Andorate Auxiliary Water Connector, Andorate Valves Set

K191231 · Smartdata Suzhou Co., Ltd. · ODC · Jun 7, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K191231
• Device Name: Andorate Auxiliary Water Connector, Andorate Valves Set
• Applicant: Smartdata Suzhou Co., Ltd.
• Product Code: ODC · Gastroenterology, Urology
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 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.

Device Story

Andorate Valves Set and Auxiliary Water Connector are single-use, sterile accessories for Pentax 90 series endoscopes. The set includes a suction valve, air/water valve, and biopsy valve; the connector facilitates irrigation. Used in hospitals/clinics by medical staff during GI endoscopy. Suction valve controls aspiration of fluids/debris; air/water valve cleans the lens; biopsy valve covers the port, allows instrument passage, maintains insufflation, and prevents biomaterial leakage. The auxiliary water connector includes a backflow valve to prevent fluid/biomaterial return to the sterile water source. These devices eliminate manual cleaning/reprocessing requirements, reducing infection risks. Output is mechanical control of endoscope functions; healthcare providers use these to maintain visualization and procedural integrity during endoscopy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including endoscope compatibility, flow testing, leak testing (vacuum/air/water), depression force, backflow performance, biocompatibility (ISO 10993), and sterilization validation (ISO 11135).

Technological Characteristics

Materials: Polycarbonate, Acrylonitrile Butadiene Styrene (ABS), silicone, Stainless Steel 304. Principle: Mechanical valve control and fluid path management. Dimensions: Connector length 40.70 mm, max diameter 11.73 mm. Connectivity: None (mechanical interface). Sterilization: Ethylene Oxide (EO) gas. Software: None.

Indications for Use

Indicated for use with Pentax 90 series endoscopes during gastrointestinal endoscopic procedures to control suction, air/water functions, provide irrigation, and cover the biopsy port.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ENDOGATOR (K092429)
• DEFENDO™ Disposable Suction Valve (K102581)
• DEFENDO™ Disposable Air/Water Valve (K102409)
• DEFENDO™ Disposable Biopsy Valve (K090851)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known)

K191231

### 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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## K191231 Page 1 of 11

### 510(k) Summary

[phone]

### 1. Submission Sponsor

| Submitter's Name: | Smartdata Suzhou Co., Ltd |
|---------------------------------|----------------------------------------------------------------------------------|
| Submitter's Address: | 4f, Block 7, 198#, Jinshan Rd<br>New District<br>Suzhou, Jiangsu 215011<br>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 [phone]

[e-mail]

### 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 |

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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

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## 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.

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#

Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.

