(140 days)
The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
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.
The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.
The provided text describes the acceptance criteria and the study conducted for Medivators' Defendo Fujifilm 700 Single-Use Valves Set, which includes several types of valves and a cleaning adapter. It's important to note that this submission is for accessories to endoscopes, not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical questions related to AI/SaMD (like ground truth, expert adjudication, MRMC studies, training set details) are not applicable to this type of device clearance.
The study focuses on demonstrating the substantial equivalence of these new single-use accessories to existing predicate devices, primarily through engineering and performance testing, and biocompatibility.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with numerically reported device performance against those criteria in a summary format. Instead, it describes various "Non-Clinical Performance Testing" conducted for each component (Air/Water Valve, Suction Valve, Biopsy Valve, Auxiliary Waterjet Valve (Connector), Cleaning Adapter). The conclusion states that the "subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use," implying that all tests performed achieved their respective pass/fail criteria.
However, we can infer the types of acceptance criteria from the performed tests:
| Device Component | Type of Testing and Implied Acceptance Criteria | Reported Device Performance (Implied) |
|---|---|---|
| Air/Water Valve | - Gas (Air and CO2) flow rate testing: Likely to ensure sufficient airflow for insufflation. - Water flow rate testing: Likely to ensure sufficient water flow for lens washing. - Backflow prevention testing: To prevent backflow of contents. - Mechanical testing: - Depression Force - Valve Application Force - Valve Removal Force - Force to Disassemble via Axial Pull (Ensures proper function, insertion, removal, and integrity). - Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
| Suction Valve | - Suction Bypass: To ensure proper suction path. - Suction Rate (water and soil): To demonstrate adequate aspiration capability. - Mechanical testing: - Depression Force - Valve Application Force - Valve Removal Force - Force to Disassemble via Axial Pull (Ensures proper function, insertion, removal, and integrity). - Valve Operation / Procedure Duration Test: To ensure durability and consistent performance throughout a typical endoscopic procedure duration. | Met criteria (Substantially Equivalent) |
| Biopsy Valve | - Workability / Instrument Access Testing: To ensure smooth passage and exchange of endoscopic instruments. - Slit Length / Dimensional Stability: To maintain proper sealing and instrument passage. - Confirmatory testing: To ensure continued performance as intended, especially given the change in sterility status compared to a prior predicate. | Met criteria (Substantially Equivalent) |
| Auxiliary Waterjet Valve (Connector) | - Flow Rate / Durability Testing: To ensure adequate irrigation flow and sustained performance. - Backflow Prevention Test: To prevent backflow. | Met criteria (Substantially Equivalent) |
| Cleaning Adapter | - Gas Flow Rate: To ensure proper air channel cleaning. - Water Flow Rate: To ensure proper water channel cleaning. - Mechanical Testing: - Depression Force - Adapter Application Force - Adapter Removal Force (Ensures proper function, insertion, and removal). - Button Cycling / Durability Testing: To ensure repeated functional use for pre-cleaning. | Met criteria (Substantially Equivalent) |
| Packaging | - ISO 11607/ASTM 4169 testing: To ensure sterile barrier maintenance after shipping/transit. | Met criteria (Sterile Barrier Maintained) |
| Biocompatibility | - ISO 10993-1 assessment: "Biocompatibility testing conducted on the patient-contacting portions... in accordance with the ISO 10993 standard." "The test result shows that the subject devices are biocompatible." | Met criteria (Biocompatible) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (N) for each of the performance tests. It states that "Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination."
Data provenance: The testing was performed by Medivators (A Subsidiary of STERIS Corporation) in Conroe, Texas, USA. It's engineering performance test data, not patient data, so "country of origin of the data" in the sense of patient demographics is not applicable. The data is retrospective based on the tests performed for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as this is a 510(k) submission for physical medical device accessories (valves, connectors, adapters), not an AI/software device that requires human expert review for "ground truth" establishment from medical images or clinical data. The "ground truth" for these performance tests is based on engineering specifications, physical measurements, and functional requirements.
4. Adjudication method for the test set
Not applicable, as this is related to expert consensus for AI/SaMD ground truth, which is not relevant for this device.
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
Not applicable. This is not an AI/SaMD.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD.
