(244 days)
The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax 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, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).
The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.
The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel 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.
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 tubset 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.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
The provided text describes a 510(k) premarket notification for a set of single-use endoscopy valves. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study with acceptance criteria for device performance. Therefore, the document does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria, such as clinical effectiveness or diagnostic accuracy.
The document discusses non-clinical performance testing to support substantial equivalence, but these tests are not presented as meeting specific clinical acceptance criteria or performed as a comparative effectiveness study with human readers or standalone algorithm performance.
Here's an attempt to answer your questions based on the available information, noting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not use the term "acceptance criteria" for clinical performance. Instead, it describes non-clinical performance testing conducted to demonstrate the safety and effectiveness of the device as substantially equivalent to predicate devices. The "reported device performance" are the results of these non-clinical tests.
| Device Component | Test Performed | Implicit "Acceptance Criteria" (Substantial Equivalence) | Reported Performance (Implied "Met") |
|---|---|---|---|
| Air/Water Valve | Gas (Air and CO2) flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Water flow rate | Comparable flow rates to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Backflow prevention | Effective prevention of backflow, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Suction Valve | Suction Bypass | Effective suction bypass, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Suction Rate (water and soil) | Effective suction of water and soil at rates comparable to predicate device or within acceptable range for intended function. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical testing (Depression Force, Valve Application Force, Valve Removal Force, Sonic Weld Break Testing) | Forces within acceptable ergonomic and functional range, comparable to predicate. Structural integrity maintained. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Valve Operation / Procedure Duration Test | Consistent and reliable operation throughout simulated procedure duration, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Biopsy Valve | Leak Testing | Minimal or no leakage, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Insufflation Testing | Effective maintenance of insufflation, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Auxiliary Waterjet (Connector) | Flow Durability Testing | Durable flow comparable to predicate, capable of extended use as intended. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. |
| Check Valve Functionality (Back Flow Prevention) | Effective backflow prevention, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| Mechanical Strength Testing | Adequate mechanical strength for intended use, comparable to predicate. | Testing performed; results deemed sufficient to demonstrate substantial equivalence to predicate device. | |
| All Devices | Packaging Testing (ISO 11607/ASTM 4169) | Packaging maintains sterile barrier after shipping/transit, demonstrating sterility assurance. | Testing completed; packaging maintains sterile barrier. |
| All Devices | Biocompatibility (ISO 10993) | Patient-contacting portions of the device are biocompatible. | Test results show the subject devices are biocompatible. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size for individual non-clinical tests (e.g., how many valves were tested for flow rate or mechanical properties). It refers to "testing" as being performed on "the subject device."
The data provenance is from non-clinical performance testing conducted by the manufacturer, Medivators (A Subsidiary of STERIS Corporation), located in Conroe, TX 77303, USA. These are laboratory-based tests, not clinical data from patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this 510(k) submission. The "ground truth" concept is typically relevant for studies involving diagnostic accuracy or clinical outcomes where human expert assessment is needed. This submission relies on engineering and laboratory testing for functional performance and safety.
4. Adjudication Method for the Test Set
This information is not applicable to this 510(k) submission. Adjudication methods (like 2+1 or 3+1) are used in clinical trials to establish a definitive diagnosis or outcome, often from multiple expert opinions. The testing mentioned here is non-clinical and lab-based.
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
This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic imaging devices, often involving AI. The devices described here are single-use endoscopic valves, which are mechanical accessories, not diagnostic imaging devices or AI tools.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. Standalone algorithm performance is relevant for AI-based devices. The devices described here are mechanical endoscopic accessories.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The document speaks of "non-clinical performance testing" and "biocompatibility assessment" to demonstrate substantial equivalence to predicate devices. The "ground truth," in this context, would be the established functional performance characteristics and safety profiles of the predicate devices, along with relevant engineering standards and regulatory requirements. It is based on engineering benchmarks, physical measurements, and internationally recognized standards (e.g., ISO 10993 for biocompatibility, ISO 11607/ASTM 4169 for packaging).
8. The Sample Size for the Training Set
This information is not applicable. A "training set" refers to data used to train machine learning algorithms. The devices described are mechanical accessories and do not involve AI or machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 6, 2024
Medivators (A Subsidiary of STERIS Corporation) Nick Wang Senior Manager, Regulatory Affairs 3150 Pollok Drive Conroe, Texas 77303
Re: K232004
Trade/Device Name: Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: ODC Dated: February 2, 2024 Received: February 2, 2024
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.
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"
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(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.
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).