| Comparison table for the ANDORATE® Valves Set | | | | | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Specification | DEFENDO<br>Disposable<br>Suction Valve | DEFENDO<br>Disposable<br>Air/Water Valve | DEFENDO<br>Disposable<br>Biopsy Valve | ANDORATE® Valves Set | Substantial<br>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<br>Name | Endoscope and<br>accessories | Endoscope and<br>accessories | Endoscope and<br>accessories | Endoscope and accessories | Identical |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes | Identical |
| Indications for<br>Use | The DEFENDO<br>Disposable<br>Suction valve is<br>intended to be<br>used control the<br>suction function<br>of an endoscope<br>during a GI<br>Endoscopic<br>procedure. | The DEFENDO<br>Disposable<br>Air/Water valve is<br>intended to be<br>used control the<br>air/water function<br>of an endoscope<br>during a GI<br>Endoscopic<br>procedure. | The DEFENDO<br>Disposable<br>biopsy valve is<br>intended to be<br>cover the<br>endoscope<br>biopsy port<br>during an<br>endoscopy<br>procedure. In<br>addition, the<br>valve provides<br>access for<br>endoscopic<br>device passage<br>and exchange,<br>helps maintain<br>insufflation and<br>minimizes<br>leakage of<br>biomaterial from<br>the biopsy port<br>throughout the | The Andorate® Auxiliary Water Connector<br>(GAR048) is used in conjunction with irrigation<br>tubing, intended to provide<br>irrigation via irrigation fluids such as sterile water<br>supplied to the Pentax 90 series endoscope during<br>gastrointestinal endoscopic procedures when used<br>in conjunction with an irrigation pump.<br>The Suction Valve component of the Andorate®<br>Valves Set (GAR037) is used to control the<br>suction function of an endoscope (for Pentax 90<br>series Endoscope) during a GI Endoscopic<br>procedure.<br>The Disposable Air/Water Valve component of the<br>Andorate® Valves Set (GAR037) is used to<br>control the air/water function of an endoscope (for<br>Pentax 90 series Endoscope) during a GI<br>Endoscopic procedure.<br>The Biopsy Valve component of the Andorate®<br>Valves Set (GAR037) is used to cover the<br>endoscope biopsy port during an endoscopy<br>procedure. In addition, the valve provides access<br>for endoscopic device passage and exchange, helps<br>maintain insufflation and minimizes leakage of | Substantial<br>Equivalence |
| Comparison table for the ANDORATE® Valves Set | | | | | |
| Specification | DEFENDO<br>Disposable<br>Suction Valve | DEFENDO<br>Disposable<br>Air/Water Valve | DEFENDO<br>Disposable<br>Biopsy Valve | ANDORATE® Valves Set | Substantial<br>Equivalence |
| | | | endoscopic<br>procedure | biomaterial from the biopsy port throughout the<br>endoscopic procedure. | |
| Environment<br>of Use | Hospital and/or<br>clinics | Hospital and/or<br>clinics | Hospital and/or<br>clinics | Hospital and/or clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Yes | Yes | Identical |
| Material | Nitrile Butadiene<br>Rubber,<br>Thermoplastic<br>Elastomer,<br>Polycarbonate,<br>Styrene<br>ethylene-<br>butene-styrene<br>block<br>copolymer, High<br>impact<br>polystyrene,<br>stainless steel<br>304 | | | Suction Valve component of the Andorate®<br>Valves Set:<br>Polycarbonate, Acrylonitrile Butadiene Styrene,<br>silicone, Stainless Steel 304 | Substantial<br>Equivalence |
| Material | | Thermoplastic<br>Elastomer,<br>Polycarbonate,<br>Stainless Steel<br>304 | | Air/Water Valve component of the Andorate®<br>Valves Set:<br>Acrylonitrile Butadiene Styrene, silicone, Stainless<br>Steel 304 | Substantial<br>Equivalence |
| Material | | | Thermoplastic<br>Elastomer | Biopsy Valve component of the Andorate®<br>Valves Set:<br>Silicone | Substantial<br>Equivalence |
| Packaging | Suction, air<br>/water and<br>biopsy valves are<br>housed in a | Suction, air /water<br>and biopsy valves<br>are housed in a<br>single tray and | Suction, air<br>/water and<br>biopsy valves are<br>housed in a | Suction, air /water and biopsy valves are housed in<br>a single tray and packaged in a sealed pouched | Identical |
| Comparison table for the ANDORATE® Valves Set | | | | | |
| Specification | DEFENDO<br>Disposable<br>Suction Valve<br>single tray and<br>packaged in a<br>sealed pouched | DEFENDO<br>Disposable<br>Air/Water Valve<br>packaged in a<br>sealed pouched | DEFENDO<br>Disposable<br>Biopsy Valve<br>single tray and<br>packaged in a<br>sealed pouched | ANDORATE® Valves Set | Substantial<br>Equivalence |
| Manufacturing<br>method | Injection<br>moulding and<br>overmoulding. | | | Suction Valve component of the Andorate®<br>Valves Set:<br>Injection moulding and overmoulding. | Substantial<br>Equivalence |
| Manufacturing<br>method | | Injection molded | | Air/Water Valve component of the Andorate®<br>Valves Set:<br>Injection moulding | Substantial<br>Equivalence |
| Manufacturing<br>method | | | Injection<br>moulding | Biopsy Valve component of the Andorate®<br>Valves Set:<br>Injection moulding | Substantial<br>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<br>Endoscope | Pentax GI<br>Endoscope | Pentax GI<br>Endoscope | Pentax 90 series Endoscope | Substantial<br>Equivalence |

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# K191231
Page 5 of 11

Andorate® Valves Set and
Andorate® Auxiliary Water Connector
Smartdata Suzhou Co., Ltd.

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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 | Substantial<br>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<br>Name | Endoscope and accessories | Endoscope and accessories…