(31 days)
Not Found
No
The description focuses on a peristaltic pump for irrigation and does not mention any AI/ML components or image processing.
No.
The device facilitates direct washing during endoscopy to clear the view, but it does not directly treat a disease or condition itself. It is an accessory device to improve visualization during a diagnostic or therapeutic procedure.
No
The device is described as a flushing pump used to clear the endoscopic view, not to diagnose a condition. Its function is to facilitate visualization, not to interpret or analyze medical data for diagnostic purposes.
No
The device description explicitly states it is a "peristaltic pump," which is a hardware component. The performance studies also include testing of physical components like tubing and packaging.
Based on the provided information, the Olympus Flushing Pump OFP is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "wash the site being visualized" during GI endoscopy to clear the view. This is a therapeutic or procedural aid, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a peristaltic pump for delivering irrigation water. This aligns with a device used during a procedure, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) to diagnose a condition, determine a state of health, or monitor a treatment. The device's function is purely mechanical – to clear the field of view.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Olympus Flushing Pump OFP does not fit this description.
N/A
Intended Use / Indications for Use
The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized.
Product codes
FEQ
Device Description
The Olympus Flushing Pump is peristaltic pump which facilitates direct washing of debris from the observation site during endoscopic examinations. The peristaltic pump and associated tubing allow irrigation water to be controlled and directed to the observation site to remove blood, faeces or other organic matter that may be obstructing the endoscopic view.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Validation activities to support the use of the modified Auxiliary Water Irrigation Tube consisted of four main elements:
- Biocompatibility testing of the PVC tubing
- Validation of the Gamma Sterilization Process
- Validation of the Irrigation Tube Packaging
- Performance testing of the new irrigation tube
Testing of the modified irrigation tube has demonstrated that the OFP fulfills prospectively defined performance criteria and that the modified system meets user needs.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K100803
PyelqZ
510(k) Summary (per 21 CFR 807.92) Olympus Flushing Pump OFP-1
1. SPONSOR/APPLICANT
APR 2 2 2010
KeyMed (Medical & Industrial) Ltd. Stock Road Southend-On-Sea Essex SS2 5QH United Kingdom
2. CONSULTANT/CONTACT
Medical Device Consultants, Inc. 11440 West Bernardo Drive, Suite 300 San Diego, CA 92127 Telephone: 858-753-1961 Facsimile: 858-753-1962
Primary Contact: Ron Warren
3. DEVICE NAME
| Proprietary Name: | Olympus Flushing Pump OFP-1 |
|---|---|
| Common/Usual Name: | Endoscopic Flushing or Lavage Pump |
| Classification Name: | Endoscope and accessories |
4. DEVICE CLASSIFICATION
An endoscope and accessories has been classified by the Gastroenterology/Urology Devices Panel as a Class II device per 21 CFR 876.1500, Product Code FEQ.
5. PREDICATE DEVICES
The predicate device is the Olympus OFP cleared on May 12, 2000 under K000948.
6. DEVICE DESCRIPTION
The Olympus Flushing Pump is peristaltic pump which facilitates direct washing of debris from the observation site during endoscopic examinations. The peristaltic pump
1
K100803
Page 2 of 2
and associated tubing allow irrigation water to be controlled and directed to the observation site to remove blood, faeces or other organic matter that may be obstructing the endoscopic view.
7. INTENDED USE/INDICATIONS FOR USE
The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, facces or other organic matter obscure the endoscopic view, to wash the site being visualized.
8. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The subject of this Special 510(k) is a modification of the Olympus Flushing Pump OFP that was previously cleared on May 12, 2000 under Premarket Notification Number K000948. The subject of this Special 510(k) is a modification of the Auxiliary Water Irrigation Tube used in the OFP. The modifications are:
- A change in the component material of the tubing from Tygon (proprietary ● polyvinyl chloride) to polyvinyl chloride (PVC) - both materials are Class VI biocompatible.
- . Provision of the tubing in a sterilized package (previous tubing was supplied nonsterile)
No modification is being made to the OFP system hardware or other components. The change to the water irrigation tubing is being made to provide greater customer convenience by offering a sterilized irrigation ready for off-the-shelf use, and for manufacturing efficiencies by using a tubing material in use for other KeyMed systems.
9. PERFORMANCE TESTING
Validation activities to support the use of the modified Auxiliary Water Irrigation Tube consisted of four main elements:
- Biocompatibility testing of the PVC tubing o
- Validation of the Gamma Sterilization Process 0
- o Validation of the Irrigation Tube Packaging
- Performance testing of the new irrigation tube o
Testing of the modified irrigation tube has demonstrated that the OFP fulfills prospectively defined performance criteria and that the modified system meets user needs.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
KeyMed (Medical & Industrial) Ltd. % Mr. Ronald S. Warren, RAC Principal Consultant, Regulatory Services Medical Device Consultants, Inc. 11440 W. Bernardo Drive, Suite 300 SAN DIEGO CA 92127
APR 22 2010
Re: K100803
Trade/Device Name: Olympus Endoscopic Flushing Pump Model OFP-1 Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FEQ Dated: March 19, 2010 Received: March 24, 2010
Dear Mr. Warren:
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 (reporting of medical
3
Page 2 -
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,
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
100803 510(k) Number (if known):
Device Name: Olympus Endoscopic Flushing Pump Model OFP-1
Indications for Use:
The Olympus Flushing Pump OFP is indicated for use during GI endoscopy, when blood, faeces or other organic matter obscure the endoscopic view, to wash the site being visualized.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulin
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K100803