(271 days)
Not Found
No
The device description focuses on mechanical components and functionality, with no mention of AI/ML terms or data-driven performance metrics.
No
The device is described as an accessory to facilitate intubation during endoscopic procedures, such as colonoscopy, and for removing polyps or foreign bodies. It provides external support to an endoscope and helps maintain its shape, but it does not directly treat, prevent, or diagnose any disease or condition itself. Its function is purely facilitative in a procedural context.
No
The device, an overtube, is used to facilitate endoscope intubation and removal of polyps/foreign bodies. Its description as an endoscopic accessory designed to provide external support for an endoscope indicates it is an assistive tool for procedures, not a device that diagnoses conditions.
No
The device description clearly details a physical, mechanical device (a tube with links, cables, and a handle) and the performance studies mention mechanical and functional bench testing, indicating it is a hardware device.
Based on the provided information, the USGI Endoscopic Overtube is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is used with an endoscope to facilitate procedures like intubation, changing endoscopes, and removing polyps/foreign bodies. These are all in vivo procedures performed directly on a patient's body.
- Device Description: The description details a mechanical device designed to provide external support to an endoscope. It does not mention any components or functions related to testing samples of human origin (like blood, urine, tissue, etc.) outside of the body.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The USGI Endoscopic Overtube is a surgical accessory used during endoscopic procedures performed inside the body.
N/A
Intended Use / Indications for Use
The USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
Product codes
FED, FDF, KOG
Device Description
The USGI Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then lock in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly.
The USGI Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The overtube is constructed from multiple nested links that are held together by four cables. Each link is bowl shaped, but without a bottom and has four equally spaced annular holes running longitudinally through the wall thickness. The purpose of the holes is to accommodate the tension wires which pass through each link. The wires are connected to the tip but slide freely through all other links. Applying tension to the wires squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
This 510(k) notice includes mechanical and functional bench testing that demonstrate that the USGI Endoscopic Overtube performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 2 7 2015
USGI Medical, Inc. % Judy F. Gordon, D.V.M. Regulatory Consultant ClingReg Consulting Services, Inc. 2 Delphinus IRVINE. CA 92612
Re: K023902
Trade/Device Name: USGI Shape Locking Endoscopic Oveertube Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED, FDF Dated (Date on orig SE ltr): May 19, 2003 . Received (Date on orig SE Itr): May 22, 2003
Dear Dr. Gordon,
This letter corrects our substantially equivalent letter of August 20, 2003.
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
1
Page 2 -
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
2
Page 1 of 1
510(k) Number (if known):
Device Name: USG! Endoscopic Overtube
Indications for Use:
.
The USGI Endoscopic Overtube is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
| OR | Over-The-Counter Use | ||
|---|---|---|---|
| (Optional Format 1-2-96) |
| (Division Sign-Off) | Nancy C. Brogdon |
|---|---|
| --------------------- | ------------------------------------------------------------------------------- |
Division of Reproductive, Abdominal, and Radiological Devices
| 510(k) Number | K0 23902 |
|---|---|
| --------------- | ---------- |
3
SUMMARY OF SAFETY & EFFECTIVENESS
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 | USGI Medical, Inc.
940 Calle Amanecer, Suite A
San Clemente, CA 92674
Tel: (949) 369-3890
Fax: (949) 369-3891 |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Judy F. Gordon, D.V.M.
ClinReg Consulting Services. Inc.
2 Delphinus
Irvine, CA 92612
Tel: (949) 854-6314
Fax : (949) 854-9652
e-mail: judygordon@earthlink.net |
| TRADE NAME: | USGI Endoscopic Overtube |
| COMMON NAME: | Overtube |
| CLASSIFICATION
NAME: | Endoscope and accessories |
| DEVICE
CLASSIFICATION: | Class 2 per 21 CFR §876.1500 |
| PRODUCT CODE | 78 (KOG) |
| PREDICATE DEVICE: | Olympus ST-C3 Overtube (K903842), the Bard Endoscopic
Overtube (K973500), and the NDO Surgical, Inc. Overtube
(K002018) |
Description of the Device Subject to Premarket Notification:
The USGI Endoscopic Overtube is an endoscopic accessory designed to provide The OOO! Endoscope without hindering its flexibility and maneuverability. It is an overtube guide that can conform to any bend configuration of the scope and then le an overlabor in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly.
INDICATION FOR USE:
The USGI Endoscopic Overtube is an endoscopic accessory designed to provide external support to an endoscope without hindering its flexibility or maneuverability. It is intended to be used with an endoscope to facilitate intubation, e.g., colonoscopy, change of endoscopes, removal of multiple polyps and/or foreign bodies.
4
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TECHNICAL CHARACTERISTICS:
The USGI Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The overtube is constructed from multiple nested links that are held together by four cables. Each link is bowl shaped, but without a bottom and has four equally spaced annular holes running longitudinally through the wall thickness. The purpose of the holes is to accommodate the tension wires which pass through each link. The wires are connected to the tip but slide freely through all other links. Applying tension to the wires squeezes the links together. The friction between links maintains their relative positions, allowing the practitioner to "lock in" a shape.
PERFORMANCE DATA:
All components that come in direct contact with the patient have a long history of use in medical devices and are biocompatibile This 510(k) notice includes mechanical and functional bench testing that demonstrate that the USGI Endoscopic Overtube performs as intended.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The USGI Endoscopic Overtube is substantially equivalent to the Olympus ST-C3 Overtube (cleared for market under K903842), the Bard Endoscopic Overtube (cleared for market under K973500), and the NDO Surgical, Inc. Overtube (cleared for market under K002018). All four devices have the same indication for use and are made of the same materials (patient-contacting materials). Bench testing demonstrates that the devices are functionally equivalent.