(295 days)
Not Found
No
The device description and intended use focus solely on mechanical components for controlling fluid and gas flow in endoscopes. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: The device is a collection of sterile units (valves and connectors) intended to control the flow of fluids, gases, and materials during endoscopy procedures. While it facilitates procedures that diagnose or treat conditions, the device itself does not directly perform therapy. It is an accessory to an endoscope.
No
The device is a collection of sterile disposable valves intended to control flow and prevent leakage in endoscopes during procedures. It does not perform any diagnostic function such as capturing images, analyzing data, or identifying medical conditions.
No
The device is described as a collection of sterile, single-use physical components (valves and connectors) intended to be fitted to an endoscope. The description focuses on the mechanical function and physical properties of these components, with no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Disposable Endoscope Valve Sets are mechanical components designed to control the flow of fluids and gases within an endoscope during a procedure. They facilitate the endoscopic procedure itself (e.g., clearing the view, providing irrigation, allowing instrument passage) but do not analyze or test any biological samples.
- Intended Use: The intended use clearly describes the device's function in controlling flow and preventing leakage during endoscopic procedures. It does not mention any diagnostic testing of samples.
- Device Description: The description details the mechanical function of each valve component in relation to the endoscope and the procedure. There is no mention of sample collection, analysis, or diagnostic output.
- Lack of Diagnostic Metrics: The performance studies focus on mechanical and functional aspects (flow rates, leakage, compatibility, sterilization, biocompatibility) rather than diagnostic metrics like sensitivity, specificity, or AUC.
In summary, the Disposable Endoscope Valve Sets are accessories used with an endoscope to facilitate a medical procedure. They do not perform any diagnostic testing on biological samples, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
-
Air/Water Valve: 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.
-
Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.
-
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Product codes
ODC
Device Description
The Disposable Endoscope Valve Sets is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended 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 an Auxiliary Water Connector.
- The Suction Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
- The Air/Water Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the air/ water port of the endoscope, 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 component of the Disposable Endoscope Valve Sets 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 Auxiliary Water Connector component of the Disposable Endoscope Valve Sets is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
And there were no prior submissions for the subject devices.
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
The SML Med-Tech Solutions Limited has performed bench testing to support substantial equivalence. The following tests were performed on the subject devices and predicate devices.
For Suction Valve SML001_PT01_SU, SML001_PT02_SU, SML001_PT03_SU, SML002_LP01_SU, SML002_LP02_SU, SML003_FJ01_SU, SML003_FJ02_SU:
- Endoscope Compatibility
- Depression Force
- Leakage Test
- Suction Flow
For Air/Water Valve SML001_PT01_AW, SML002_LP01_AW, SML003_FJ01_AW:
- Endoscope Compatibility
- Air flow rate
- Water flow rate
- Leakage Test
- Depression Force
- Backflow Performance Test
For Biopsy Valve SML001_PT01_BP, SML002_LP01_BP / SML003_FJ01_BP:
- Endoscope Compatibility
- Leakage Test
For Auxiliary Water Connector SML001_PT01_AU, SML002_LP01_AU, SML003_FJ01_AU:
- Endoscope Compatibility
- Leakage Test
- Water flow rate
- Backflow Performance Test
Sterilization: All the subject devices are sold in sterile packages. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10-6. EO residuals on the components are below the maximum levels defined in ISO 10993-7:2008.
Biocompatibility: Biocompatibility testing was conducted on the subject device in accordance with the ISO 10993 standards and FDA guidelines. It included: In Vitro Cytotoxicity Test, Skin sensitization Test, Irritation or intracutaneous reactivity Test. The subject devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the subject devices are biocompatible.
Package integrity: Package integrity tests were performed, including visual inspection, seal strength test (ASTM F88/F88M-2015), and dye penetration testing (ASTM F1929-2015), on both unaged and aged products (accelerated aging followed by simulated distribution). The test results show that the subject devices maintain a sterile barrier for the entirety of the proposed shelf life, after simulated distribution.
