(30 days)
The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve.
-
The Andorate Disposable Suction Valve is used to control the suction of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
-
The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
-
The Andorate 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.
The Andorate® Valves Set and Andorate® Auxiliary Water Connector are intended for single-use and are supplied sterile. Single-use valves sets and auxiliary water connector help preventing potential safety risks and eliminate the need for manual cleaning and reprocessing. The valves set and auxiliary water connector are easily incorporated into infection prevention policies as a single use item.
The Andorate® Auxiliary Water Connector is manufactured for use in conjunction with irrigation tubing, and together with Pentax 90 series endoscope. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. The auxiliary water connector is designed to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The Andorate® Valves Set is manufactured for use with Pentax 90 series endoscope. The suction, air/water, and biopsy valves are housed in a single tray and packaged in sealed packed. The valves set is sold as a sterile device.
- The Suction Valve component of the Andorate® Valves Set is designed to o 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 component of the Andorate® Valves Set is intended to O 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 subject devices in this submission have the same operation and method of action as the predicate devices. In the submission, Andorate® Valves Set and Andorate® Auxiliary Water Connector are the only subject device. This submission does not include irrigation tubing or irrigation pump.
The provided document describes the K191231 submission for the Andorate® Valves Set (GAR037) and Andorate® Auxiliary Water Connector (GAR048). This is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics against those criteria, and information about expert consensus, training sets, and MRMC studies is not available in this document as it's typically required for software-as-a-medical-device (SaMD) or AI-driven diagnostic devices.
However, based on the information provided, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a table of quantitative acceptance criteria with corresponding performance metrics for the proposed devices in the way an AI/SaMD 510(k) summary would. Instead, it lists the types of non-clinical performance tests conducted to demonstrate substantial equivalence to predicate devices, focusing on functional and safety aspects. The reported performance is generally stated as having met the requirements, implying equivalence to the predicates.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Andorate® Valves Set (GAR037) | ||
| Assembling Integrity (Suction Valve, Biopsy Valve) | Maintain structural integrity upon assembly. | Testing performed; implicit compliance. |
| Endoscope Compatibility (All Valves) | Compatible with Pentax 90 series Endoscopes. | Testing performed; implicit compliance. |
| Depression Force (Suction Valve, Air/Water Valve) | Operate within acceptable force ranges. | Testing performed; implicit compliance. |
| Vacuum Leak Test (Suction Valve, Biopsy Valve) | No significant vacuum leakage. | Testing performed; implicit compliance. |
| Suction Flow Test (Suction Valve) | Achieve adequate suction flow. | Testing performed; implicit compliance. |
| Air Leakage Testing (Air/Water Valve) | No significant air leakage. | Testing performed; implicit compliance. |
| Water Flow Test (Air/Water Valve) | Achieve adequate water flow. | Testing performed; implicit compliance. |
| Squeegee Leak Test (Biopsy Valve) | No significant leakage during device passage/exchange. | Testing performed; implicit compliance. |
| Andorate® Auxiliary Water Connector (GAR048) | ||
| Compatibility with Irrigation Tubing | Compatible with standard irrigation tubing. | Testing performed; implicit compliance. |
| Compatibility with Endoscope | Compatible with Pentax 90 series Endoscopes. | Testing performed; implicit compliance. |
| Water Flow Test | Achieve adequate water flow. | Testing performed; implicit compliance. |
| Air Leakage Test | No significant air leakage. | Testing performed; implicit compliance. |
| Water Leakage Test | No significant water leakage. | Testing performed; implicit compliance. |
| Backflow Performance Test | Prevent backflow of water/biomaterials. (Explicitly mentioned: "prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.") | Testing performed; implicit compliance. |
| Sterilization | SAL of 10^-6 for EO sterilization. EO residuals below ANSI/AAMI/ISO 10993-7. | Achieved SAL of 10^-6. EO residuals below maximum levels. |
| Shelf Life | Maintain sterility and intended performance for 3 years. | Demonstrated through accelerated aging, packaging integrity tests. |
| Biocompatibility | Meet ISO 10993 guidelines for mucosal membrane contact. | Tests (Systemic Toxicity, Cytotoxicity, Skin Sensitization, Irritation) show biocompatibility. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size of Test Set: The document does not specify exact sample sizes for each non-clinical performance test. It states that "Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization." This implies a representative sample was tested, but no specific number is given.
