(12 days)
Not Found
No
The description details a simple electromechanical pump controlled by a potentiometer and foot pedal, with no mention of AI or ML terms or functionalities.
No
The device is described as an irrigation pump used for washing catheters and endoscope channels, which is a supportive function for endoscopic procedures rather than directly treating a medical condition.
No
Explanation: The device is an irrigation pump used for delivering fluids during endoscopic procedures, not for identifying a medical condition or disease.
No
The device description explicitly details hardware components like a pump, motor, potentiometer, control dial, foot pedal, air switch, and peristaltic pump head.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels." This describes a device used during an endoscopic procedure to irrigate or wash, which is a therapeutic or procedural function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a pump that delivers fluid for irrigation. It doesn't mention any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic results, which are hallmarks of IVD devices.
Therefore, the Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is a medical device used for irrigation during endoscopy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
Product codes (comma separated list FDA assigned to the subject device)
KOG
Device Description
The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.
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
Male/Female pediatric to adult
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)
The EMI and Safety Testing shall be conducted and meet spacified acceptance criteria before the device is marketed.
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.
0
Attachment H Reply to deficiency
AFR 1 9 2006
Date: 3/28/06
510(k) Summary 21 CFR 807.92
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR part 807.92.
1. Company making the submission:
Byrne Medical, Inc. Company Name: 2021 Airport Road, Conroe, TX 77301 Address: Telephone: (936) 539-0381 (936) 639-0393 Fax Christopher Meador Contact: e-mail: cmeador@byrnemedical.com
2. Device:
| Proprietary Name: | EndoGator Endoscopy Irrigation Pump |
|---|---|
| Common Name: | Endoscopy Irrigation Pump |
| Classification Name: | Endoscope and/or Accessories |
3. Predicate Devices:
Meditron Endolav Model EL-100, K882048, Xylog Corp., 83 Hobart St, Hackensack, NJ 07601
র্বা Classifications Names & Citations:
- 21 CFR 876.1500, Class II, KOG, Gastroenterology and Urology.
5. Description:
The Byrne Medical, Inc., EndoGator Endoscopy Irrigation Pump is used for Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
The EGP-100 pump will provide an adjustable flow-rate from 0-550ml/min, which is based on a variable motor RPM. The motor is controlled by the use of a potentiometer and control dial. A foot pedal activated air switch controls the running or stopping of the purnp motor and a peristaltic pump head. These parts will not cause contamination of sterile water during deliverance.
1
6. Indications for Use:
Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
7. Contra-indications:
None noted at the time of this submission.
8. Comparison:
The general method of operation and construction between the predicate device and the Byrne Medical, Inc., EndoGator pump is simulator. Indications for use are the same for both devices.
The Byrne Medical, Inc., EndoGator pump is smaller and the weight is less.
Specifications comparison:
| Parameter | EndoGator EGP-100
This Submission | Meditron Endovav
EL-100
K882048 | Parameter
is the
same |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | Endoscopic irrigation for
use with washing
catheters, integral
endoscope water jet
channels, and
endoscope working
channels. | Endoscopic irrigation
for use with washing
catheters, integral
endoscope water jet
channels, and
endoscope working
channels. | Yes |
| Regulation # | 21 CFR 876.1500 | 21 CFR 876.1500 | Yes |
| Target Population | Male/Female pediatric to adult | Male/Female pediatric to adult | Yes |
| Prescription Device | Yes | Yes | Yes |
| Dimensions (H x W xD) | 3.5" x 6" x 8" | 4.5" x 5" x 8" | No |
| Classification | Class I, Type BF,
Ordinary Equipment for
Continuous operation | Class I, Type BF,
Ordinary Equipment for
Continuous operation | Yes |
| Min and Max flow rate | Min - 0 ml/min
Max - 550 ml/min | Min - 15 ml/min
Max - 650 ml/min | No |
| Pressure | Min - 0 PSI
Max - 48 PSI | Min - 2 PSI
Max - 40 PSI | No |
| Pump type | Peristaltic | Peristaltic | Yes |
். Test Review:
The EMI and Safety Testing shall be conducted and meet spacified acceptance criteria before the device is marketed.
2
Conclusions:
The conclusion drawn trom this comparison, together with required passage of electromagnetic compatibility and safety testing, is that the Byrne Medical, Inc. EndoGator pump is equivalent in safety and efficacy to its predicated device.
T. Ricards
Christopher Meador Regulatory Affairs and Quality Control Manager
Date: 3/28/06
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure. The symbol is composed of three curved lines that converge at the bottom.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Byrne Medical, Inc. c/o Mr. Daniel W. Lehtonen Staff Engineer - Medical Devices and Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OH 44087
K060962 Rc:
Trade/Device Name: EndoGator Model # EGP-100 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: April 6, 2006 Received: April 7, 2006
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.
APR 19 2006
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/3/Picture/9 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo, the text "Protecting and Promoting Public Health" is written in a decorative font. The logo is circular and contains the letters FDA in a stylized font. The word "Centennial" is written below the letters FDA.
4
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancv C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Attachment C Reply to deficiencies
Indications for Use Statement
510(k) Number K060962
EndoGator Model # EGP-100 Device Name:
Indications for Use: Endoscopic irrigation for use with washing catheters integral endoscope water jet channels and endoscope working channels.
Prescription Use ત્ત્વન્ય (Part 21 CFR 801 Subpart D) ANDIOR
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)
David R. Larson
Division Sign Off
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K060962