(142 days)
The Disposable Endoscopy Adapter 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable Water Jet Adapter: 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 Endoscopy Adapter 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. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
This document pertains to the 510(k) premarket notification for a medical device called the "Disposable Endoscopy Adapter Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies. Therefore, the questions related to AI/MRMC studies, human reader improvement, and extensive clinical ground truth establishment are not applicable in this context.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Nature of the Device and Submission:
The Disposable Endoscopy Adapter Set is a collection of sterile units (Air/Water Valve, Suction Valve, Biopsy Valve, Water Jet Adapter) intended to be fitted to endoscope working channels/ports to control fluid/gas flow and prevent leakage/back-flow. This is a Class II device.
The submission is a 510(k), which aims to demonstrate that the new device is "substantially equivalent" to a predicate device already on the market (in this case, "Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769" from Wilson Instruments (SHA) Co., LTD). Substantial equivalence is primarily proven through comparison of technological characteristics and non-clinical performance data, rather than large-scale clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a physical medical device (endoscopy adapters) and not an AI/software device, the "acceptance criteria" are not framed in terms of AI performance metrics (like sensitivity, specificity, AUC) but rather through adherence to recognized standards and successful completion of pre-defined non-clinical tests to demonstrate equivalence to the predicate.
| Acceptance Criterion (Regulatory/Technical Standard) | Reported Device Performance (Test Results) | Notes |
|---|---|---|
| Biocompatibility | Meets ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing" requirements. Materials (Silicone Rubber, ABS, SUS304 for proposed device vs. SIR, ABS, TPE, Stainless steel 304 for predicate) deemed "Substantially equivalent supported by biocompatibility testing." | This ensures the materials used in the device are safe for contact with the body. |
| Sterilization Efficacy & Residuals | Meets ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices" and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals" requirements. Sterilization method (EO Sterilization) is "Same" as predicate. | Ensures the device is sterile and safe for use, and that no harmful residuals remain from the sterilization process. |
| Physical Properties/Functional Performance | "The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing." Specific comparisons made for "Compatible Endoscopes" (Olympus, PENTAX, Fujifilm) for various valve types, stated as "Substantially equivalent supported by bench testing." | These tests evaluate the device's ability to perform its intended function, such as controlling fluid/gas flow, preventing back-flow/leakage, and compatibility with various endoscopes. This demonstrates the device functions as intended and similarly to the predicate. |
| Comparison to Predicate Device's Intended Use | "Substantially equivalent" in Indication for Use. Detailed functional descriptions of each valve type (Air/Water, Suction, Biopsy, Water Jet Adapter) are presented as functionally equivalent to the predicate. | The intended use of the proposed device aligns with that of the predicate, minimizing new risks. |
| Comparison to Predicate Device's Technological Characteristics (General) | "Substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use" as the predicate device. Differences are stated as "do not raise any questions regarding its safety and effectiveness." | This general statement underpins the substantial equivalence claim. |
| Product Code, Regulation Number, Classification | "Same" as predicate (ODC, 21 CFR 876.1500, Class II respectively). | Demonstrates the device fits within the same established regulatory framework as the predicate. |
| Environment of Use | "Same" as predicate (Hospital/clinics). | Assures suitability for the intended clinical environment. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify exact sample sizes for the "bench tests" performed. For physical device testing, sample sizes are typically determined by statistical methods for device validation (e.g., AQL sampling plans) or by industry standards for specific tests, but these details are not provided in this high-level summary.
- Data Provenance: The testing was performed as part of the submission by Yangzhou Fartley Medical Instrument Technology Co., Ltd. and their consultant Shanghai Thinkwell Consulting Co., Ltd. The country of origin for the manufacturing and testing would be China. The data would be considered prospective with respect to the regulatory submission, meaning the tests were specifically conducted to support this 510(k).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This question is not applicable to this 510(k) submission. "Ground truth" for physical device performance (like fluid flow, material properties, sterility) is established through standardized laboratory testing, rather than expert consensus on medical images or clinical outcomes. The "experts" would be the engineers, microbiologists, and other technical personnel who conducted and validated the bench tests, adhering to established international standards (ISO). Their specific number or qualifications are not typically detailed in the public 510(k) summary, as their expertise is presumed in conducting validated tests.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1 or 3+1) are for interpreting subjective data, typically in diagnostic imaging studies where multiple readers might interpret the same case. For physical device performance, tests have objective pass/fail criteria based on measured parameters and adherence to specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic tool. No AI component is mentioned, and therefore, no MRMC study or AI-related effectiveness claim was made or required.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. There is no algorithm or software component mentioned for this device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Bench Testing: Objective measurements of physical properties, appearance, and functional performance (e.g., flow control, prevention of back-flow/leakage, compatibility with endoscopes).
- Biocompatibility Testing: Laboratory tests to ensure the materials are non-toxic and compatible with biological systems.