- Data Provenance: The tests were performed on "Smartdata samples from initial production lots," which would originate from Smartdata Suzhou Co., Ltd. in China. The data is retrospective in the sense that it was collected from manufactured devices for the purpose of the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable and not provided. The devices are physical medical instruments (valves and connectors), not diagnostic or AI-driven devices that would require expert consensus for ground truth. Performance was evaluated through objective bench testing.
4. Adjudication Method for the Test Set
- This is not applicable as the tests performed are objective bench tests, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic devices (especially those involving image interpretation by human readers) to assess the impact of AI assistance on reader performance. The devices in this submission are accessories for endoscopes, not diagnostic tools.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone (algorithm only) study was not done. This is relevant for AI algorithms. The devices are mechanical accessories, not algorithms.
7. Type of Ground Truth Used
- The "ground truth" for the performance tests was defined by established engineering and medical device standards, functional requirements, and comparison to the predicate devices. For example, for a "Vacuum Leak Test," the ground truth is simply the absence of leakage beyond a specified threshold, determined by the test method. For biocompatibility, it's compliance with ISO 10993 standards.
8. Sample Size for the Training Set
- Not applicable. These are physical hardware devices; there is no "training set" in the context of an AI/ML algorithm. Their design and manufacturing processes are developed through traditional engineering methods and validated through bench testing.
9. How the Ground Truth for the Training Set Was Established
- Not applicable as there is no training set for these devices.
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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 and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below that.
June 7, 2019
Smartdata Suzhou Co., Ltd % Thomas Schorre Responsible Third-Party Official Accelerated Device Approval Services, LLC 6800 S.W. 40th Street. Ste. 444 Ludlum, FL 33155-3708
Re: K191231
Trade/Device Name: Andorate Valves Set (GAR037) and Andorate Auxiliary Water Connector (GAR048) Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODC, OCX Dated: May 3, 2019 Received: May 8, 2019
Dear Thomas Schorre:
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,
for
Shani P. Haugen, Ph.D. Acting, Assistant Division 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)
Device Name
Andorate Valves Set (GAR037) and Andorate Auxiliary Water Connector (GAR048)
Indications for Use (Describe)
The Andorate Auxiliary Water Connector (Model GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The disposable Andorate Valves Set (Model GAR037) consists of one suction valve, one air/water valve and one biopsy valve.
-
The Andorate Disposable Suction Valve is used to control the suction of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
-
The Andorate Disposable Air/Water valve is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
-
The Andorate 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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{3}------------------------------------------------
K191231 Page 1 of 11
510(k) Summary
+852 6393 5184
1. Submission Sponsor
| Submitter's Name: | Smartdata Suzhou Co., Ltd |
|---|---|
| Submitter's Address: | 4f, Block 7, 198#, Jinshan RdNew DistrictSuzhou, Jiangsu 215011CHINA |
| Establishment Registration No.: | 3008058134 |
Andorate® Valves Set and Andorate® Auxiliary Water Connector Smartdata Suzhou Co., Ltd.
Esta
2. Sponsor Contact
Contact Person:
Telephone:
Email:
Cindy Ye General Manager +86 512 6598 3722
3. Date Prepared
June 6th, 2019
4. Device Identification
| Trade Device Name: | Andorate® Auxiliary Water Connector (GAR048) |
|---|---|
| Product code: | OCX |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Classification: | II |
| Trade Device Name: | Andorate® Valves Set (GAR037) |
| Product code: | ODC |
| Classification Name: | Endoscope and Accessories |
| Regulation Number: | 21 CFR 876.1500 |
| Classification: | II |
5. Predicate Device Identification
| Predicate Device 510(k) No.: | K092429 |
|---|---|
| Predicate Device Trade Name: | ENDOGATOR |
| Predicate Device Product Code: | FEQ |
| 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 |
{4}------------------------------------------------
Andorate® Valves Set and Andorate® Auxiliary Water Connector Smartdata Suzhou Co., Ltd.
