(166 days)
Not Found
No
The device description details a simple peristaltic pump with user-adjustable speed controlled by a digital controller. There is no mention of learning, adaptation, or complex algorithmic decision-making characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No.
The device is intended to wash blood, feces, and other organic matter from the gastric and colonic mucosa and to aid in filling areas of the gastrointestinal tract with water to assist examinations, which are not considered therapeutic actions.
No
The device is described as a flushing pump that aids in cleaning the site during endoscopic procedures and filling areas for examination. While it assists in procedures where diagnosis occurs, it does not itself perform any diagnostic function (e.g., imaging, analysis of biological samples).
No
The device description clearly outlines hardware components including a motorized pump, peristaltic pump head, digital controller, LEDs, footswitch, buttons, water container, and tubing. The performance studies also include testing related to electrical safety and biocompatibility of physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to wash blood, feces, and other organic matter from the gastric and colonic mucosa during endoscopic procedures and to aid in filling areas of the gastrointestinal tract with water for ultrasound examinations. This is a therapeutic or procedural support function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The device is a pump designed to transfer water. This aligns with its intended use for flushing and filling, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (like blood, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
The device is clearly intended for use in vivo (within the body) to facilitate endoscopic procedures and ultrasound examinations.
N/A
Intended Use / Indications for Use
The OFP-2 and accessories are intended for use in medical facilities under the direction of a trained physician.
The OFP-2 is intended for use:
- . During endoscopic procedures to wash blood, feces and other organic matter from the site being visualised, diagnosed or treated.
- To aid in filling areas of the gastrointestinal tract with water in order to aid in . examinations performed with trans-endoscopic ultrasound probes
The OLYMPUS FLUSHING PUMP (OFP-2) and its accessories are intended for use during endoscopic procedures to wash blood, feces and other organic matter from the gastric and colonic mucosa site being visualized, diagnosed and to aid in the filling areas of the gastrointestinal tract with water in order to aid in examinations preformed with trans-endoscopic ultrasound probes.
Product codes (comma separated list FDA assigned to the subject device)
FEQ
Device Description
The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope.
The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected.
The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button.
The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastric and colonic mucosa, gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical facilities under the direction of a trained physician.
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)
Risk Management of the OFP-2 and its tubing was performed to ISO 14971 and included a device hazard analysis.
Biocompatibility of the Water Container and tubing has been established by subjecting the container, a tube and the Instrument Channel Adapter to the following tests:
- L929 MEM elution test to ISO 10993-5 .
- Intracutaneous Injection Test to ISO 10993-10 .
- Kligman Maximization Test to ISO 10993-10 .
Electrical safety testing of the OFP-2 and its accessories was performed to:
- . IEC 60601-1:1988
- EN 60601-1:1990 ●
- UL 60601-1:2003 .
- CAN/CSA-C22.2 No. 601.1-M90 .
Additional testing was performed to:
- IEC 60601-1-1 .
- IEC 60601-2-18 .
The effectiveness of steam sterilization on the water container was validated, as was the robustness of the water container when subjected to steam sterilization over the expected useful life of the container.
The performance of the OFP-2 and its accessories was verified and validated.
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
Image /page/0/Picture/0 description: The image shows the word "OLYMPUS" in a bold, sans-serif font. The letters are black and appear to have a slightly distressed or textured effect, as if they have been stamped or printed with some wear. The background is plain and white, which makes the word stand out.
OLYMPUS KEYMED KeyMed House, Stock Road, Southend-on-Sea, Essex, SS2 5QH, UK
Your Vision, Our Future
Telephone: +44 (0)1702 616333 Facsimile: +44 (0)1702 465677
K 100899-
SEP 1 3 2010
510 (K) SUMMARY OLYMPUS ENDOSCOPIC FLUSHING PUMP OFP-2
Contact Name: Company: KeyMed (Medical & Industrial Equipment) Ltd Address: KeyMed House Stock Road Southend-on-Sea Essex SS2 5QH UK Telephone: +44 (0)1702 616 333 Fax: +44 (0)1702 465 677 E-mail:
| Owner/Operator #: | 8020728 |
|---|---|
| Establishment Registration #: | 9611174 |
Date of Preparation:
22 March 2010
| Name of Device: | Olympus Endoscopic Flushing Pump (OFP-2) |
|---|---|
| Common Name: | Endoscopic Flushing or Lavage Pump |
| Classification Name: | Pump, Air, Non-Manual, For Endoscope |
| Product Code: | FEQ (21 CFR 876.1500) |
| (as per classification of predicate device) | |
| Basis of submission: | This submission claims substantial equivalence to the |
| following legally marketed devices: | |
| Olympus Endoscopic Flushing Pump, OFP-1 | |
| (K000948) |
Image /page/0/Picture/13 description: The image contains three logos. The first logo is a circle with the word "REGISTERED" around the edge and a symbol in the center. The second logo is a square with a crown and the letters "UKAS" above the number "009". The third logo is partially visible and contains the words "POSITIVE" and "DISABLED".