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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) K232004
Device Name
Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Valve, Endogator Pentax Single Use Connector
Indications for Use (Describe)
The Defendo Pentax Single Use Air/Water Valve is intended to control the air/water function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax Single Use Suction Valve is intended to control the suction function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax 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, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endogator Pentax Single Use Connector is intended to be used in conjunction with Endogator Irrigation Tubing to provide irrigation via sterile water during GI endoscopic procedures with an irrigation pump (or cautery unit).
| 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/4/Picture/0 description: The image shows the STERIS logo. The logo includes the word "STERIS" in large, bold, sans-serif font. Above the word STERIS is the text "K232004 Page 1 of 9" in a smaller font. Below the word STERIS is a graphic of several horizontal wavy lines in blue.
510(k) Summary
Defendo Pentax Single Use Valves Set
| Manufacturer: | Medivators3150 Pollok DriveConroe, TX 77303 |
|---|---|
| Submitter: | Nick Wang, Ph.D. RACSenior Manager, Regulatory AffairsPhone: 440-392-7482 |
- 29 February 2024 Summary Date:
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1. Device Name
| Trade Name: | Defendo Pentax Single Use Valves Set |
|---|---|
| Device Classification: | Class II |
| Common/usual Name: | Defendo Pentax Single Use Biopsy Valve,Defendo Pentax Single Use Air/Water Valve,Defendo Pentax Single Use Suction Valve,Endogator Pentax Single Use Connector |
| Classification Name: | Endoscope and Accessories |
| Classification Number: | 21 CFR 876.1500 |
| Product Code: | ODC |
2. Predicate Device(s)
Primary predicate is listed first:
K102409 - Defendo Disposable Air/Water Valve Model 100304 K102581 - Defendo Disposable Suction Valve Model 100305 K090851 - Defendo Biopsy Valves K220395 - Endogator Endoscopy Irrigation Tubing
3. Description of Device
The Defendo Pentax Single Use Valves Set, the subject of this 510(k), are a family of ready-to-use, sterile, single-use valves designed to be used on the Pentax endoscopes as accessories. The specific valves include the Defendo Pentax Single Use Air/Water Valve, the Defendo Pentax Single Use Suction Valve, the Defendo Pentax Single Use Biopsy Valve, and the Endogator Pentax Single Use Connector.
- . The Air/Water valve allows the end-user to control and maintain air or CO2 insufflation down the endoscope's accessory channel 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.
- . 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.
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- . The Connector allows attachment between the irrigation tubset 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.
These valves are supplied in various kits. The kits are combinations of two or more of the different valves listed above.
4. Intended Use
The Defendo Pentax 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 Defendo Pentax Single Use Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.
The Defendo Pentax 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, help maintain sufflation, and minimize leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endogator Pentax Single Use 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).
5. Technological Characteristic Comparison Table
Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table - Air / Water Valve
| Feature | Defendo PentaxSingle UseAir/Water Valve(Subject Device) | DefendoDisposableAir/Water Valve(PredicateK102409) | Comparison |
|---|---|---|---|
| Intended use | The Defendo PentaxSingle Use Air/WaterValve is intended tobe used to controlthe air/water functionon an endoscopeduring a Glendoscopicprocedure. | The DefendoDisposable Air/WaterValve is intended tobe used to controlthe air/water functionon an endoscopeduring a GIendoscopicprocedure. | Same |
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| Feature | Defendo PentaxSingle UseAir/Water Valve(Subject Device) | DefendoDisposableAir/Water Valve(PredicateK102409) | Comparison |
|---|---|---|---|
| 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: ~41 mmDiameter: ~17mm | Air/Water Valve:Length: ~46 mmDiameter: ~17 mm | Similar |
| Target Population | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Pentax endoscope | Olympus endoscope | Reason forthis 510(k) |
| Packaging | Supplied as a kit inPETG Tray withTyvek Lid | Supplied individuallyinTyvek Pouch | Packagesystems allmaintainsterile barrier |
Table 2. Proposed/Predicate Device Technological Characteristics Comparison Table – Suction Valve
| Feature | Defendo PentaxSingle Use SuctionValve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
|---|---|---|---|