- Sterilization Validation: Microbiological testing to confirm sterility assurance level (SAL) and ethylene oxide residuals meet standards.
- Adherence to Standards: Compliance with recognized international standards (ISO 10993, ISO 11135-1) serves as the "ground truth" for safety and performance in these areas.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device, not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.
June 17, 2022
Yangzhou Fartley Medical Instrument Technology Co., Ltd. % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd Room 211/6F, Xinling Road, Minhang District Shanghai, Shanghai 201100 China
Re: K220210
Trade/Device Name: Disposable Endoscopy Adapter Set Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: ODC Dated: May 9, 2022 Received: May 16, 2022
Dear Ethan Liu:
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 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Device Name
Disposable Endoscopy Adapter Set
The Disposable Endoscopy Adapter 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable Water Jet Adapter: 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are interconnected and have a three-dimensional appearance. A yellow line extends from the top right of the letter "Y", adding a contrasting color element to the design.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
5.1 Submitter
| Submitted by: | Yangzhou Fartley Medical Instrument Technology Co., Ltd.Address:Beizhou Road, Lidian Town, Guangling District, Yangzhou225106 Jiangsu, China |
|---|---|
| Contact Person: | Ethan LiuRA SpecialistShanghai Thinkwell Consulting Co., LtdAddress: Room 211/6F, Xinling Road, Minhang District, Shanghai,China.Phone: 0086-15216699240Email: xtdeepwater@126.com |
| Date Prepared: | Jan 27, 2022 |
5.2 Device
| Device Name: | Disposable Endoscopy Adapter Set |
|---|---|
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.3 Predicate Device
| Device Name: | Disposable Endoscope Valves Set, Disposable EndoscopeValves Set B, K200769 |
|---|---|
| Manufacturer: | Wilson Instruments (SHA) Co., LTD |
| Classification Name: | Endoscope Channel Accessory |
| Regulatory Class: | II |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Product Code: | ODC |
5.4 Device Description
The Disposable Endoscopy Adapter 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. The sterile units may consist of Disposable Air/Water Valve, Disposable Suction Valve, Disposable Biopsy Valve and Disposable Water Jet Adapter. Disposable Endoscopy Adapter Set
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are bold and interconnected, with a slight slant to the right. A yellow line extends from the top right of the "Y", adding a touch of color to the otherwise monochromatic design. The overall impression is of a modern and dynamic logo.
may be configured as single valve or multiple valves in any combination up to a maximum of 4 valves.
5.5 Indication for Use:
The Disposable Endoscopy Adapter 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable 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.
-
Disposable Water Jet Adapter: This unit is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
5.6 Comparison of Technological Characteristics
The Disposable Endoscopy Adapter Set has substantially equivalent device design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the predicate device Wilson Instruments (SHA) Co., LTD's Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769. The differences between the proposed device and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below.
| Item | Disposable EndoscopyAdapter Set(ProposedDevice) | Disposable Endoscope ValvesSet, Disposable EndoscopeValves Set B, K200769 | Discussion |
|---|---|---|---|
| Indicationfor Use | The Disposable EndoscopyAdapter Set is a collectionof several sterile units. It isintended to be fitted tomultiple endoscopeworking channels/ports tocontrol the flow of fluids,gases and other materials. | The Disposable EndoscopeValves Set is a collection ofseveral sterile units. It isintended to be fitted tomultiple endoscope workingchannels/ports to control theflow of fluids, gases and othermaterials. It includes anair/water valve, a suctionvalve, a biopsy valve and awater connector. | Substantiallyequivalent |
| - Disposable Air/WaterValve: This unit is intendedto be fitted to an endoscopeair/water channel to controlthe inflow of medical gasesand water, whilstpreventing back-flow. | - Disposable Air/Water Valves:This unit is intended to befitted to an endoscopeair/water channel to control theinflow of medical gases andwater, whilst preventing | ||
| - Disposable Suction Valve: | |||
| Item | Disposable EndoscopyAdapter Set(ProposedDevice) | Disposable Endoscope ValvesSet, Disposable EndoscopeValves Set B, K200769 | Discussion |
| This unit is intended to befitted to an endoscopesuction channel to controlthe operations of suction,whilst preventing inflow ofair. | back-flow. | ||
| - Disposable Biopsy Valve:This unit is intended to befitted to an endoscopebiopsy port to preventleakage of gases and bodyfluids during an endoscopicprocedure. | - Disposable Suction Valves:This unit is intended to befitted to an endoscope suctionchannel to control theoperations of suction, whilstpreventing inflow of air. | ||
