Endorate Valve Sets

K181509 · Smartdata Suzhou Co., Ltd. · OCX · Jul 6, 2018 · Gastroenterology, Urology

Device Facts

• Record ID: K181509
• Device Name: Endorate Valve Sets
• Applicant: Smartdata Suzhou Co., Ltd.
• Product Code: OCX · Gastroenterology, Urology
• Decision Date: Jul 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Endorate™ Disposable Suction Valve is intended to be used control the suction function of an endoscope during a GI Endoscopic procedure. The Endorate™ Disposable Air/Water Valve is intended to be used control the air/water function of an endoscope during a GI Endoscopic procedure. The Endorate™ Disposable Biopsy Valve is intended 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

Endorate™ Valve Sets comprise single-use, sterile suction, air/water, and biopsy valves for GI endoscopes. Suction valve attaches to suction port to aspirate fluids/debris; air/water valve attaches to air/water port to cleanse lens; biopsy valve covers biopsy port to allow instrument passage/exchange while maintaining insufflation and preventing biomaterial leakage. Used in hospitals/clinics by physicians/nurses. Eliminates manual cleaning/reprocessing; reduces infection risk. Bench testing confirms performance equivalence to predicate devices.

Clinical Evidence

No clinical data. Bench testing only. Performance supported by testing of production lots including scope compatibility, valve depression force, leak testing, air ventilation/insufflation, water flow, and squeegee performance. Sterilization validated to SAL 10^-6 per ISO 10993-7.

Technological Characteristics

Materials: Acrylonitrile-Butadiene-Styrene (ABS), Silicone, Stainless Steel 304. Manufacturing: Injection molded. Sterilization: Ethylene Oxide (EO) gas. Shelf life: 3 years. Form factor: Disposable valve set for GI endoscopes. Connectivity: None (mechanical).

Indications for Use

Indicated for use during GI endoscopic procedures to control suction, air/water functions, and to cover the biopsy port for device passage/exchange, insufflation maintenance, and leakage minimization. Compatible with Olympus, Fujinon, and Pentax gastrointestinal endoscopes.

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

• 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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 6, 2018

Smartdata Suzhou Co., Ltd % Dave Yungvirt Official Third Party Correspondent Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, NJ 07041

Re: K181509

Trade/Device Name: Endorate™ Valves Sets Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCX, ODC Dated: June 7, 2018 Received: June 8, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 medical devices and radiation-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 ([e-mail]) or phone [phone] 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

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# K181509 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<br>New District<br>Suzhou, Jiangsu 215011<br>CHINA |
| Establishment Registration No .: | 3008058134 |

## 2. Sponsor Contact

| Contact Person: | Cindy Ye<br>General Manager |
|-----------------|-------------------------------------|
| Telephone: | [phone]<br>[phone] |
| Email: | [e-mail] |

## 3. Date Prepared 6th Jul 2018

### 4. Device Identification Trade Device Name:

Trade Device Name: Common Device Name: Product Code Name: Regulation Number/Name: Classification

Trade Device Name: Common Device Name: Product Code Name: Requlation Number/Name: Classification

Trade Device Name: Common Device Name: Product Code Name: Regulation Number/Name: Classification

Endorate™ Valve Sets

Endorate™ Disposable Suction Valve Suction Valve for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 Endoscope and accessories 2

Endorate™ Disposable Air/Water Valve Air/Water Valve for Endoscope OCX - Endoscopic Irrigation/Suction System 876.1500 Endoscope and accessories 2

Endorate™ Disposable Biopsy Valve Biopsy Valve for Endoscope ODC - Endoscope Channel Accessory 876.1500 Endoscope and accessories 2

{3}------------------------------------------------

| 5. Predicate Device Identification | |
|------------------------------------|-------------------------------------|
| 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 |

## 6. General Device Description:

The Endorate™ valve set consists of one suction valve, one air/water valve and one biopsy valve. The Endorate™ device is intended for single-use, and is supplied sterile. Sterile, singleuse suction valve, air/water valve and biopsy valve help prevent potential safety risks and eliminate the need for manual cleaning and reprocessing. These valves easily incorporate into infection prevention policies as a single use item. The following table 5.1 shows the components in the Smartdata's valves set.

| Components | Qty | Product Code Name | Regulation<br>Number | Classification |
|-----------------|-----|--------------------------------------|----------------------|----------------|
| Suction Valve | 1 | ODC – Endoscope<br>Channel Accessory | 876.1500 | 2 |
| Air/Water Valve | 1 | ODC – Endoscope<br>Channel Accessory | 876.1500 | 2 |
| Biopsy Valve | 1 | ODC – Endoscope<br>Channel Accessory | 876.1500 | 2 |

#### Table 5.1 Endorate™ Disposable Valves Sets

The suction valve is designed to 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 is intended 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.

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The Endorate™ Disposable Biopsy Valves are manufactured in two configurations - one for use with Olympus®/Fujinon® gastrointestinal endoscopes and the other for use with Pentax® gastrointestinal endoscopes. Both Olympus®/Fujinon® and Pentax® versions are sold as non-sterile device, individually packed.

