(28 days)
Not Found
No
The device description and intended use focus on mechanical valves for controlling functions of an endoscope. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device components (suction valve, air/water valve, and biopsy valve) are used to control the functions of an endoscope and to manage the biopsy port during a GI endoscopic procedure. They do not directly treat or diagnose a disease or condition, but rather facilitate the endoscopic procedure itself.
No
The device description indicates that the Endorate™ valves control functions of an endoscope (suction, air/water, biopsy port cover) during GI endoscopic procedures. These are operational enhancements for the endoscope, not diagnostic functions that identify a disease or condition.
No
The device description clearly details physical, disposable valves (suction, air/water, and biopsy valves) intended for use with endoscopes. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Endorate™ valves are accessories used during an endoscopic procedure to control the function of the endoscope itself (suction, air/water flow, and biopsy port access). They do not analyze any biological samples or provide diagnostic information based on those samples.
- Intended Use: The intended use clearly describes the valves' role in facilitating the endoscopic procedure, not in analyzing biological specimens.
- Device Description: The description focuses on the mechanical function of the valves and their role in infection prevention during the procedure.
- Performance Studies: The performance studies described are bench tests evaluating the mechanical and functional aspects of the valves, not the accuracy or performance of a diagnostic test.
The Endorate™ valves are medical devices used to assist in a medical procedure, but they do not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The disposable Endorate™ valves sets consists of one suction valve, one air/water valve and one biopsy valve.
The Endorate™ Disposable Suction valve is used to control the suction function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ Disposable Air/Water valve is used to control the air/water function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
Product codes (comma separated list FDA assigned to the subject device)
OCX, ODC
Device Description
The Endorate™ valve set consists of one suction valve, one air/water valve and one biopsy valve. The Endorate™ device is intended for single-use, and is supplied sterile. Sterile, single-use suction valve, air/water valve and biopsy valve help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single use item.
The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope.
The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
The Endorate™ Disposable Biopsy Valves are manufactured in two configurations - one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. Both Olympus®/Fujinon® and Pentax® versions are sold as non-sterile device, individually packed.
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
Hospital and or 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)
Smartdata performed bench testing to support substantial equivalence. The following testing was performed on Smartdata samples from initial production lots, including sterilization.
9.1. Disposable Suction Valve
- 9.1.1 Scope Compatibility
- 9.1.2 Valve Depression Force
- 9.1.3 Leak Test
9.2. Disposable Air/Water Valve
- 9.2.1 Scope Compatibility
- 9.2.2 Valve Depression Force
- 9.2.3 Air Ventilation and Insufflation
- 9.2.4 Water Flow Performance
9.3. Biopsy Valve
- 9.3.1 Scope Compatibility
- 9.3.2 Leak Testing
- 9.3.3 Squeegee Performance
A detailed record is attached as Appendix A in Section 18.
Sterilization: The Endorate™ valve set has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10-6. EO residuals on the valve sets are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
Shelf Life: The Endorate™ valve set have a three (3) year expiration date, based on the design and material equivalence to the predicate device and existing sterile barrier data from Smartdata existing packaging. The Smartdata valve sets are packaged in a paper/film pouch like other sterile products Smartdata currently manufactures. These pouches have been tested by Smartdata, including accelerated aging, seal strength, dye penetration and packaging persistence bacteria performance and shown to provide and maintain a sterile barrier for at least three (3) years.
Based on the technological characteristics and overall performance of the devices in bench testing, Smartdata believes that no significant differences exist between the proposed valve set and the predicate devices. The Smartdata valve set do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the Smartdata valve set and the predicate device are substantially equivalent.
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.
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 contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 6, 2018
Smartdata Suzhou Co., Ltd % Dave Yungvirt Official Third Party Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041
Re: K181509
Trade/Device Name: Endorate™ Valves Sets Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX, ODC Dated: June 7, 2018 Received: June 8, 2018
Dear Dave Yungvirt:
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. 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 statutes and regulations administered by other Federal agencies.
