(169 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI/ML or data processing.
No
The device is used to connect irrigation tubing to an endoscope, facilitating the supply of fluids. It does not directly treat or diagnose a disease or condition itself.
No
Explanation: The device is described as an "Auxiliary Water Connector" used to provide "irrigation fluids." Its function is to facilitate the delivery of water, not to detect, diagnose, monitor, or treat any medical condition. The performance studies focus on mechanical integrity and flow, not diagnostic accuracy.
No
The device description clearly states it is a physical connector with a backflow valve, intended for single-use and supplied sterile. It is a hardware component used in conjunction with other hardware (irrigation tubing, endoscope, irrigation pump).
Based on the provided information, the Andorate™ Auxiliary Water Connector (Model GAR027) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to provide irrigation fluids during gastrointestinal endoscopic procedures. This is a procedural aid used in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description focuses on its function in connecting to an endoscope and preventing backflow of fluids during the procedure. It doesn't mention any analysis of biological samples or diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
- Measuring analytes or biomarkers
The device is clearly intended to facilitate a medical procedure (endoscopy) by providing irrigation, which is a supportive function during the procedure itself.
N/A
Intended Use / Indications for Use
The Andorate™ Auxiliary Water Connector (Model GAR027) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Olympus 160 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
Product codes
OCX
Device Description
The Andorate™ Auxiliary Water Connector is intended for single-use and are supplied sterile. Single-use auxiliary water connector help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The auxiliary water connector easily incorporate into infection prevention policies as a single use item. The Andorate™ Auxiliary Water Connector are manufactured for use in conjunction with irrigation tubing, and together with Olympus 160 series endoscopes. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. In the submission, Andorate™ Auxiliary Water Connector is the only subject device. This submission does not include irrigation tubing or irrigation pump. The auxiliary water connector are designed to the auxiliary water port of the endoscopes. The auxiliary water connector consist of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle. The backflow performance was tested to ensure it prevents backflow of substances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital and or clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Smartdata performed bench testing to support substantial equivalence, including:
- Compatibility with irrigation tubing
- Compatibility with endoscope
- Water Flow Test
- Air Leakage Test
- Water Leakage Test
- Backflow Performance Test
- Sterilization (EO gas, SAL of 10-6, residuals below ANSI/AAMI/ISO 10993-7:2008)
- Shelf Life (3 years, based on accelerated aging, seal strength, dye penetration, microbial barrier properties, vacuum leak test, and sterility test)
- Biocompatibility (Acute Systemic Toxicity Test, In Vitro Cytotoxicity, Skin sensitization, Irritation (Rectal Irritation Test)). The device is classified as surface devices with mucosal membrane contact for a limited duration (not more than 24 hours). The test result shows that the auxiliary water connector is biocompatible.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
K182998 Page 1 of 5
K182998 510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor
| Submitter's Name: | Smartdata Suzhou Co., Ltd |
|---|---|
| Submitter's Address: | 4f, Block 7, 198#, Jinshan Rd |
| New District | |
| Suzhou, Jiangsu 215011 | |
| CHINA | |
| Establishment Registration No.: | 3008058134 |
2. Sponsor Contact
| Contact Person: | Cindy Ye
General Manager |
|-----------------|-------------------------------------|
| Telephone: | +86 512 6598 3722
+852 6393 5184 |
| Email: | cindy.ye@smartdatamedical.com |
3. Date Prepared
17 Apr 2019
4. Device Identification
| Trade Device Name: | Andorate™ Auxiliary Water Connector |
|---|---|
| Part No. | GAR027 |
| Common Device Name: | Connector between the tube and endoscope |
| Classification Name: | Endoscope and accessories |
| Product Code | OCX - Endoscopic Irrigation/Suction System |
| Regulation Number: | 876.1500 |
| Device Class | 2 |
5. Predicate Device Identification
Predicate Device 510(k) No.: Predicate Device Trade Name: Predicate Device Product Code: K092429 ENDOGATOR FEQ
6. Device Description:
The Andorate™ Auxiliary Water Connector is intended for single-use and are supplied sterile. Single-use auxiliary water connector help prevential safety risks and eliminate the need for manual cleaning and reprocessing. The auxiliary water connector easily incorporate
1
into infection prevention policies as a single use item. Table 1 shows the components included in the application.
| Components | Qty | Product Code | Regulation Number | Classification |
|---|---|---|---|---|
| Andorate™ Auxiliary | ||||
| Water Connector | 1 | OCX – Endoscopic | ||
| Irrigation/Suction System | 876.1500 | 2 |
| Table 1 – Components included in the application | |||
|---|---|---|---|
| -- | -------------------------------------------------- | -- | -- |
The Andorate™ Auxiliary Water Connector are manufactured for use in conjunction with irrigation tubing, and together with Olympus 160 series endoscopes. The auxiliary water connector is individually packed in sealed package, sold as a sterile device. In the submission, Andorate™ Auxiliary Water Connector is the only subject device. This submission does not include irrigation tubing or irrigation pump.
The auxiliary water connector are designed to the auxiliary water port of the endoscopes. The auxiliary water connector consist of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the sterile water bottle. The backflow performance was tested to ensure it prevents backflow of substances.
According to the Medical Device Recalls database in FDA website, no product recall was found for the predicate device. 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.
There were no prior submissions for the Smartdata's auxiliary water connector.
7. Intended Use:
The Andorate™ Auxiliary Water Connector (Model GAR027) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Olympus 160 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
8. Technological Characteristics
The following table (Table 2) is summaries of the Andorate™ Auxiliary Water Connector technological characteristics as compared to the predicate device from ENDOGATOR.