### 7. Intended Use:

The Endorate™ Disposable Suction Valve is intended to be used control the suction function of an endoscope during a GI Endoscopic procedure.

The Endorate™ Disposable Air/Water Valve is intended to be used control the air/water function of an endoscope during a GI Endoscopic procedure.

The Endorate™ Disposable Biopsy Valve is intended 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 (Table 5.2.1, Table 5.2.2 and Table 5.2.3) are a summary of the Endorate™ suction valve, air/water valve and biopsy valve technological characteristics as compared to the predicate device from DEFENDO™.

Table 5.2.1 Summary of design, features and principles of operation between the Endorate™ suction valve technological characteristics as compared to the predicate device from DEFENDO™ - Suction Valve

| Specification | Predicate Device | Proposed Device | Substantial<br>Equivalence |
|---------------------|-------------------------------------------------|---------------------------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable<br>Suction Valve | Endorate™ Disposable<br>Suction Valve | N/A |
| K number | K102581 | --- | N/A |
| Manufacturer | Medivators, Inc. a<br>Cantel Medical<br>Company | Smartdata Suzhou Co., Ltd | N/A |
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation Name | Endoscope and<br>accessories | Endoscope and accessories | Identical |
| Supplied<br>Sterile | Yes | Yes | Identical |
| Compatibility | GI Endoscopes | Olympus®<br>140/160/180/190/240/260<br>series Endoscope | Similar |

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| Intended Use | The DEFENDO™<br>Disposable Suction<br>valve is intended to be<br>used control the<br>suction function of an<br>endoscope during a GI<br>Endoscopic procedure. | The ENDORATE™<br>Disposable Suction valve is<br>intended to be used control<br>the suction function of an<br>endoscope during a Gl<br>Endoscopic procedure. | Identical |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Environment<br>of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Identical |
| Material | Polycarbonate,<br>Styrene-ethylene-<br>butene-styrene block<br>copolymer, Stainless<br>Steel 304 | Acrylonitrile-Butadiene-<br>Styrene Copolymer,<br>Silicone, Stainless steel 304 | Similar |
| Manufacturing<br>Method | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,<br>Biopsy Valves are<br>housed in a single tray<br>and packaged in a<br>sealed pouch. | Suction, Air/Water, Biopsy<br>Valves are housed in a<br>single tray and packaged in a<br>sealed pouch. | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |

Table 5.2.2 Summary of design, features and principles of operation between the Endorate™ air/water valve technological characteristics as compared to the predicate device from DEFENDO™. – Air/Water Valve

| Specification | Predicate Device | Proposed Device | Substantial<br>Equivalence |
|----------------|----------------------------------------------|-----------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable<br>Air/Water Valve | Endorate™ Disposable<br>Air/Water Valve | N/A |
| K number | K102409 | --- | N/A |
| Manufacturer | Medivators, Inc. a Cantel<br>Medical Company | Smartdata Suzhou Co., Ltd | N/A |
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |

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| Regulation<br>Name | Endoscope and<br>accessories | Endoscope and<br>accessories | Identical |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Supplied<br>Sterile | Yes | Yes | Identical |
| Compatibility | Olympus®<br>140/160/180/240/260<br>Series GI Endoscopes | Olympus®<br>140/160/180/190/240/260<br>series Endoscope | Similar |
| Intended Use | The DEFENDO™<br>Disposable Air/Water<br>valve is intended to be<br>used control the<br>air/water function of an<br>endoscope during a GI<br>Endoscopic procedure. | The ENDORATE™<br>Disposable Air/Water valve<br>is intended to be used<br>control the air/water<br>function of an endoscope<br>during a GI Endoscopic<br>procedure. | Identical |
| Environment<br>of Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, Styrene-<br>ethylene-butene-styrene<br>block copolymer,<br>Stainless Steel 304 | Acrylonitrile-Butadiene-<br>Styrene Copolymer,<br>Silicone, Stainless steel 304 | Similar |
| Manufacturing<br>Method | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,<br>biopsy valves are<br>housed in a single tray<br>and packaged in a<br>sealed pouch. | Suction, Air/Water, biopsy<br>valves are housed in a<br>single tray and packaged in<br>a sealed pouch. | Identical |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |

Table 5.2.3 Summary of design, features and principles of operation between the Endorate™ biopsy valve technological characteristics as compared to the predicate device from DEFENDO™. – Biopsy Valve

| Specification | Predicate Device | Proposed Device | Substantial<br>Equivalence |
|---------------|-------------------------------------|--------------------------------------|----------------------------|
| Device name | DEFENDO™ Disposable<br>Biopsy Valve | Endorate™ Disposable Biopsy<br>Valve | N/A |
| K number | K090851 | --- | N/A |