1
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
K181509 510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
| Submitter's Name: | Smartdata Suzhou Co., Ltd |
|---|---|
| Submitter's Address: | 4f, Block 7, 198#, Jinshan Rd |
| New District | |
| Suzhou, Jiangsu 215011 | |
| CHINA | |
| Establishment Registration No .: | 3008058134 |
2. Sponsor Contact
| Contact Person: | Cindy Ye
General Manager |
|-----------------|-------------------------------------|
| Telephone: | +86 512 6598 3722
+852 6393 5184 |
| Email: | cindy.ye@smartdatamedical.com |
3. Date Prepared 6th Jul 2018
4. Device Identification Trade Device Name:
Trade Device Name: Common Device Name: Product Code Name: Regulation Number/Name: Classification
Trade Device Name: Common Device Name: Product Code Name: Requlation Number/Name: Classification
Trade Device Name: Common Device Name: Product Code Name: Regulation Number/Name: Classification
Endorate™ Valve Sets
Endorate™ Disposable Suction Valve Suction Valve for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 Endoscope and accessories 2
Endorate™ Disposable Air/Water Valve Air/Water Valve for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 Endoscope and accessories 2
Endorate™ Disposable Biopsy Valve Biopsy Valve for Endoscope ODC - Endoscope Channel Accessory 876.1500 Endoscope and accessories 2
3
| 5. Predicate Device Identification | |
|---|---|
| Predicate Device 510(k) No.: | K102581 |
| Predicate Device Trade Name: | DEFENDO™ Disposable Suction Valve |
| Predicate Device Product Code: | ODC |
| Predicate Device 510(k) No.: | K102409 |
| Predicate Device Trade Name: | DEFENDO™ Disposable Air/Water Valve |
| Predicate Device Product Code: | ODC |
| Predicate Device 510(k) No.: | K090851 |
| Predicate Device Trade Name: | DEFENDO™ Disposable Biopsy Valve |
| Predicate Device Product Code: | ODC |
6. General Device Description:
The Endorate™ valve set consists of one suction valve, one air/water valve and one biopsy valve. The Endorate™ device is intended for single-use, and is supplied sterile. Sterile, singleuse suction valve, air/water valve and biopsy valve help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single use item. The following table 5.1 shows the components in the Smartdata's valves set.
| Components | Qty | Product Code Name | Regulation
Number | Classification |
|-----------------|-----|--------------------------------------|----------------------|----------------|
| Suction Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 |
| Air/Water Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 |
| Biopsy Valve | 1 | ODC – Endoscope
Channel Accessory | 876.1500 | 2 |
Table 5.1 Endorate™ Disposable Valves Sets
The suction valve is designed to be attached to the suction port of the endoscope and the air/water valve is designed to be attached to the air/water port of the endoscope.
The activation of the suction valve allows the user to aspirate excess fluids or other debris obscuring the endoscopic image, while the activation of the air/water valve allows the user to control air and water flow to assist in cleansing the lens during procedures.
The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
4
The Endorate™ Disposable Biopsy Valves are manufactured in two configurations - one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. Both Olympus®/Fujinon® and Pentax® versions are sold as non-sterile device, individually packed.
7. Intended Use:
The Endorate™ Disposable Suction Valve is intended to be used control the suction function of an endoscope during a GI Endoscopic procedure.
The Endorate™ Disposable Air/Water Valve is intended to be used control the air/water function of an endoscope during a GI Endoscopic procedure.
The Endorate™ Disposable Biopsy Valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
8. Technological Characteristics
The following tables (Table 5.2.1, Table 5.2.2 and Table 5.2.3) are a summary of the Endorate™ suction valve, air/water valve and biopsy valve technological characteristics as compared to the predicate device from DEFENDO™.
