(37 days)
Not Found
No
The document describes a standard video endoscopy system and does not mention any AI or ML capabilities, image processing beyond basic visualization, or data sets for training or testing such algorithms.
Yes
Explanation: The "Intended Use" states that the device "can be used for both diagnostic and therapeutic interventions."
Yes
The "Intended Use" section clearly states, "The 3 CCD HD ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions."
No
The device description explicitly states it consists of a camera control unit and a connectable camera head, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications: The device is described as being used for "video endoscopy" and "diagnostic and therapeutic interventions" in conjunction with endoscopes. It's used for visualization during surgical procedures. This is a direct interaction with the patient's body for imaging and procedural guidance, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the camera system's role in providing "High Definition visualization during minimally invasive surgical procedures."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for use in surgical and diagnostic procedures performed directly on the patient, which falls under the category of medical devices used for imaging and visualization, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 3 CCD HD Endocam 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.
The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The 3 CCD HD Endocam 5550 consists of a camera control unit and a connectable camera head. The camera head connects to an endoscope for High Definition visualization during minimally invasive surgical procedures.
The camera controller provides outputs for video monitoring, video recording, and connecting to the RWMIC-NET Operating Room Control System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscopy
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)
Bench testing of specifications were verified / validated and software validation was performed to assure safe and effective operation / control of the software functions.
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.
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.
0
510(k) Summary
Submitter: | Date of Preparation: | |
---|---|---|
April 10, 2009 | ||
Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: |
Division name (if applicable): | N.A. | 14 184 79 |
Street address: | 353 Corporate Woods Parkway | Phone number (include area code): |
( 847 ) 913 1113 | ||
City: | Vernon Hills | FAX number (include area code): |
State/Province: | Illinois | ( 847 ) 913 5803 |
Country: | USA | |
ZIP / Postal Code: | IL 60061 | |
Contact name: | Mr. Ron Haselhorst | |
Contact title: | Quality Assurance / Regulatory Affairs Manager | |
Product Information: | ||
Trade name: | 3 CCD HD Endocam 5550 | Model number: |
Common name: | Endoscopic Video Camera System. | 5550 |
Classification name: | ||
Endoscope and Accessories, Class II | ||
(21 CFR 876.1500, Product Code GCJ) | ||
Information on devices to which substantial equivalence is claimed: | ||
510(k) Number | Trade or proprietary or model name | Manufacturer |
1 K063457 | 1 TrueHD Digital Camera System | 1 ConMed Linvatec |
2 K023659 | 2 1 CCD Endocam 5520 System | 2 Richard Wolf Medical Instruments Corp. |
Device Description:
The 3 CCD HD Endocam 5550 consists of a camera control unit and a connectable camera head. The camera head connects to an endoscope for High Definition visualization during minimally invasive surgical procedures.
The camera controller provides outputs for video monitoring, video recording, and connecting to the RWMIC-NET Operating Room Control System.
Intended Use:
1
The 3 CCD HD Endocam 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.
Indications and Field of Use:
The 3 CCD HD Endocam 5550 is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.
Technological Characteristics:
The technology of the Richard Wolf 3 CCD HD Camera System is similar if not identical to the technology of the referenced predicate device HD Camera Systems as they utilize the similiar components.
The camera system uses a High Definition Camera head progressively scanned. All pixel information from each CCD is scanned sixty times a second and there are more than 700,000 pixels.
The camera controller provides High Definition Serial Digital Interface (HD-SDI) and Digital Video Interface (DVI) ports for connection to a High Definition monitor in a 720p 1080I & 1080P with either a 5 x 4 or 16 x 9 aspect ratio format. This type of technology is similar to all High Definition camera systems.
Sterilization:
The camera head is to be sterilized prior to each procedure using a sterilization method defined in instruction manual BB-A 253-1 US.
The camera controller is to be cleaned with a soft cloth moistened with surface disinfectant, alcohol or spirit as defined in instruction manual GA-A 253-US.
Substantial Equivalence:
The Richard Wolf Medical Instruments Corporation 3 CCD HD Endocam 5550 is substantially equivalent to the ConMed Linvatec HD Digital Camera System (K063457) and Richard Wolf Medical Instruments Corp.CCD Endocam 5520 System (K023659) due to the fact that they both utilize similar camera system components and technology as the CCD HD Endocam 5550 for the same approved intended uses. Further, CCD HD Endocam 5550 introduces now new patient risks or concerns.
Performance Data:
Bench testing of specifications were verified / validated and software validation was performed to assure safe and effective operation / control of the software functions.
Clinical Data:
No clinical data was required to confirm safety and effectiveness.
Conclusion:
Testing has shown that the Richard Wolf 3 CCD HD Endocam 5550 performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices.
2
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 2008
Richard Wolf Medical Instruments Corporation % Underwriters Laboratories, Inc. Mr. Ned Devine 333 Pfingsten Road Northbrook, Illinois 60062
Re: K080977
Trade/Device Name: 3 CCD HD Endocam 5550 Regulation Number: 21 CFR 876,1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: May 6, 2008 Received: May 7, 2008
Dear Mr. Devine:
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.
4
Page 2 - Mr. Ned Devine
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Mulkerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): KO809177
Device Name: 3 CCD HD Endocam 5550.
Intended Use: The 3 CCD HD ENDOCAM 5550 has been designed for video endoscopy and can be used for both diagnostic and therapeutic interventions. In conjunction with video recorders, video printers and other video devices it can be used for recording and storing video images.
Indications and field of Use: The 3 CCD Endocam is intended for use in a variety of endoscopic surgical procedures including but not limited to orthopedic, gynecologic, laparoscopic, urologic, sinuscopic, plastic, and as an accessory for microscopic surgery.
Prescription use (Part 21 CFR 801 Subpart D)
and / or
Over-The Counter Use (Part 21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ANOTHER PAGE IF NEEDED
Concurrence of CDHR office of Device Evaluation (ODE)
Neil RP Osl for
Division Sign-Off
mxm
Division of General, Restorative, and Neurological Devices
510(k) Number K080977
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