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K181509
Page 6 of 8

| Manufacturer | Medivators, Inc. a Cantel<br>Medical Company | Smartdata Suzhou<br>Co., Ltd | N/A |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation Name | Endoscope and<br>accessories | Endoscope and<br>accessories | Identical |
| Supplied Sterile | Sterile of the Olympus® /<br>Fujinon® Style and<br>Pentax® Style | Non Sterile of the<br>Olympus ® /<br>Fujinon® Style and<br>Pentax® Style | Similar |
| Compatibility | Olympus® / Fujinon® and<br>Pentax ® Endoscopes | Olympus® /<br>Fujinon® and<br>Pentax ®<br>Endoscopes | Identical |
| Intended Use | The DEFENDO™<br>Disposable biopsy valve is<br>intended to be cover the<br>endoscope biopsy port<br>during an endoscopy<br>procedure. In addition, the<br>valve provides access for<br>endoscopic device<br>passage and exchange,<br>helps maintain insufflation<br>and minimizes leakage of<br>biomaterial from the biopsy<br>port throughout the<br>endoscopic procedure. | The Endorate™<br>Disposable biopsy<br>valve is intended to<br>cover the endoscope<br>biopsy port during<br>an endoscopy<br>procedure. In<br>addition, the valve<br>provides access for<br>endoscopic device<br>passage and<br>exchange, helps<br>maintain insufflation<br>and minimizes<br>leakage of<br>biomaterial from the<br>biopsy port<br>throughout the<br>endoscopic<br>procedure. | Identical |
| Environment of<br>Use | Hospital and or clinics | Hospital and or<br>clinics | Identical |
| Single Use,<br>Disposable | Yes | Yes | Identical |
| Material | Styrene-ethylene-butene-<br>styrene block copolymer | Silicone | Similar |
| Manufacturing<br>Method | Injection molded | Injection molded | Identical |
| | | | |
| Slit in the valve<br>cap | 1.7-2.0mm | 1.7-2.0mm | Identical |
| Removable Cap<br>with Slit for<br>Device Passage | Yes | Yes | Identical |
| Packaging | Suction, Air/Water, biopsy<br>valves are housed in a<br>single tray and packaged in<br>a sealed pouch. Biopsy<br>valve is also sold<br>individually packaged in a<br>sealed pouch. | Suction, Air/Water,<br>biopsy valves are<br>housed in a single<br>tray and packaged in<br>a sealed pouch.<br>Non Sterile Biopsy<br>valve is also sold<br>individually<br>packaged in a<br>sealed pouch.<br>Biopsy valve is<br>either in blue or<br>black depending on<br>the availability. | Similar |
| Sterilization | EO gas | EO gas | Identical |
| Shelf Life | Three years | Three years | Identical |

{8}------------------------------------------------

## 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. Disposable Suction Valve

- 9.1.1 Scope Compatibility
- 9.1.2 Valve Depression Force
- 9.1.3 Leak Test

## 9.2. Disposable Air/Water Valve

- 9.2.1 Scope Compatibility
- 9.2.2 Valve Depression Force
- 9.2.3 Air Ventilation and Insufflation
- 9.2.4 Water Flow Performance

## 9.3. Biopsy Valve

- 9.3.1 Scope Compatibility
- 9.3.2 Leak Testing
- 9.3.3 Squeegee Performance

A detailed record is attached as Appendix A in Section 18.

{9}------------------------------------------------

## 9.4 Sterilization

The Endorate™ valve set which consists of one suction valve, one air/water valve and one biopsy valve, is sold in sterile package, like the Medivators predicate device. The valve set has been sterilized in a validated EO sterilization cycle. The EO sterilization cycle has a Sterility Assurance Level (SAL) of 10°. EO residuals on the valve sets are below the maximum levels defined in ANSI/AAMI/ISO 10993-7:1995 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide sterilization residuals. The Smartdata valve sets, and the predicate devices, are not labeled as pyrogen-free because they do not have any blood or cerebrospinal fluid contact. The Smartdata suction vale, air/water valve and biopsy valve are packaged in a paper/film pouch like other sterile products Smartdata currently manufactures.These pouches have been tested by Smartdata and shown to provide and maintain a sterile barrier for at least three (3) years.

## 9.5 Shelf Life

The Endorate™ valve set 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 valve sets are packaged in a paper/film pouch like other sterile products Smartdata currently manufactures. These pouches have been tested by Smartdata, including accelerated aging, seal strength, dye penetration and packaging persistence bacteria performance and shown to provide and maintain a sterile barrier for at least three (3) years.

### 10. Clinical Testing

Suction valve, air/water valve and biopsy valve 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 valve set which consists of suction valve, air/water valve and biopsy valve, have 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 valve set and the predicate devices.

The Smartdata valve set do not raise any new issues of safety and effectiveness.

From a clinical perspective and comparing design specifications, the Smartdata valve set and the predicate device are substantially equivalent.

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# Indications for Use

510(k) Number (if known) K181509

Device Name Endorate™ Valves Sets

Indications for Use (Describe)

The disposable Endorate™ valves sets consists of one suction valve, one air/water valve and one biopsy valve.

The Endorate™ Disposable Suction valve is used to control the suction function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.

The Endorate™ Disposable Air/Water valve is used to control the air/water function of an endoscope (for Olympus 160 series Endoscope) during a GI Endoscopic procedure.

The Endorate™ 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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