(224 days)
No
The summary describes a mechanical accessory for endoscopes and does not mention any computational or analytical functions that would suggest AI/ML.
No
The device is described as an accessory that provides an additional channel for inserting, advancing, and removing endoscopic devices during procedures, rather than directly treating a disease or condition.
No.
The device is described as an accessory for inserting, advancing, and removing endoscopic devices, specifically designed to preserve the working channel of the endoscope for other instruments. Its stated intended use is to aid in the mechanical aspects of endoscopy rather than to provide diagnostic information or evaluate a medical condition.
No
The device description clearly states it is an "External Channel Device (ECD)" and an "endoscopic accessory," indicating it is a physical hardware component.
Based on the provided information, the EndoFLIP® EF-800 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is an "external channel for an endoscope... used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures." This describes a tool used during a medical procedure to facilitate the use of other instruments.
- Device Description: The description reinforces this by stating it's an "endoscopic accessory designed to provide an additional channel external to the endoscope."
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, tissue, or urine) or to provide information for the diagnosis of a disease or condition. IVDs are specifically designed for this purpose.
- Focus on Procedure Support: The entire description and intended use revolve around supporting the endoscopic procedure itself, not analyzing biological samples or providing diagnostic information.
Therefore, the EndoFLIP® EF-800 is a medical device used to facilitate endoscopic procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures
The EndoFLIP® ECD is single patient use, disposable.
Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
Product codes
FED
Device Description
The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper gastrointestinal tract, including the small intestine (in relation to predicate device K100081)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
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)
Age testing and compatibility with endoscopes were performed, similar to the tests conducted for the predicate K060923 Smart Medical - NaviAID BGE. The ECD EF-800 raises no new safety or efficacy concerns.
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
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
K110531
| Company | Crospon Ltd.
Galway Business Park
Dangan
Galway, Ireland
Tel - 011 [353] (91) 519882
Fax - 011 [353] (91) 519873 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | John O'Dea, Ph.D. |
| Proprietary or Trade Name: | EndoFLIP® ECD EF-800 |
| Common/Usual Name: | Endoscopic access overtube, gastroenterology-urology |
| Classification / CFR: | FED / CFR 876.1500 |
| Device: | EndoFLIP® ECD EF-800 |
| Predicate Devices: | US Endoscopy Enteroscopy Overtube (K100081)
Smart Medical NaviAID BGE (K060923) |
Device Description:
The EndoFLIP® ECD EF-800 External Channel Device (ECD) is an endoscopic accessory designed to provide an additional channel external to the endoscope for inserting, advancing, and removing endoscopic devices thereby preserving the working channel of the endoscope for other instruments.
Indications for Use:
The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 - 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures
| Patient Population: | Patients undergoing endoscopic procedures | Attributes | EndoFLIP®
ECD EF-800 | Smart Medical
NaviAID BGE – K060923 | US Endoscopy
Enteroscopy Overtube - K100081 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Environment of Use: | Hospitals, Sub-acute care institutions, Surgery Centers, doctor's
offices where endoscopic procedures may be performed | Indications for Use | The EndoFLIP® EF-800 is an
external channel for an endoscope
(9.0 to 12.2 mm in diameter) used
to aid in the insertion advancement
| An accessory to an endoscope and
is intended to ensure complete
positioning of a standard
endoscope in the small intestine
(i.e., an endoscope that is 10 -13
mm in diameter and is used for
standard intestinal endoscopic
visualization | Indicated for use to aid the insertion,
advancement, and removal of
appropriately sized endoscopes and
endoscopic devices during
diagnostic and therapeutic
endoscopic procedures in the upper
gastrointestinal tract, including the
small intestine |
| Contraindications: | The ECD EF-800 is contraindicated where endoscopy is
contraindicated. | Environments of use | Hospitals, Sub-acute care
institutions, Surgery Centers,
doctor's offices where endoscopic
procedures may be performed | Hospitals, Sub-acute care
institutions, Surgery Centers,
doctor's offices where endoscopic
procedures may be performed | Hospitals, Sub-acute care
institutions, Surgery Centers,
doctor's offices where endoscopic
procedures may be performed |
| Patient Population | Patients undergoing endoscopic
procedures | Patients undergoing endoscopic
procedures | Patients undergoing endoscopic
procedures | | |
| Contraindications | The ECD EF-800 is contraindicated
where endoscopy is contraindicated. | The contraindications include
those specific to the endoscopic
procedure. Relative
contraindications include:
• Bowel obstruction
• Concomitant Coumadin use
• Diverticulitis
Recent (within the last 3 months)
coronary ischemia or CVA
(stroke) | Not stated | | |
1
510(k) Summary
្រី
f
: -
Table of Comparison of Proposed Device vs. Predicate
.
