The 7 mm Extended Length Endoscope is intended for visualization of a surgical working cavity in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Device Description

The 7 mm Extended Length Endoscope consists of an elongated shaft that houses glass fibers for light delivery and an achromatic optical lens system (enclosed within the shaft and proximal hub) for image return. The distal shaft has a window for viewing and threads for attachment of the Dissection Tip. The proximal hub has a light guide post for attachment of light guides and an eyepiece with a clear viewing window for attachment of medical camera couplers. The Endoscope provides illumination and visualization of the working space during tissue dissection, vessel ligation, and vessel transection. With the Dissection Tip attached, the Endoscope is used to perform blunt dissection to separate tissue. The distal tip of the Endoscope has threads on the scope body for attachment of the Dissection Tip. The Dissection Tip may be removed once dissection is completed so that the Endoscope can continue to be used for visualization of a procedure.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (7 mm Extended Length Endoscope), which focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria in the way a new, innovative device might.

Therefore, the document does not contain the specific information required to complete all sections of your request. It's a regulatory submission, not a research paper detailing a study designed to meet specific performance metrics.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the document. The 510(k) summary states, "All necessary testing was performed on the 7 mm Extended Length Endoscope with Dissection Tip to ensure that the product is substantially equivalent to the predicate devices and that the modifications do not affect safety and effectiveness." However, it does not detail specific performance criteria (e.g., resolution, field of view, illumination intensity, durability metrics) or the results of those tests. The focus is on demonstrating that the new device is "identical" or "substantially equivalent" in materials, design, and manufacturing to existing cleared devices, implying similar performance rather than establishing new, explicit performance targets.

Since no specific criteria or performance metrics are detailed, a table cannot be constructed.

2. Sample Size Used for the Test Set and Data Provenance:

This information is not provided. The document mentions "testing was performed" but does not specify any sample sizes for a test set or the types of data (e.g., patient data, bench test data) that were collected, nor its provenance (country, retrospective/prospective). This is typical for a 510(k) where the primary argument is substantial equivalence, relying on existing data and performance of predicate devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided. Since no specific performance study with a test set and associated ground truth is detailed, there's no mention of experts or their qualifications.

4. Adjudication Method for the Test Set:

This information is not provided. As no ground truth establishment process is described, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided. The 510(k) summary does not describe any MRMC study comparing human readers with and without AI assistance. The device is an endoscope, a visualization and dissection tool, not an AI-powered diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This information is not provided. The device is a physical endoscope and does not appear to incorporate any standalone algorithms or AI for performance evaluation without a human user.

7. Type of Ground Truth Used:

This information is not provided. As explained, no specific performance study with a detailed ground truth methodology is presented in this 510(k) summary.

8. Sample Size for the Training Set:

This information is not provided. This device is a hardware instrument, not an AI/ML algorithm that would typically have a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not provided. As above, this concept doesn't apply to the type of device described.

In summary, the provided 510(k) document is a regulatory submission for premarket notification, not a detailed technical report of a performance study designed to meet explicit acceptance criteria with specific data sets and expert adjudications. The core argument for clearance is "substantial equivalence" to existing, legally marketed predicate devices, meaning that its design, materials, and intended use are similar enough that new, extensive performance studies demonstrating novel acceptance criteria are not required beyond ensuring the modifications don't negatively impact safety and effectiveness.

Summary

{0}------------------------------------------------

510(K) SUMMARY

0/42Jo

JAN 1 0 2002

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Name, Address, Phone and Fax number of the Applicant A.

Guidant Corporation Cardiac Surgery 3200 Lakeside Drive Santa Clara, CA 95054

Telephone: (408) 845-1842 (408) 845-1800 Fax:

B. Contact Person

Anne Schlagenhaft Regulatory Affairs Associate

C. Date Prepared

December 4, 2001

D. Device Name

Trade Name: 7 mm Extended Length Endoscope

Classification Name: Endoscope and accessories

ய் Device Description

{1}------------------------------------------------

Endoscope has threads on the scope body for attachment of the Dissection Tip. The Dissection Tip may be removed once dissection is completed so that the Endoscope can continue to be used for visualization of a procedure.

Intended Use r.

G. Substantial Equivalence

The 7 mm Extended Length Endoscope with Dissection Tip is substantially equivalent to the 5mm Endoscope, cleared by the Food and Drug Administration under K960637 on June 14, 1996, and the VasoView™ Dissection Cannula, K981700, cleared on February 18, 1998. The design of the 7 mm Extended Length Endoscope with Dissection Tip is identical to the current Endoscope with a thicker scope body wall and incorporation of the dissection cone of the VasoView Dissection Cannula. The subject device is composed of materials that are identical to the currently marketed devices. The 7 mm Extended Length Endoscope is substantially equivalent in intended use, materials, manufacturing processes, technological characteristics, and components to the current devices.

Device Testing Results and Conclusion H.

All necessary testing was performed on the 7 mm Extended Length Endoscope with Dissection Tip to ensure that the product is substantially equivalent to the predicate devices and that the modifications do not affect safety and effectiveness.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2002

Guidant Corporation c/o Ms. Michelle Weidman KEMA Medical 4377 County Line Road, Suite 202 Chalfont, Pennsylvania 18914

Re: K014250

Trade/Device Name: 7 mm Extended Length Endoscope Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: December 21, 2001 Received: December 26, 2001

Dear Ms. Weidman:

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.

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.

{3}------------------------------------------------

Page 2 & Ms. Michelle Weidman

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K__ O / 425 O

Device Name:

7 mm Extended Length Endoscope

Indications For Use:

The 7 mm Extended Length Endoscope is indicated for visualization of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation/vessel harvesting of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter Use
------------------	---	----	----------------------

(Rer 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number	K014250
---------------	---------

Regulation Number and Section

§ 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.