(15 days)
Not Found
No
The description focuses on traditional optical and fiber optic technology for visualization and illumination, with no mention of AI/ML, image processing, or data analysis beyond basic visualization.
No
The device is used for visualization during surgical procedures, not for treatment or therapy.
No
Explanation: The device is an endoscope used for visualization during surgical procedures, not for diagnosing a medical condition. Its function is to provide illumination and visualization of the working space, which is an interventional or procedural use.
No
The device description clearly outlines physical hardware components such as a shaft, glass fibers, optical lens system, distal shaft window, proximal hub, light guide post, and eyepiece. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity." This describes a device used in vivo (within the body) for direct visualization during surgery.
- Device Description: The description details a device with a shaft, optical fibers, lenses, and an eyepiece for viewing. This aligns with the physical characteristics of an endoscope used for internal visualization.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any analysis of specimens or diagnostic testing performed on samples.
Therefore, the Essex Endoscope, as described, is a surgical endoscope used for visualization during procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Essex Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.
Product codes
GCJ
Device Description
The Essex Endoscope consists of a shaft that houses glass fibers for light delivery and an optical lens system for image return. The distal shaft has a window for viewing. 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 surgical procedures.
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
K023627 1/2
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) 845-1842 Fax: (408) 845-1855
B. Contact Person
Anne Schlagenhaft Regulatory Affairs Associate
C. Date Prepared
September 9, 2002
D. Device Name
Trade Name: Guidant Essex Endoscope
Classification Name: Endoscope and accessories
E. Device Description
The Essex Endoscope consists of a shaft that houses glass fibers for light delivery and an optical lens system for image return. The distal shaft has a window for viewing. 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 surgical procedures.
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Ko23627 2/2
Guidant Corporation Cardiac Surgery
510(k) Notification Essex Endoscope
F. Intended Use
The Essex Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.
G. Substantial Equivalence
The Endoscope is substantially equivalent to the 5mm Endoscope, cleared under K960637 on June 14, 1996. The design of the Essex Endoscope is identical to the current Endoscope with a slightly smaller diameter, shorter shaft, and a right angle viewing port. The subject device is composed of materials that are identical to the currently marketed device. The Endoscope is substantially equivalent in intended use, materials, manufacturing processes, technological characteristics, and components to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle, represented by three curved lines that suggest the bird's head, body, and tail.
Public Health Service
NOV 1 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guidant Corporation c/o Ms. Michelle Weidman Office Assistant Coordinator KEMA Medical 4377 County Line Road Chalfont, PA 18914
Re: K023627
Trade/Device Name: Essex Endoscope Model SXD-1000 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 1 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,
Miriam C. Provost
Fov 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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02362 510(k) Number (if known): K
Device Name:
Guidant Essex Endoscope
Indications For Use:
The Endoscope is indicated for use in general endoscopic procedures and other minimally invasive surgical procedures to visualize a surgical working cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ 1
OR (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Miriam C. Provost (Optional Format 1-2-96)
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K023627