(15 days)
Not Found
No
The description focuses on the mechanical function of a reusable surgical instrument for dissection and instrument introduction, with no mention of AI/ML terms or functionalities.
No
The device is used for dissection of tissue and introduction of surgical instruments, not for treating a disease or condition.
No
The device is described as a surgical instrument for dissection and introduction of other instruments, not for diagnosing conditions. It facilitates endoscopic surgical procedures.
No
The device description clearly describes a physical, reusable device consisting of tubular cannulae and a disposable tip, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Essex Dissection Cannula is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details a reusable device for surgical manipulation and visualization, not for testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Essex Dissection Cannula does not fit this description.
N/A
Intended Use / Indications for Use
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.
Product codes
GCJ
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.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
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.
2
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 ..