(104 days)
Not Found
No
The description focuses on tubing and accessories for irrigation during endoscopic procedures and does not mention any AI/ML components or functionalities.
No.
The device facilitates irrigation during endoscopic procedures, which is a supportive function and not a direct therapeutic intervention for a disease or condition.
No
The device is intended to provide irrigation during GI endoscopic procedures. Its function is to deliver sterile water, not to diagnose medical conditions.
No
The device description explicitly lists physical components (tubing, accessories, bottle cap/tube set/connector, cartridge) and describes performance studies involving flow and pressure testing, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for providing irrigation during GI endoscopic procedures. This is a direct intervention on the patient during a medical procedure, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details tubing, accessories, and a cartridge for delivering sterile water. This aligns with a system used for irrigation during a procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The EndoGator™ system operates in vivo (within the body) during a medical procedure.
N/A
Intended Use / Indications for Use
The EndoGator™ 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 (or cautery unit).
Product codes
78 KOG, FEO
Device Description
The Byrne Medical EndoGator™ System is composed of the following:
-
- EndoGator™ Irrigation Tubing, and
-
- EndoGator™ Irrigation Accessories
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
Flow and pressure testing was completed with representative scopes and evaluated based on various pump settings; real-time flow rate data was collected.
Key Metrics
Not Found
Predicate Device(s)
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
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Summary
Assigned 510(k) Number K 0 92429
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR Part 807.92.
NOV 1 9 2009
- Company making the submission and owner: 1.
| Company (owner) | |
|---|---|
| Name: | Byrne Medical, Inc. 3150 Pollok Drive Conroe, TX 77303 |
| Telephone: | 936-539-0391 |
| Fax: | 936-539-2381 |
| Contact: | Don Byrne, President |
| E-mail: | dbyrne@byrnemedical.com |
- Device:
૩.
| Proprietary Name: | EndoGator™ System |
|---|---|
| Common Name: | Water Bottle Adapter |
| Classification Name: | Endoscopes and |
| Accessories |
Predicate Device(s):
| Device Name | Manufacturer | "K" № |
|---|---|---|
| EndoGator™ | Byrne Medical, Inc. | K031773 |
| Endoscopic Flushing Pump | ||
| Model OFP-1 | Olympus® | K000948 |
-
- Classification and Product Code:
21 CFR § 876.1500, Class II, 78 KOG.
- Classification and Product Code:
5. Description:
The Byrne Medical EndoGator™ System is composed of the following:
-
- EndoGator™ Irrigation Tubing, and
-
- EndoGator™ Irrigation Accessories
-
- Indications for Use Statement:
The EndoGator™ 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 (or cautery unit).
1
-
- Summary of Technological Characteristics and Differences:
The EndoGator™ System consists of a bottle cap/tube set/connector made from materials that are appropriate for the application. The EndoGator™ Cartridge is a replacement for some predicate device water systems.
- Summary of Technological Characteristics and Differences:
The EndoGator™ System and all predicate devices provide water to irrigator pumps or cauterizing units.
The difference between some systems is the labeling of duration of use.
-
- Contraindications:
The EndoGator™ System is not designed, sold or intended for use except as indicated in labeling.
- Contraindications:
No other contraindications are known for this device.
-
- Testing:
The EndoGator™ System has been subjected to extensive safety, performance, and validations prior to release.
- Testing:
Flow and pressure testing was completed with representative scopes and evaluated based on various pump settings; real-time flow rate data was collected.
- Conclusions:
The conclusion drawn from these tests is that the EndoGator™ System is functionally equivalent in safety and efficacy to its predicate device.
Don Byrne, President
Date:
1 EDITED Sec 5 Summa
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Byrne Medical, Inc. % Mr. Daniel W. Lehtonen Sr. Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087
NOV 1 9 2009
Re: K092429
Trade/Device Name: EndoGator™ System Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEO Dated: October 22, 2009 Received: October 23, 2009
Dear Mr. Lehtonen:
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.
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 of medical
3
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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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
EndoGator™ System
The EndoGator™ 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 (or cautery unit).
Prescription Use YES (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 Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K092429