(287 days)
Not Found
No
The device description and performance studies focus on mechanical components and fluid/gas control, with no mention of AI, ML, image processing, or data analysis.
No
This device is a set of valves and connectors for endoscopes that control the flow of fluids, gases, and materials during procedures. It assists in the operation of the endoscope but does not directly diagnose, treat, or prevent disease, which are characteristic functions of a therapeutic device.
No
The device description and intended use state that it controls the flow of fluids, gases, and other materials in an endoscope. This is a functional role within an endoscopic procedure, not one that gathers or analyzes data for diagnostic purposes.
No
The device description clearly indicates it is a collection of physical, sterile units (valves and connectors) intended to be fitted to endoscopes. It describes bench testing related to physical properties like flow control, sealing, and mechanical forces, as well as biocompatibility and sterilization, all of which are characteristic of hardware devices. There is no mention of software as a component or function.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly describes the device as being fitted to endoscopes to control the flow of fluids, gases, and materials during an endoscopic procedure. It facilitates the procedure itself, rather than analyzing samples taken from the body.
- Device Description: The description reinforces its function as a component of the endoscope system for controlling flow and preventing backflow.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on the mechanical and functional aspects of the valves (flow control, sealing, fitting, biocompatibility, sterilization, shelf-life), not on the accuracy or reliability of diagnostic results.
- Anatomical Site: While the anatomical site is GI, the device's function is related to the procedure within the GI tract, not the analysis of samples from it.
In summary, the device is a procedural accessory for endoscopy, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
Product codes (comma separated list FDA assigned to the subject device)
ODC
Device Description
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals/clinics
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
Biocompatibility of the Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (
§ 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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
January 6, 2021
Wilson Instruments (SHA) Co., LTD Juan Wu, MS Building 5, No. 258 Shuangbang Rd. Xujing Town Qingpu Dist Shanghai, 201702 CHINA
Re: K200769
Trade/Device Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: November 20, 2020 Received: November 27, 2020
Dear Juan Wu:
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 (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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
for
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
2
Indications for Use
510(k) Number (if known) K200769
Device Name Disposable Endoscope Valves Set Disposable Endoscope Valves Set B
Indications for Use (Describe)
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve. This is a single-use device.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
| 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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3
510(k) summary
I. Submitter
Device submitter: WILSON INSTRUMENTS (SHA) CO., LTD Building 5, No.258 Shuangbang Rd., Xujing Town Qingpu Dist, Shanghai, CHINA, 201702
Primary contact person: Juan Wu Regulatory Affairs Phone: +86 21-39290696 ext 8027 Email: wilson.ra803@wilson.sh.cn
Date of preparation: Nov.20, 2020.
II. Device
Trade Name of Device: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B Common name: Endoscope and accessories Regulation Number: 21 CFR 876.1500 Regulatory Class: II Product code: ODC Review Panel: Gastroenterology/Urology
III. Predicate Devices
| Trade name: | DEFENDO™ Disposable Air/Water Valve for GI Endoscopes |
|---|---|
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC |
| Premarket Notification: | K102409 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Disposable Suction Valve for GI Endoscopes |
| Common name: | Endoscopes and accessories |
| Classification: | Class II, 21 CFR 876.1500 |
| Product Code: | ODC, FDF |
| Premarket Notification: | K102581 |
| Manufacturer: | Medivators Inc formerly Byrne Medical |
| Trade name: | DEFENDO™ Biopsy Valve for Olympus and Fujinon Endoscopes |
| DEFENDO™ Biopsy Valve for Pentax Endoscopes |
4
Endoscopes and accessories Common name: Classification: Class II, 21 CFR 876.1500 ODC Product Code: Premarket Notification: K090851 Medivators Inc formerly Byrne Medical Manufacturer: Trade name: EndoGator™ System Common name: Endoscopes and accessories Class II, 21 CFR 876.1500 Classification: FEQ Product Code: Premarket Notification: K092429
Manufacturer: Medivators Inc formerly Byrne Medical
IV. Device description
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports of Pentax GI Video Endoscopes to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
V. Indications for use
The Disposable Endoscope Valves Set is a collection of several sterile units. It is intended to be fitted to multiple endoscope working channels/ports to control the flow of fluids, gases and other materials. It includes an air/water valve, a suction valve, a biopsy valve and a water connector.
