(224 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFLIP® ECD EF-800, structured as requested.
The provided document is a 510(k) Summary, which is typically a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. In many cases, for devices of this type (an accessory to an endoscope), the "acceptance criteria" are demonstrating equivalence in technical characteristics and performance to predicate devices, rather than establishing new clinical thresholds. The "study" often refers to non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the K110531 submission, the "acceptance criteria" are implied by the comparison to predicate devices, focusing on demonstrating similar functional, material, and safety characteristics. The performance reported is primarily through compatibility and age testing to ensure the device performs as expected for its intended use.
| Acceptance Criteria (Implied from Predicate Comparison) | Reported Device Performance (EndoFLIP® ECD EF-800) |
|---|---|
| Indications for Use Equivalence | Identified as equivalent to predicate K100081 (US Endoscopy overtube) for aiding insertion, advancement, and removal of endoscopic devices during procedures in the upper GI tract, including small intestine. |
| Technology Similarity | Similar to predicate K060923 (Smart Medical NaviAID BGE) – a simple double lumen tube with a tapered tip. Note: without the balloon accessory present in the predicate. |
| Material Biocompatibility | Materials in contact were tested to ISO 10993-1 (Cytotoxicity, Irritation, and Sensitization). |
| Environment of Use Equivalence | Identical to predicate K060923 (Smart Medical NaviAID BGE) – Hospitals, Sub-acute care institutions, Surgery Centers, doctor's offices. |
| Patient Population Equivalence | Identical to predicate K060923 (Smart Medical NaviAID BGE) – Patients undergoing endoscopic procedures. |
| Shelf Life | Age testing performed. (Details of specific duration or passing criteria are not provided in this summary.) |
| Compatibility with Endoscopes | Compatibility testing performed to verify its ability to slide over endoscopes. (Details of specific compatibility parameters are not provided.) |
| Safety and Efficacy Concerns | The device "raises no new safety or efficacy concerns" compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
For the "Performance Testing" mentioned (Age testing and Compatibility testing), the document does not specify:
- The exact sample size used for these tests.
- The origin of data (e.g., country of origin).
- Whether the data was retrospective or prospective.
These tests are typically bench or lab-based rather than clinical studies with human participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information (number and qualifications of experts for ground truth) is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an endoscopic accessory undergoing performance testing (age testing, compatibility testing), the "ground truth" would be established by objective measurements and standardized test protocols, not by expert consensus on, for example, image interpretation. Therefore, this information is not applicable in the context of the provided regulatory submission.
4. Adjudication Method for the Test Set
As the performance testing described is objective (age testing, compatibility with endoscopes), there is no mention of an adjudication method (like 2+1 or 3+1). Such methods are typically used when subjective expert assessments need to be reconciled, which is not the case here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. MRMC studies are typically clinical trials designed to compare the diagnostic performance of different methods (e.g., AI vs. human readers, or human readers with vs. without AI assistance) across multiple readers and cases. This submission focuses on demonstrating substantial equivalence of a physical medical device accessory through comparison of technical specifications and non-clinical performance tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, this is not applicable. The EndoFLIP® ECD EF-800 is a physical medical device accessory (an external channel for an endoscope), not a diagnostic algorithm or an AI-powered system. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.
7. The Type of Ground Truth Used
For the performance tests mentioned:
- Age testing: The "ground truth" would be the stability and integrity of the device materials and function over a specified period, verified by empirical observation/measurement (e.g., material degradation, functional checks after accelerated aging) against predefined engineering specifications.
- Compatibility testing: The "ground truth" would be the successful and unimpeded sliding of the device over various endoscope diameters, verified by direct observation/measurement (e.g., successful navigation, absence of damage to either device) against specified dimensional and functional tolerances.
This is based on engineering specifications and objective physical measurements, not expert consensus, pathology, or outcomes data in a clinical sense.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical accessory, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As stated above, this device does not utilize a training set in the context of machine learning.
{0}------------------------------------------------
K110531
| Company | Crospon Ltd.Galway Business ParkDanganGalway, IrelandTel - 011 [353] (91) 519882Fax - 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 MedicalNaviAID BGE – K060923 | US EndoscopyEnteroscopy Overtube - K100081 |
|---|---|---|---|---|---|
| Environment of Use: | Hospitals, Sub-acute care institutions, Surgery Centers, doctor'soffices where endoscopic procedures may be performed | Indications for Use | The EndoFLIP® EF-800 is anexternal channel for an endoscope(9.0 to 12.2 mm in diameter) usedto aid in the insertion advancement | An accessory to an endoscope andis intended to ensure completepositioning of a standardendoscope in the small intestine(i.e., an endoscope that is 10 -13mm in diameter and is used forstandard intestinal endoscopicvisualization | Indicated for use to aid the insertion,advancement, and removal ofappropriately sized endoscopes andendoscopic devices duringdiagnostic and therapeuticendoscopic procedures in the uppergastrointestinal tract, including thesmall intestine |
| Contraindications: | The ECD EF-800 is contraindicated where endoscopy iscontraindicated. | Environments of use | Hospitals, Sub-acute careinstitutions, Surgery Centers,doctor's offices where endoscopicprocedures may be performed | Hospitals, Sub-acute careinstitutions, Surgery Centers,doctor's offices where endoscopicprocedures may be performed | Hospitals, Sub-acute careinstitutions, Surgery Centers,doctor's offices where endoscopicprocedures may be performed |
| Patient Population | Patients undergoing endoscopicprocedures | Patients undergoing endoscopicprocedures | Patients undergoing endoscopicprocedures | ||
| Contraindications | The ECD EF-800 is contraindicatedwhere endoscopy is contraindicated. | The contraindications includethose specific to the endoscopicprocedure. Relativecontraindications include:• Bowel obstruction• Concomitant Coumadin use• DiverticulitisRecent (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 MedicalNaviAID BGE - K060923 | US EndoscopyEnteroscopy Overtube - K100081 |
|---|---|---|---|
| aid in the insertion advancementand removal of endoscopicaccessories during endoscopicprocedures. | aid the insertion, advancement,and removal of appropriatelysized endoscopes and endoscopicdevices | aid the insertion, advancement, andremoval of appropriately sizedendoscopes 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 aresingle patient use, disposable | Supplied non-sterile, and aresingle patient use, disposable | Supplied non-sterile, and are singlepatient use, disposable |
| Performance Testing | |||
| Shelf life | Age testing | Age testing | -- |
| Ability to slide overendoscope | 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
§ 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.