(28 days)
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.
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 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. 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.
This document describes the Smartdata Suzhou Co., Ltd. Endorate™ Valves Sets (K181509), which includes a suction valve, air/water valve, and biopsy valve, and its substantial equivalence to predicate devices. The information provided heavily relies on comparisons with existing predicate devices rather than independent performance metrics with acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria in a typical "Pass/Fail" format with specific thresholds. Instead, it demonstrates substantial equivalence through a direct comparison of technological characteristics and performance in bench testing to predicate devices (DEFENDO™ Disposable Suction Valve K102581, DEFENDO™ Disposable Air/Water Valve K102409, and DEFENDO™ Disposable Biopsy Valve K090851). The performance is reported as meeting the functional requirements through "bench testing."
Below is a summary of the non-clinical tests performed and the implied "performance" relative to the predicate, demonstrating that the device functions as intended and is similar to the predicate.
| Test Category | Specific Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Disposable Suction Valve | Scope Compatibility | Compatible with specified endoscopes (e.g., Olympus 140/160/180/190/240/260 series). | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Valve Depression Force | Functional depression force similar to predicate. | Bench testing performed. (Implicitly met based on SE claim) | |
| Leak Test | No leakage during operation. | Bench testing performed. (Implicitly met based on SE claim) | |
| Disposable Air/Water Valve | Scope Compatibility | Compatible with specified endoscopes. | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Valve Depression Force | Functional depression force similar to predicate. | Bench testing performed. (Implicitly met based on SE claim) | |
| Air Ventilation and Insufflation | Proper air flow and insufflation as intended. | Bench testing performed. (Implicitly met based on SE claim) | |
| Water Flow Performance | Proper water flow as intended. | Bench testing performed. (Implicitly met based on SE claim) | |
| Biopsy Valve | Scope Compatibility | Compatible with specified endoscopes (Olympus/Fujinon and Pentax GI endoscopes). | Bench testing performed, demonstrating compatibility. (Implicitly met based on SE claim) |
| Leak Testing | Minimizes leakage of biomaterial. | Bench testing performed. (Implicitly met based on SE claim) | |
| Squeegee Performance | Provides access for device passage and exchange, helps maintain insufflation. | Bench testing performed. (Implicitly met based on SE claim) | |
| Sterilization & Shelf Life | Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶, EO residuals below ISO 10993-7. | Validated EO sterilization cycle achieved SAL of 10⁻⁶. EO residuals below maximum levels. |
| Shelf Life | Maintain sterile barrier for at least three years. | Three (3) year expiration date supported by accelerated aging, seal strength, dye penetration, and packaging persistence bacteria performance of pouches. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the "initial production lots" subjected to bench testing. The data provenance is implied to be from internal testing by Smartdata Suzhou Co., Ltd. (China), and it is a retrospective evaluation against predicate devices rather than a prospective study with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The study did not involve establishing ground truth through expert consensus for a test set, as it was a bench testing comparison to predicate devices, not a diagnostic or AI performance study.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an endoscopic accessory, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the entire non-clinical performance evaluation can be considered a "standalone" evaluation of the device's mechanical and functional characteristics. However, this terminology usually applies to AI algorithms. For this medical device (endoscopic valves), the "standalone" performance refers to its ability to meet its functional requirements (e.g., suction, air/water control, biopsy access, leakage prevention) as demonstrated through the bench tests without human intervention in the operation beyond initiating the tests.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance tests was inherent in the design specifications, functional requirements, and established performance of the legally marketed predicate devices. The device was considered to meet "ground truth" if its performance in bench tests was found to be substantially equivalent to the predicate devices and met basic functional expectations. Industry standards (e.g., ISO 10993-7 for sterilization) also served as a form of ground truth for specific parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for this device.
