(30 days)
Not Found
No
The device description and intended use are purely mechanical components for controlling fluid and access during endoscopic procedures. There is no mention of any computational or analytical functions that would suggest the use of AI/ML.
No
The device provides irrigation and valve control for an endoscope; it does not directly treat a disease or medical condition itself.
No
The device description indicates that it is an accessory used with an endoscope to control fluids, air, and provide access during gastrointestinal endoscopic procedures. It does not perform any diagnostic function.
No
The device description clearly outlines physical components (valves, connector) made of materials and intended for single-use, sterile packaging. The performance studies also focus on physical characteristics like sterility, packaging, and biocompatibility, not software validation.
Based on the provided text, the devices described (Andorate Auxiliary Water Connector and Andorate Valves Set) are not IVD (In Vitro Diagnostic) devices.
Here's why:
- Intended Use: The intended use clearly states that these devices are used during gastrointestinal endoscopic procedures to assist with irrigation, suction, air/water control, and biopsy port access. This is a direct interaction with the patient's body during a medical procedure.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. The Andorate devices do not perform this function.
- Device Description: The description reinforces their use as accessories for an endoscope during a procedure, not for analyzing samples.
Therefore, these devices fall under the category of medical devices used in vivo (within the body) during a procedure, not in vitro (outside the body) for diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ODC, OCX
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mucosal membrane
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and/or clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Test:
- Andorate® Valves Set (GAR037) - Component: Disposable Suction Valve:
- Assembling Integrity
- Endoscope Compatibility
- Depression Force
- Vacuum Leak Test
- Suction Flow Test
- Andorate® Valves Set (GAR037) - Component: Disposable Air/Water Valve:
- Endoscope Compatibility Testing
- Air Leakage Testing
- Assembling Integrity Verification
- Depression Force Testing
- Water Flow Test
- Andorate® Valves Set (GAR037) - Component: Disposable Biopsy Valve:
- Assembling Integrity
- Endoscope Compatibility
- Vacuum Leak Test
- Squeegee Leak Test
- Andorate® Auxiliary Water Connector (GAR048):
- Compatibility with irrigation tubing
- Compatibility with endoscope
- Water Flow Test
- Air Leakage Test
- Water Leakage Test
- Backflow Performance Test
Sterilization:
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.
Shelf Life:
The Andorate® Valves Set and Andorate® Auxiliary Water Connector have a three (3) year expiration date. Tests conducted included accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test and the sterility test. 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.
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
The test result shows that both the valves set and auxiliary water connector is biocompatible.
Clinical Testing:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K092429, K102581, K102409, K090851
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health 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) |
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
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 Rd |
| New District | |
| Suzhou, Jiangsu 215011 | |
| CHINA | |
| 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 | DEFENDO | ||||
| Disposable | |||||
| Suction Valve | DEFENDO | ||||
| Disposable | |||||
| Air/Water Valve | DEFENDO | ||||
| Disposable | |||||
| Biopsy Valve | ANDORATE® Valves Set | Substantial | |||
| Equivalence | |||||
| 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 |
| Regulation | |||||
| Name | Endoscope and | ||||
| accessories | Endoscope and | ||||
| accessories | Endoscope and | ||||
| accessories | Endoscope and accessories | Identical | |||
| Supplied | |||||
| Sterile | Yes | Yes | Yes | Yes | Identical |
| Indications for | |||||
| Use | The DEFENDO | ||||
| Disposable | |||||
| Suction valve is | |||||
| intended to be | |||||
| used control the | |||||
| suction function | |||||
| of an endoscope | |||||
| during a GI | |||||
| Endoscopic | |||||
| procedure. | The DEFENDO | ||||
| Disposable | |||||
