(30 days)
The Water Bottle Cap irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle. Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures. Connectors / accessories are used to connect to the different endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. A female luer connector is used to connect the device to the series 160 / 180 Olympus endoscopes. Customers may use a luered blunt needle to connect to series 140 endoscopes. The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that accepts industry standard irrigation tubing.
The provided document is a 510(k) Pre-market Notification for a medical device called the "EndoChoice Water Bottle Cap Irrigation System." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with strict acceptance criteria and performance metrics for a novel technology.
As such, many of the requested elements for describing a typical AI/ML or diagnostic device study (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of device submission. This device is a fairly simple mechanical system (tubing and connectors) for irrigation during endoscopic procedures.
However, I can extract the relevant information regarding acceptance criteria (implied by the substantial equivalence argument) and the "study" (non-clinical testing) that supports it.
1. Table of Acceptance Criteria and Reported Device Performance
Note: For this type of device (a mechanical irrigation system being modified from a predicate), "acceptance criteria" are not reported as specific numerical thresholds for diagnostic performance. Instead, the acceptance criteria are implicitly met by demonstrating that the modified device's performance, materials, and intended use are equivalent to the predicate device, and that it passes standard benchtop functional and biocompatibility tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: Operate as intended without malfunction, provide irrigation. | "Benchtop functional performance testing" conducted (all test results passed). |
| Biocompatibility: Materials are safe for patient contact. | "Biocompatibility testing in conformance with ISO 10993-1.0" conducted (all test results passed). |
| Material Equivalence: Modified materials maintain safety and function. | Materials changed (various PVC and Polycarbonate formulations), but testing confirmed safety and efficacy is equivalent to predicate device. |
| Intended Use Equivalence: Same indications for use. | Intended use is "identical" to the predicate device. |
| Design Equivalence: Overall design and operating principle maintained. | Design and operating principle are "identical" or "equivalent" to the predicate device. |
The other requested information is largely not applicable because this is a 510(k) submission for a modified, substantially equivalent device, not a de novo submission for an AI/ML algorithm or a complex diagnostic. The "study" mentioned is standard non-clinical testing rather than a clinical trial assessing diagnostic accuracy.
Here's why and what information can be provided for the remaining points:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. "Benchtop functional performance testing" and "Biocompatibility testing" are typically laboratory-based tests on device units, not on patient data. There's no "test set" in the sense of patient data.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for diagnostic performance is not relevant here. The "ground truth" for functional testing is whether the device performs its intended mechanical action (e.g., fluid flow, absence of leaks) and for biocompatibility, whether it meets ISO standards. These are verified by engineering and toxicology experts, not clinical diagnosticians.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There's no "test set" requiring adjudication in the context of clinical diagnostic performance.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a mechanical irrigation system, not an AI/ML-driven diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For functional performance, the ground truth is defined by engineering specifications and successful execution of mechanical actions (e.g., fluid delivery, no leaks). For biocompatibility, the truth is compliance with ISO 10993-1.0. These are determined by laboratory test results and standard adherence, not clinical expert consensus or pathology.
- 8. The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML algorithm or a learning system.
- 9. How the ground truth for the training set was established: Not applicable. (See #8)
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K133747 Page 1 of 5 JAN - 8 2014
Special 510(k) Summary
1. Company Identification
EndoChoice, Inc. 11800 Wills Road Alpharetta, GA 30009 Telephone (678) 708 4743 FAX (678) 567 8218 Establishment Registration: 300759133
2. Contact Person
Daniel Hoefer Regulatory Affairs Manager
3. Device Name
| Trade name: | EndoChoice Water Bottle Cap Irrigation System |
|---|---|
| Common/Usual Name: | Water bottle cap irrigation system |
| Classification name: | Endoscopic irrigation/suction system |
4. Device Classification
| Common Name: | Colonoscope and accessories, flexible / rigid |
|---|---|
| Classification | Endoscope accessories, 21CFR 876.1500 |
| Product Code: | FEQ |
| Committee: | Gastroenterology/Urology |
5. Intended Use
The water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
6. Device Description
The EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle.
Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing
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runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures.
Connectors / accessories are used to connect to the different endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination.
A female luer connector is used to connect the device to the series 160 / 180 Olympus endoscopes. Customers may use a luered blunt needle to connect to series 140 endoscopes. The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours.
EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that accepts industry standard irrigation tubing.
7. Substantial Equivalence
7.1. Predicate devices
The modified EndoChoice Water Bottle Cap Irrigation System is substantially equivalent to the unmodified EndoChoice Water bottle (K120862) manufactured by EndoChoice, Inc. The intended use, design, materials and labeling are all substantially equivalent.
This submission has been prepared to address changes in the materials to the tubing, which have been made to improve manufacturing yield of the device and to limit the amount of irrigation water that is emitted after the pump's foot pedal control has been deactivated.
7.2. Intended Use
The indications for use the device under review is the same as the predicate unmodified EndoChoice Water bottle (K120862) manufactured by EndoChoice. In each case, the water bottle cap irrigation system (tubing and accessories to accommodate various endoscopes and irrigation purnps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
7.3. Technical Characteristics
Like the predicate device, the modified EndoChoice water bottle cap system is comprised of a polycarbonate standard water bottle cap, medical grade PVC tubing that extends from the endoscope connector into the water bottle, and a medical grade Stainless Steel cylinder that serves as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down in the water bottle.