No clinical study is included in this submission.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
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January 17, 2023
SML Med-Tech Solutions Limited % Cassie Lee, Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong CHINA
Re: K220884
Trade/Device Name: Disposable Endoscope Valve Sets Regulation Number: 21 CFR 876.1500 Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODC Dated: October 13, 2022 Received: October 14, 2022
Dear Cassie Lee:
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,
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
2
Indications for Use
510(k) Number (if known) K220884
Device Name Disposable Endoscope Valve Sets
Indications for Use (Describe)
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
-
Air/Water Valve: 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.
-
Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction. whilst preventing inflow of air.
-
Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
-
Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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 of K220884
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: January 11, 2023
2. Submitter's Information
Sponsor Name: SML Med-Tech Solutions Limited Address: Rm 406, WAH YIU INDL CTR, 30-32 AU PUI WAN ST, FO TAN, N.T., Hong Kong Establishment Registration Number: Applying Post Code: 518119 Contact name: Mark KO (Marketing Director) Tel: (852) 2690 1113 Phone: +86 138 2302 2407 Fax: (852) 2601 2074 E-mail: mark@sml-medtech.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Common Name: Endoscope and accessories Classification Name: Endoscope Channel Accessory Trade Name: Disposable Endoscope Valve Sets Review Panel: Gastroenterology/Urology Product Code: ODC Regulation Number: 21 CFR 876.1500 Regulatory Class: Class II
4. Predicate Device Information
Sponsor: Wilson Instruments (SHA) Co., LTD
4
Common Name: Endoscope and accessories Classification Name: Endoscope Channel Accessory Trade Name: Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B 510(k) Number: K200769 Review Panel: Gastroenterology/Urology Product Code: ODC Regulation Number: 21 CFR 876.1500 Regulatory Class: Class II
5. Device Description
The Disposable Endoscope Valve Sets is a collection of several sterile units, it is intended for single-use and supplied sterile. The subject device is intended 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 an Auxiliary Water Connector.
- The Suction Valve component of the Disposable Endoscope Valve Sets is designed to be attached । to the suction port of the endoscope, allowing the user to aspirate excess fluids or other debris obscuring the endoscopic image.
- । The Air/Water Valve component of the Disposable Endoscope Valve Sets is designed to be attached to the air/ water port of the endoscope, 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 component of the Disposable Endoscope Valve Sets 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 Auxiliary Water Connector component of the Disposable Endoscope Valve Sets is designed to be attached to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve that prevents the backflow of water or biomaterials from the endoscope to the sterile water bottle.
And there were no prior submissions for the subject devices.
6. Intended Use / Indications for Use
The Disposable Endoscope Valve Sets 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 an Auxiliary Water Connector.
- -Air/Water Valve: 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.
5
- -Suction Valve: This unit is intended to be fitted to an endoscope suction channel to control the operations of suction, whilst preventing inflow of air.
- Biopsy Valve: This unit is intended to be fitted to an endoscope biopsy port to prevent leakage of gases and body fluids during an endoscopic procedure.
- Auxiliary Water Connector: This unit is intended to provide irrigation via sterile water supply during -GI endoscopic procedures when used in conjunction with an irrigation pump.
