(27 days)
Not Found
No
The device description focuses on mechanical components for fluid delivery and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an irrigation system used to provide sterile water during GI endoscopic procedures. It does not treat or diagnose a disease or condition, but rather facilitates a medical procedure.
No
The device is an irrigation system used to provide sterile water during GI endoscopic procedures. It does not perform any diagnostic functions; its purpose is to facilitate the procedure by delivering fluid.
No
The device description clearly outlines physical components such as a polycarbonate cap, PVC tubing, and a stainless steel cylinder. It is a hardware device for fluid delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide irrigation via sterile water supply during GI endoscopic procedures. This is a therapeutic or procedural support function, not a diagnostic one.
- Device Description: The device is a system for delivering sterile water for irrigation. It does not analyze biological samples or provide information for diagnosis.
- Lack of Diagnostic Elements: There is no mention of analyzing patient samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
- Performance Studies: The performance studies focus on functional performance and biocompatibility, which are relevant to a medical device used in a procedure, not an IVD.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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 with an irrigation pump.
Product codes (comma separated list FDA assigned to the subject device)
FEQ
Device Description
The EndoChoice Water Bottle Cap Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures.
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 while in the water bottle.
The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap.
Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow.
As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow.
Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter.
The water bottle cap system is supplied sterile and can be used up to 24 hours.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
GI
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 27, 2016
EndoChoice, Inc. Daniel Hoefer Regulatory Affairs Manager 11810 Wills Rd. Alpharetta, GA 30009
Re: K161482
Trade/Device Name: EndoChoice Water Bottle Cap Irrigation System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: FEQ Dated: May 26, 2016 Received: May 31, 2016
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. 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
1
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.
Sincerely yours,
Joyce M. Whang -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
2
Indications for Use
510(k) Number (if known) K161482
Device Name
EndoChoice Water Bottle Cap Irrigation System
Indications for Use (Describe)
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 with an irrigation pump.
| Type of Use (Select one or both, as applicable) |
|---|
| Prescription Use (Part 201.2 and Part) |
| Over-The-Counter Use (21 CFR 201.6 |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
EndoChoice Water Bottle Cap Irrigation System
1. Company Identification
Applicant:
EndoChoice, Inc. 11810 Wills Road Alpharetta, GA 30009 Establishment Registration: 3007591333
2. Contact Person
Daniel Hoefer Sr. Regulatory Affairs Manager EndoChoice, Inc.
3. Device Name
| Trade name: | EndoChoice Water Bottle Cap Irrigation System |
|---|---|
| Common/Usual Name: | Water Bottle Cap Irrigation 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 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 Irrigation System is a sterile, consumable, 24-hour multi-patient use device designed to fit commercially available sterile water bottles and irrigation pumps for providing sterile water during endoscopic procedures.
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
4
as both the water intake portion of the disposable water bottle cap and a weight to hold the tubing down while in the water bottle.
The bottle tubing is added into the sterile water bottle and the irrigation system is fastened via the tubing system cap.
Flexible pump tubing connected to the top of the water bottle cap runs to the tubing connector reducer. This flexible tubing is the part of the device that is placed into the irrigation pump. A tubing connector reducer joins the flexible tubing and rigid tubing. The rigid tubing runs to the tubing Luer connector. The tubing Luer connector has the first one-way check valve which prevents potential backflow of fluid from the endoscope into the tubing set. The separately packaged, single-use endoscope connectors (used to connect the tubing set to the auxiliary water channel) also contain one-way valves used to prevent potential backflow.
As with the predicate, the separately packaged, single-use connectors are used to connect to different endoscope models, and all include the second one-way valve to prevent contamination due to potential backflow.
Between patients, the endoscope connectors must be changed to ensure that there is no risk of cross contamination. EndoChoice water bottle irrigation tubing fits standard threaded lid disposable sterile water bottles of approximately 33 mm diameter.
The water bottle cap system is supplied sterile and can be used up to 24 hours.
7. Substantial Equivalence
The modified EndoChoice Water Bottle Cap Irrigation System is equivalent to the legally marketed unmodified EndoChoice Water Bottle Cap Irrigation System (K133747). 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 Irrigation System leave the device equivalent to the unmodified predicate and that the differences between the devices do not raise new issues of safety or effectiveness.
5
| Comparison Table | ||
|---|---|---|
| EndoChoice Water Bottle Cap | ||
| Irrigation System | ||
| (Unmodified) | EndoChoice Water Bottle | |
| Cap Irrigation System | ||
| (Modified) | ||
| 510(k) number | K133747 | Pending |
| Compatibility with currently available | ||
| endoscopes | Olympus 140, 160, 180, | |
| Endoscopes | Olympus 140, 160, 180, | |
| And Fuse Endoscopes | ||
| Sterilization Method | Ethylene Oxide | Unchanged |
| Compatibility with commercially available | ||
| sterile water bottles | Compatible with Standard 33 mm | |
| water bottle caps | Unchanged | |
| Compatibility with Olympus OFP-2 | ||
| irrigation pumps | N/A | Compatible |
| Indications for use statement | 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. | Unchanged | |
| Contraindications | Those specific to any endoscopic | |
| procedure | Unchanged | |
| Materials (patient contacting) | ||
| Flexible Pump Tubing | PVC - Flexchem | PVC - APEX, change in |
| PVC formulation, equivalent | ||
| to previous formulation | ||
| Flexible Pump Tubing dimensions | Outer diameter 6.4 mm, inner | |
| diameter 3.2mm | Outer diameter 9.7 mm, inner | |
| diameter 6.5 mm | ||
| Compression Luer Connector / Reducer | Polycarbonate, Makrolon 2558 | Polycarbonate, PC 110, |
| equivalent to previous | ||
| formulation | ||
| Rigid Tubing | PVC, MD80-GS-PVC | Unchanged |
| Tubing Connector Reducer | Polycarbonate, Makrolon 2558 | Polycarbonate, Makrolon |
| 2458, change in formulation, | ||
| equivalent to previous | ||
| formulation | ||
| Bottle Tubing | PVC 5420 | PVC 3304A, change in PVC |
| formulation, equivalent to | ||
| previous formulation | ||
| Bottle Tubing Weight | Stainless Steel Grade 303 | Stainless Steel Grade 304, |
| change in stainless steel | ||
| formulation, equivalent to | ||
| previous formulation | ||
| Male Luer Base | PC110 | Polycarbonate Makrolon |
| 2458, change in formulation, | ||
| equivalent to previous | ||
| formulation | ||
| Female Luer Connector | PC110 | Unchanged |
| EndoChoice Water Bottle Cap Irrigation System (Unmodified) | EndoChoice Water Bottle Cap Irrigation System (Modified) | |
| Materials (no patient contact) / Use | ||
| Packaging | Individually packaged in Tyvek Peel Pouch | Unchanged |
| Tyvek package | Dimension: 320 mm x 150 mm, part# 1059B | Dimension: 340 mm x 240 mm, part# 1073B, dimensional change and Tyvek type change are equivalent to previous package |
| Use | Disposable, 24-hour multi-patient use | Unchanged |
6
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 Irrigation System is equivalent to the legally marketed predicate device. It is the same or equivalent in terms of design, intended use, materials, and labeling.