2
| Functions | EndoFLIP®
ECD EF-800 | Smart Medical
NaviAID BGE - K060923 | US Endoscopy
Enteroscopy Overtube - K100081 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | aid in the insertion advancement
and removal of endoscopic
accessories during endoscopic
procedures. | aid the insertion, advancement,
and removal of appropriately
sized endoscopes and endoscopic
devices | aid the insertion, advancement, and
removal of appropriately sized
endoscopes and endoscopic devices |
| Intraoperative use | Yes | Yes | Yes |
| Design | | | |
| Components | | | |
| Dual lumen shaft | Yes | Yes | No (single lumen) |
| Clip | Yes | Yes | No |
| Reinforcing wire | Yes | Yes | Yes |
| Tapered tip | Yes | Yes | Yes |
| Dual lumen | | | |
| Working | Yes | Yes | No |
| Endoscope | Yes | Yes | Yes Only a channel for endoscope |
| Dimensions (mm) | | | |
| Overall OD | 20.3 mm | 20.3 mm | 19.5 mm (single lumen) |
| Working lumen ID | 4.0 mm | 4.0 mm | Not available |
| Endoscope lumen | Up to 13 mm | Up to 13 mm | 16.7 mm |
| Overall length | 718 mm | 1900 mm | 500 mm |
| Working length | 700 mm | -- | -- |
| Sterility | Supplied non-sterile, and are
single patient use, disposable | Supplied non-sterile, and are
single patient use, disposable | Supplied non-sterile, and are single
patient use, disposable |
| Performance Testing | | | |
| Shelf life | Age testing | Age testing | -- |
| Ability to slide over
endoscope | Compatibility testing | Compatibility testing | Not available |
| Materials | | | |
| Biocompatibility | ISO 100993-1 | ISO 10993-1 | ISO 10993-1 |
510(k) Summary
Page 59
3
510(k) Summary Page 4 of 4 30-Sep-11
Substantial Equivalence:
The EndoFLIP® ECD EF-800 is viewed as substantially equivalent to the predicate devices because:
Indications -
Equivalent to predicate - K100081 - US Endoscopy overtube - indicated for use to aid the insertion, advancement, and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.
Technology -
Similar to the predicate K060923, without the balloon accessory, Smart Medical - NaviAID BGE, a simple double lumen tube with a tapered tip at one end.
Materials -
The materials in contact were tested to ISO 109931 - Cytotoxicity, Irritation, and Sensitization
Environment of Use -
Identical to predicate - K060923 - Smart Medical NaviAID BGE - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
Patient Population -
Identical to predicate - K060923 - Smart Medical NaviAID BGE - Patients undergoing endoscopic procedures.
Comparative Performance and Specifications
We have performed age testing and compatibility with endoscopes similar to the tests performed by the predicate K060923 Smart Medical - NaviAID BGE.
The ECD EF-800 raises no new safety or efficacy concerns.
4
Image /page/4/Picture/1 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" written around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Crospon Ltd. % Mr. Paul Dryden President ProMedic, Inc. 24301 Woodsage Drive BONITA SPRINGS FL 34134
OCT - 6 2011
Re: K110531
Trade/Device Name: EndoFLIP® EF-800 External Channel Device Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: 11 Product Code: FED Dated: September 30, 2011 Received: October 4, 2011
Dear Mr. Dryden:
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. 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 device-related
5
Page 2
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/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,
Hubert Lemmer MD
Herbert P. Lemer, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.
Enclosure
6
Indications for Use Statement
Page 1 of 1
K110531 510(k) Number:
Device Name: EndoFLIP® EF-800 External Channel Device
Indications for Use:
1:
The EndoFLIP® EF-800 is an external channel for an endoscope (9.0 to 12.2 mm in diameter) used to aid in the insertion, advancement, and removal of endoscopic devices during endoscopic procedures
The EndoFLIP® ECD is single patient use, disposable.
Environments of use - Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices where endoscopic procedures may be performed.
Prescription Use XX (Part 21 CFR 801 Subpart D) 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)
uctive, Gastro-Renal, and