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Flexible pump tubing of larger diameter is connected to the top of the water bottle cap and runs to the tubing compression ring. This flexible tubing is the part of the device that is placed into the irrigation pump. From the tubing compression ring, more rigid tubing runs to the rigid tubing luer connector and the one way check valve which prevents reverse direction fluid from the endoscope into the tubing set. Once connected, the device provides flow of sterile irrigation water during endoscopy procedures.
Connectors / accessories are used to connect to different endoscope models, including Olympus series 160, 180, and 190, and Fusc endoscopes. Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination.
The cap of the system and associated tubing is connected to standard bottles, providing sterile water to rinse tissue for improved viewing and access. The water bottle cap system is supplied sterile and can be used up to 24 hours.
EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles. The device can be used with any peristaltic irrigation pump that that accepts tubing of approximately 5/16 inch diameter (8mm).
Changes to the device include the material formulation and supplier of the tubing each type of tubing that comprises the device (see below), and inner diameter and outer diameter changes to the flexible tubing.
7.4. Performance Characteristics
The steps for operator use of each of the devices are equivalent. The instructions for use describe how to connect the device to standard endoscopes using connector assemblies, which are unchanged from the predicate. The device is also connected via the threaded water bottle cap to standard sterile water bottles, with the water intake tubing inserted into the bottle. The user then can use a footswitch-controlled irrigation pump to provide irrigation during endoscopy procedures.
| Comparison with Predicate Device | |||
|---|---|---|---|
| EndoChoice WaterBottle CapIrrigation System(Predicate) | Modification toEndoChoice WaterBottle Cap IrrigationSystem | Substantialequivalence | |
| Manufacturer | EndoChoice, Inc. | EndoChoice, Inc. | identical |
| 510k number | K120862 | Pending | |
| Compatibility with | Olympus series 160, | Olympus 160, 180, | Equivalent |
7.5. Substantial Equivalence Table
EndoChoice, Inc. Water bottle cap irrigation system Special 510(k) Submission December 6, 2013
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| currently availableendoscopes | 180, 190 | 190 | |
|---|---|---|---|
| Supplied Sterile | Yes | Yes | identical |
| Intended use | Single-use up to 24 hours (connectors single patient use) | Single-use up to 24 hours (connectors single patient use) | identical |
| Operating principle | Peristaltic irrigation pump attached to flexible tubing draws sterile irrigation water through tubing inserted into bottle and connected to irrigation port of endoscope | Peristaltic irrigation pump attached to flexible tubing draws sterile irrigation water through tubing inserted into bottle and connected to irrigation port of endoscope | identical |
| Patient Contacting Materials: | |||
| Flexible Pump Tubing | PVC ME62 | PVC Flexchem 5051-02 | Similar:Change in formulation of PVC |
| Joint Connector | PC1100 | Polycarbonate - Makrolon 2558 | Similar:Change in formulation of polycarbonate |
| Rigid Tubing | PVC 5420 | PVC MD80-GS-PVC | Similar:Change in formulation of PVC |
| Rigid Tubing Luer Connector | PVC 5420 | Polycarbonate - Makrolon 2558 | Similar:Change from PVC to polycarbonate |
| Bottle TubingBottle Tubing Weight | PVC 5420Stainless Steel | SameSame | identicalidentical |
| Male Luer BaseFemale luer connector | PC1100PC1100 | SameSame | identicalidentical |
| Compatibility with commercially available sterile water bottles | Yes | Yes | Identical |
| Indications for use statement | The EndoChoice water bottle cap system | The EndoChoice water bottle cap system | identical |
EndoChoice, Inc.
EndoChoice, Inc.
Water bottle cap irrigation system Special 510(k) Submission
December 6, 2013
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| (tubing and accessoriesto accommodatevarious endoscopes andirrigation pumps) isintended to provideirrigation via sterilewater supply during GIendoscopic procedureswhen used inconjunction with anirrigation pump. | (tubing and accessoriesto accommodatevarious endoscopesand irrigation pumps)is intended to provideirrigation via sterilewater supply during GIendoscopic procedureswhen used inconjunction with anirrigation pump. | ||
|---|---|---|---|
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -- |
8. Non-clinical testing
The following non-clinical testing has been performed on the modified EndoChoice Water Bottle Cap Irrigation System:
- � Benchtop functional performance testing
- Biocompatibility testing in conformance with ISO 10993-1. 0
All test results passed, demonstrating that the safety and efficacy is equivalent to the predicate device.
9. Conclusion
The EndoChoice Water Bottle Cap Irrigation System is substantially equivalent to the predicate devices listed above. It is the same or equivalent in terms of design, intended use, materials, and labeling.
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person embracing another person, representing health and human services.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 8, 2014
EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009
Re: K133747
Trade/Device Name: EndoChoice Water Bottle Cap Irrigation System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEQ Dated: December 6, 2013 Received: December 9, 2013
Dear Daniel Hoefer,
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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Page 2 - Daniel Hoefer
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Herbert P. Lerner -S
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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Indications for Use
510(k) Number (if known): K133747
Device Name: EndoChoice Water Bottle Cap Irrigation System
Indications for Use:
The Water Bottle Cap irrigation System (tubing and accessories to accommodate various endoscopes and irrigation pumps) is intended to provide irrigation via sterile water supply during GI endoscopic procedures when used in conjunction with an irrigation pump.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Herbert P. Lerne 2014.01.08 13:11:20 -
§ 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.