(42 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics, with no mention of AI/ML algorithms or data processing.
No
The device is described as a cleaning adapter used to pre-clean endoscopes post-procedure and is not intended for use with patients, indicating it's a accessory for device maintenance, not a therapeutic device.
No.
The device is intended for cleaning endoscopes post-procedure, not for diagnosing any medical condition in a patient.
No
The device description clearly outlines a physical, single-use, sterile disposable valve with multiple components (cap, spring, boot, stem, etc.) used for flushing endoscope channels. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to pre-clean an 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 used "as part of the pre-cleaning process" and "to help clear the air/water channel." It explicitly states it is "not intended to be used with patients."
- Lack of Diagnostic Activity: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing information about a patient's health status, disease, or condition.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the cleaning adapter (button cycling, flow rates, attachment forces, etc.), not on diagnostic accuracy or clinical performance related to patient diagnosis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Single Use Cleaning Adapter is intended to be used only to pre-clean an 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, 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 nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through 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 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing involved:
- Button cycling/leak test: Pass
- Fluid Flow Path: Pass
- Air Flow Rate: Pass
- CO2 Flow Rate: Pass
- Water Flow Rate: Pass
- Backpressure Hold Test: Pass
- Valve to Port Attachment Force: Pass
- Valve to Port Removal Force: Pass
- Valve Depression Force: Pass
- Cap breakage strength: Pass
- Sterile Barrier: Visual Inspection: Pass
- Sterile Barrier: Dye Penetration: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 8, 2024
Steris Corporation Disha Kabrawala Senior Regulatory Affairs Specialist 14605 28th Avenue North Minneapolis, Minnesota 55447
Re: K243075
Trade/Device Name: Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323,4000096,4003269,4003280) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: September 27, 2024 Received: September 27, 2024
Dear Disha Kabrawala:
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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Shanil P. Haugen -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323.4000096.4003269. 4003280)
Indications for Use (Describe)
The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope's air/water channel post-procedure, and not to be used during a patient 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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4
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510(k) Summary For Defendo Single Use Cleaning Adapter for Olympus Endoscopes
STERIS Corporation 5960 Heisley Road Mentor, OH 44060
Contact: Disha Kabrawala Senior Regulatory Affairs Specialist Tel: 732-319-7766 Email: disha kabrawala@steris.com
Submission Date: November 6, 2024
STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600
5
1. Device Name
| Trade Name: | Defendo Olympus Single Use Cleaning Adapter for
Olympus Endoscopes (100322, 100323, 4000096,
4003269, 4003280) |
|--------------------|----------------------------------------------------------------------------------------------------------------------|
| 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 Single Use Cleaning Adapter for Olympus Endoscopes, K240352.
Device Description 3.
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, 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 nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through 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 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.
6
Technological Characteristics Comnarison Table 5.
A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.
| Features | Defendo Olympus Single
Use Cleaning Adaptor,
K240352
- Predicate Device | Defendo Cleaning Adaptor
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 - Orange
Spring
Spring cup (substrate)
Boot (overmold)
Cleaning Valve stem
Valve stem backflow umbrella
valve
Valve stem sealing gaskets (4)
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 | Identical |
| Sterile/Non-
sterile | Non-Sterile | Sterile | Different
Although the predicate device is non-
sterile and the proposed is sterile, the
testing provided in this submission
shows that this change does not
impact safety, effectiveness or how
the device is used. |
| Sterilization
Method | None | EtO | Different
Ethylene oxide sterilization is a
commonly used sterilization method
and the testing provide in this
submission shows that sterilization
does not impact the safety or
effectiveness of the device or how it's
used. packaging as the procedural
valves. |
| Sterilization
Assurance
Level | None | 10-6 | Different
The testing provide in this submission
shows that sterilization does not
impact the safety or effectiveness of
the device or how it's used. |
| Usage | Single use | | Identical |
| Materials
(by component) | Cap – Polycarbonate | Cap - Polycarbonate | Identical |
| | Cap Colorant – Mevopur
Orange NC2M820004-ZN | Cap Colorant – Mevopur
Orange NC2M820004-ZN | Identical |
| | Spring – Stainless steel | Spring - Stainless steel | |
| | Spring Cup (substrate) –
Polycarbonate | Spring Cup (substrate) -
Polycarbonate | |
| | Boot (overmold) –
Thermoplastic elastomer | Boot (overmold) –
Thermoplastic elastomer | |
| | Valve Stem – Polycarbonate | Valve Stem - Polycarbonate | |
| | Valve Stem Colorant –
Mevopur Orange
NC2M820004-ZN | Valve Stem Colorant -
Mevopur Orange
NC2M820004-ZN | |
| | Valve stem sealing gaskets –
Thermoplastic elastomer | Valve stem sealing gaskets -
Thermoplastic elastomer | |
| | Valve stem backflow umbrella
valve – Thermoplastic
elastomer | Valve stem backflow umbrella
valve - Thermoplastic
elastomer | |
| | Gasket colorant - Clariant
Mevopur PE9SAA17700 PE
2% Black | Gasket colorant - Clariant
Mevopur PE9SAA17700 PE
2% Black | |
Table 1. Technological Characteristics Comparison Table
7
6. Summary of Non-Clinical Performance Testing
The purpose of this Special 510(k) is to obtain clearance for a sterile version of the Defendo Cleaning Adapter that is used on Olympus endoscopes. The non-clinical testing involved the following:
| Testing Conducted | Acceptance Criteria | Results |
|---|---|---|
| Button cycling/leak test | Meet acceptance criteria | Pass |
| Fluid Flow Path | Meet acceptance criteria | Pass |
| Air Flow Rate | Meet acceptance criteria | Pass |
| CO2 Flow Rate | Meet acceptance criteria | Pass |
| Water Flow Rate | Meet acceptance criteria | Pass |
| Backpressure Hold Test | Meet acceptance criteria | Pass |
| Valve to Port Attachment Force | Meet acceptance criteria | Pass |
| Valve to Port Removal Force | Meet acceptance criteria | Pass |
| Valve Depression Force | Meet acceptance criteria | Pass |
| Cap breakage strength | Meet acceptance criteria | Pass |
Non-clinical testing consisted of the following:
Packaging Testing:
| Testing Conducted | Acceptance Criteria | Results |
|---|---|---|
| Sterile Barrier: Visual Inspection | Meet acceptance criteria | Pass |
| Sterile Barrier: Dye Penetration | Meet acceptance criteria | Pass |
8
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 Single Use Cleaning Adapter for Olympus Endoscopes, K240352, Class II (21 CFR 876.1500), product code ODC.