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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 (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
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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 RdNew DistrictSuzhou, Jiangsu 215011CHINA |
| Establishment Registration No .: | 3008058134 |
2. Sponsor Contact
| Contact Person: | Cindy YeGeneral Manager |
|---|---|
| Telephone: | +86 512 6598 3722+852 6393 5184 |
| Email: | cindy.ye@smartdatamedical.com |
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 | RegulationNumber | Classification |
|---|---|---|---|---|
| Suction Valve | 1 | ODC – EndoscopeChannel Accessory | 876.1500 | 2 |
| Air/Water Valve | 1 | ODC – EndoscopeChannel Accessory | 876.1500 | 2 |
| Biopsy Valve | 1 | ODC – EndoscopeChannel 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 | SubstantialEquivalence |
|---|---|---|---|
| Device name | DEFENDO™ DisposableSuction Valve | Endorate™ DisposableSuction Valve | N/A |
| K number | K102581 | --- | N/A |
| Manufacturer | Medivators, Inc. aCantel MedicalCompany | 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 andaccessories | Endoscope and accessories | Identical |
| SuppliedSterile | Yes | Yes | Identical |
| Compatibility | GI Endoscopes | Olympus®140/160/180/190/240/260series Endoscope | Similar |
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| Intended Use | The DEFENDO™Disposable Suctionvalve is intended to beused control thesuction function of anendoscope during a GIEndoscopic procedure. | The ENDORATE™Disposable Suction valve isintended to be used controlthe suction function of anendoscope during a GlEndoscopic procedure. | Identical |
|---|---|---|---|
| Environmentof Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,Disposable | Yes | Yes | Identical |
| Material | Polycarbonate,Styrene-ethylene-butene-styrene blockcopolymer, StainlessSteel 304 | Acrylonitrile-Butadiene-Styrene Copolymer,Silicone, Stainless steel 304 | Similar |
| ManufacturingMethod | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,Biopsy Valves arehoused in a single trayand packaged in asealed pouch. | Suction, Air/Water, BiopsyValves are housed in asingle tray and packaged in asealed 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 | SubstantialEquivalence |
|---|---|---|---|
| Device name | DEFENDO™ DisposableAir/Water Valve | Endorate™ DisposableAir/Water Valve | N/A |
| K number | K102409 | --- | N/A |
| Manufacturer | Medivators, Inc. a CantelMedical 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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| RegulationName | Endoscope andaccessories | Endoscope andaccessories | Identical |
|---|---|---|---|
| SuppliedSterile | Yes | Yes | Identical |
| Compatibility | Olympus®140/160/180/240/260Series GI Endoscopes | Olympus®140/160/180/190/240/260series Endoscope | Similar |
| Intended Use | The DEFENDO™Disposable Air/Watervalve is intended to beused control theair/water function of anendoscope during a GIEndoscopic procedure. | The ENDORATE™Disposable Air/Water valveis intended to be usedcontrol the air/waterfunction of an endoscopeduring a GI Endoscopicprocedure. | Identical |
| Environmentof Use | Hospital and or clinics | Hospital and or clinics | Identical |
| Single Use,Disposable | Yes | Yes | Identical |
| Material | Polycarbonate, Styrene-ethylene-butene-styreneblock copolymer,Stainless Steel 304 | Acrylonitrile-Butadiene-Styrene Copolymer,Silicone, Stainless steel 304 | Similar |
| ManufacturingMethod | Injection molded | Injection molded | Identical |
| Packaging | Suction, Air/Water,biopsy valves arehoused in a single trayand packaged in asealed pouch. | Suction, Air/Water, biopsyvalves are housed in asingle tray and packaged ina 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 | SubstantialEquivalence |
|---|---|---|---|
| Device name | DEFENDO™ DisposableBiopsy Valve | Endorate™ Disposable BiopsyValve | N/A |
| K number | K090851 | --- | N/A |
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K181509
Page 6 of 8
| Manufacturer | Medivators, Inc. a CantelMedical Company | Smartdata SuzhouCo., Ltd | N/A |
|---|---|---|---|
| Product code | ODC | ODC | Identical |
| Classification | 2 | 2 | Identical |
| Regulation No | 876.1500 | 876.1500 | Identical |
| Regulation Name | Endoscope andaccessories | Endoscope andaccessories | Identical |
| Supplied Sterile | Sterile of the Olympus® /Fujinon® Style andPentax® Style | Non Sterile of theOlympus ® /Fujinon® Style andPentax® Style | Similar |
| Compatibility | Olympus® / Fujinon® andPentax ® Endoscopes | Olympus® /Fujinon® andPentax ®Endoscopes | Identical |
| Intended Use | The DEFENDO™Disposable biopsy valve isintended to be cover theendoscope biopsy portduring an endoscopyprocedure. In addition, thevalve provides access forendoscopic devicepassage and exchange,helps maintain insufflationand minimizes leakage ofbiomaterial from the biopsyport throughout theendoscopic procedure. | The Endorate™Disposable biopsyvalve is intended tocover the endoscopebiopsy port duringan endoscopyprocedure. Inaddition, the valveprovides access forendoscopic devicepassage andexchange, helpsmaintain insufflationand minimizesleakage ofbiomaterial from thebiopsy portthroughout theendoscopicprocedure. | Identical |
| Environment ofUse | Hospital and or clinics | Hospital and orclinics | Identical |
| Single Use,Disposable | Yes | Yes | Identical |
| Material | Styrene-ethylene-butene-styrene block copolymer | Silicone | Similar |
| ManufacturingMethod | Injection molded | Injection molded | Identical |
| Slit in the valvecap | 1.7-2.0mm | 1.7-2.0mm | Identical |
| Removable Capwith Slit forDevice Passage | Yes | Yes | Identical |
| Packaging | Suction, Air/Water, biopsyvalves are housed in asingle tray and packaged ina sealed pouch. Biopsyvalve is also soldindividually packaged in asealed pouch. | Suction, Air/Water,biopsy valves arehoused in a singletray and packaged ina sealed pouch.Non Sterile Biopsyvalve is also soldindividuallypackaged in asealed pouch.Biopsy valve iseither in blue orblack depending onthe 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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§ 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.