Image /page/0/Picture/14 description: The image contains two distinct graphic elements. On the left, a portion of text is visible, with the word "PEOPLE" clearly discernible. To the right, there is a logo featuring a stylized letter "Q" with a wing extending from it, topped by a crown. Below the "Q", the text "THE QUEEN'S" is present, although the rest of the text is not clear.
Image /page/0/Picture/15 description: The image shows two logos for The Queen's Awards for Enterprise. Each logo features a stylized letter "e" with a crown above it. The left logo has the text "QUEEN'S AWARDS FOR ENTERPRISE" below the letter, while the right logo has the text "THE QUEEN'S AWARD FOR ENTERPRISE".
Image /page/0/Picture/16 description: The image shows a logo for "The Queen's Awards for Enterprise 2006". The logo features a stylized letter "E" with a wing-like design extending from its left side. Above the "E" is a crown, symbolizing the British monarchy. The text "THE QUEEN'S AWARDS FOR ENTERPRISE 2006" is arranged below the "E" in a stacked format.
Otympus KeyMed is an operating division of KeyMed (Medical & Industrial Equipment) Ltd. Company Registered in England No. 966735
ed in England (No. 900700)
1
Image /page/1/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. Below the word is a thick black line. Underneath the line, the phrase "Your Vision, Our Future" is written in a smaller font.
K 100899
Page 2 of 3
DEVICE DESCRIPTION
The Olympus Endoscopic Flushing Pump (OFP-2) is a motorised pump designed to transfer water from a bottle, via a tube, to an endoscope.
The OFP-2 uses a peristalic pump head to move the water through the tube. The speed of rotation of the pump head is adjustable by the user, over nine steps, using flow control buttons on the front of the pump. The flow control buttons are connected to a digital controller that governs speed of rotation of the pump head. Nine LEDs on the front of the pump indicate the speed setting that has been selected.
The pump is operated by a footswitch or a button on the endoscope. It has an on/off button and a standby button.
The OFP includes a water container supplied non-sterile to be processed before use. Two water tubes of different lengths and an instrument channel adapter are supplied sterile. The Instrument Channel Adapter (MAJ-1606) and Instrument Channel Water Tube (MAJ-1607) are supplied sterile for single use only. to pump water through the instrument channel of the endoscope. The Auxilliary Channel Water Tube (MAJ-1608) is supplied sterile for single day only use.
INDICATIONS FOR USE
The OFP-2 and accessories are intended for use in medical facilities under the direction of a trained physician.
The OFP-2 is intended for use:
- . During endoscopic procedures to wash blood, feces and other organic matter from the site being visualised, diagnosed or treated.
- To aid in filling areas of the gastrointestinal tract with water in order to aid in . examinations performed with trans-endoscopic ultrasound probes
SUMMARY OF TESTING
Risk Management of the OFP-2 and its tubing was performed to ISO 14971 and included a device hazard analysis.
Biocompatibility of the Water Container and tubing has been established by subjecting the container, a tube and the Instrument Channel Adapter to the following tests:
- L929 MEM elution test to ISO 10993-5 .
- Intracutaneous Injection Test to ISO 10993-10 .
- Kligman Maximization Test to ISO 10993-10 .
Electrical safety testing of the OFP-2 and its accessories was performed to:
- . IEC 60601-1:1988
- EN 60601-1:1990 ●
- UL 60601-1:2003 .
- CAN/CSA-C22.2 No. 601.1-M90 .
Additional testing was performed to:
- IEC 60601-1-1 .
- IEC 60601-2-18 .
2
Image /page/2/Picture/0 description: The image shows the word "OLYMPUS" in large, bold, black letters. A horizontal line is underneath the word. Below the line, the text "Your Vision, Our Future" is written in a smaller font.
i