6. Device Description:
The Andorate® Valves Set and Andorate® Auxiliary Water Connector are intended for single-use and are supplied sterile. Single-use valves sets and auxiliary water connector help preventing potential safety risks and eliminate the need for manual cleaning and reprocessing. The valves set and auxiliary water connector are easily incorporated into infection prevention policies as a single use item. Table 1 shows the components included in the application.
The Andorate® Auxiliary Water Connector is manufactured for use in conjunction with irrigation tubing, and together with Pentax 90 series endoscope. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. The auxiliary water connector is designed to the auxiliary water port of the endoscopes. The auxiliary water connector consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle.
The Andorate® Valves Set is manufactured for use with Pentax 90 series endoscope. The suction, air/water, and biopsy valves are housed in a single tray and packaged in sealed packed. The valves set is sold as a sterile device.
- The Suction Valve component of the Andorate® Valves Set is designed to o 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 component of the Andorate® Valves Set is intended to O 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 subject devices in this submission have the same operation and method of action as the predicate devices. In the submission, Andorate® Valves Set and Andorate® Auxiliary Water Connector are the only subject device. This submission does not include irrigation tubing or irrigation pump.
According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate devices. According to the FDA MAUDE database, safety issues on fluid leakage and backflow were identified. In the performance test, the leakage test and backflow test were conducted for verification purposes.
There were no prior submissions for the Andorate® valves set and auxiliary water connector.
7. Intended Use:
The Andorate® Auxiliary Water Connector (GAR048) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation via irrigation fluids such as sterile water supplied to the Pentax 90 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
The Suction Valve component of the Andorate® Valves Set (GAR037) is used to control the suction
{5}------------------------------------------------
K191231 Page 3 of 11
Andorate® Valves Set and Andorate® Auxiliary Water Connector Smartdata Suzhou Co., Ltd.
function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure. The Disposable Air/Water Valve component of the Andorate® Valves Set (GAR037) is used to control the air/water function of an endoscope (for Pentax 90 series Endoscope) during a GI Endoscopic procedure.
The Biopsy Valve component of the Andorate® Valves Set (GAR037) 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.
8. Technological Characteristics
The following tables are summaries of the subject device's technological characteristics as compared to the predicate devices.
{6}------------------------------------------------
Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.
| Comparison table for the ANDORATE® Valves Set | |||||
|---|---|---|---|---|---|
| Specification | DEFENDODisposableSuction Valve | DEFENDODisposableAir/Water Valve | DEFENDODisposableBiopsy Valve | ANDORATE® Valves Set | SubstantialEquivalence |
| K number | K102581 | K102409 | K090851 | K191231 | n/a |
| Manufacturer | Medivators, Inc. | Medivators, Inc. | Medivators, Inc. | ANDORATE® Valves Set | n/a |
| Product code | ODC | ODC | ODC | ODC | Identical |
| Classification | II | II | II | II | Identical |
| Regulation No | 876.1500 | 876.1500 | 876.1500 | 876.1500 | Identical |
| RegulationName | Endoscope andaccessories | Endoscope andaccessories | Endoscope andaccessories | Endoscope and accessories | Identical |
| SuppliedSterile | Yes | Yes | Yes | Yes | Identical |
