(247 days)
The Clear-Vu System is a single-use, disposable laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
The Clear-Vu System consists of a multi-lumen sheath assembly mounted on the shaft of the laparoscope, which connects to the existing CO₂ insufflation circuit to defog the laparoscope lens and divert surgical debris, and connects to the existing surgical irrigation system to clean the lens via saline flush.
The provided text describes the Clear-Vu™ System, an endoscope lens cleaning and defogging device. However, it does not contain the specific details required to fully answer your request, such as a table of acceptance criteria, reported device performance figures, sample sizes for test sets, expert qualifications, or details about MRMC studies.
Based on the information available in the document, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided text. The document indicates that the device was subjected to simulated use testing and preclinical animal testing to "demonstrate its effectiveness." However, the specific metrics or thresholds that would define "effectiveness" (i.e., the acceptance criteria) are not provided.
- Reported Device Performance: Not explicitly stated in the provided text. The document claims the device demonstrated "effectiveness" in simulated use and animal testing, but no quantitative performance results (e.g., success rates, time to clear, optical clarity improvements) are given.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not provided. The text mentions "simulated use testing" and "preclinical animal testing in a porcine model" but does not specify the number of simulated cases or the number of animals used.
- Data Provenance: The preclinical animal testing was conducted in a porcine model. For the simulated use testing, the provenance is a "surgical environment simulation chamber," implying a controlled laboratory setting. It is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not provided. The document does not mention the use of experts to establish ground truth for performance testing. Given the nature of the device (cleaning and defogging), "ground truth" during testing would likely be assessed through objective measures of lens clarity or subjective assessment by observers, rather than a diagnostic 'truth' established by experts.
4. Adjudication Method for the Test Set
- Not provided. Since the document doesn't detail how the effectiveness was measured, it also doesn't specify any adjudication method for those measurements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not performed/reported. The document makes no mention of a human-in-the-loop study or an MRMC comparative effectiveness study involving human readers with or without AI assistance. The device is an accessory, not an AI diagnostic tool.
6. Standalone Performance Study
- Yes, a standalone study was done, but details are limited. The performance testing described (simulated use and preclinical animal testing) evaluates the algorithm/device's functionality in isolation, without direct human intervention as part of the performance measurement. The device "facilitates" cleaning and defogging, implying it performs this function on its own, and the tests were to demonstrate its effectiveness in performing this function. However, the specific metrics and results of this standalone performance are not provided.
7. Type of Ground Truth Used
- Observational effectiveness. For the simulated use and animal testing, the "ground truth" would be established by observing whether the device successfully defogged and cleaned the laparoscope lens as intended. This is an objective assessment of function rather than a diagnostic truth. For example, measures of visibility before and after cleaning, or the absence of fog/debris.
8. Sample Size for the Training Set
- Not applicable / Not provided. The Clear-Vu System is a mechanical accessory device, not an AI/ML algorithm that requires a "training set." Therefore, this question is not relevant to the described device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML algorithm, there is no training set and no ground truth establishment for it.
Summary of Missing Information:
The most significant missing information for a complete answer includes:
- Specific quantitative acceptance criteria for device effectiveness.
- Quantitative results of the device's performance in simulated use and animal studies.
- Actual sample sizes for the testing.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Minimally Invasive Devices, LLC % Mr. Michael H. Southworth, RAC Principal & Senior Consultant Southworth & Associates, LLC 1035 Waldo Way Twinsburg, OH 44087
JUL 2 7 2015
Re: K080613
Trade/Device Name: Clear-Vu™ System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCT, GCJ Dated (Date on orig SE ltr): October 28, 2008 Received (Date on orig SE Itr): October 30, 2008
Dear Mr. Southworth,
This letter corrects our substantially equivalent letter of November 6, 2008.
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
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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 (reporting of medical device-related 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: __K480613
Device Name: Clear Vu System
Indications for Use: Clear-Vu is a single-use, disposable laparoscopic accessory device that is intended to facilitate intra-operative defogging and cleaning of the lens of a laparoscope during minimally-invasive surgery while maintaining visualization of the surgical site.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
16
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Norman M. Whan
eproductive, Abdomin and Radiological Devic 510(k) Number
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510(k) Summary of Safety and Effectiveness Clear-Vu System Minimally Invasive Devices, LLC
:
.
NOV - 6 2008
| 510(k) Submitter | Minimally Invasive Devices, LLC1275 Kinnear RoadColumbus, Ohio 43212 | NOV - 6 2008 |
|---|---|---|
| Contact Person | Wayne L. Poll, MD, ChairmanPhone: (614) 580-2022Fax: (614) 889-7630E-mail: waynepoll@hotmail.com | |
| Date Prepared | Revised October 28, 2008 | |
| Device Name | Proprietary Name: Clear-Vu SystemCommon Name: endoscope lens cleaning and defogging deviceClassification Name: "accessory, endoscope," a class II device inaccordance with 21 CFR § 876.1500 | |
| Intended Use | The Clear-Vu System is a single-use, disposable laparoscopic accessorydevice intended to facilitate intra-operative defogging and cleaning ofthe lens of a laparoscope during minimally-invasive surgery whilemaintaining visualization of the surgical site. | |
| Device Description | The Clear-Vu System consists of a multi-lumen sheath assemblymounted on the shaft of the laparoscope, which connects to theexisting CO₂ insufflation circuit to defog the laparoscope lens anddivert surgical debris, and connects to the existing surgical irrigationsystem to clean the lens via saline flush. | |
| SubstantialEquivalence | The Clear-Vu System is substantially equivalent in terms of safety andeffectiveness to the following predicate devices:1. Defogging Heated Endoscopic Lens Protector / K062779New Wave Surgical Corp.2. Endo-Scrub® 2 / K982594Xomed, Inc.3. SeeClear™ Laparoscopic Smoke Evacuation System/510(k) ExemptJLJ Medical Devices International, LLC | |
| TechnologicalComparison | The Clear-Vu System is substantially equivalent to the cited predicatedevices in terms of intended use, and the technological differences arenot significant relative to the safety or effectiveness of the new device. | |
| Performance Testing-Bench | The device was subjected to simulated use testing to demonstrate itseffectiveness in a surgical environment simulation chamber. | |
| Performance Testing-Animal | The device was subjected to preclinical animal testing to demonstrate itseffectiveness in a porcine model. |
§ 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.