(90 days)
Not Found
No
The summary describes a standard video endoscopy camera system and does not mention any AI or ML capabilities, image processing beyond basic video capture, or performance metrics typically associated with AI/ML algorithms.
Yes
The "Intended Use / Indications for Use" section states that the device "can be used for diagnostic and therapeutic applications."
Yes
The "Intended Use / Indications for Use" states that the device "can be used for diagnostic and therapeutic applications."
No
The device description explicitly mentions "Various Camera Heads with and without integrated lenses and CCD endoscopes are available," indicating hardware components beyond just software.
Based on the provided information, the 1 CCD ENDOCAM 5520 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "video endoscopy and video microscopy" for "diagnostic and therapeutic applications." This describes a device used for visualizing internal body structures or microscopic samples in vivo or ex vivo for diagnostic or therapeutic purposes, not for testing samples in vitro (outside the body).
- Device Description: The description mentions "Camera Heads" and "CCD endoscopes," which are components used in endoscopic procedures, not for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any components or functions typically associated with IVD devices, such as reagents, assays, sample preparation, or analysis of biological samples in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The 1 CCD ENDOCAM 5520 is a visualization tool used in medical procedures.
N/A
Intended Use / Indications for Use
The 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications.
Product codes (comma separated list FDA assigned to the subject device)
FET
Device Description
The 1-CCD Endocam 5520 device is a further development of previous 1-CCD Endocams with additional features. Various Camera Heads with and without integrated lenses and CCD endoscopes are available.
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)
The Endocam systems 5520 was tested for conformity with the specified standards UL2601-1, IEC601-2-18, CSA22.2No.601.1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K982965, K983279, K950502, K002328, K964173
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of a bird or other winged creature.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Richard Wolf Medical Instruments Corporation Robert L. Casarsa Quality Assurance Manager 353 Corporate Woods Parkway Vernon Hills, IL 60061
JUL 2 7 2015
Re: K023659 Trade/Device Name: 1 - CCD Endocam 5520 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated (Date on orig SE ltr): October 31, 2002 Received (Date on orig SE ltr): October 31, 2002
Dear Mr. Casarsa,
This letter corrects our substantially equivalent letter of January 29, 2003.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5.0 INDICATIONS FOR USE
510(k) Number (if known): — KO23659
1-CCD Endocam 5520 System Device Name:
Intended use: The 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)
Muriam C. Provost
ivision Sign-Off) Division of General, Restorative --- d Neurological Devices
Ko23659
Prescription Use Per 21 CFR 801.109 OR
Over-The Counter
5-1 revised 1/22/03
(Optional Formal 12-96)
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Image /page/3/Picture/1 description: The image shows the logo for Richard Wolf Medical Instruments Corporation. The logo features the words "RICHARD WOLF" in bold, block letters, with "RICHARD" stacked above "WOLF". Below the name is the text "Medical Instruments Corporation" in a smaller font. To the right of the text is a square containing a stylized image of a wolf.
Image /page/3/Picture/2 description: The image contains a sequence of alphanumeric characters. The sequence begins with the letters 'K0', followed by the numbers '23659'. The characters are written in a simple, sans-serif font, and the image appears to be a close-up of the sequence.
353 Corporate Woods Parkway Vernon Hills. IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
13.0 510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | October 31, 2002 |
| Division name (if applicable): | N.A. | FDA establishment registration number: |
| 14 184 79 | ||
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code): |
| City: | Vernon Hills | ( 847 ) 913 1113 |
| State/Province: | Illinois | FAX number (include area code): |
| Country: | USA | ( 847 ) 913 0924 |
| ZIP / Postal Code: | IL 60061 | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager | |
| Product Information: | ||
| Trade name: | 1 CCD Endocam | |
| Model number: | 5520.xxx; 85520.xxx, 8934.551 | |
| 85264.xxx | ||
| 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 K982965 | 1 1-CCD endocam 5502 and 3-CCD endocam 5507 with CF camera heads | 1 Richard Wolf |
| 2 K983279 | 2 1-CCD multi-endocam 5502 with electronic CCD endoscope | 2 Richard Wolf |
| 3 K950502 | 3 1-CCD endocam 5501 | 3 Richard Wolf |
| 4 K002328 | 4 SIOS-Interface for 3CCD Endocam 5507.752 | 4 Richard Wolf |
| 5 K964173 | 5 C-mount objective lenses, autoclavable | 5 Richard Wolf |
1.0 Description
The 1-CCD Endocam 5520 device is a further development of previous 1-CCD Endocams with additional features. Various Camera Heads with and without integrated lenses and CCD endoscopes are available.
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2.0 Intended Use
The 1 CCD ENDOCAM 5520 is designed for video endoscopy and video microscopy and can be used for diagnostic and therapeutic applications. The 1 CCD ENDOCAM 5520 is designed for connection to various camera heads and CCD endoscopes.
In conjunction with video recorders / video printers and other video equipment it can be used for recording and storing video images.
The camera heads and the CCD endoscope are used in connection with the 1 CCD ENDOCAM 5520 controller for diagnostic and therapeutic applications. Free rotation and self-alignment of the urological camera heads results in an endoscope image, which is always correctly positioned.
Technological Characteristics 3.0
The 1-CCD Endocam 5520 System has additional features such as digital zoom, mirror imaging, anti-Moiré, and interfaces for digital video output (IEEE 1394), RIWONET control, keyboard and remote control.
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and 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
The Endocam systems 5520 was tested for conformity with the specified standards UL2601-1, IEC601-2-18, CSA22.2No.601.1.
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 instructions manual.
By: ...Albert L. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Det 20. 200. 2. 2. ............