| Air/Water valve is | |||||
| intended to be | |||||
| used control the | |||||
| air/water function | |||||
| of an endoscope | |||||
| during a GI | |||||
| Endoscopic | |||||
| procedure. | The DEFENDO | ||||
| Disposable | |||||
| biopsy valve is | |||||
| intended to be | |||||
| cover the | |||||
| endoscope | |||||
| biopsy port | |||||
| during an | |||||
| endoscopy | |||||
| procedure. In | |||||
| addition, the | |||||
| valve provides | |||||
| access for | |||||
| endoscopic | |||||
| device passage | |||||
| and exchange, | |||||
| helps maintain | |||||
| insufflation and | |||||
| minimizes | |||||
| leakage of | |||||
| biomaterial from | |||||
| the biopsy port | |||||
| throughout the | The Andorate® Auxiliary Water Connector | ||||
| (GAR048) is used in conjunction with irrigation | |||||
| tubing, 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 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 | Substantial | ||||
| Equivalence | |||||
| Comparison table for the ANDORATE® Valves Set | |||||
| Specification | DEFENDO | ||||
| Disposable | |||||
| Suction Valve | DEFENDO | ||||
| Disposable | |||||
| Air/Water Valve | DEFENDO | ||||
| Disposable | |||||
| Biopsy Valve | ANDORATE® Valves Set | Substantial | |||
| Equivalence | |||||
| endoscopic | |||||
| procedure | biomaterial from the biopsy port throughout the | ||||
| endoscopic procedure. | |||||
| Environment | |||||
| of Use | Hospital and/or | ||||
| clinics | Hospital and/or | ||||
| clinics | Hospital and/or | ||||
| clinics | Hospital and/or clinics | Identical | |||
| Single Use, | |||||
| Disposable | Yes | Yes | Yes | Yes | Identical |
| Material | Nitrile Butadiene | ||||
| Rubber, | |||||
| Thermoplastic | |||||
| Elastomer, | |||||
| Polycarbonate, | |||||
| Styrene | |||||
| ethylene- | |||||
| butene-styrene | |||||
| block | |||||
| copolymer, High | |||||
| impact | |||||
| polystyrene, | |||||
| stainless steel | |||||
| 304 | Suction Valve component of the Andorate® | ||||
| Valves Set: | |||||
| Polycarbonate, Acrylonitrile Butadiene Styrene, | |||||
| silicone, Stainless Steel 304 | Substantial | ||||
| Equivalence | |||||
| Material | Thermoplastic | ||||
| Elastomer, | |||||
| Polycarbonate, | |||||
| Stainless Steel | |||||
| 304 | Air/Water Valve component of the Andorate® | ||||
| Valves Set: | |||||
| Acrylonitrile Butadiene Styrene, silicone, Stainless | |||||
| Steel 304 | Substantial | ||||
| Equivalence | |||||
| Material | Thermoplastic | ||||
| Elastomer | Biopsy Valve component of the Andorate® | ||||
| Valves Set: | |||||
| Silicone | Substantial | ||||
| Equivalence | |||||
| Packaging | Suction, air | ||||
| /water and | |||||
| biopsy valves are | |||||
| housed in a | Suction, air /water | ||||
| and biopsy valves | |||||
| are housed in a | |||||
| single tray and | Suction, air | ||||
| /water and | |||||
| biopsy valves are | |||||
| housed in a | Suction, air /water and biopsy valves are housed in | ||||
| a single tray and packaged in a sealed pouched | Identical | ||||
| Comparison table for the ANDORATE® Valves Set | |||||
| Specification | DEFENDO | ||||
| Disposable | |||||
| Suction Valve | |||||
| single tray and | |||||
| packaged in a | |||||
| sealed pouched | DEFENDO | ||||
| Disposable | |||||
| Air/Water Valve | |||||
| packaged in a | |||||
| sealed pouched | DEFENDO | ||||
| Disposable | |||||
| Biopsy Valve | |||||
| single tray and | |||||
| packaged in a | |||||
| sealed pouched | ANDORATE® Valves Set | Substantial | |||
| Equivalence | |||||
| Manufacturing | |||||
| method | Injection | ||||
| moulding and | |||||
| overmoulding. | Suction Valve component of the Andorate® | ||||
| Valves Set: | |||||
| Injection moulding and overmoulding. | Substantial | ||||
| Equivalence | |||||
| Manufacturing | |||||
| method | Injection molded | Air/Water Valve component of the Andorate® | |||
| Valves Set: | |||||
| Injection moulding | Substantial | ||||
| Equivalence | |||||
| Manufacturing | |||||
| method | Injection | ||||
| moulding | Biopsy Valve component of the Andorate® | ||||
| Valves Set: | |||||
| Injection moulding | Substantial | ||||
| Equivalence | |||||
| Sterilization | EO gas | EO gas | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Three years | Three years | Identical |
| Compatibility | Pentax GI | ||||
| Endoscope | Pentax GI | ||||
| Endoscope | Pentax GI | ||||
| Endoscope | Pentax 90 series Endoscope | Substantial | |||
| Equivalence |
7
K191231
Page 5 of 11
Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.