Table 5.2.1 Summary of design, features and principles of operation between the Endorate™ suction valve technological characteristics as compared to the predicate device from DEFENDO™ - Suction Valve
| Specification | Predicate Device | Proposed Device | Substantial
Equivalence |
|---------------------|-------------------------------------------------|---------------------------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable
Suction Valve | Endorate™ Disposable
Suction Valve | N/A |
| K number | K102581 | --- | N/A |
| Manufacturer | Medivators, Inc. a
Cantel Medical
Company | Smartdata Suzhou Co., Ltd | N/A |
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation Name | Endoscope and
accessories | Endoscope and accessories | Identical |
| Supplied
Sterile | Yes | Yes | Identical |
| Compatibility | GI Endoscopes | Olympus®
140/160/180/190/240/260
series Endoscope | Similar |
5
| Intended Use | The DEFENDO™
Disposable Suction
valve is intended to be
used control the
suction function of an
endoscope during a GI
Endoscopic procedure. | The ENDORATE™
Disposable Suction valve is
intended to be used control
the suction function of an
endoscope during a Gl
Endoscopic procedure. | Identical |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,
Disposable | Yes | Yes | Identical |
| Material | Polycarbonate,
Styrene-ethylene-
butene-styrene block
copolymer, Stainless
Steel 304 | Acrylonitrile-Butadiene-
Styrene Copolymer,
Silicone, Stainless steel 304 | Similar |
| Manufacturing
Method | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,
Biopsy Valves are
housed in a single tray
and packaged in a
sealed pouch. | Suction, Air/Water, Biopsy
Valves are housed in a
single tray and packaged in a
sealed pouch. | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |
Table 5.2.2 Summary of design, features and principles of operation between the Endorate™ air/water valve technological characteristics as compared to the predicate device from DEFENDO™. – Air/Water Valve
| Specification | Predicate Device | Proposed Device | Substantial
Equivalence |
|----------------|----------------------------------------------|-----------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable
Air/Water Valve | Endorate™ Disposable
Air/Water Valve | N/A |
| K number | K102409 | --- | N/A |
| Manufacturer | Medivators, Inc. a Cantel
Medical Company | Smartdata Suzhou Co., Ltd | N/A |
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
6
| Regulation
Name | Endoscope and
accessories | Endoscope and
accessories | Identical |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Supplied
Sterile | Yes | Yes | Identical |
| Compatibility | Olympus®
140/160/180/240/260
Series GI Endoscopes | Olympus®
140/160/180/190/240/260
series Endoscope | Similar |
| Intended Use | The DEFENDO™
Disposable Air/Water
valve is intended to be
used control the
air/water function of an
endoscope during a GI
Endoscopic procedure. | The ENDORATE™
Disposable Air/Water valve
is intended to be used
control the air/water
function of an endoscope
during a GI Endoscopic
procedure. | Identical |
| Environment
of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,
Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, Styrene-
ethylene-butene-styrene
block copolymer,
Stainless Steel 304 | Acrylonitrile-Butadiene-
Styrene Copolymer,
Silicone, Stainless steel 304 | Similar |
| Manufacturing
Method | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,
biopsy valves are
housed in a single tray
and packaged in a
sealed pouch. | Suction, Air/Water, biopsy
valves are housed in a
single tray and packaged in
a sealed pouch. | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |
Table 5.2.3 Summary of design, features and principles of operation between the Endorate™ biopsy valve technological characteristics as compared to the predicate device from DEFENDO™. – Biopsy Valve
| Specification | Predicate Device | Proposed Device | Substantial
Equivalence |
|---------------|-------------------------------------|--------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable
Biopsy Valve | Endorate™ Disposable Biopsy
Valve | N/A |
| K number | K090851 | --- | N/A |
7
K181509
Page 6 of 8
| Manufacturer | Medivators, Inc. a Cantel
Medical Company | Smartdata Suzhou
Co., Ltd | N/A |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation Name | Endoscope and
accessories | Endoscope and
accessories | Identical |
| Supplied Sterile | Sterile of the Olympus® /
Fujinon® Style and
Pentax® Style | Non Sterile of the
Olympus ® /
Fujinon® Style and
Pentax® Style | Similar |
| Compatibility | Olympus® / Fujinon® and
Pentax ® Endoscopes | Olympus® /
Fujinon® and
Pentax ®
Endoscopes | Identical |
| Intended Use | The DEFENDO™
Disposable biopsy valve is
intended to be cover the
endoscope biopsy port
during an endoscopy
procedure. In addition, the
valve provides access for
endoscopic device
passage and exchange,
helps maintain insufflation
and minimizes leakage of
biomaterial from the biopsy
port throughout the
endoscopic procedure. | The Endorate™
Disposable biopsy
valve is intended to
cover the endoscope
biopsy port during
an endoscopy
procedure. In
addition, the valve
provides access for
endoscopic device
passage and
exchange, helps
maintain insufflation
and minimizes
leakage of
biomaterial from the
biopsy port
throughout the
endoscopic
procedure. | Identical |
| Environment of
Use | Hospital and or clinics | Hospital and or
clinics | Identical |
| Single Use,
Disposable | Yes | Yes | Identical |
| Material | Styrene-ethylene-butene-
styrene block copolymer | Silicone | Similar |
| Manufacturing
Method | Injection molded | Injection molded | Identical |
| | | | |
| Slit in the valve
cap | 1.7-2.0mm | 1.7-2.0mm | Identical |
| Removable Cap
with Slit for
Device Passage | Yes | Yes | Identical |
| Packaging | Suction, Air/Water, biopsy
valves are housed in a
single tray and packaged in
a sealed pouch. Biopsy
valve is also sold
individually packaged in a
sealed pouch. | Suction, Air/Water,
biopsy valves are
housed in a single
tray and packaged in
a sealed pouch.