-
Disposable Air/Water Valves: This unit is intended to be fitted to an endoscope air/water channel to control the inflow of medical gases and water, whilst preventing back-flow.
-
Disposable Suction Valves: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
-
Disposable Biopsy Valves: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Disposable Endoscope Water Connectors: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
5
The Disposable Endoscope Valves Set B is a collection of sterile device intended to be fitted to multiple endoscope working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of fluids, gases, and other materials. It includes a suction valve, an air/water valve.
-
Air/Water Valves: This device is intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases and water, whilst preventing backflow.
-
Suction Valves: The device is intended to be fitted to an endoscope suction channel to enable the operator to control suction whilst preventing inflow of air.
VI Comparison of technological characteristics with the predicate devices
The Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B have similar technological characteristics and fundamental design as the predicate device. The differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.
| Device
feature | Disposable
Air/Water
Valves (subject device) | DEFENDO™ Disposable
Air/Water Valve K102409
(predicate device) | Discussion |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Picture | WS-VO-01
WS-VP-01
| | Same structure |
| Indications
for use | The device is intended to be
fitted to an endoscope
air/water channel to control
the inflow of medical gases
and water, whilst preventing
back-flow. | 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. | Substantially
equivalent. Both
devices are used
with the
endoscopes to
control the
air/water function. |
| Product code | ODC | ODC | Substantially
equivalent. |
| Regulation
number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
Table 1 Substantial equivalence discussion - Disposable Air/Water Valve
6
K200769 Page 4 of 11 pages
| Compatible
endoscopes | Olympus
WS-VO-01:
140/160/180/190/240/260/2
90 series endoscopes
WS-VP-01: PENTAX GI
Video Endoscope
90K/90i Series; K10/i10
Series | Olympus
140/160/180/240/260
series endoscopes | Substantially
equivalent
supported by
performance
testing. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | WS-VO-01: SIR, ABS, TPE,
Stainless steel 304
WS-VP-01: SIR, ABS, TPE,
Stainless steel 304 | PC, TPE, Stainless steel 304 | Substantially
equivalent,
both
devices
are
evaluated
according to ISO
10993-1. |
| Environment
of use | Hospitals/clinics | Hospitals/clinics | Identical |
7
| Device
feature | Disposable Suction Valves
(subject device) | DEFENDO™ Disposable
Suction Valve for GI
Endoscopes K102581
(predicate device) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Picture | WS-VO-02
Image: Disposable Suction Valve | Image: DEFENDO Disposable Suction Valve | Same structure |
| | WS-VP-02
Image: Disposable Suction Valve | | |
| Indications
for use | The device is intended to be
fitted to an endoscope
suction channel to control
the operations of suction,
whilst preventing inflow of
air. | The DEFENDO™
Disposable Suction Valve is
intended to be used to
control the suction function
on an endoscope during a
GI endoscopic procedure. | Substantially
equivalent. Both
devices are used
with the
endoscopes to
control the suction
function. |
| Product code | ODC | ODC | Substantially
equivalent. |
| Regulation
number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatible
endoscopes | WS-VO-02: Olympus
140/160/180/190/240/260/2
90 series endoscopes
WS-VP-02: PENTAX GI
Video Endoscope
90K/90i Series; K10/i10
Series | Olympus
140/160/180/190/240/260
series endoscopes | Substantially
equivalent
supported by
performance
testing. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| | | | |
| Material | WS-VO-02: SIR, ABS, TPE,
Stainless steel 304, Stainless
steel 17-4PH
WS-VP-02: SIR, ABS, TPE,
Stainless steel 304 | NBR, PC, TPE, Stainless
steel 304 | Substantially
equivalent, both
devices are
evaluated