7. Comparison to predicate device
| Elements of
| Comparison | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| Company | SML Med-Tech Solutions Limited | Wilson Instruments (SHA) Co., | ||
| LTD | -- | |||
| 510 (k) Number | K220884 | K200769 | -- | |
| Trade Name | Disposable Endoscope Valve Sets | Disposable Endoscope Valves | ||
| Set, Disposable Endoscope | ||||
| Valves Set B | -- | |||
| Product Code | ODC | ODC | Same | |
| Common Name | Endoscope and accessories | Endoscope and accessories | Same | |
| Classification Name | Endoscope Channel Accessory | Endoscope Channel Accessory | Same | |
| Classification | Class II | Class II | Same | |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Comparison of Air/Water Valve | ||||
| Indications for use | 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. | 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. | Same | |||
| Compatible | ||||
| endoscopes | SML002_LP01_AW: Olympus® 140/ | |||
| 160/ 180/ 190/ 240/ 260/ 290 Series | ||||
| GI Endoscope | ||||
| SML001_PT01_AW: Pentax® 90/ | ||||
| i10 GI Endoscope | ||||
| SML003_FJ01_AW: Fujifilm® 700 | ||||
| Series GI Endoscope | WS-VO-01: Olympus | |||
| 140/160/180/190/240/260/290 | ||||
| series endoscopes | ||||
| WS-VP-01: PENTAX GI | ||||
| Video Endoscope 90K/90i | ||||
| Series; K10/i10 Series | Similar | |||
| Note 1 | ||||
| Sterile | EO sterilization | EO sterilization | Same | |
| Single Use | Yes | Yes | Same | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Result | |
| Material | ABS, Silicone Rubber, TPE, | |||
| Stainless steel 304 | WS-VO-01: SIR, ABS, TPE, | |||
| Stainless steel 304 | ||||
| WS-VP-01: SIR, ABS, TPE, | ||||
| Stainless steel 304 | Same | |||
| Environment | ||||
| of use | Hospitals/clinics | Hospitals/clinics | Same | |
| Comparison of Suction Valve | ||||
| Indications for use | This unit is intended to be fitted to | |||
| an endoscope suction channel to | ||||
| control the operations of suction, | ||||
| whilst preventing inflow of air. | This unit is intended to be fitted | |||
| to an endoscope suction channel | ||||
| to control the operations of | ||||
| suction, whilst preventing inflow | ||||
| of air. | Same | |||
| Compatible | ||||
| endoscopes | SML002_LP01_SU, | |||
| SML002_LP02_SU: Olympus® 140/ | ||||
| 160/ 180/ 190/ 240/ 260/290 Series | ||||
| GI Endoscope | ||||
| SML001_PT01_SU, | ||||
| SML001_PT02_SU, | ||||
| SML001_PT03_SU: Pentax® 90/ i10 | ||||
| GI Endoscope | ||||
| SML003_FJ01_SU, | ||||
| SML003_FJ02_SU: Fujifilm® 700 | ||||
| Series GI Endoscope | 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 | Similar | |||
| Note 1 | ||||
| Sterile | EO sterilization | EO sterilization | Same | |
| Single Use | Yes | Yes | Same | |
| Material | ABS, PC, Silicone Rubber, Stainless | |||
| steel 304 | WS-VO-02: SIR, ABS, TPE, | |||
| Stainless steel 304, Stainless | ||||
| steel 17-4PH | ||||
| WS-VP-02: SIR, ABS, TPE, | ||||
| Stainless steel 304 | Similar | |||
| Note 2 | ||||
| Environment | ||||
| of use | Hospitals/clinics | Hospitals/clinics | Same | |
| Comparison of Biopsy Valve | ||||
| Indications for use | This unit is intended to be fitted to | This unit is intended to be fitted | Same | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Result | |
| an endoscope biopsy port to prevent | ||||
| leakage of gases and body fluids | ||||
| during an endoscopic procedure. | to an endoscope biopsy port to | |||
| prevent leakage of gases and | ||||
| body fluids during an endoscopic | ||||
| procedure. | ||||
| Compatible | ||||
| endoscopes | SML002_LP01_BP: Olympus® 140/ | |||
| 160/ 180/ 190/ 240/ 260/290 Series | ||||
| GI Endoscope | ||||
| SML001_PT01_BP: Pentax® 90/ i10 | ||||
| GI Endoscope | ||||
| SML003_FJ01_BP: Fujifilm® 700 | ||||
| Series GI Endoscope | Olympus | |||
| 140/160/180/190/240/260/2 | ||||
| 90 series endoscopes | Similar | |||
| Note 1 | ||||
| Sterile | EO sterilization | EO sterilization | Same | |
| Single Use | Yes | Yes | Same | |
| Material | Silicone Rubber | Silicon rubber | Similar | |
| Note 2 | ||||
| Environment | ||||
| of use | Hospitals/clinics | Hospitals/clinics | Same | |
| Comparison of Water Connector | ||||
| Indications for use | This unit is intended to provide | |||
| irrigation via sterile water supply | ||||
