(93 days)
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures,
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quik-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 EndoMedical 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 document is a 510(k) summary for the EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for an AI/ML medical device.
Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document because it is not typically required or included in a 510(k) submission for this type of device.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the way one would see for an AI/ML device. Instead, it describes non-clinical tests conducted to address safety and performance characteristics related to minor design differences compared to predicate devices. The "reported device performance" is a general statement about the success of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Optical qualities of sheath window | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Sheath mechanical tests | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Finished device barrier testing | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Overall safety for intended use | "reliably achieves the desired affect and is safe for its intended use." |
| No new questions of safety or effectiveness for endoscope barrier sheaths | "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 the data provenance
Not applicable. The document describes non-clinical material and functional testing of the device itself, not a study involving human or image data with a "test set" in the context of an AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant to this type of device and submission. The "ground truth" for the non-clinical tests would have been established by standard engineering and material science measurement techniques and validated against industry standards or predicate device performance.
4. Adjudication method for the test set
Not applicable. No "test set" of clinical cases requiring adjudication by human experts is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/ML device, and no MRMC study was conducted or is described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML device; therefore, no algorithm-only performance was assessed.
7. The type of ground truth used
The "ground truth" for the non-clinical tests would have been established through:
- Engineering specifications and standards: For mechanical tests and optical qualities.
- Microbiological testing standards: For barrier testing.
- Comparison to predicate device performance: To ensure similarity and non-inferiority.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device; there is no "training set" or corresponding ground truth establishment process in the AI/ML context.
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K061663
Document Date: 5/05/06
- 6 2006
510(k) Summary 5.
May 5, 2006 Date Prepared Revised for ENT/Bronchoscope only May 30, 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 EndoSheathSystem | |
| 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-F100Sigmoidoscope | |
| Contact | Marc Jaker, Vice PresidentRTC, Inc. - Memcath Technologies, LLC1777 Oakdale AveWest St. Paul, MN 55118Phone: 651-450-7400 Fax: 651-450-7555 |
Intended Use
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures,
Device Description
The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quik-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 EndoMedical 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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Substantial Equivalence Comparison
The intended use of the EndoMedical Technologies Quik-Cover is similar to the predicate devices in that the sheaths are sterile, disposable protective accessories used to cover endoscopes, catheters 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 endoscope barrier sheaths, a distal polymeric window. Some models of the EndoMedical Technologies Quik-Cover™ and predicate devices also include a side working channel. The EndoMedical Technologies Quik-Cover application method is similar to the predicate devices in that the sheath slides on and off with no vacuum/ pressure source required.
The EndoMedical Technologies Quik-Cover™ sheath material 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 Quil-Cover Flexible Endoscope Barrier Sheath is, therefore, substantially equivalent to currently marketed devices.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 6 2006
Memcath Technologies c/o Marc Jaker Vice President RTC, Inc. - Memcath Technologies, LLC 1777 Oakdale Avenue West St., Paul, MN 55118-4031
Re: K061663
K001005
Trade/Device Name: Quik-Cover Protective Barrier Sheath Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope and accessories Regulatory Class: Class II Product Code: EOB Dated: August 16, 2006 Received: August 17, 2006
Dear Mr. Jaker:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 ro(x) promatics is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regars manetical Device Amendments, or to commerce prior to May 28, 1970, the characted with the provisions of the Federal Food, Drug. devices that have been recure approval of a premarket approval approval application (PMA). and Cosment Act (Act) that do not require approvine controls provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of You may, therefore, market the device, basjon to the manual registration, listing of general controls provisions of the free herefore required in the manage inst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (SCC above) into s. Existing major regulations affecting your device .
It may be subject to such additional controls. Existing major regulations it may be subject to such additional control - Internage - Title 21, Parts 800 to 898. In addition, FDA can be found in the Code of Peceral concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri- s issuation of a complies with other requirements of the Act that FDA has made a decemination administered by other Federal agencies. You must or any Federal Statutes and regulations administered of registration and listing (21 comply will an the Act s requirements, mercess communities practice requirements as set CFR Part 807), labeling (21 CFR Part 801), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mr. Marc Jaker
.. +
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 (240) 276-0115. 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 yours,
M.B. EgdahlmsiWD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement 1.
510(k) Number (if known): K061663
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 the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures.
Prescription Use XX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ion Sign-Off) sion of Ophthalmic
Number K5061163
Prescription Use . (Per 21 CFR 801.109)
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.