7. The type of ground truth used
The "ground truth" for the performance of these physical accessories is defined by established engineering and functional specifications, industry standards (e.g., ISO 11607 for packaging, ISO 10993 for biocompatibility), and the performance of the legally marketed predicate devices. The tests verify that the subject devices meet these specifications for safe and effective use.
8. The sample size for the training set
Not applicable. This is not an AI/SaMD, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable.
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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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2023
Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303
Re: K232329
Trade/Device Name: Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC, FDF, OCX, FEQ Dated: November 21, 2023 Received: November 21, 2023
Dear Nick Wang:
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.
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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).
Your device is also subject to, among other requirements, the Ouality 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 medical devices and radiation-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).
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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
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Indications for Use
510(k) Number (if known) K232329
Device Name
Defendo Fujifilm 700 Single Use Biopsy Valve; Defendo Fujifilm 700 Single Use Air/Water Valve; Defendo Fujifilm 700 Single Use Suction Valve; ENDOGATOR Fujifilm 700 Single Use Connector; Defendo Fujifilm 700 Single Use Cleaning Adapter
Indications for Use (Describe)
The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Single Use Suction Valve is intended to be used to control the suction on an endoscope during a GI endoscopic procedure.
The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
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) | |
|---|---|
| </span> Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K232329 Page 1 of 11
510(k) Summary
Defendo Fujifilm 700 Single-Use Valves Set
| Manufacturer: | Medivators3150 Pollok DriveConroe, TX 77303 |
|---|---|
| Submitter: | Nick Wang, Ph.D. RACSenior Manager, Regulatory AffairsPhone: 440-392-7482 |
06 Dec 2023 Summary Date:
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1. Device Name
| Trade Name: | Defendo Fujifilm 700 Single-Use Valves Set |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Defendo Fujifilm 700 Single Use Biopsy Valve;Defendo Fujifilm 700 Single Use Air/WaterValve; Defendo Fujifilm 700 Single UseSuction Valve; ENDOGATOR Fujifilm 700Single Use Connector; Defendo Fujifilm 700Single Use Cleaning Adapter |
| Classification Name: | Endoscope and accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | ODC, FDF, OCX, and FEQ |
2. Predicate Device(s)
Primary predicate is listed first:
K102409 - Defendo Disposable Air/Water Valve Model 100304
K102581 - Defendo Disposable Suction Valve Model 100305
K210342 - BioShield- Biopsy Valve
K220395 - Endogator Endoscopy Irrigation Tubing
K172916 - FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L
and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 (Air/Water Cleaning Adapter)
3. Description of Device
The Defendo Fujifilm 700 Single-Use Valves Set consists of a family of ready-to-use, sterile, single-use valves designed to be used on the Fujifilm 700 series GI endoscopes as accessories. The specific valves that are the subject of this 510(k) include the Defendo Fujifilm 700 Single-Use Air/Water Valve, the Defendo Fujifilm 700 Single-Use Suction Valve, the Defendo Fujifilm 700 Single Use Biopsy Valve, the Endogator Fujifilm 700 Connector, and the Defendo Fujifilm 700 Cleaning Adapter.
- . The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's air/water feed channels and control the water used to wash the lens of the endoscope during an endoscopic procedure.
- The Suction valve allows the user to control suction through the endoscope's accessory channel and serves as a fluid-removal conduit to aspirate fluids from the patient. This allows the clinician to remove fluids/soil from the GI tract during an endoscopic procedure.
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- The Biopsy valve allows instruments/devices to be passed through it while maintaining insufflation, allowing suction, and guiding instruments through the biopsy channel during endoscopic procedures.
- The Connector allows attachment between the irrigation tube set via its luer connection and the compatible endoscope at its dedicated auxiliary water connection. This is sometimes also referred to as the auxiliary water jet valve.
- The Cleaning Adapter allows the user to pre-clean the air and water channels at the bedside prior to endoscope reprocessing.
These valves are supplied in various sets. Each set may include combinations of two or more of the valves listed above.
4. Intended Use
The Single Use Biopsy Valve is intended for covering the endoscope biopsy port during an endoscopy procedure. The Single Use Biopsy Valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Single Use Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.
The Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The Single Use ENDOGATOR™ Connector is intended to be used in conjunction with ENDOGATOR™ Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures when used with an irrigation pump (or cautery unit).
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.
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5. Technological Characteristic Comparison Table
Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table – Air / Water Valve
| Feature | Defendo Fujifilm 700Single-Use Air/WaterValve(Subject Device) | Defendo DisposableAir/Water Valve(Predicate K102409) | Comparison |
|---|---|---|---|
| Intended use | The Single UseAir/Water Valve isintended to be used tocontrol the air/waterfunction on anendoscope during a GIendoscopic procedure. | The Defendo DisposableAir/Water Valve isintended to be used tocontrol the air/waterfunction on anendoscope during a GIendoscopic procedure. | Same |
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single-Use | Single-Use | Same |
| Main DeviceDimensions(lengths/widths) | Air/Water Valve:Length: ~43.5 mmDiameter: ~19.2 mm | Air/Water Valve:Length: ~46 mmDiameter: ~17 mm | Similar, theslightdifferences aredue to thedifferences inthe endoscopeport. |
| Target Population | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Fujifilm 700 series GIendoscope | Olympus endoscope | Reason for this510(k) |
| Packaging | Supplied as a kit inPETG Tray with TyvekLid | Supplied individually inTyvek Pouch | Packagesystems allmaintain sterilebarrier |
| Table 2. Proposed/Predicate Device Technological Characteristics |
|---|
| Comparison Table – Suction Valve |
| Feature | Defendo Fujifilm 700Single-Use SuctionValve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
|---|---|---|---|
| Intended Use | The Single UseSuction Valve is | The DefendoDisposable Suction | Same |
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| Feature | Defendo Fujifilm 700Single-Use SuctionValve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
|---|---|---|---|
| intended to be used tocontrol the suctionfunction on anendoscope during a GIendoscopic procedure. | Valve is intended to beused to control thesuction function on anendoscope during a GIendoscopic procedure. | ||
| Sterile/Non-sterile | Sterile | Sterile | Same |
| Sterilization Method | EtO | EtO | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single-Use | Single-Use | Same |
| Main DeviceDimensions(lengths/widths) | Suction Valve:Length: ~28.0 mmDiameter: ~17.2 mm | Suction Valve:Length: ~27 mmDiameter: ~18 mm | Similar, theslightdifferencesare due to thedifferences intheendoscopeport. |
| Target Population | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Fujifilm 700 series GIendoscope | Olympus endoscope | Reason forthis 510(k) |
| Packaging | Supplied as a kit inPETG Tray with TyvekLid | Supplied individually inTyvek Pouch | Packagesystems allmaintainsterile barrier |
Table 5-3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve
| Feature | Defendo Single-UseFujifilm 700 BiopsyValves(Subject Device) | BioShield BiopsyValve (for FujifilmEndoscopes)(Predicate K210342) | Comparison |
|---|---|---|---|
| Intended Use | The Single Use BiopsyValve is intended forcovering the endoscopebiopsy port during anendoscopy procedure.The single use BiopsyValve provides accessfor endoscopic device | The single-useBioShield biopsyvalve is used to coverthe opening to thebiopsy/suctionchannel ofgastrointestinalendoscopes. It | SimilarThe intended usefor the subjectdevice biopsy valveis identical to thatof other DefendoBiopsy Valves |
| Feature | Defendo Single-UseFujifilm 700 BiopsyValves(Subject Device) | BioShield BiopsyValve (for FujifilmEndoscopes)(Predicate K210342) | Comparison |
| passage and exchange,helps maintainsufflation, andminimizes leakage ofbiomaterial from thebiopsy port throughoutthe endoscopicprocedure. | provides access forendoscopic devicepassage andexchange, helpsmaintain insufflation,minimizes leakage ofbiomaterial from thebiopsy portthroughout theendoscopic procedureand provides accessfor irrigation. | currently marketedby Medivators. Theminor differences inlanguage betweenthe BioShield andDefendo valves aremainly editorial innature and do notrepresent adifferent intendeduse. | |
| Sterile/Non-sterile | Sterile | Sterile and Non-Sterile | See note below |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssuranceLevel | 10-6 | 10-6 | Same |
