Cleaning
Adapter is intended to be used
only to pre-clean the
endoscope's air/water channel
post-procedure, and not to be
used during a patient
procedure. | The Single Use Cleaning
Adapter is intended to be
used only to pre-clean the
endoscope's air/water
channel post-procedure,
and not to be used during
a patient procedure. | Identical |
| Construction | Cap
Cap Colorant - Yellow
Spring
Spring cup (substrate)
Boot (overmold)
Cleaning Valve stem
Valve stem sealing gaskets (5)
Gaskets Colorant - Black | Cap
Cap Colorant - Orange
Spring
Spring cup (substrate)
Boot (overmold)
Cleaning Valve Stem
Valve stem backflow
umbrella valve
Valve stem sealing gaskets
(4)
Gaskets Colorant - Black | Similar
The only difference is the
proposed device has a valve
stem backflow umbrella
valve. This component is
not utilized in the function
of the proposed device as
there are no concerns for
preventing backflow. It is
generated from the current
mold used in manufacturing. |
| Sterile/Non-
sterile | Sterile | Non-Sterile | Different
Although the predicate
device is sterile and the
proposed is non-sterile, this
does not impact safety,
effectiveness or how the
device is used. Sterility is
not critical for the device
because it is not used in
patient procedures and the
endoscopes on which it is
used go on for further
processing. 1 |
Table 1. Technological Characteristics Comparison Table
1 Please note that there have been other devices cleared by FDA that are used in a non-sterile condition that either have direct contact with an endoscope after processing that will be used in a patient (ProArmor Endoscope Tip Protector, K191715) or contact a patient directly (Roth Net, K182909). Whereas these do not have the same intended use as the Olympus Cleaning Adapter, they are non-sterile devices that will come in contact with a patient.
6
6. Summary of Non-Clinical Performance Testing
The purpose of this Special 510(k) is to obtain clearance for a non-sterile version of the Defendo Fujifilm 700 Single Use Cleaning Adapter that is used on Olympus endoscopes. The non-clinical testing involved the following:
| Testing Conducted | Acceptance Criteria | Results |
|---|---|---|
| Button cycling/external leak | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
| Force to depress | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Force to Attach | Meet acceptance criteria | Pass |
The above testing is similar to testing conducted for the predicate device under 510(k), K232329.
Conclusion
Based on the intended use, technological characteristics and non-clinical performance data, the subject device is substantially equivalent to the legally marketed predicate device, Defendo Fujifilm 700 Single Use Cleaning Adapter, K232329, Class II (21 CFR 876.1500), product code ODC.