(40 days)
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.
The EndoMedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quilt-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end which is preloaded on a deployment tube. Some models of the EndoMedival Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.
The provided text describes a medical device, the EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath, and its 510(k) summary for FDA clearance. However, the document does not contain the specific details required to fully address your request in the format you specified, particularly regarding detailed acceptance criteria, study methodologies, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies (MRMC).
The document states that "Nonclinical performance testing demonstrated that the EndoMedical Technologies Quik-Cover reliably achieves the desired affect and is safe for its intended use." This is a general statement of results, not a detailed breakdown of acceptance criteria and performance data.
Here's what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Qualities of Sheath Window | Not explicitly stated in terms of specific metrics or thresholds. The study mentions this as a nonclinical test performed. |
| Sheath Mechanical Tests | Not explicitly stated in terms of specific metrics or thresholds (e.g., tensile strength, tear resistance, puncture resistance). The study mentions this as a nonclinical test performed. |
| Finished Device Barrier Testing | Not explicitly stated in terms of specific metrics or thresholds (e.g., microbial barrier effectiveness, fluid impermeability). The study mentions this as a nonclinical test performed. |
| Overall Safety and Effectiveness | "Nonclinical performance testing demonstrated that the EndoMedical Technologies Quik-Cover reliably achieves the desired affect and is safe for its intended use." "No new questions of safety or effectiveness for endoscope barrier sheaths were raised during the testing." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are described as "nonclinical," suggesting laboratory testing rather than human clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable/not specified. The testing was nonclinical (laboratory-based) and focused on device performance characteristics rather than medical image interpretation or clinical diagnosis requiring expert ground truth.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. Given the nonclinical nature of the tests, an adjudication method for expert consensus on ground truth would not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the substantial equivalence of device properties (material, design, nonclinical performance) to predicate devices, not on the impact of the device on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Yes, in a sense. The described "nonclinical tests" are standalone evaluations of the device's physical and functional properties (e.g., optical qualities, mechanical strength, barrier integrity) without human interaction during the test itself. This is not an "algorithm only" study as it's a physical device, but it represents standalone device performance.
7. Type of Ground Truth Used
- Type of Ground Truth: For the nonclinical tests mentioned (optical qualities, mechanical tests, barrier testing), the "ground truth" would be objective physical and material standards, specifications, and test methods designed to measure these properties. For example, a barrier test might have a measurable standard for microbial penetration, or a mechanical test might have a specified breaking point.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
Summary of Gaps:
The provided 510(k) summary is typical for a physical medical device seeking substantial equivalence. It focuses on demonstrating that the new device shares similar fundamental technology and performance characteristics with existing cleared devices. It does not contain the detailed clinical trial or AI model validation information you are requesting. For such a device, "acceptance criteria" are usually internal design specifications and performance standards against which the manufactured product is tested. The "study" proving it meets criteria refers to the nonclinical bench testing outlined, but the specific metrics and results are not detailed in this summary.
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Document Date: 5/05/06
510(k) Summary 5.
| Date Prepared | May 5, 2006 |
|---|---|
| New Device | EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath |
| Predicate Devices | K000767 Memcath Urology Introducer Sheath |
| K042531 UPDATED SLIP Urology Introducer Sheath, Percutaneous Systems, Inc. | |
| K990354 Vision-Sciences EndoSheaths for use with Flexible ENT Scopes | |
| K021344 Vision-Sciences Flexible Fiberoptic Bronchoscope and EndoSheath System | |
| K040215 Vision-Sciences Flexible Cystoscope with EndoSheath System | |
| K031786 Vision-Sciences Trans-Nasal Esophagoscope with EndoSheath System | |
| K963344 SS-F32 EndoSheath for use with the Vision-Sciences Model S-F100 Sigmoidoscope | |
| Contact | Marc Jaker, Vice PresidentRTC, Inc. - Memcath Technologies, LLC1777 Oakdale AveWest St. Paul, MN 55118Phone: 651-450-7400 Fax: 651-450-7555Email: mjaker@rtcincmn.com |
Intended Use
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.
Device Description
The EndoMedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quilt-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end which is preloaded on a deployment tube. Some models of the EndoMedival Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.
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Comment: Removed references to ENT and broncho
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Substantial Equivalence Comparison
The intended use of the EndoMedical Technologics Quik-Cover™ is similar to the predicate devices in that the sheaths are sterile, disposable protective accessories used to cover endoscopes, cathelers or instruments to help prevent the transmission of pathogens.
The EndoMedical Technologies Quik-Cover™ device configuration is similar to the predicate devices in that all devices are comprised of a membrane sheath, a proximal connector and, with respect to the that an are novel a ventify a distal polymeric window. Some models of the EndoMedical Technologies Quik-Cover™ and predicate devices also include a side working channel. The EndoMedical Technologics Quik-Cover™ application method is similar to the predicate devices ir that the shealth slides on and off with no vacuum/ pressure source required.
The EndoMedical Technologies Quik-Cover™ sheath material is identical to the sheath material for the Memcath Urology Introducer Sheath (K000767) and the SLIP Urology Introducer Sheath (K042531) predicate devices. Safety and performance characteristics related to minor design differences have been addressed through the following nonclinical tests:
- Optical qualities of sheath window .
- Sheath mechanical tests .
- . Finished device barrier testing
Nonclinical performance testing demonstrated that the EndoMedical Technologies Quik-Cover reliably achieves the desired affect and is safe for its intended use. No new questions of safety or effectiveness for endoscope barrier sheaths were raised during the testing. The EndoMedical Technologies Quilt-Cover Flexible Endoscope Barrier Sheath is, therefore, substantially equivalent to currently marketed devices.
Koc1324
PG. 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 20 2006
Mr. Marc Jaker Vice President RTC, Inc .- Memcath Technologies LLC 1777 Oakdale Ave. WEST ST. PAUL MN 55118
Re: K061324
Trade/Device Name: EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: May 8, 2006 Received: May 18, 2006
Dear Mr. Jaker:
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 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.
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Page 2 -
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 4.
510(k) Number (if known): K061324
Device Name: EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath
Indications for Use: The EndoMedical Technologies Quik-Cover™ flexible endoscope barrier sheath provides a sterile, disposable protective covering for endoscopes used during examination of structures such as the bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.
Over-The-Counter Use Prescription Use XX AND/OR (21 CFR 80I Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
Radiological Devices
510(k) Number K061324
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§ 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.