K153588 · Endochoice, Inc. · FEQ · Feb 24, 2016 · Gastroenterology, Urology
Device Facts
Record ID
K153588
Device Name
EndoChoice Water Bottle Cap System
Applicant
Endochoice, Inc.
Product Code
FEQ · Gastroenterology, Urology
Decision Date
Feb 24, 2016
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.1500
Device Class
Class 2
Indications for Use
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
Device Story
Sterile disposable water bottle cap system; connects to air/CO2 source and standard sterile water bottle; attaches to endoscope air/water port. Pressurized air/CO2 from processor forces water through tubing to endoscope; flow controlled by endoscope air/water valve and integrated tubing clip. Used by trained endoscopy professionals in clinical settings. Facilitates irrigation during endoscopy; improves visualization; aids clinical decision-making. Disposable; 24-hour maximum use.
Clinical Evidence
Bench testing only. Includes functional performance testing post-aging and biocompatibility testing per ISO 10993-1. All tests passed.
Technological Characteristics
Materials: PC-110, Stainless Steel, PVC (DEHP-free), TPE, Polypropylene, HDPE, LDPE, NBR. Sterilization: Ethylene Oxide. Form factor: Cap with tubing and flow-control clip. Connectivity: Mechanical interface to endoscope air/water port and external air/CO2 processor. Disposable, 24-hour use.
Indications for Use
Indicated for use by trained endoscopy professionals to supply sterile water to endoscopes during endoscopic procedures. Compatible with commercially available sterile water bottles and air/CO2 sources. Contraindications are those specific to any endoscopic procedure.
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.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
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Image /page/0/Picture/1 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 an abstract symbol resembling an eagle or bird in flight, composed of three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2016
Endochoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Road Alpharetta, GA 30009
> K153588 Trade/Device Name: EndoChoice Water Bottle Cap System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FEQ Dated: January 22, 2016 Received: January 27, 2016
Dear Daniel Hoefer,
Re:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. 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 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 Industry and Consumer Education 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.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K153588
Device Name
EndoChoice Water bottle cap system
#### Indications for Use (Describe)
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with commercially available sterile water bottles.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# 510(k) Summary EndoChoice Water Bottle Cap System
## 1. Company Identification
#### Applicant:
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 3007591333
#### 2. Contact Person
Daniel Hoefer Regulatory Affairs Manager EndoChoice, Inc.
#### 3. Device Name
| Trade name: | EndoChoice Water Bottle Cap System |
|----------------------|------------------------------------|
| Common/Usual Name: | Water bottle cap system |
| Classification name: | FEQ; Endoscope and Accessories |
#### 4. Device Classification
| Classification | Endoscope and accessories, 21CFR 876.1500 |
|----------------|-------------------------------------------|
| Product Code: | FEQ |
| Committee: | Gastroenterology/Urology |
#### 5. Intended Use
The EndoChoice water bottle cap system is intended to be used with an air source or carbon dioxide (CO2) with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles.
#### 6. Device Description
The EndoChoice water bottle cap system is a sterile disposable device designed to fit commercially available sterile water bottles for providing sterile water during endoscopic procedures. The water bottle cap system is designed with a clip that is placed on the tubing to stop water flow from the water bottle when the endoscope is not in use.
The device attaches via a connector to the air/water port of an endoscope. The water bottle cap itself is attached to a standard sterile water bottle. Air supplied from the processor unit then pressurizes the water bottle, providing water flow when then air/water valve of the endoscope is depressed. Some models provide a feature that provides an option to use a CO2 air source. Instructions state that the device is to be used by trained endoscopy professionals.
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## 7. Substantial Equivalence
The modified EndoChoice Water Bottle Cap System is substantially equivalent to the legally marketed unmodified EndoChoice Water Bottle Cap System (K142155). A feature comparison of the two devices is shown below.
Based on the intended use, technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the modifications to the EndoChoice water bottle cap system leave the device substantially equivalent to the unmodified predicate and that the differences between the devices do not raise new issues of safety or effectiveness.
| | Comparison Table | |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| | EndoChoice Water Bottle Cap System (Unmodified) | EndoChoice Water Bottle Cap System (Modified) |
| 510(k) number | K142155 | K153588 |
| Compatibility with currently available endoscopes | Olympus 140, 160, 180, and Fuse Endoscopes | Olympus 140, 160, 180, and Fuse Endoscopes |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| Compatibility with commercially available sterile water bottles | Compatible with Standard 33 mm water bottle caps | Unchanged |
| Indications for use statement | The EndoChoice water bottle cap system is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with commercially available sterile water bottles. | Unchanged |
| Contraindications | Those specific to any endoscopic procedure | Unchanged |
| Materials (patient contacting) | PC-110, Stainless Steel, PVC, TPE | PC-110, Stainless Steel, PVC (not manufactured with materials that contain DEHP), TPE |
| Materials (no patient contact) | TPE 2109-35, Polypropylene, HDPE, LDPE, , adhesive paper, NBR | Unchanged |
| Packaging | Individually packaged in Tyvek Peel Pouch | Unchanged |
| Use | Disposable, maximum use 24 hours | Unchanged |
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## 8. Non-clinical testing
Non-clinical testing has been performed on the device. Specifically, the following has been completed on the accessory water bottle, cap, and tubing:
- Benchtop functional performance testing, post-aging
- Biocompatibility testing in conformance with ISO 10993-1 .
All test results passed, demonstrating that the device is safe and effective in comparison with the predicate device.
#### 9. Conclusion
The modified EndoChoice Water Bottle Cap System is equivalent to the legally marketed predicate device. It is the same or equivalent in terms of design, intended use, materials, and labeling.
