(90 days)
Not Found
No
The device description and performance studies focus on mechanical function and biocompatibility, with no mention of AI/ML terms or data-driven performance metrics.
No
The primary function of this device is to facilitate the colonoscopy procedure by preventing sigmoid loop reformation and minimizing mucosal pinching, rather than to treat a disease or condition. It acts as an accessory to the endoscope.
No
The device is described as an overtube used during colonoscopy to facilitate scope advancement and prevent sigmoid loop reformation, which are procedural and therapeutic functions, not diagnostic ones.
No
The device description clearly outlines physical components such as a soft distal tip, irrigation line, proximal seal, hydrophilic coating, and optional adhesive anchor, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- Device Function: The Colonic Splinting Overtube is a physical device used during a colonoscopy procedure to aid in the advancement of an endoscope within the body. It does not perform any tests on samples.
- Intended Use: The intended use clearly describes a mechanical function within the body to facilitate a medical procedure, not a diagnostic test on a sample.
Therefore, based on the provided information, the Colonic Splinting Overtube is a medical device used for a procedural purpose, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FED
Device Description
The US Endoscopy Colonic Splinting Overtube is an overtube that includes a soft distal . tip, an irrigation line, proximal seal at the handle, a hydrophilic coating, and an optional adhesive anchor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sigmoid colon
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)
Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible.
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.
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
ONFIDENTIAL United States Endoscopy Group, Inc. July 17, 2009
510(k) Premarket Notification: Traditional Colonic Splinting Overtube
K 0922i OCT 20 2009
pg 1 of x
510(k) SUMMARY FOR THE US ENDOSCOPY COLONIC SPLINTING OVERTUBE
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Applicant:
United States Endoscopy Group, Inc. 5976 Heisley Road Mentor, Ohio 44060
Contact Persons:
Craig L. Moore, General Counsel Bob Bishui, Regulatory Affairs Manager 5976 Heisley Road Mentor, Ohio 44060 Telephone No .: (440) 639-4494 Fax No .: (440) 639-6256
| Device Common Name: | Colonic Splinting Overtube |
|---|---|
| --------------------- | ---------------------------- |
None at this time. Trade Name:
Endoscope and Accessories Classification Name:
Class II, per 21 CFR 876.1500 Device Classification:
Product Code: 78 (FDF)
Predicate Devices:
K023259 Soft Sleeve Colonoscope Splint (International Healthcare Technologies, a division of Helix Medical, Inc.)
Endo-Ease™ Advantage Endoscopic Overtube K052084 (Spirus Medical, Inc.)
253
Guardus® Overtube K040836 (US Endoscopy)
1
CONFIDENTIAL United States Endoscopy Group, Inc. July 17, 2009
Product Description:
The US Endoscopy Colonic Splinting Overtube is an overtube that includes a soft distal . tip, an irrigation line, proximal seal at the handle, a hydrophilic coating, and an optional adhesive anchor.
Indication For Use:
The Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.
Safety and Performance:
Substantial equivalence for the new device was based on design characteristics, a comparison to legally marketed predicate devices, and performance testing. Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible.
Conclusion:
Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the proposed US Endoscopy Colonic Splinting Overtube has been shown to be safe and effective for its intended use.
254
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a clear, sans-serif font. The emblem appears to be a stylized representation of the human form, possibly symbolizing the department's focus on health and well-being.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Craig L. Moore General Counsel United States Endoscopy Group, Inc. 5976 Heisley Road MENTOR OH 44060
OCT 20 2009
Re: K092221
Trade/Device Name: Colonic Splinting Overtube Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED Dated: July 17, 2009 Received: July 22, 2009
Dear Mr. Moore:
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 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.
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 of medical
3
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janina M. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL United States Endoscopy Group, Inc. July 17, 2009
510(k) Premarket Notification: Traditional Colonic Splinting Overtube
Page __ 1__ of _______________________________________________________________________________________________________________________________________________________________
13
INDICATIONS FOR USE
510(k) Number (if known): / 0922221
Device Name: Colonic Splinting Overtube
Indications for Use:
The Colonic Splinting Overtube is indicated for use with an endoscope to prevent the reformation of the sigmoid loop subsequent to the reduction of the curvature of the sigmoid colon by the endoscope during the colonoscopy procedure. The Colonic Splinting Overtube is intended to provide for easy advancement of the scope while minimizing mucosal pinching.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| (Part 21 CFR 801 Subpart D) |
OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K092221 |
|---|---|
| --------------- | --------- |