according to ISO
10993-1. |
| Environment
of use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 2 Substantial equivalence discussion – Suction Valve
8
K200769 Page 6 of 11 pages
9
| Device
feature | Disposable Biopsy Valves
(subject device) | DEFENDO™ Biopsy Valve
(predicate
K090851 device) | Discussion |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Picture | | | Same structure |
| Indications
for use | The device is intended to be
fitted to an endoscope
biopsy port to prevent
leakage of gases and body
fluids during an endoscopic
procedure | The DEFENDO™ Disposable Biopsy Valve is
indicated for covering the
endoscope biopsy port
during an endoscopy
procedure. The 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. | Substantially
equivalent. Both
devices are used
on the endoscopes
biopsy port to
prevent leakage. |
| Product code | ODC | ODC | Substantially
equivalent. |
| Regulation
number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
| Classification | II | II | Identical |
| Compatible
endoscopes | Olympus
140/160/180/190/240/260/2
90 series endoscopes | Olympus GI endoscopes | Substantially
equivalent, both
devices are used
for Olympus GI
endoscopes. |
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | Silicon rubber | TPE | Different while both
devices are
evaluated
according to ISO
10993-1. |
| Environment
of use | Hospitals/clinics | Hospitals/clinics | Identical |
Table 3 Substantial equivalence discussion – Biopsy Valve
10
K200769 Page 8 of 11 pages
11
| Table 4 Substantial equivalence discussion – Water Connector | |||
|---|---|---|---|
| Device | |||
| feature | Disposable Endoscope | ||
| Water Connectors (subject | |||
| device) | EndoGator™ System | ||
| K092429 | |||
| (predicate | |||
| device) | Discussion | ||
| Indications | |||
| for use | The device is intended to | ||
| provide irrigation via sterile | |||
| water supply during GI | |||
| endoscopic procedures | |||
| when used in conjunction | |||
| with an irrigation pump. | The EndoGator™ system | ||
| (tubing and accessories to | |||
| accommodate various | |||
| endoscopes and irrigation | |||
| pumps) is intended to | |||
| provide irrigation via sterile | |||
| water supply during GI | |||
| endoscopic procedures | |||
| when used in conjunction | |||
| with an irrigation pump (or | |||
| cautery unit) | Substantially | ||
| equivalent. Both | |||
| devices are used | |||
| to provide irrigation | |||
| during GI | |||
| endoscopic | |||
| procedures. | |||
| Picture | Image: Disposable Endoscope Water Connectors | Image: EndoGator System | The predicate |
| water connector is | |||
| a component of the | |||
| EndoGator™ | |||
| system. Both | |||
| devices consist of | |||
| luer taper to be | |||
| connected to the | |||
| water tubing, | |||
| connector be | |||
| connected to the | |||
| endoscope and the | |||
| intermediate check | |||
| piece to prevent | |||
| backflow. | |||
| Product code | ODC | FEQ | Different as the |
| predicate device | |||
| consists of a | |||
| pump, tubing and | |||
| accessories. | |||
| Regulation | |||
| number | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical |
12
K200760 Page 10 of 11
| Classification | II | II | Page 10 of 11 pages |
|---|---|---|---|
| Compatible | |||
| endoscopes | Olympus | ||
| 140/160/180/190/240/260/2 | |||
| 90 series endoscopes | Olympus GI endoscopes | Substantially | |
| equivalent, both | |||
| devices are used for | |||
| Olympus GI | |||
| endoscopes. | |||
| Sterile | EO sterilization | EO sterilization | Identical |
| Single Use | Yes | Yes | Identical |
| Material | SIR, PVC, PC, Stainless | ||
| steel 303 | NBR, SIR, ABS | Different while both | |
| devices are | |||
| evaluated | |||
| according to ISO | |||
| 10993-1. | |||
| Environmen | |||
| t of use | Hospitals/clinics | Hospitals/clinics | Identical |
VII Performance data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
Biocompatibility of the Disposable Endoscope Valves Set and Disposable Endoscope Valves Set B were evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface - Mucosal Membrane" with a contact duration of "Limited (