(88 days)
Not Found
No
The device description focuses on mechanical shape-locking technology and does not mention any computational or data-driven components indicative of AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is an accessory designed to facilitate the intubation process during procedures like colonoscopy and the removal of polyps or foreign bodies. It does not directly treat a condition or disease.
No
The device is described as an endoscopic accessory to facilitate intubation and aid in procedures like changing endoscopes, removing polyps, or foreign bodies. Its function is to support and stabilize the endoscope, not to provide diagnostic information about a patient's condition.
No
The device description clearly outlines a physical, mechanical device (an overtube with links, cables, handle, etc.) and the performance studies are mechanical and functional bench testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used with an endoscope to facilitate procedures like intubation, changing endoscopes, and removing polyps or foreign bodies. This describes a device used in vivo (within the body) during a medical procedure.
- Device Description: The description details a physical device designed to provide external support to an endoscope and maintain its shape. It describes mechanical components (links, cables, handle, tips, liners, skin).
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical accessory used during an endoscopic procedure.
N/A
Intended Use / Indications for Use
The USGI Shape Locking 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 (comma separated list FDA assigned to the subject device)
FED, FDF, 78 (KOG)
Device Description
The USGI Shape Locking 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 be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly.
The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 Shape Locking Endoscopic Overtube performs as intended.
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
Image /page/0/Picture/1 description: The image is a black and white 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
JUL 27 2015
USGI Medical, Inc. Mr. Jeff Anderson Regulatory Consultant 1140 Calle Cordillera, Suite A & B San Clemente, CA 92673
Re: K033954
Trade/Device Name: USGI Endoscopic Sheath Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FED, FDF Dated (Date on orig SE ltr): December 19, 2003 Received (Date on orig SE ltr): December 22, 2003
Dear Mr. Anderson,
This letter corrects our substantially equivalent letter of March 19, 2004.
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 vours.
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
INDICATIONS FOR USE STATEMENT 2.Q
Page 1 of 1
510(k) Number (if known): Ko 33 9 5 4
Device Name: USGI Endoscopic Sheath
:
Indications for Use:
The USG! Shape Locking Endoscopic Overtube is intended to be used with an The USGI Onape Edoking Endocopic, Onlonoscopy, 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 | ✓ | OR | Over-The-Counter Use __________ |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
| CONFIDENTIAL |
|---|
| USGI Medical |
| December 19, 2003 |
| (Division Sign-Off) |
|---|
| Division of Reproductive, Abdominal, and Radiological Devices |
| 510(k) Number: K033954 |
3
10.0 SUMMARY OF SAFETY AND 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.
1140 Calle Cordillera
San Clemente, CA 92674 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Jeffrey A. Anderson
Regulatory Consultant
USGI Medical, Inc.
1140 Calle Cordillera
San Clemente, CA 92674
Tel: (949) 633-5067
FAX (949) 369-3891
e-mail: Janderson@usgimedical.com |
| TRADE NAME: | USGI Shape Locking 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: | USGI Shape Locking Endoscopic Overtube (K0239021) |
SUBSTANTIALLY EQUIVALENT TO:
USGI Shape Locking Endoscopic Overtube (cleared for market under K023902)
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The USGI Shape Locking 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 be shape locked in that form. In the "shape locked" configuration, the scope can be further advanced or withdrawn repeatedly.
INDICATION FOR USE:
The USGI Shape Locking 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.
4
TECHNICAL CHARACTERISTICS:
K033954 pg 2 of 2
The USGI Shape Locking Endoscopic Overtube is a shape locking tube with an atraumatic tip, a slip coated inner liner, a smooth outer skin, and a handle. The Shape Locking Tube is constructed from multiple nested links that are held together by four cables. Applying tension to the cables 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 Shape Locking Endoscopic Overtube performs as intended.
Basis for Determination of Substantial Equivalence:
The USGI Shape Locking Endoscopic Overtube is substantially equivalent to the previous version of the USGI Shape Locking Overtube (cleared for market under K023902). Both 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.