| - Disposable Water JetAdapter: This unit isintended to provideirrigation via sterile watersupply during GIendoscopic procedureswhen used in conjunctionwith an irrigation pump. | - Disposable Biopsy Valves:This unit is intended to befitted to an endoscope biopsyport to prevent leakage ofgases and body fluids duringan endoscopic procedure. | ||
| - Disposable Endoscope WaterConnectors: This unit isintended to provide irrigationvia sterile water supply duringGI endoscopic procedureswhen used in conjunction withan irrigation pump. | |||
| The Disposable EndoscopeValves Set B is a collection ofsterile device intended to befitted to multiple endoscopeworking channels/ports toenable an endoscope operatorcontrol the function of theworking channels/ports andprevent retrograde flow offluids, gases, and othermaterials. It includes a suctionvalve, an air/water valve. Thisis a single-use device. -Air/Water Valves: This deviceis intended to be fitted to anendoscope air/water channel toenable the operator to controlinflow of medical gases andwater, whilst preventingbackflow. - Suction Valves: | |||
| Item | Disposable EndoscopyAdapter Set(ProposedDevice) | Disposable Endoscope ValvesSet, Disposable EndoscopeValves Set B, K200769 | Discussion |
| The device is intended to befitted to an endoscope suctionchannel to enable the operatorto control suction whilstpreventing inflow of air. | |||
| ProductCode | ODC | ODC | Same |
| RegulationNumber | 21 CFR 876.1500 | 21 CFR 876.1500 | Same |
| Classification | II | II | Same |
| Air/Water Valve | |||
| CompatibleEndoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series,K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | WS-VO-01:Olympus140/160/180/190/240/260/2 90series endoscopesWS-VP-01: PENTAX GIVideo Endoscope 90K/90iSeries, K10/i10 Series | Substantiallyequivalentsupported bybench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber, ABS,SUS304 | WS-VO-01: SIR, ABS, TPE,Stainless steel 304WS-VP-01: SIR, ABS, TPE,Stainless steel 304 | Substantiallyequivalentsupported bybiocompatibilitytesting. |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Suction Valve | |||
| CompatibleEndoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | WS-VO-02: Olympus140/160/180/190/240/260/2 90series endoscopesWS-VP-02: PENTAX GIVideo Endoscope 90K/90iSeries; K10/i10 Series | Substantiallyequivalentsupported bybench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | ABS, Silicone Rubber,SUS304 | WS-VO-02: SIR, ABS, TPE,Stainless steel 304 | Substantiallyequivalent |
| Item | Disposable EndoscopyAdapter Set(ProposedDevice) | Disposable Endoscope ValvesSet, Disposable EndoscopeValves Set B, K200769 | Discussion |
| WS-VP-02: SIR, ABS, TPE,Stainless steel 304 | biocompatibilitytesting. | ||
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Biopsy Valve | |||
| CompatibleEndoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | Olympus140/160/180/190/240/260/290series endoscopes | Substantiallyequivalentsupported bybench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Silicone Rubber | Silicone Rubber | Same |
| EnvironmentUse | Hospital/clinics | Hospital/clinics | Same |
| Water Jet Adapter | |||
| CompatibleEndoscopes | Olympus140/160/180/190/240/260/290 series endoscopes;PENTAX GI VideoEndoscope 90K/90i Series;K10/i10 Series;Fujifilm® 500/600/700 series endoscopes | Olympus140/160/180/190/240/260/290series endoscopes | Substantiallyequivalentsupported bybench testing. |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Material | Metal Type:PC,SUS303,Silicone RubberPlastic Type: PC, SiliconeRubber | NBR, SIR, ABS | Substantiallyequivalentsupported bybiocompatibilitytesting. |
| EnvironmentUse | Hospitals/clinics | Hospitals/clinics | Same |
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the word "FRITIEY" in a stylized, sans-serif font. The word is in blue, except for a yellow extension on the right side of the letter "Y". The letters are slanted to the right, giving the word a dynamic appearance.
K220210
Page 3 of 6
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are connected and slanted to the right, giving the word a dynamic appearance. A thin, yellow line extends from the top of the "Y", adding a subtle accent to the design. The overall impression is modern and professional.
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "ARTLEY" in a stylized, italicized font. The letters are primarily blue, with a yellow accent on the right side of the "Y". The font appears to be bold and slanted, giving the word a dynamic and modern look. The overall design is clean and simple, with a focus on the word itself.
5.7 Non-clinical Performance Data
The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "ARTLEY" in a stylized, blue font. The letters are bold and slightly slanted to the right, giving the word a dynamic appearance. A thin, yellow line extends from the top of the "Y", adding a subtle accent to the overall design.
devices - Part 7: ethylene oxide sterilization residuals" .
The following bench tests were performed on Disposable Endoscopy Adapter Set: Appearance, Physical properties. The results of all testing were passing.
5.8 Clinical Test Data
No Clinical Study is included in this submission.
5.9 Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Yangzhou Fartley Medical Instrument Technology Co., Ltd. has demonstrated that proposed device Disposable Endoscopy Adapter Set is substantially equivalent to Wilson Instruments (SHA) Co., LTD's currently marketed Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, K200769.
§ 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.