| during GI endoscopic procedures | ||||
| when used in conjunction with an | ||||
| irrigation pump. | This unit is intended to provide | |||
| irrigation via sterile water supply | ||||
| during Gl endoscopic | ||||
| procedures when used in | ||||
| conjunction with an irrigation | ||||
| pump. | Same | |||
| Compatible | ||||
| endoscopes | SML002_LP01_AU: Olympus® 140/ | |||
| 160/ 180/ 190/ 240/ 260/290 Series | ||||
| GI Endoscope | ||||
| SML001_PT01_AU: Pentax® 90/ i10 | ||||
| GI Endoscope | ||||
| SML003_FJ01_AU: Fujifilm® 700 | ||||
| Series GI Endoscope | Olympus | |||
| 140/160/180/190/240/260/2 | ||||
| 90 series endoscopes | Similar | |||
| Note 1 | ||||
| Sterile | EO sterilization | EO sterilization | Same | |
| Single Use | Yes | Yes | Same | |
| Material | PC, Silicone Rubber | SIR, PVC, PC, Stainless | Similar | |
| Elements of | ||||
| Comparison | Subject Device | Predicate Device | Result | |
| steel 303 | Note 2 | |||
| Environment | ||||
| of use | Hospitals/clinics | Hospitals/clinics | Same |
6
7
8
Comparison in Detail(s):
Note 1:
Although the "Compatible endoscopes" of the subject device is a little different from the predicate device, the subject device is designed for intended use with the corresponding endoscopes mentioned and all the components of the subject device have good compatibility with the compatible endoscopes. So, the differences between the subject device and predicate device will not affect the safety and effectiveness.
Note 2:
Although the "Material" of the subject device is a little different from the predicate device, they all met the requirements of the ISO 10993 series biocompatibility standards. So, the differences between the subject device and predicate device will not affect the safety and effectiveness.
8. Test Summary
8.1 Summary of Non-Clinical Performance Testing
1)
The SML Med-Tech Solutions Limited has performed bench testing to support substantial equivalence. The following tests were performed on the subject devices and predicate devices.
For Suction Valve SML001_PT01_SU, SML001_PT02_SU, SML001_PT03_SU, SML002_LP01_SU, SML002_LP02_SU, SML003_FJ01_SU, SML003_FJ02_SU:
- -Endoscope Compatibility
- -Depression Force
- Leakage Test -
- । Suction Flow
For Air/Water Valve SML001_PT01_AW, SML002_LP01_AW, SML003_FJ01_AW:
- । Endoscope Compatibility
- -Air flow rate
- -Water flow rate
- Leakage Test -
- Depression Force -
- Backflow Performance Test י
9
For Biopsy Valve SML001_PT01_BP, SML002_LP01_BP / SML003_FJ01_BP:
- Endoscope Compatibility -
- । Leakage Test
For Auxiliary Water Connector SML001_PT01_AU, SML002_LP01_AU, SML003_FJ01_AU:
- -Endoscope Compatibility
- -Leakage Test
- Water flow rate -
- -Backflow Performance Test
Sterilization 2)
All the subject devices are sold in sterile packages, like the predicate devices have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the components are below the maximum levels defined in ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals.
3) Biocompatibility
The biocompatibility of the subject devices was conducted 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 is conducted on the subject device in accordance with the ISO 10993 standards. It included the following tests:
- -In Vitro Cytotoxicity Test
- । Skin sensitization Test
- -Irritation or intracutaneous reactivity Test
The subject devices are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the subject devices are biocompatible.
4) Package integrity
The package integrity test of the subject devices has been established to study whether the packaging will maintain a sterile barrier for the entirety of the proposed shelf life, after simulated distribution. And visual inspection, seal strength test (ASTM F88/F88M-2015), and dye penetration testing (ASTM F1929-2015) have been conducted on the subject device before aging products, and products have undergone accelerated aging followed by simulated distribution. The test results show that the subject devices maintain a sterile barrier for the entirety of the proposed shelf life, after simulated distribution.
8.2 Summary of Clinical Performance Test
10
No clinical study is included in this submission.
9. Final Conclusion:
The subject device Disposable Endoscope Valve Sets is substantially equivalent to the predicate device.