(17 days)
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.
The provided text describes a 510(k) summary for the USGI TransPort™ Endoscopic Access Device. This device is an "Endoscopic Overtube" and its submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding acceptance criteria and performance studies is not directly available in this document.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of acceptance criteria and the reported device performance
This information is not present in the provided 510(k) summary. The summary states: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." However, it does not detail specific acceptance criteria or the reported performance metrics from this bench testing.
2. Sample size used for the test set and the data provenance
No test set data for performance evaluation (e.g., in a clinical study) is described in this 510(k) submission. The "bench testing" mentioned suggests in-vitro or simulated use, not a human-based test set from a specific country or retrospective/prospective data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the summary does not describe a clinical study requiring ground truth establishment by experts.
4. Adjudication method for the test set
This information is not applicable as the summary does not describe a clinical study requiring adjudication.
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
This information is not applicable. The device is an endoscopic access device, not an AI-powered diagnostic tool. Therefore, MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as the device is not an algorithm or AI-powered.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable as the summary describes functional "bench testing" for a physical device, not a diagnostic or AI algorithm requiring ground truth.
8. The sample size for the training set
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI algorithm requiring a training set and ground truth establishment.
Summary of available information from the K072405 document:
- Device Name: USGI TransPort™ Endoscopic Access Device
- Intended Use: To be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
- Comparison Basis: Substantially equivalent to predicate devices (USGI Medical TransPort™ Endoscopic Access Device K061216 and ShapeLock™ Endoscopic Access Device K033954) in terms of intended use, technology, and materials.
- Performance Claim: "Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use." (No specific criteria or results provided in this summary).
In conclusion, the provided 510(k) summary for K072405 focuses on demonstrating substantial equivalence through comparison and general bench testing, not on providing detailed acceptance criteria and performance data from a clinical or AI-centric study. Therefore, most of the requested fields are not applicable to the content of this specific document.
{0}------------------------------------------------
K०724०5
510(k) 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 CFR 807.92
SUBMITTER INFORMATION 1.
| a. Company Name: | USGI Medical |
|---|---|
| ------------------ | -------------- |
b. Company Address:
1140 Calle Cordillera San Clemente, CA 92673
Vice President of Clinical, Regulatory & Quality
Mary Lou Mooney
August 24, 2007
Access Device
- c. Telephone: (949) 369-3890 Fax: (949) 369-3891
d. Contact Person:
e. Date Summary Prepared:
2. DEVICE IDENTIFICATION
- a. Trade/Proprietary Name: TransPort™ Endoscopic
- b. Common Name: Endoscopic Overtube
c. Classification Name:
Endoscope and accessories, 876.1500
IDENTIFICATION OF PREDICATE DEVICES 3.
| TransPortTM Endoscopic Access Device | USGI Medical(K061216) |
|---|---|
| ShapeLockTM Endoscopic Access Device | USGI Medical(K033954) |
{1}------------------------------------------------
USGI Medical Special 510(k) Device Modification USGI TransPort™ Endoscopic Access Device
K 072405
Pg. 2 of 2
4. DESCRIPTION OF THE DEVICE
The TransPort Endoscopic Access Device is comprised of a flexible shaft that can be rigidized and locked into position, a steerable tip and multiple lumens that allow insertion and exchange of flexible instruments. It is supplied as two separately packaged components, i.e., a reusable, metal body and a strerile, single use disposable sheath.
5. STATEMENT OF INTENDED USE
The TransPort Endoscopic Access Device is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible instruments.
COMPARISON WITH PREDICATE DEVICES 6.
The TransPort Endoscopic Access Device is comparable to the predicate devices in terms of intended use, technology, and materials.
Bench testing was conducted to ensure that the device performs as intended when used according to its instructions for use.
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
SEP 1 8 2007
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Mary Lou Moonev Vice President of Clinical, Regulatory & Quality USGI Medical 1140 Calle Cordillera SAN CLEMENTE CA 92673
Re: K072405
Trade/Device Name: USGI TransPort" Endoscopic Access Device Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FED and ODB Dated: August 24, 2007 Received: August 27, 2007
Dear Ms. Mooney:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image is a circular seal with the text "TDS-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars at the bottom of the seal. The text around the perimeter of the seal is difficult to read due to the image quality.
ting and I gomoting 9
{3}------------------------------------------------
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrlv/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
510(k) Number (if known): Ko 7 2 4 05
Device Name: USGI TransPort™ Endoscopic Access Device
Indications For Use:
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
Prescription Use د (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hui Leiner
Division of Reproductive, AR and Radiological Devi 510/k) Number
Page 1 of
§ 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.