(250 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 irrigation system is designed to supply sterile water when used in conjunction with an irrigation pump.
This submission describes the EndoChoice Water bottle cap irrigation system, a device designed to supply sterile water during GI endoscopic procedures when used with an irrigation pump. The submission focuses on demonstrating substantial equivalence to a predicate device, the Byrne Medical, Inc. EndoGator System (K092429).
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list numerical acceptance criteria. Instead, it frames the performance in terms of "equivalent performance" to the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Water flow rate | Demonstrated equivalent performance compared to the predicate device. |
| Device leakage | Demonstrated equivalent performance compared to the predicate device. |
| Durability (up to 24 hours use) | Tested to ensure effective function. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Performance Data: using a simulated setup" but doesn't quantify the number of devices or trials.
- Data Provenance: The testing was conducted by EndoChoice, Inc. and is retrospective, based on simulated setups to compare directly with the predicate device. The country of origin for the data is implicitly the USA, where EndoChoice, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No experts were used to establish ground truth in the traditional sense. The performance evaluation was based on engineering tests (water flow rate, leakage, durability) rather than clinical readings or expert consensus on medical images.
4. Adjudication Method for the Test Set
No adjudication method was used, as the performance evaluation was based on objective engineering measurements against the predicate device, not subjective interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This device is an irrigation system accessory, not an AI diagnostic tool requiring human reader performance analysis.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the performance evaluation described (water flow rate, leakage, durability testing) can be considered a standalone assessment of the device's physical and functional characteristics. It does not involve human interaction or interpretation in its primary performance assessment.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is essentially the performance of the legally marketed predicate device (Byrne Medical, Inc. EndoGator System), against which the new device demonstrated equivalence in specific engineering parameters (water flow rate, leakage). Additionally, durability was assessed against a 24-hour use timeframe.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training" in this context would be the design and manufacturing processes guided by engineering principles.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reasons as point 8.
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K 120862 page 1 of 2
NOV 2 7
This 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.
| Submitter Name andAddress: | EndoChoice, Inc.11810 Wills Rd, Suite 100Alpharetta, GA 30009 |
|---|---|
| Contact Person: | Theron GoberQuality and Regulatory Manager |
| Phone Number: | 678-534-6021 |
| Fax Number: | 770-962-6981 |
| EstablishmentRegistration Number: | 300759133 |
| Date Prepared: | March 12, 2012 |
| Device Trade Name(s): | EndoChoice Water bottle cap irrigation system: |
| Device Common Name: | Water bottle cap irrigation system |
| Classification Name: | FEQ; Endoscope and accessories |
| Predicate Device(s): | Byrne Medical, Inc. EndoGator System (K092429) |
| General DeviceDescription: | The EndoChoice water bottle cap irrigation system isdesigned to supply sterile water when used in conjunction withan irrigation pump. |
| Intended Use: | The Water Bottle Cap irrigation system (tubing andaccessories to accommodate various endoscopes andirrigation pumps) is intended to provide irrigation via sterilewater supply during GI endoscopic procedures when used inconjunction with an irrigation pump. |
| TechnologicalCharacteristics: | From a clinical perspective and comparing designspecifications, the EndoChoice water bottle cap irrigationsystem and the predicate device are substantially equivalent.Based on the technological characteristics and overallperformance of the device, EndoChoice, Inc. believes that nosignificant differences exist between the proposed waterbottle cap irrigation system and the predicate device. |
EndoChoice, Inc. believes the minor differences of the water
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K120862 page 2 of 2
bottle cap system and its predicate device should not raise any concerns regarding the overall safety or effectiveness.
The device and the predicate device performance were tested Performance Data: using a simulated setup for water flow rate and device leakage. The proposed device demonstrated equivalent performance when compared to the predicate device. The device also was subjected to testing that simulated device wear to ensure the device would function effectively for up to 24 hours use.
Conclusion:
Based on the technological characteristics and overall performance of the devices, EndoChoice, Inc. believes that the water bottle cap irrigation system and the predicate device selected are substantially equivalent and that the differences between the devices are minor which do not raise new issues of safety or effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2012
EndoChoice, Inc. % Mr. Theron Gober Director, RA / QA 11810 Wills Road, Suite 100 ALPHARETTA GA 30009
Re: K120862
Trade/Device Name: Water Bottle cap irrigation system Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEQ Dated: October 12, 2012 Received: October 17, 2012
Dear Mr. Gober:
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 – Mr. Theron Gober
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,
Benjamin R. Fisher -S
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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Proprietary to EndoChoice, Inc.
INDICATIONS FOR USE
510(k) Number (if known): ___ K /2 0 86 2
Device Name: 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Benjamin R. Fisher -S 2012.11.27 18:30:35 -05'00'
Division Sian-Off ion of Reproductive, Gast ological Devt 510(k) Numbe
EndoChoice, Inc. Water bottle cap irrigation system 510(k) Submission October 12, 2012
§ 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.