(103 days)
The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
The Megachannel Endoscopic Overtube is a disposable flexible PVC tube that is to be used with an endoscope. The overtube includes a proximal handle with insufflation sealing cap that accommodates a standard 12.8 mm diameter colonoscope. A removable introducer plug is attached to the distal tip to facilitate the introduction of the overtube through the gastrointestinal tract.
The provided text describes a medical device called the "Megachannel Endoscopic Overtube" and its 510(k) submission for market clearance. This document is a summary of the device and its claimed substantial equivalence to predicate devices, rather than a detailed study report on acceptance criteria and performance of an AI-powered device.
Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) is not applicable or not available in this specific document, as it pertains to a traditional medical device (an overtube) and not an AI/ML-powered one. The submission focuses on functional and safety testing to demonstrate equivalence, not on AI model performance metrics.
However, I can extract the information that is present according to your categories:
1. Table of acceptance criteria and reported device performance
The document does not explicitly state numerical "acceptance criteria" or "reported device performance" in the way one would for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, the performance demonstration is based on functional and safety testing to show equivalence to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness equivalent to predicate devices for intended use | "The Megachannel Endoscopic Overtube has been demonstrated to be as safe and effective as the predicate devices for its intended use." |
| Successful functional testing | "The Megachannel Endoscopic Overtube has successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices." |
2. Sample sized used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "functional testing" was performed, but does not detail the number of devices tested or the specific conditions/data used for this testing.
- Data Provenance: Not applicable/not specified. This is a physical device, and "data provenance" (country of origin, retrospective/prospective) is typically associated with data used to train and test AI models.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. The device is an overtube, and "ground truth" as typically defined for AI algorithms is not relevant to its functional testing. Testing would involve engineering and performance assessments (e.g., material strength, dimensions, sealing capabilities).
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not specified. This concept is relevant to establishing ground truth for diagnostic AI, not for functional testing of a physical medical device like an overtube.
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
- MRMC Study: No. This document describes a physical medical device, not an AI-powered one that would assist human readers.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of AI. For this device, "performance" would be validated against engineering specifications, user requirements, and comparison to predicate device performance. This would likely involve measurements of physical properties, durability, and user interface elements, rather than diagnostic "ground truth" data.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a physical device; there is no "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As there is no AI training set, this question is irrelevant to the provided document.
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Minos Medical
15560-C Rockfield Boulevard ● Irvine, CA 92618
Phone: 949-215-1835 |Fax: 949-625-8625
5 510(k) Summary
| Submitter: | Minos Medical15560-C Rockfield BoulevardIrvine, CA 928618 | JUN 10 2008 |
|---|---|---|
| Contact Person: | Tom Colonna,Director of Quality | |
| Date Prepared: | February 27, 2008 | |
| Trade name: | Megachannel Endoscopic Overtube | |
| ClassificationName: | Endoscope and Accessories (21 CFR 876.1500) | |
| Name:PredicateDevices: | US Endoscopy Guardus Overtube (K040836) | |
| Spirus Medical Endo-Ease Overtube (K0520840) | ||
| DeviceDescription: | The Megachannel Endoscopic Overtube is a disposableflexible PVC tube that is to be used with an endoscope.The overtube includes a proximal handle withinsufflation sealing cap that accommodates a standard12.8 mm diameter colonoscope. A removableintroducer plug is attached to the distal tip to facilitatethe introduction of the overtube through thegastrointestinal tract. | |
| Intended Use: | To be used with endoscopes as a channel for multipleinsertions of the endoscope into the lowergastrointestinal tract. | |
| ComparativeAnalysis: | The Megachannel Endoscopic Overtube has beendemonstrated to be as safe and effective as thepredicate devices for its intended use. | |
| Functional/SafetyTesting: | The Megachannel Endoscopic Overtube hassuccessfully undergone functional testing. Theseproducts have been shown to be equivalent to thepredicate devices. | |
| Conclusion: | The Megachannel Endoscopic Overtube is substantiallyequivalent to the predicate devices. |
:
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 0 2008
Mr. Tom Colonna Director of Quality Minos Medical 15560 -C Rockfield Blvd. IRVINE CA 92618
Re: K080550
Trade/Device Name: Megachannel Endoscopic Overtube Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODB Dated: May 2, 2008 Received: May 5, 2008
Dear Mr. Colonna:
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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 Cbrogdon
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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Minos Medical 15560-C Rockfield Boulevard · Irvine, CA 92618 Phone: 949-215-1835 Fax: 949-625-8625
Indications for Use Statement 4
510(k) Number (if known):
(if known): K080550
Device Name: Megachannel Endoscopic Overtube
Indications for Use:
The Megachannel Endoscopic Overtube is indicated for use in conjunction with an endoscope for tissue or foreign body manipulations and/or where multiple removal and reinsertions of the endoscope are required.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Helmut Renn
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
Page 1 of _1
February 27, 2008 510(k) Notification for Megachannel Endoscopic Overtube CONFIDENTIAL .
§ 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.