| Usage | Single-Use | Single-Use | Same |
| Main DeviceDimensions(lengths/widths) | Length: ~16.8 mmWidth (handle to tip):~32.4 mm | Length: ~16.8 mmWidth (handle to tip):~32.4 mm | Same |
| TargetPopulation | Patients undergoing anendoscopic procedure | Patients undergoingan endoscopicprocedure | Same |
| Energy Used/Delivered | None | None | Same |
| CompatibleEndoscopes | Fujifilm 700 series GIendoscope | Fuji Gen 5 or laterendoscopes | Same |
| Packaging | Continue to be suppliedindividually in TyvekPouch (predicate) andsupplied as a set inPETG Tray with TyvekLid (new). | Supplied individually inTyvek Pouch | Package systemsall maintain sterilebarrier |
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Note: Defendo Fujifilm 700 Single Use Biopsy Valve, the subject valve, is identical to the black non-sterile BioShield Biopsy Valve from K210342, with the only difference is that the subject device is EO sterilized in the valves set. Device testing included in K210342 on both the sterile and non-sterile blue BioShield Biopsy Valves provides evidence that EO sterilization does not negatively affect device performance and both the sterile and non-sterile versions of the device met the performance requirements and performed as expected as the biopsy valve. In this submission, STERIS performed additional confirmatory testing to ensure the biopsy valve included in the subject device (black sterile) continued to perform as intended.
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| Feature | Endogator Fujifilm 700Connector(Subject Device) | EndogatorConnector(Predicate K220395) | Comparison |
|---|---|---|---|
| Intended Use | The Single UseENDOGATOR™Connector is intended tobe used in conjunctionwith ENDOGATOR™Irrigation Tubing toprovide irrigation viasterile water during Glendoscopic procedureswhen used with anirrigation pump (orcautery unit). | The Endogatorsystem is intended toprovide irrigation viasterile water supplyduring GI endoscopicprocedure when suedin conjunction with anirrigation pump (orcautery unit). | Similar(Languagemodified for thesubject deviceto reflect theconnectorprovided doesnot include theEndogatortubing) |
| Sterile/Non-sterile | Sterile | Sterile | Same |
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single-Use | Single-Use | Same |
| Main DeviceDimensions(lengths/widths) | Length: ~22 mmDiameter: ~12.7 mm | Length: ~22 mmDiameter: ~12.7 mm | Same |
| Target Population | Patients undergoing anendoscopic procedure | Patients undergoing anendoscopic procedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| CompatibleEndoscopes | Fujifilm 700 series GIendoscope | None specified(commonly used withFujifilm endoscopes) | Same |
| Packaging | Continue to be suppliedindividually in TyvekPouch (predicate) andsupplied as a set inPETG Tray with TyvekLid (new). | Supplied individually inTyvek Pouch | Packagesystems allmaintain sterilebarrier |
Table 5-4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector
Note: Endogator Fujifilm 700 Connector (subject device) is the same as the Endogator Backflow Valve in the Endogator system (predicate device). The backflow valve is commonly used as the Auxiliary Water Jet Connector for the Fujifilm 700 Series endoscopes. Testing has been performed to provide evidence that the valve is compatible with and functions as intended when used with the Fujifilm 700 series GI endoscopes
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Table 5-5. Proposed/Predicate Device Technological Characteristics Comparison Table – Cleaning Adapter
| Feature | Defendo Fujifilm700 Single-UseCleaningAdapter(Subject Device) | FUJIFILM EndoscopeModels EG-760R, EG-760Z, EC-760R-V/Land EC-760ZP-V/L,and FUJIFILM WaterTank Model WT-603(Predicate K172916) | Comparison |
|---|---|---|---|
| Intended use | The Single UseCleaning Adapteris intended to beused only to pre-clean theendoscope'sair/water channelpost-procedure,and not to beused during apatient procedure. | The predicate reusableair/water channelcleaning adapter is anaccessory to Fujifilm700 endoscopes. Whileno indications for usefor the accessory isdirectly stated. Theadapter's intendedpurpose is to pre-cleanthe endoscope'sair/water channel post-procedure.The cleared indicationsfor use statementprovide in the predicate510(k) is the indicationsfor use statement of theentire endoscope, notjust the cleaningadapter accessory.# | Same, the intendedpurposes of thepredicate andsubject cleaningadapters are thesame. |