| Indications forUse | The DEFENDODisposableSuction valve isintended to beused control thesuction functionof an endoscopeduring a GIEndoscopicprocedure. | The DEFENDODisposableAir/Water valve isintended to beused control theair/water functionof an endoscopeduring a GIEndoscopicprocedure. | The DEFENDODisposablebiopsy valve isintended to becover theendoscopebiopsy portduring anendoscopyprocedure. Inaddition, thevalve providesaccess forendoscopicdevice passageand exchange,helps maintaininsufflation andminimizesleakage ofbiomaterial fromthe biopsy portthroughout the | The Andorate® Auxiliary Water Connector(GAR048) is used in conjunction with irrigationtubing, intended to provideirrigation via irrigation fluids such as sterile watersupplied to the Pentax 90 series endoscope duringgastrointestinal endoscopic procedures when usedin conjunction with an irrigation pump.The Suction Valve component of the Andorate®Valves Set (GAR037) is used to control thesuction function of an endoscope (for Pentax 90series Endoscope) during a GI Endoscopicprocedure.The Disposable Air/Water Valve component of theAndorate® Valves Set (GAR037) is used tocontrol the air/water function of an endoscope (forPentax 90 series Endoscope) during a GIEndoscopic procedure.The Biopsy Valve component of the Andorate®Valves Set (GAR037) is used to cover theendoscope biopsy port during an endoscopyprocedure. In addition, the valve provides accessfor endoscopic device passage and exchange, helpsmaintain insufflation and minimizes leakage of | SubstantialEquivalence |
| Comparison table for the ANDORATE® Valves Set | |||||
| Specification | DEFENDODisposableSuction Valve | DEFENDODisposableAir/Water Valve | DEFENDODisposableBiopsy Valve | ANDORATE® Valves Set | SubstantialEquivalence |
| endoscopicprocedure | biomaterial from the biopsy port throughout theendoscopic procedure. | ||||
| Environmentof Use | Hospital and/orclinics | Hospital and/orclinics | Hospital and/orclinics | Hospital and/or clinics | Identical |
| Single Use,Disposable | Yes | Yes | Yes | Yes | Identical |
| Material | Nitrile ButadieneRubber,ThermoplasticElastomer,Polycarbonate,Styreneethylene-butene-styreneblockcopolymer, Highimpactpolystyrene,stainless steel304 | Suction Valve component of the Andorate®Valves Set:Polycarbonate, Acrylonitrile Butadiene Styrene,silicone, Stainless Steel 304 | SubstantialEquivalence | ||
| Material | ThermoplasticElastomer,Polycarbonate,Stainless Steel304 | Air/Water Valve component of the Andorate®Valves Set:Acrylonitrile Butadiene Styrene, silicone, StainlessSteel 304 | SubstantialEquivalence | ||
| Material | ThermoplasticElastomer | Biopsy Valve component of the Andorate®Valves Set:Silicone | SubstantialEquivalence | ||
| Packaging | Suction, air/water andbiopsy valves arehoused in a | Suction, air /waterand biopsy valvesare housed in asingle tray and | Suction, air/water andbiopsy valves arehoused in a | Suction, air /water and biopsy valves are housed ina single tray and packaged in a sealed pouched | Identical |
| Comparison table for the ANDORATE® Valves Set | |||||
| Specification | DEFENDODisposableSuction Valvesingle tray andpackaged in asealed pouched | DEFENDODisposableAir/Water Valvepackaged in asealed pouched | DEFENDODisposableBiopsy Valvesingle tray andpackaged in asealed pouched | ANDORATE® Valves Set | SubstantialEquivalence |
| Manufacturingmethod | Injectionmoulding andovermoulding. | Suction Valve component of the Andorate®Valves Set:Injection moulding and overmoulding. | SubstantialEquivalence | ||
| Manufacturingmethod | Injection molded | Air/Water Valve component of the Andorate®Valves Set:Injection moulding | SubstantialEquivalence | ||
| Manufacturingmethod | Injectionmoulding | Biopsy Valve component of the Andorate®Valves Set:Injection moulding | SubstantialEquivalence | ||
| Sterilization | EO gas | EO gas | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Three years | Three years | Identical |
| Compatibility | Pentax GIEndoscope | Pentax GIEndoscope | Pentax GIEndoscope | Pentax 90 series Endoscope | SubstantialEquivalence |
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K191231
Page 5 of 11
Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.
{8}------------------------------------------------
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K191231
Page 7 of 11
Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.