8
9
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 | Substantial | ||||
| Equivalence | |||||||
| 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 | ||||
| Regulation | |||||||
| Name | Endoscope and accessories | Endoscope and accessories | Identical | ||||
| Supplied | |||||||
| Sterile | Yes | Yes | Identical | ||||
| Indications for | |||||||
| Use | The ENDOGATOR® system is intended to provide | ||||||
| irrigation via sterile water during GI endoscopic | |||||||
| procedures when used in conjunction with an | |||||||
| irrigation pump (or cautery unit). | The Andorate® Auxiliary Water Connector | ||||||
| (GAR048) is used in conjunction with irrigation | |||||||
| tubing, 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 | |||||||
| 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. | Substantial | ||||||
| Equivalence | |||||||
| Comparison table for the ANDORATE® Auxiliary Water Connector | |||||||
| Specification | ENDOGATOR | ANDORATE® Auxiliary Water Connector | Substantial | ||||
| Equivalence | |||||||
| Environment | |||||||
| of 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, Silicone | |||||||
| Rubber | Polycarbonate, silicone | Substantial | |||||
| Equivalence | |||||||
| Packaging | Auxiliary water connector is packaged in a sealed | ||||||
| pouch. | Auxiliary water connector is packaged in a sealed | ||||||
| pouch. | Identical | ||||||
| Manufacturing | |||||||
| method | Injection moulding with ultrasonic welding | Injection moulding | Substantial | ||||
| Equivalence | |||||||
| Sterilization | EO gas | EO gas | Identical | ||||
| Shelf Life | Three years | Three years | Identical | ||||
| Compatibility | Pentax GI Endoscope | Pentax 90 series Endoscope | Substantial | ||||
| Equivalence | |||||||
| Dimension | Length: 32.14 mm | ||||||
| Max. diameter: 15.43 mm | Length: 40.70 mm | ||||||
| Max. diameter: 11.73 mm | Substantial | ||||||
| Equivalence | |||||||
| Connection | |||||||
| port | One side with insertion cylinder with silicone on the | ||||||
| top and thread on the bottom: | |||||||
| Length: 10.32 mm | |||||||
| Diameter: 6.07 mm | |||||||
| Diameter of thread: 7.94 mm | |||||||
| Other side with female luer lock: | |||||||
| Diameter: 7.78 mm | One side with insertion cylinder with silicone ring on | ||||||
| the top and thread on the bottom: | |||||||
| Length: 10.16 mm | |||||||
| Diameter: 6.06 mm | |||||||
| Diameter of thread: 7.93 mm | |||||||
| Other side with female luer lock: | |||||||
| Diameter: 7.77 mm | Substantial | ||||||
| Equivalence | |||||||
| Backflow | |||||||
| Prevention | |||||||
| Design | Diaphragm in the connector allow pressurized water | ||||||
| passing through in one-way but not the other way | Diaphragm in the connector allow pressurized water | ||||||
| passing through in one-way but not the other way | Substantial | ||||||
| Equivalence |
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.
12
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.
13
K191231 Page 11 of 11 of 11
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.