(103 days)
K040836, K0520840
Not Found
No
The description focuses on the mechanical function and materials of a disposable overtube, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates endoscopic procedures but does not directly treat a disease or condition; its function is mechanical guidance and protection for the endoscope.
No
The device description indicates it is a flexible tube used with an endoscope for tissue/foreign body manipulations and facilitating multiple insertions, not for diagnosing conditions.
No
The device description clearly states it is a "disposable flexible PVC tube" with a handle and introducer plug, indicating it is a physical hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Megachannel Endoscopic Overtube is a physical device used in conjunction with an endoscope to facilitate procedures within the gastrointestinal tract. Its function is to aid in the manipulation and removal of tissue or foreign bodies and to allow for multiple insertions of the endoscope.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device is used directly within the body during an endoscopic procedure.
Therefore, the Megachannel Endoscopic Overtube is a medical device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To be used with endoscopes as a channel for multiple insertions of the endoscope into the lower gastrointestinal tract.
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.
Product codes (comma separated list FDA assigned to the subject device)
ODB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Megachannel Endoscopic Overtube has successfully undergone functional testing. These products have been shown to be equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
US Endoscopy Guardus Overtube (K040836), Spirus Medical Endo-Ease Overtube (K0520840)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Minos Medical
15560-C Rockfield Boulevard ● Irvine, CA 92618
Phone: 949-215-1835 |Fax: 949-625-8625
5 510(k) Summary
| Submitter: | Minos Medical
15560-C Rockfield Boulevard
Irvine, CA 928618 | JUN 10 2008 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Tom Colonna,
Director of Quality | |
| Date Prepared: | February 27, 2008 | |
| Trade name: | Megachannel Endoscopic Overtube | |
| Classification
Name: | Endoscope and Accessories (21 CFR 876.1500) | |
| Name:
Predicate
Devices: | US Endoscopy Guardus Overtube (K040836) | |
| | Spirus Medical Endo-Ease Overtube (K0520840) | |
| Device
Description: | 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. | |
| Intended Use: | To be used with endoscopes as a channel for multiple
insertions of the endoscope into the lower
gastrointestinal tract. | |
| Comparative
Analysis: | The Megachannel Endoscopic Overtube has been
demonstrated to be as safe and effective as the
predicate devices for its intended use. | |
| Functional/Safety
Testing: | The Megachannel Endoscopic Overtube has
successfully undergone functional testing. These
products have been shown to be equivalent to the
predicate devices. | |
| Conclusion: | The Megachannel Endoscopic Overtube is substantially
equivalent to the predicate devices. | |
:
1
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.
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 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
3
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 .