| Comparison table for the ANDORATE® Auxiliary Water Connector | |||||||
|---|---|---|---|---|---|---|---|
| Specification | ENDOGATOR | ANDORATE® Auxiliary Water Connector | SubstantialEquivalence | ||||
| K number | K092429 | K191231 | n/a | ||||
| Manufacturer | Medivators, Inc. | ANDORATE® Valves Set | n/a | ||||
| Product code | FEQ | OCX | Identical | ||||
| Classification | II | II | Identical | ||||
| Regulation No | 21 CFR 876.1500 | 21 CFR 876.1500 | Identical | ||||
| RegulationName | Endoscope and accessories | Endoscope and accessories | Identical | ||||
| SuppliedSterile | Yes | Yes | Identical | ||||
| Indications forUse | The ENDOGATOR® system is intended to provideirrigation via sterile water during GI endoscopicprocedures when used in conjunction with anirrigation pump (or cautery unit). | The Andorate® Auxiliary Water Connector(GAR048) is used in conjunction with irrigationtubing, intended to provide irrigationvia irrigation fluids such as sterile water supplied tothe Pentax 90 series endoscope during gastrointestinalendoscopic procedures when used in conjunction withan irrigation pump.The Suction Valve component of the Andorate®Valves Set (GAR037) is used to control the suctionfunction of an endoscope (for Pentax 90 seriesEndoscope) during a GI Endoscopic procedure.The Disposable Air/Water Valve component of theAndorate® Valves Set (GAR037) is used to controlthe air/water function of an endoscope (for Pentax 90series Endoscope) during a GI Endoscopic procedure.The Biopsy Valve component of the Andorate®Valves Set (GAR037) is used to cover the endoscopebiopsy port during an endoscopy procedure. Inaddition, the valve provides access for endoscopicdevice passage and exchange, helps maintaininsufflation and minimizes leakage of biomaterialfrom the biopsy port throughout the endoscopicprocedure. | SubstantialEquivalence | ||||
| Comparison table for the ANDORATE® Auxiliary Water Connector | |||||||
| Specification | ENDOGATOR | ANDORATE® Auxiliary Water Connector | SubstantialEquivalence | ||||
| Environmentof Use | Hospital and or clinics | Hospital and or clinics | Identical | ||||
| Single Use,Disposable | Yes | Yes | Identical | ||||
| Material | Nitrile Butadiene Rubber, Methyl methacrylate-Acrylonitrile-Butadiene-Styrene Copolymer, SiliconeRubber | Polycarbonate, silicone | SubstantialEquivalence | ||||
| Packaging | Auxiliary water connector is packaged in a sealedpouch. | Auxiliary water connector is packaged in a sealedpouch. | Identical | ||||
| Manufacturingmethod | Injection moulding with ultrasonic welding | Injection moulding | SubstantialEquivalence | ||||
| Sterilization | EO gas | EO gas | Identical | ||||
| Shelf Life | Three years | Three years | Identical | ||||
| Compatibility | Pentax GI Endoscope | Pentax 90 series Endoscope | SubstantialEquivalence | ||||
| Dimension | Length: 32.14 mmMax. diameter: 15.43 mm | Length: 40.70 mmMax. diameter: 11.73 mm | SubstantialEquivalence | ||||
| Connectionport | One side with insertion cylinder with silicone on thetop and thread on the bottom:Length: 10.32 mmDiameter: 6.07 mmDiameter of thread: 7.94 mmOther side with female luer lock:Diameter: 7.78 mm | One side with insertion cylinder with silicone ring onthe top and thread on the bottom:Length: 10.16 mmDiameter: 6.06 mmDiameter of thread: 7.93 mmOther side with female luer lock:Diameter: 7.77 mm | SubstantialEquivalence | ||||
| BackflowPreventionDesign | Diaphragm in the connector allow pressurized waterpassing through in one-way but not the other way | Diaphragm in the connector allow pressurized waterpassing through in one-way but not the other way | SubstantialEquivalence |
{10}------------------------------------------------
{11}------------------------------------------------
The product code of predicate device for the auxiliary water connector (FEQ) is different from the proposed device (OCX). The predicate device ENDOGATOR consist of irrigation accessories (auxiliary water connector, Model: 100242). According to the FDA AccessGUDID system, ENDOGATOR auxiliary water connector (Model: 100242) was classified as product code OCX. Smartdata select the auxiliary water connector (Model: 100242) for the determination of substantial equivalence of proposed auxiliary water connector with the predicate device.
9. Non-Clinical Performance Data
Smartdata performed bench testing to support substantial equivalence. The following testing were performed on Smartdata samples from initial production lots, including sterilization.