Table 2 Summary of design, features and principles of operation between the Andorate™ Auxiliary Water Connector technological characteristics as compared to the predicate device from ENDOGATOR™ - Water Connector for Olympus GI Endoscope
| Specification | Predicate Device | Proposed Device | Substantial
Equivalence |
|---------------|--------------------------------------------------------------------|----------------------------------------|----------------------------|
| Device name | ENDOGATOR
(Irrigation Accessories
auxiliary water connector) | ANDORATE™ Auxiliary Water
Connector | N/A |
| K number | K092429 | --- | N/A |
| Manufacturer | Medivators, Inc. a Cantel
Medical Company | Smartdata Suzhou Co., Ltd | N/A |
2
510(k) Premarket Notification: Traditional
Smartdata Suzhou Co., Ltd.
CONFIDENTIAL
| Product code | FEQ | OCX | N/A |
|---|---|---|---|
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation | |||
| Name | Endoscope and accessories | Endoscope and accessories | Identical |
| Supplied Sterile | Yes | Yes | Identical |
| Compatibility | Olympus GI Endoscope | Olympus 160 series Endoscope | Similar |
| Intended 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 (Model GAR027) is used | |||
| in conjunction with irrigation tubing | |||
| (not supplied), intended to provide | |||
| irrigation via irrigation fluids such as | |||
| sterile water supplied to the Olympus | |||
| 160 series endoscope during | |||
| gastrointestinal endoscopic | |||
| procedures when used in conjunction | |||
| with an irrigation pump. | Identical | ||
| Environment of | |||
| Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use, | |||
| Disposable | Yes | Yes | Identical |
| Material | Methyl methacrylate | ||
| Acrylonitrile-Butadiene- | |||
| Styrene, | |||
| polydimethylsiloxane, | |||
| Styrene- ethylene-butene- | |||
| styrene | Polycarbonate, silicone | Similar | |
| 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 | Similar | |
| Dimension | Length: 30.26 | ||
| Max. diameter: 12.61 | Length: 36.08 mm | ||
| Max. diameter: 11.73 mm | Similar | ||
| Connection port | One side with screw thread: | ||
| Diameter 1.80 mm | |||
| Other side with female luer | |||
| lock: Diameter 7.79 mm | One side with screw thread: | ||
| Diameter 1.79 mm | |||
| Other side with female luer lock: | |||
| Diameter 7.77 mm | Similar | ||
| 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 | Identical | ||
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |
3
CONFIDENTIAL
The product code of predicate device (FEG) is different from the proposed device (OCX). The predicate device ENDOGATOR consist of irrigation accessories (auxiliary water connector. Model: 100241). According to the FDA AccessGUDID system. ENDOGATOR auxiliary water connector (Model: 100241) was classified as product code OCX. Smartdata select the auxiliary water connector (Model: 100241) for the determination of substantial equivalence of proposed device with the predicate device
9. Non-Clinical Performance Data
Smartdata performed bench testing to support substantial equivalence. The following testing was performed on Smartdata samples from initial production lots, including sterilization.
9.1 Andorate™ Auxiliary Water Connector (GAR027)
- 9.1.1 Compatibility with irrigation tubing
- 9.1.2 Compatibility with endoscope
- 9.1.3 Water Flow Test
- 9.1.4 Air Leakage Test
- 9.1.5 Water Leakage Test
- 9.1.6 Backflow Performance Test
9.2 Sterilization
The Andorate™ Auxiliary Water Connector is sold in sterile package, like the Medivators predicate device. The auxiliary water connector have been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10-6. EO residuals on the 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 Smartdata auxiliary water connector, and the predicate devices, are not labeled as pyrogen-free because thev do not have any blood or cerebrospinal fluid contact.
9.3 Shelf Life
The Andorate™ Auxiliary Water Connector have a three (3) year expiration date, based on the design and material equivalence to the predicate device and existing sterile barrier data from Smartdata existing packaging. The Smartdata auxiliary water connector are packaged in a paper/film pouch respectively like other sterile products Smartdata currently manufactures. These pouches have been tested by Sanitation Environment Technology Institute, Soochow University ,which is an CNAS accredited laboratory. The tested 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 auxiliary water connector after the accelerated aging process. The test result can imply that the 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™ Auxiliary Water Connector was conducted in accordance with the FDA guideline "Use of International Standard ISO 10993-1,
4
"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 (Rectal Irritation Test)
The 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 the auxiliary water connector is biocompatible.
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 device and provides data to show substantial equivalence to the predicate device.
11.Conclusion
Smartdata Andorate™ Auxiliary Water Connector has the same intended use as the predicate device.
Based on the technological characteristics and overall performance of the devices in bench testing, Smartdata believes that no significant differences exist between the proposed auxiliary water connector, and the predicate devices.
The Smartdata auxiliary water connector do not raise any new issues of safety and effectiveness.
From a clinical perspective and comparing design specifications, the Smartdata auxiliary water connector, and the predicate device are substantially equivalent.
5
Indications for Use
510(k) Number (if known) K182998
Device Name Andorate™ Auxiliary Water Connector
Indications for Use (Describe)
The Andorate™ Auxiliary Water Connector (Model GAR027) is used in conjunction with irrigation tubing (not supplied), intended to provide irrigation fluids such as sterile water supplied to the Olympus 160 series endoscope during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
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April 17, 2019
Smartdata Suzhou Co., Ltd. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd. Warren, NJ 07059
Re: K182998
Trade/Device Name: Andorate™ Auxiliary Water Connector Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX Dated: March 29, 2019 Received: April 2, 2019
Dear Dave Yungvirt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
7
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure