(140 days)
Not Found
No
The device description and intended use clearly define the device as a set of single-use mechanical valves and connectors for endoscopes. There is no mention of software, algorithms, image processing, or any other components typically associated with AI/ML. The performance studies focus on mechanical and flow characteristics.
No
The device components are accessories for endoscopes, designed to control air/water, suction, provide biopsy port access, or facilitate irrigation/cleaning. Their primary function is to enable and maintain the conditions for an endoscopic procedure, not to directly treat a disease or condition. They assist in the diagnostic and interventional aspects of endoscopy but are not therapeutic in themselves.
No
The device is a set of single-use valves and connectors used during endoscopic procedures to facilitate device passage, maintain insufflation, control air/water/suction functions, and for cleaning. Its intended uses are operational and supportive during an endoscopy, not for diagnosing any condition.
No
The device description clearly states that the device consists of "a family of ready-to-use, sterile, single-use valves" which are physical components designed to be used on endoscopes. The performance studies also describe testing of physical properties like flow rate, mechanical strength, and biocompatibility. There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the devices as accessories for endoscopes used during GI endoscopic procedures. They facilitate access, maintain insufflation, control air/water and suction, and provide irrigation. None of these functions involve examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description confirms they are valves and connectors designed to be used on the endoscope during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
The devices are accessories used during a medical procedure on a patient, not for laboratory testing of samples.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
ODC, FDF, OCX, and FEQ
Device Description
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.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI tract (Gastrointestinal tract), esophagus, stomach, duodenum, rectum, and large intestine (for compatible endoscopes).
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
- Force to Disassemble via Axial Pull
- Valve Operation / Procedure Duration Test
Suction Valve
- Suction Bypass
- Suction Rate (water and soil)
- Mechanical testing
- Depression Force
- Valve Application Force
- Valve Removal Force
- 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
- Adapter Application Force
- Adapter Removal Force
- 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.
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, K210342, K220395, K172916
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
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.
1
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).
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) 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) | |
|---|---|
| \ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
K232329 Page 1 of 11
510(k) Summary
Defendo Fujifilm 700 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 |
06 Dec 2023 Summary Date:
5
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/Water | |
| Valve; Defendo Fujifilm 700 Single Use | |
| Suction Valve; ENDOGATOR Fujifilm 700 | |
| Single Use Connector; Defendo Fujifilm 700 | |
| Single 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.
6
- 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.
7
5. Technological Characteristic Comparison Table
Table 1. Proposed/Predicate Device Technological Characteristics Comparison Table – Air / Water Valve
| Feature | Defendo Fujifilm 700
Single-Use Air/Water
Valve
(Subject Device) | Defendo Disposable
Air/Water Valve
(Predicate K102409) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended use | 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 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 |
| 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: ~43.5 mm
Diameter: ~19.2 mm | Air/Water Valve:
Length: ~46 mm
Diameter: ~17 mm | Similar, the
slight
differences are
due to the
differences in
the endoscope
port. |
| 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 | Fujifilm 700 series GI
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 Fujifilm 700
Single-Use Suction
Valve
(Subject Device) | Defendo Disposable
Suction Valve
(Predicate K102581) | Comparison |
|--------------|-------------------------------------------------------------------------|------------------------------------------------------------|------------|
| Intended Use | The Single Use
Suction Valve is | The Defendo
Disposable Suction | Same |
8
| Feature | Defendo Fujifilm 700
Single-Use Suction
Valve
(Subject Device) | Defendo Disposable
Suction Valve
(Predicate K102581) | Comparison |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | intended to be used to
control the suction
function on an
endoscope during a GI
endoscopic procedure. | Valve is intended to be
used to control the
suction function on an
endoscope during a GI
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) | Suction Valve:
Length: ~28.0 mm
Diameter: ~17.2 mm | Suction Valve:
Length: ~27 mm
Diameter: ~18 mm | Similar, the
slight
differences
are due to the
differences in
the
endoscope
port. |
| 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 | Fujifilm 700 series GI
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 5-3. Proposed/Predicate Device Technological Characteristics Comparison Table – Biopsy Valve
| Feature | Defendo Single-Use
Fujifilm 700 Biopsy
Valves
(Subject Device) | BioShield Biopsy
Valve (for Fujifilm
Endoscopes)
(Predicate K210342) | Comparison |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The single-use
BioShield biopsy
valve is used to cover
the opening to the
biopsy/suction
channel of
gastrointestinal
endoscopes. It | Similar
The intended use
for the subject
device biopsy valve
is identical to that
of other Defendo
Biopsy Valves |
| Feature | Defendo Single-Use
Fujifilm 700 Biopsy
Valves
(Subject Device) | BioShield Biopsy
Valve (for Fujifilm
Endoscopes)
(Predicate K210342) | Comparison |
| | passage and exchange,
helps maintain
sufflation, and
minimizes leakage of
biomaterial from the
biopsy port throughout
the endoscopic
procedure. | provides access for
endoscopic device
passage and
exchange, helps
maintain insufflation,
minimizes leakage of
biomaterial from the
biopsy port
throughout the
endoscopic procedure
and provides access
for irrigation. | currently marketed
by Medivators. The
minor differences in
language between
the BioShield and
Defendo valves are
mainly editorial in
nature and do not
represent a
different intended
use. |
| Sterile/Non-
sterile | Sterile | Sterile and Non-
Sterile | See note below |
| 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: ~16.8 mm
Width (handle to tip):
~32.4 mm | Length: ~16.8 mm
Width (handle to tip):
~32.4 mm | Same |
| Target
Population | Patients undergoing an
endoscopic procedure | Patients undergoing
an endoscopic
procedure | Same |
| Energy Used/
Delivered | None | None | Same |
| Compatible
Endoscopes | Fujifilm 700 series GI
endoscope | Fuji Gen 5 or later
endoscopes | Same |
| Packaging | Continue to be supplied
individually in Tyvek
Pouch (predicate) and
supplied as a set in
PETG Tray with Tyvek
Lid (new). | Supplied individually in
Tyvek Pouch | Package systems
all maintain sterile
barrier |
9
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.
10
| Feature | Endogator Fujifilm 700
Connector
(Subject Device) | Endogator
Connector
(Predicate K220395) | Comparison |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Single Use
ENDOGATOR™
Connector is intended to
be used in conjunction
with ENDOGATOR™
Irrigation Tubing to
provide irrigation via
sterile water during Gl
endoscopic procedures
when used with an
irrigation pump (or
cautery unit). | The Endogator
system is intended to
provide irrigation via
sterile water supply
during GI endoscopic
procedure when sued
in conjunction with an
irrigation pump (or
cautery unit). | Similar
(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: ~22 mm
Diameter: ~12.7 mm | Length: ~22 mm
Diameter: ~12.7 mm | Same |
| Target Population | Patients undergoing an
endoscopic procedure | Patients undergoing an
endoscopic procedure | Same |
| Energy
Used/Delivered | None | None | Same |
| Compatible
Endoscopes | Fujifilm 700 series GI
endoscope | None specified
(commonly used with
Fujifilm endoscopes) | Same |
| Packaging | Continue to be supplied
individually in Tyvek
Pouch (predicate) and
supplied as a set in
PETG Tray with Tyvek
Lid (new). | Supplied individually in
Tyvek Pouch | Package
systems all
maintain sterile
barrier |
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 Fujifilm
700 Single-Use
Cleaning
Adapter
(Subject Device) | FUJIFILM Endoscope
Models EG-760R, EG-
760Z, EC-760R-V/L
and EC-760ZP-V/L,
and FUJIFILM Water
Tank Model WT-603
(Predicate K172916) | Comparison |
|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Single Use
Cleaning Adapter
is intended to be
used only to pre-
clean the
endoscope's
air/water channel
post-procedure,
and not to be
used during a
patient procedure. | The predicate reusable
air/water channel
cleaning adapter is an
accessory to Fujifilm
700 endoscopes. While
no indications for use
for the accessory is
directly stated. The
adapter's intended
purpose is to pre-clean
the endoscope's
air/water channel post-
procedure.
The cleared indications
for use statement
provide in the predicate
510(k) is the indications
for use statement of the
entire endoscope, not
just the cleaning
adapter accessory.# | Same, the intended
purposes of the
predicate and
subject cleaning
adapters are the
same. |
| Sterility | Sterile | Non-Sterile | While sterility is not
critical for the
adapter application,
the subject adapter
is provided sterile as
it is in the same
packaging
configuration as the
other valves in the
set. |
| Usage | Single-Use | Reprocessed | Reason for this
510k, subject
adapter is a single-
use adapter,
whereas the
predicate is reusable
and requires
reprocessing.
Single-use
configuration
mitigates the risk of |
| Feature | Defendo Fujifilm
700 Single-Use
Cleaning
Adapter
(Subject Device) | FUJIFILM Endoscope
Models EG-760R, EG-
760Z, EC-760R-V/L
and EC-760ZP-V/L,
and FUJIFILM Water
Tank Model WT-603
(Predicate K172916) | Comparison |
| Main Device
Dimensions
(lengths/widths) | Length: ~45.7 mm
Diameter: ~19.2
mm | Length: ~45.8 mm
Diameter: ~18.7 mm | Similar, the minor
difference do not
affect device
performance. |
| Target
Population | Patients
undergoing an
endoscopic
procedure. The
cleaning adapter
does not have any
patient contact as
it is used post-
procedure. | Patients undergoing an
endoscopic procedure.
The cleaning adapter
does not have any
patient contact as it is
used post-procedure. | Same |
| Energy
Used/Delivered | None | None | Same |
| Method of
Application | Manual actuation | Manual actuation | Same |
| Compatible
Endoscopes | Fujifilm 700 Series
GI endoscope | Fujifilm 700 Series Gl
endoscope | Same |
| Packaging | Supplied as a set
in PETG Tray with
Tyvek Lid | Supplied with
endoscope or
individually | Subject device
package system
maintains sterile
barrier |
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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.