9.1 Performance Test
- 9.1.1 Andorate® Valves Set (GAR037) Component: Disposable Suction Valve
- Assembling Integrity 9.1.1.1
- 9.1.1.2 Endoscope Compatibility
- 9.1.1.3 Depression Force
- 9.1.1.4 Vacuum Leak Test
- 9.1.1.5 Suction Flow Test
9.1.2 Andorate® Valves Set (GAR037) - Component: Disposable Air/Water Valve
- 9.1.2.1 Endoscope Compatibility Testing
- 9.1.2.2 Air Leakage Testing
- 9.1.2.3 Assembling Integrity Verification
- 9.1.2.4 Depression Force Testing
- 9.1.2.5 Water Flow Test
9.1.3 Andorate® Valves Set (GAR037) - Component: Disposable Biopsy Valve
- 9.1.3.1 Assembling Integrity
- 9.1.3.2 Endoscope Compatibility
- 9.1.3.3 Vacuum Leak Test
- 9.1.3.4 Squeegee Leak Test
9.1.4 Andorate® Auxiliary Water Connector (GAR048)
- 9.1.4.1 Compatibility with irrigation tubing
- 9.1.4.2 Compatibility with endoscope
- 9.1.4.3 Water Flow Test
- 9.1.4.4 Air Leakage Test
- 9.1.4.5 Water Leakage Test
- 9.1.4.6 Backflow Performance Test
9.2 Sterilization
Both the Andorate® Valves Set and Andorate® Auxiliary Water Connector are sold in sterile packaging, like the Medivators' predicate devices. The subject 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 ANSI/AAMI/ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The subject devices and predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact.
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Andorate® Valves Set and Andorate® Auxiliary Water Connector Smartdata Suzhou Co., Ltd.
9.3 Shelf Life
The Andorate® Valves Set and Andorate® Auxiliary Water Connector have a three (3) year expiration date, based on the design and material equivalence to the predicate devices and existing sterile barrier data from Smartdata existing packaging. The subject devices are packaged in a paper/film pouch respectively like other sterile products that Smartdata currently manufactures. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University .which is an CNAS accredited laboratory. The tests conducted including accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. Smartdata conducted the performance test for the valves set and auxiliary water connector after the accelerated aging process. The test result can imply that both the valves set and water auxiliary connector can provide and maintain a sterile barrier and its intended performance for at least three (3) years.
9.4 Biocompatibility
The biocompatibility of the Andorate® Valves Set and Andorate® Auxiliary Water Connector were 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"". It included the following tests.
- Acute Systemic Toxicity Test -
- -In Vitro Cytotoxicity
- -Skin sensitization
- -Irritation
Both the valves set and auxiliary water connector are classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that both the valves set and auxiliary water connector isbiocompatible.
10. Clinical Testing
Similar devices 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 devices and provides data to show substantial equivalence to the predicate device.
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Andorate® Valves Set and Andorate® Auxiliary Water Connector Smartdata Suzhou Co., Ltd.
11. Determination of substantial equivalence based on an assessment of performance data
Performance testing was conducted to evaluate and characterize the performance of the subject devices to support a determination of substantial equivalence to the predicate devices. A comparison was made against the predicates, where data was available. The subject devices haveundergone sterility, packaging, biocompatibility, and bench testing to demonstrate that any differences do not raise questions of safety or efficacy. The following tests were performed on the subject devices:
- . ISO 10993-5
- ISO 10993-7 .
- . ISO 10993-10
- ISO 10993-11 ●
- ISO 11135-1
- . ISO 11138-1
- . ISO 11138-2
- ISO 11737-1
- . ISO 11737-2
- . ASTM D4169-16
- . ASTM F1980-16
- ASTM F88/F88M-15
- . ASTM F1929-15
- ASTM D3078-02
- AAMI TIR 16
The subject devices were found to have a safety and effectiveness profile that is the same as the predicate devices and is determined to be substantially equivalent. In summary, the subject devices have the following similarities to the predicate devices:
- . Has the same indications for use
- Has the same intended use
- . Used in the same anatomical site
- . Uses the same technological characteristics
- . Uses the same principles of operation
- . Uses the same sterilization methodology
- Biocompatible for its intended use
12. Conclusion
Smartdata's Andorate® Valves Set and Andorate® Auxiliary Water Connector have the same intended use as the predicate devices.
Based on the technological characteristics and overall performance of the devices in bench testing, Smartdata believes that no significant differences exist between the proposed valves set and auxiliary water connector, and the predicate devices.
The subject devices do not raise any new issues of safety and effectiveness. From a clinical perspective and comparing design specifications, the subject devices and the predicate device are substantially equivalent.
§ 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.