The Essex Dissection Cannula is intended for use in dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures.
The Essex Dissection Cannula is indicated for dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures including percutaneous thoracic and pericardial surgery.

Device Description

The Essex Dissection Cannula is a reusable device designed for dissection of tissue and introduction of instruments for visualization and manipulation during endoscopic surgical procedures. The device consists of two tubular cannulae for introduction of instrumentation into the surgical site. One lumen allows insertion of an endoscope for illumination and visualization of the procedure. Another lumen provides access for surgical instruments. A disposable Dissection Tip may be attached to the end of the cannula for dissection of tissue.

AI/ML Overview

The provided text is a 510(k) summary for the Essex Dissection Cannula. It outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission would for novel, high-risk devices. For lower-risk devices like this cannula, the "proof" often lies in the argument that the new device is fundamentally similar to a device already deemed safe and effective.

Therefore, I cannot provide the requested information from the given text.

This document does not contain the information required to populate the following sections:

A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented.
Sample size used for the test set and the data provenance: No test set information is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
Adjudication method for the test set: No test set or adjudication method is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
The type of ground truth used: No ground truth is mentioned.
The sample size for the training set: This is a physical medical device, not a machine learning model, so no training set is relevant.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Notification Essex Dissection Cannula

510(K) SUMMARY

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

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

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

Telephone: (408) 845-1913 Fax: (408) 845-1855

B. Contact Person Anne Schlagenhaft Requlatory Affairs Associate

C. Date Prepared September 9, 2002

D. Device Name

Trade Name: Essex Dissection Cannula Classification Name: Endoscope and accessories

ய் Device Description

The Essex Dissection Cannula is a reusable device designed for dissection of tissue and introduction of instruments for visualization and manipulation during endoscopic surgical procedures. The device consists of two tubular cannulae for introduction of instrumentation into the surgical One lumen allows insertion of an endoscope for illumination and site. visualization of the procedure. Another lumen provides access for surgical instruments. A disposable Dissection Tip may be attached to the end of the cannula for dissection of tissue.

F. Intended Use

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K023629 2/2

The Essex Dissection Cannula is intended for use in dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures.

G. Substantial Equivalence

The Essex Dissection Cannula is substantially equivalent to the VasoView® Dissection Cannula, cleared under K981700 on May 29, 1998. Both cannulae are intended for use in endoscopic surgery for tissue dissection and introduction of an endoscope. The Essex Dissection Cannula is substantially equivalent to the predicate device in intended use, technological characteristics, materials, manufacturing processes, and components.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with a series of curved lines that form a shape resembling a bird or a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2002

Guidant Cardiac Surgery c/o Ms. Michelle Weidman Office Assistant Coordinator KEMA Medical 4377 County Line Road Chalfont, PA 18914

Re: K023629

Trade/Device Name: Essex Dissection Cannula Model SXD-1100 Essex Dissection Tip Model SXD-1200 Regulation Number: 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 25, 2002 Received: October 28, 2002

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.

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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 vours.

Miriam C. Provost

for 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

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510(k) Number (if known): K__________________________________________________________________________________________________________________________________________________

Device Name: Cannula

Indications For Use:

The Essex Dissection Cannula is indicated for dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures including percutaneous thoracic and pericardial surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF 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) miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices K023629

510(k) Number ..

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.