| Intended Use | The Defendo PentaxSingle Use SuctionValve is intended tobe used to controlthe suction functionon an endoscopeduring a Glendoscopicprocedure. | The DefendoDisposable SuctionValve is intended tobe used to control thesuction function onan endoscope duringa GI endoscopicprocedure. | Same |
| Sterile/Non-sterile | Sterile | Sterile | Same |
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| Feature | Defendo PentaxSingle Use SuctionValve(Subject Device) | Defendo DisposableSuction Valve(Predicate K102581) | Comparison |
|---|---|---|---|
| SterilizationMethod | EtO | EtO | Same |
| SterilizationAssurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main DeviceDimensions(lengths/widths) | Suction Valve:Length: ~35 mmDiameter: ~17 mm | Suction Valve:Length: ~27 mmDiameter: ~18 mm | Similar |
| Materials | Polycarbonate,Stainless Steel,ThermoplasticElastomer, Colorant,and Rubber | Polycarbonate,Stainless Steel, andThermoplasticElastomer | Similar |
| Target Population | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| Method ofApplication | Manual actuation | Manual actuation | Same |
| CompatibleEndoscopes | Pentax endoscope | Olympus endoscope | Reason forthis 510(k) |
| Packaging | Supplied as a kit inPETG Tray withTyvek Lid | Supplied individuallyinTyvek Pouch | Packagesystems allmaintainsterile barrier |
Table 3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve
| Feature | Defendo PentaxSingle Use BiopsyValve(Subject Device) | Defendo BiopsyValve for PentaxValves(PredicateK090851) | Comparison |
|---|---|---|---|
| Intended Use | The Defendo PentaxBiopsy Valve isintended for coveringthe endoscope biopsyport during anendoscopy procedure.The single use BiopsyValve provides access | The Defendo BiopsyValve is intended forcovering theendoscope biopsyport during anendoscopyprocedure. Thevalve provides | Same |
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| Feature | Defendo PentaxSingle Use BiopsyValve(Subject Device) | Defendo BiopsyValve for PentaxValves(PredicateK090851) | Comparison |
|---|---|---|---|
| for endoscopic devicepassage andexchange, helpmaintain sufflation,and minimize leakageof biomaterial from thebiopsy port throughoutthe endoscopicprocedure. | access forendoscopic devicepassage andexchange, helpmaintain sufflation,and minimizeleakage ofbiomaterial from thebiopsy portthroughout theendoscopicprocedure. | ||
| 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: ~18 mmDiameter: ~16 mm | Length: ~17 mmDiameter: ~17 mm | Similar |
| Target Population | Patients undergoing anendoscopic procedure | Patients undergoingan endoscopicprocedure | Same |
| Energy Used/Delivered | None | None | Same |
| CompatibleEndoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kit inPETG Tray with TyvekLid | Supplied individuallyinTyvek Pouch | Packagesystems allmaintainsterile barrier |
Table 4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector
| Feature | Endogator PentaxSingle UseConnector(Subject Device) | EndogatorConnector(K092429) | Comparison |
|---|---|---|---|
| Intended Use | The EndogatorPentax Connector isintended to be used in | The Endogatorsystem is intended | Similar |
| Feature | Endogator PentaxSingle UseConnector(Subject Device) | EndogatorConnector(K092429) | Comparison |
| conjunction withEndogator IrrigationTubing (not included)to provide irrigationvia sterile waterduring GI endoscopicprocedures whenused with an irrigationpump (or cauteryunit). | to provide irrigationvia sterile watersupply during GIendoscopicprocedure whensued in conjunctionwith an irrigationpump (or cauteryunit). | (Languagemodified forthe subjectdevice toreflect 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: ~32 mmDiameter: ~15 mm | Length: ~32 mmDiameter: ~15 mm | Same |
| Target Population | Patients undergoingan endoscopicprocedure | Patients undergoingan endoscopicprocedure | Same |
| EnergyUsed/Delivered | None | None | Same |
| CompatibleEndoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kitinPETG Tray withTyvek Lid | Supplied individuallyin Tyvek Pouch | Packagesystems allmaintainsterile barrier |
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Non-Clinical Performance Testing 4.
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 .
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- Water flow rate testing ●
- Backflow prevention testing ●
- Mechanical testing ●
- Depression Force O
- Valve Application Force O
- Valve Removal Force O
- o Sonic Weld Break Testing
- Valve Operation / Procedure Duration Test ●
Suction Valve
- Suction Bypass
- Suction Rate (water and soil) ●
- Mechanical testing ●
- Depression Force O
- o Valve Application Force
- o Valve Removal Force
- o Sonic Weld Break Testing
- Valve Operation / Procedure Duration Test ●
Biopsy Valve
- Leak Testing ●
- Insufflation Testing .
Auxiliary Waterjet Valve (Connector)
- Flow Durability Testing ●
- Check Valve Functionality Testing (Back Flow Prevention Test) .
- Mechanical Strength 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.
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.
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Conclusion 6.
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.