(244 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid control functions, with no mention of AI or ML.
No.
These devices are accessories to an endoscope, controlling functions like air/water flow, suction, and biopsy port access during GI endoscopic procedures. They do not directly treat or diagnose a disease or condition, but rather enable the endoscope to perform its intended diagnostic or therapeutic functions.
No
These devices are accessories for endoscopes, designed to control functions like air/water flow, suction, and biopsy access during GI endoscopic procedures. They facilitate the procedure but do not perform any diagnostic function themselves; they don't analyze data or provide diagnostic information.
No
The device description clearly outlines physical, single-use valves and connectors used with endoscopes, and the performance studies focus on mechanical and flow characteristics, not software functionality.
Based on the provided text, the devices described are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use of these devices is to control functions on an endoscope during a GI endoscopic procedure. This involves interacting directly with the patient's body (in vivo) during a medical procedure.
- Device Description: The description details mechanical valves and connectors used to manage air, water, suction, and instrument passage within the endoscope during a procedure. These are functional components for the endoscopic procedure itself.
- Lack of IVD Characteristics: There is no mention of these devices being used to examine specimens derived from the human body in vitro (outside the body) for the purpose of providing information about a physiological state, a state of health or disease, or a congenital abnormality.
Therefore, these devices are considered medical devices used in vivo during a surgical/diagnostic procedure, not IVDs.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract
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 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
- Mechanical testing
- Depression Force
- Valve Application Force
- Valve Removal Force
- o Sonic Weld Break Testing
- Valve Operation / Procedure Duration Test
Suction Valve
- Suction Bypass
- Suction Rate (water and soil)
- Mechanical testing
- Depression Force
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K102409, K102581, K090851, K220395
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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"
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.
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
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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510(k) Summary
Defendo Pentax Single Use Valves Set
| Manufacturer: | Medivators
3150 Pollok Drive
Conroe, TX 77303 |
|---------------|-----------------------------------------------------------------------------------|
| Submitter: | Nick Wang, Ph.D. RAC
Senior Manager, Regulatory Affairs
Phone: 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.
6
- . 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 Pentax
Single Use
Air/Water Valve
(Subject Device) | Defendo
Disposable
Air/Water Valve
(Predicate
K102409) | Comparison |
|--------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 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 Gl
endoscopic
procedure. | The Defendo
Disposable Air/Water
Valve is intended to
be used to control
the air/water function
on an endoscope
during a GI
endoscopic
procedure. | Same |
7
| Feature | Defendo Pentax
Single Use
Air/Water Valve
(Subject Device) | Defendo
Disposable
Air/Water Valve
(Predicate
K102409) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------|-------------------------------------------------------|
| Sterile/Non-
sterile | Sterile | Sterile | Same |
| Sterilization
Method | EtO | EtO | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device
Dimensions
(lengths/widths) | Air/Water Valve:
Length: ~41 mm
Diameter: ~17mm | Air/Water Valve:
Length: ~46 mm
Diameter: ~17 mm | Similar |
| Target Population | Patients undergoing
an endoscopic
procedure | Patients undergoing
an endoscopic
procedure | Same |
| Energy
Used/Delivered | None | None | Same |
| Method of
Application | Manual actuation | Manual actuation | Same |
| Compatible
Endoscopes | Pentax endoscope | Olympus endoscope | Reason for
this 510(k) |
| Packaging | Supplied as a kit in
PETG Tray with
Tyvek Lid | Supplied individually
in
Tyvek Pouch | Package
systems all
maintain
sterile barrier |
Table 2. Proposed/Predicate Device Technological Characteristics Comparison Table – Suction Valve
| Feature | Defendo Pentax
Single Use Suction
Valve
(Subject Device) | Defendo Disposable
Suction Valve
(Predicate K102581) | Comparison |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Defendo Pentax
Single Use Suction
Valve is intended to
be used to control
the suction function
on an endoscope
during a Gl
endoscopic
procedure. | The Defendo
Disposable Suction
Valve is intended to
be used to control the
suction function on
an endoscope during
a GI endoscopic
procedure. | Same |
| Sterile/Non-sterile | Sterile | Sterile | Same |
8
| Feature | Defendo Pentax
Single Use Suction
Valve
(Subject Device) | Defendo Disposable
Suction Valve
(Predicate K102581) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------|-------------------------------------------------------|
| Sterilization
Method | EtO | EtO | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device
Dimensions
(lengths/widths) | Suction Valve:
Length: ~35 mm
Diameter: ~17 mm | Suction Valve:
Length: ~27 mm
Diameter: ~18 mm | Similar |
| Materials | Polycarbonate,
Stainless Steel,
Thermoplastic
Elastomer, Colorant,
and Rubber | Polycarbonate,
Stainless Steel, and
Thermoplastic
Elastomer | Similar |
| Target Population | Patients undergoing
an endoscopic
procedure | Patients undergoing
an endoscopic
procedure | Same |
| Energy
Used/Delivered | None | None | Same |
| Method of
Application | Manual actuation | Manual actuation | Same |
| Compatible
Endoscopes | Pentax endoscope | Olympus endoscope | Reason for
this 510(k) |
| Packaging | Supplied as a kit in
PETG Tray with
Tyvek Lid | Supplied individually
in
Tyvek Pouch | Package
systems all
maintain
sterile barrier |
Table 3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve
| Feature | Defendo Pentax
Single Use Biopsy
Valve
(Subject Device) | Defendo Biopsy
Valve for Pentax
Valves
(Predicate
K090851) | Comparison |
|--------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Intended Use | The Defendo Pentax
Biopsy Valve is
intended for covering
the endoscope biopsy
port during an
endoscopy procedure.