Non Sterile Biopsy
valve is also sold
individually
packaged in a
sealed pouch.
Biopsy valve is
either in blue or
black depending on
the availability. | Similar |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |
8
9. Non-Clinical Performance Data
Smartdata performed bench testing to support substantial equivalence. The following testing was performed on Smartdata samples from initial production lots, including sterilization.
9.1. Disposable Suction Valve
- 9.1.1 Scope Compatibility
- 9.1.2 Valve Depression Force
- 9.1.3 Leak Test
9.2. Disposable Air/Water Valve
- 9.2.1 Scope Compatibility
- 9.2.2 Valve Depression Force
- 9.2.3 Air Ventilation and Insufflation
- 9.2.4 Water Flow Performance
9.3. Biopsy Valve
- 9.3.1 Scope Compatibility
- 9.3.2 Leak Testing
- 9.3.3 Squeegee Performance
A detailed record is attached as Appendix A in Section 18.
9
9.4 Sterilization
The Endorate™ valve set which consists of one suction valve, one air/water valve and one biopsy valve, is sold in sterile package, like the Medivators predicate device. The valve set has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the valve sets are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Smartdata valve sets, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact. The Smartdata suction vale, air/water valve and biopsy valve are packaged in a paper/film pouch like other sterile products Smartdata currently manufactures.These pouches have been tested by Smartdata and shown to provide and maintain a sterile barrier for at least three (3) years.
9.5 Shelf Life
The Endorate™ valve set have a three (3) year expiration date, based on the design and material equivalence to the predicate device and existing sterile barrier data from Smartdata existing packaging. The Smartdata valve sets are packaged in a paper/film pouch like other sterile products Smartdata currently manufactures. These pouches have been tested by Smartdata, including accelerated aging, seal strength, dye penetration and packaging persistence bacteria performance and shown to provide and maintain a sterile barrier for at least three (3) years.
10. Clinical Testing
Suction valve, air/water valve and biopsy valve have been on the market for many years with proven safety and efficacy for the use of the device. These devices have no direct patient contact. Based on this history and the use of the device, clinical testing was not necessary to support substantial equivalence data. The non-clinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device.
11. Conclusion
Smartdata valve set which consists of suction valve, air/water valve and biopsy valve, have the same intended use as the predicate device.
Based on the technological characteristics and overall performance of the devices in bench testing. Smartdata believes that no significant differences exist between the proposed valve set and the predicate devices.
The Smartdata valve set do not raise any new issues of safety and effectiveness.
From a clinical perspective and comparing design specifications, the Smartdata valve set and the predicate device are substantially equivalent.
10
Indications for Use
510(k) Number (if known) K181509
Device Name Endorate™ Valves Sets
Indications for Use (Describe)
The disposable Endorate™ valves sets consists of one suction valve, one air/water valve and one biopsy valve.
The Endorate™ Disposable Suction valve is used to control the suction function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ Disposable Air/Water valve is used to control the air/water function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.
The Endorate™ Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic 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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