| Sterility | Sterile | Non-Sterile | While sterility is notcritical for theadapter application,the subject adapteris provided sterile asit is in the samepackagingconfiguration as theother valves in theset. |
| Usage | Single-Use | Reprocessed | Reason for this510k, subjectadapter is a single-use adapter,whereas thepredicate is reusableand requiresreprocessing.Single-useconfigurationmitigates the risk of |
| Feature | Defendo Fujifilm700 Single-UseCleaningAdapter(Subject Device) | FUJIFILM EndoscopeModels EG-760R, EG-760Z, EC-760R-V/Land EC-760ZP-V/L,and FUJIFILM WaterTank Model WT-603(Predicate K172916) | Comparison |
| Main DeviceDimensions(lengths/widths) | Length: ~45.7 mmDiameter: ~19.2mm | Length: ~45.8 mmDiameter: ~18.7 mm | Similar, the minordifference do notaffect deviceperformance. |
| TargetPopulation | Patientsundergoing anendoscopicprocedure. Thecleaning adapterdoes not have anypatient contact asit is used post-procedure. | Patients undergoing anendoscopic procedure.The cleaning adapterdoes not have anypatient contact as it isused post-procedure. | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Fujifilm 700 SeriesGI endoscope | Fujifilm 700 Series Glendoscope | Same |
| Packaging | Supplied as a setin PETG Tray withTyvek Lid | Supplied withendoscope orindividually | Subject devicepackage systemmaintains sterilebarrier |
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The indications for use listed in the predicate 510k summary is the following: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L, and EC-760ZP-V/L have following indications for use.
FUJIFILM Endoscope Models EG-760R and EG-760Z are upper gastrointestinal endoscopes intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
FUJIFILM Endoscope Models EC-760R-V/L and EC-760ZP-V/L are lower gastrointestinal endoscopes intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine. FUJIFILM Water Tank Model WT-603 has following indications for use. The Water Tank Model WT-603 is intended for use in combination with FUJIFILM 700 system scopes to deliver air and water through the endoscope under the management of a physician in medical facilities. Do not use this product for any other purpose.
4. Non-Clinical Performance Testing
Non-clinical performance testing was performed on the subject device to support the substantial equivalence determination. The following tests were performed:
Air / Water Valve
- Gas (Air and CO2) flow rate testing ●
- Water flow rate testing ●
- Backflow prevention testing ●
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- Mechanical testing ●
- Depression Force O
- Valve Application Force O
- o Valve Removal Force
- o Force to Disassemble via Axial Pull
- Valve Operation / Procedure Duration Test .
Suction Valve
- Suction Bypass ●
- Suction Rate (water and soil) ●
- Mechanical testing .
- o Depression Force
- o Valve Application Force
- o Valve Removal Force
- o Force to Disassemble via Axial Pull
- . Valve Operation / Procedure Duration Test
Biopsy Valve
- Workability / Instrument Access Testing .
- Slit Length / Dimensional Stability .
Auxiliary Waterjet Valve (Connector)
- Flow Rate / Durability Testing ●
- Backflow Prevention Test ●
Cleaning Adapter
- . Gas Flow Rate
- Water Flow Rate ●
- Mechanical Testing ●
- Depression Force o
- Adapter Application Force o
- Adapter Removal Force O
- Button Cycling / Durability Testing ●
In addition to performance testing, ISO 11607/ASTM 4169 testing was completed to ensure the packaging of the subject device kit maintained sterile barrier after shipping/transit.
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5. Biocompatibility
The biocompatibility of the subject devices was assessed in accordance with the FDA guideline "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process". Biocompatibility testing conducted on the patient-contacting portions of the subject device in accordance with the ISO 10993 standard. The test result shows that the subject devices are biocompatible.
6. Conclusion
Based on the intended use, technological characteristics, non-clinical performance testing, and biocompatibility assessment, the subject device has shown to be substantially equivalent to the predicate and having met the acceptance criteria based on its indications for use.
§ 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.