The single use Biopsy
Valve provides access | The Defendo Biopsy
Valve is intended for
covering the
endoscope biopsy
port during an
endoscopy
procedure. The
valve provides | Same |
9
| Feature | Defendo Pentax
Single Use Biopsy
Valve
(Subject Device) | Defendo Biopsy
Valve for Pentax
Valves
(Predicate
K090851) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | for endoscopic device
passage and
exchange, help
maintain sufflation,
and minimize leakage
of biomaterial from the
biopsy port throughout
the endoscopic
procedure. | access for
endoscopic device
passage and
exchange, help
maintain sufflation,
and minimize
leakage of
biomaterial from the
biopsy port
throughout the
endoscopic
procedure. | |
| Sterile/Non-
sterile | Sterile | Sterile | Same |
| Sterilization
Method | EtO | EtO | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device
Dimensions
(lengths/widths) | Length: ~18 mm
Diameter: ~16 mm | Length: ~17 mm
Diameter: ~17 mm | Similar |
| Target Population | Patients undergoing an
endoscopic procedure | Patients undergoing
an endoscopic
procedure | Same |
| Energy Used/
Delivered | None | None | Same |
| Compatible
Endoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kit in
PETG Tray with Tyvek
Lid | Supplied individually
in
Tyvek Pouch | Package
systems all
maintain
sterile barrier |
Table 4. Proposed/Predicate Device Technological Characteristics Comparison Table - Connector
| Feature | Endogator Pentax
Single Use
Connector
(Subject Device) | Endogator
Connector
(K092429) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Endogator
Pentax Connector is
intended to be used in | The Endogator
system is intended | Similar |
| Feature | Endogator Pentax
Single Use
Connector
(Subject Device) | Endogator
Connector
(K092429) | Comparison |
| | conjunction with
Endogator Irrigation
Tubing (not included)
to provide irrigation
via sterile water
during GI endoscopic
procedures when
used with an irrigation
pump (or cautery
unit). | to provide irrigation
via sterile water
supply during GI
endoscopic
procedure when
sued in conjunction
with an irrigation
pump (or cautery
unit). | (Language
modified for
the subject
device to
reflect the
connector
provided does
not include the
Endogator
tubing) |
| Sterile/Non-
sterile | Sterile | Sterile | Same |
| Sterilization
Method | EtO | EtO | Same |
| Sterilization
Assurance Level | 10-6 | 10-6 | Same |
| Usage | Single use | Single use | Same |
| Main Device
Dimensions
(lengths/widths) | Length: ~32 mm
Diameter: ~15 mm | Length: ~32 mm
Diameter: ~15 mm | Same |
| Target Population | Patients undergoing
an endoscopic
procedure | Patients undergoing
an endoscopic
procedure | Same |
| Energy
Used/Delivered | None | None | Same |
| Compatible
Endoscopes | Pentax endoscope | Pentax endoscopes | Same |
| Packaging | Supplied as a kit
inPETG Tray with
Tyvek Lid | Supplied individually
in Tyvek Pouch | Package
systems all
maintain
sterile barrier |
10
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 .
11
- 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.
12
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.