(250 days)
Not Found
No
The summary describes a simple irrigation system (tubing and accessories) and its performance testing focuses on water flow rate and leakage, not data processing or algorithmic analysis. There are no mentions of AI, ML, image processing, or data sets.
No.
This device is an irrigation system designed to supply sterile water during GI endoscopic procedures, which is a supportive function and not a direct therapeutic intervention.
No
The device is described as an irrigation system intended to provide sterile water during GI endoscopic procedures. Its purpose is to deliver water, not to diagnose or detect medical conditions.
No
The device description explicitly states it is a "water bottle cap irrigation system (tubing and accessories)" and describes physical components designed to supply sterile water. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for providing irrigation during GI endoscopic procedures. This is a direct medical intervention performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description reinforces its function as a system for supplying sterile water for irrigation.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for procedural support during an endoscopic examination.
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 when used in conjunction with an irrigation pump.
Product codes
FEQ
Device Description
The EndoChoice water bottle cap irrigation system is designed to supply sterile water when used in conjunction with an irrigation pump.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The device and the predicate device performance were tested 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.
Key Metrics
Not Found
Predicate Device(s)
Byrne Medical, Inc. EndoGator System (K092429)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 and
Address: | EndoChoice, Inc.
11810 Wills Rd, Suite 100
Alpharetta, GA 30009 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Theron Gober
Quality and Regulatory Manager |
| Phone Number: | 678-534-6021 |
| Fax Number: | 770-962-6981 |
| Establishment
Registration 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 Device
Description: | The EndoChoice water bottle cap irrigation system is
designed to supply sterile water when used in conjunction with
an irrigation pump. |
| 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. |
| Technological
Characteristics: | From a clinical perspective and comparing design
specifications, the EndoChoice water bottle cap irrigation
system and the predicate device are substantially equivalent.
Based on the technological characteristics and overall
performance of the device, EndoChoice, Inc. believes that no
significant differences exist between the proposed water
bottle cap irrigation system and the predicate device. |
EndoChoice, Inc. believes the minor differences of the water
1
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.
2
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.
3
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
4
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