(75 days)
No
The document describes standard video processing and does not mention AI, ML, or related concepts.
Yes
The device is described as being used for both diagnostic and therapeutic interventions, indicating its role beyond just viewing.
Yes
The device is described as being used for "viewing the inside of the patient," which is a diagnostic purpose. Additionally, the "Intended Use" explicitly states it can be used for "diagnostic... interventions."
No
The device description explicitly states it is a combination of an endoscope with integrated objective lens and CCD camera, which are hardware components.
Based on the provided information, the ICCD Endocam 5502 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is used for "viewing the inside of the patient via natural or surgically created passages" for "diagnostic and therapeutic interventions." This describes a device used in vivo (within the living body) for direct visualization.
- Device Description: It's an endoscope with an integrated camera, designed to be inserted into the patient.
- Anatomical Site: "Inside of the patient."
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The ICCD Endocam 5502 does not perform such tests on samples; it provides direct visual information from within the body.
N/A
Intended Use / Indications for Use
The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.
For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.
Product codes
GCJ
Device Description
The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable. The electronic CCD Endoscope has a CCD image converter with color mosaic filter. The light falls through the integrated lenses onto the sensor which generates a signal. The signal is processed in the camera controller to a standard NTSC video signal. The electronic CCD Endoscope is insulated from earth (type BF-Equipment, according to UL2601-1 / IEC601-1.)
Mentions image processing
The signal is processed in the camera controller to a standard NTSC video signal.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside of the patient via natural or surgically created passages.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
adequately trained and qualified personnel.
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)
Independent laboratories tested Endocam 5502 and 5507 according to specified standard IEC601 1, IEC601-1-2, IEC1-1-2, IEC1-2-18 and UL2601-1, and AAMI safe current limits. Camera system 5502 conforms to the relevant provisions of Medical Device Directive 93/42/EEC
No clinical tests performed.
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.
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| RICHARD WOLF |
|---|
| MEDICAL INSTRUMENTS CORPORATION |
510(k) Summary of Safety and Effectiveness
| Company / Institution name: | Richard Wolf Medical Instruments Corp. | Date of Preparation | September 16, 1998 | ||
|---|---|---|---|---|---|
| Division name (if applicable): | N.A. | FDA establishment regulation number: | 14 184 79 | ||
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): | (847) 913-1113 | ||
| City: | Vernon Hills | State/Province: | Illinois | FAX number (include area code): | (847) 913-0924 |
| Country: | USA | ZIP/Postal Code: | 60061 | ||
| Contact name: | Mr. Robert L. Casarsa | ||||
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | 1 CCD Endocam, Electronic CCD Endoscope | Model number: | 5502, 4934 |
|---|---|---|---|
| Common name: | Endoscopic Video Camera System | Classification Name: | Endoscope and / or Accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | ||||
|---|---|---|---|---|---|---|
| 1 | K950502 | 1 | CCD Endocam | 1 | Richard Wolf M.I.C. | |
| 2 | K942817 | 2 | CCD Endocam Office | 2 | Richard Wolf M.I.C. | |
| 3 | 3 | 3 | ||||
| 4 | 4 | 4 | ||||
| 5 | 5 | 5 | ||||
| 6 | 6 | 6 |
1.0 Description
The electronic CCD Endoscope is a combination of an endoscope with integrated objective lense: and CCD camera. The CCD endoscope is connected to the camera controller 5502 via a quick connector with camera cable.
1
2.0 Intended Use
The 1CCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.
3.0 Technological Characteristics
The electronic CCD Endoscope has a CCD image converter with color mosaic filter. The light falls through the integrated lenses onto the sensor which generates a signal. The signal is processed in the camera controller to a standard NTSC video signal.
The electronic CCD Endoscope is insulated from earth (type BF-Equipment, according to UL2601-1 / IEC601-1.)
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety and effectiveness as existing devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf.
5.0 Performance Data
Independent laboratories tested Endocam 5502 and 5507 according to specified standard IEC601 1, IEC601-1-2, IEC1-1-2, IEC1-2-18 and UL2601-1, and AAMI safe current limits.
Camera system 5502 conforms to the relevant provisions of Medical Device Directive 93/42/EEC
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Sept 14 98
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 DEC
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K983279
Trade Name: 1 CCD Multi-Endocam 5502 with Electronic CCD Endoscope Regulatory Class: II Product Code: GCJ Dated: September 16, 1998 Received: September 18, 1998
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
Image /page/2/Picture/10 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a bird in flight, composed of three curved lines.
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Page 2 - Mr. Robert L. Casarsa
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): _ K9832 79
Device Name:__1 CCD Multi-Endocam 5502 with Electronic CCD Endoscope
Intended Use:
The ICCD Endocam 5502 is designed for video endoscopy and video microscopy. It can be used for both diagnostic and therapeutic interventions. The Electronic CCD Endoscopes are used for viewing the inside of the patient via natural or surgically created passages.
Indication and Field of Application:
For use in various medical disciplines, such as urology, thorax surgery, gastroenterology, by adequately trained and qualified personnel.
Contraindications:
Inflammations or bacterial contamination of wounds in the operating area. Contradindications related directly to the product are currently unknown. The attending physician must determine if the intended application is appropriate. For additional information, refer to the latest specialized medical literature.
Combinations:
Electronic CCD endoscopes are used in connection with the 1 CCD Endocam 5502 and light sources with flexible light cables, as well as, endoscopic accessories, e.g. trocar sleeves.
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Concurrence of CDRH Office of Device Evaluation (ODE)
Dece
(Divisio Division 510(k) Number
Prescription Use Per 21 CRF 801.109
Over-The Counter_