(42 days)
Not Found
No
The description focuses on standard video endoscopy technology and does not mention any AI or ML capabilities.
Yes.
The device is used for both diagnostic and therapeutic interventions, as stated in the 'Intended Use / Indications for Use' section.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "can be used for both diagnostic and therapeutic interventions."
No
The device description explicitly lists hardware components: ENDOCAM® Logic HD Controller(s), ENDOCAM & Logic HD Camera Head(s), and Objective Lens (Coupler). It is a system that includes physical hardware for image acquisition and processing.
Based on the provided information, the Richard Wolf ENDOCAM® Logic HD Camera System 5525 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is a medical device intended for use in vitro for the examination of specimens, including blood, tissues, and urine, derived from the human body, to provide information for diagnostic, monitoring, or compatibility purposes.
- Intended Use of the ENDOCAM® Logic HD Camera System: The intended use clearly states it's for "high-definition video endoscopy" and "can be used for both diagnostic and therapeutic interventions." It visualizes images of "natural and artificial cavities" within the body.
- Mechanism of Action: The device works by capturing and displaying images from inside the body using an endoscope. It does not analyze specimens outside the body.
- Lack of Specimen Handling: The description does not mention any handling or analysis of biological specimens.
The ENDOCAM® Logic HD Camera System is a medical device used for direct visualization within the body, which falls under the category of endoscopic imaging systems, not IVDs.
N/A
Intended Use / Indications for Use
The ENDOCAM® Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
Product codes (comma separated list FDA assigned to the subject device)
FET
Device Description
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is an endoscopic camera system for rigid and flexible endoscopes (e.g. Arthroscopes, Bronchoscopes, Hosteroscopes. Laparoscopes, Ureteroscopes, etc.). The Richard Wolf ENDOCAM® Logic HD Camera System 5525 allows the doctor to visualize the image of natural and artificial cavities through the endoscope by projecting images to a monitor for visual display and data storage during endoscopic diagnostic and therapeutic surgical procedures.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 consists of:
- ENDOCAM® Logic HD Controller(s)
- ENDOCAM & Logic HD Camera Head(s), and
- Objective Lens (Coupler).
Devices are used in conjunction with other ancillary equipment such as endoscopes, light source, monitors, printers, recorders, required cabling, etc.
The Richard Wolf ENDOCAM® Logic HD Camera Head(s) use ICCD or 3CCD imaging systems to provide high definition (HD) visualization and quality images. The Richard Wolf ENDOCAM® Logic HD Camera Head cable connects to the ENDOCAM® Logic HD Controller, the ENDOCAM® Logic HD Controller relays the image from the endoscope with/without the use of an objective lens (coupler) to a video monitor; projection can be either analog or digital at the user's preference.
The Richard Wolf ENDOCAM® Logic HD Controller(s) is equipped with pre-programmed presets which can be selected via touch-screen, remote control, and/or keyboard. Self-made adjustments can be stored and individually named by user. Patient data and endoscopic images can be printed or stored directly onto USB flash drive.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is compatible and can be integrated with the Richard Wolf RiwoNet / Core operating room system.
Devices included in the Richard Wolf ENDOCAM® Logic HD Camera System 5525 are reusable and do not require sterilization before use because there is no direct patient contact. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use Manual: these instructions were developed by Richard Wolf using standards outlined in ANSI / AAMI ST:2004/(R) 2010 and FDA's Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation April 1996.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video endoscopy
Anatomical Site
Natural and artificial cavities (e.g., in arthroscopy, bronchoscopy, hysteroscopy, laparoscopy, ureteroscopy)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Specialized medical personnel, medically qualified and adequately trained persons.
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)
Design verification testing demonstrates that the devices function as intended, and the performance did not raise any new issues of safety and effectiveness.
Testing was completed by Independent laboratories, certifications are on file.
No clinical tests performed.
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
Image /page/0/Picture/0 description: The image shows handwritten text. The text at the top reads "K.130423". Below that, the text reads "pg. 1 of 4". The handwriting appears to be neat and legible.
Revision 04-02-2013
APR 0 3 2013
510(k) Summary
| Submitter: | Date of Preparation: | ||
|---|---|---|---|
| Company / Institution name: | April 02, 2013 | ||
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: 14 184 79 | ||
| Division name (if applicable): | Phone number (include area code): | ||
| N.A. | ( 847 ) 913 1113 | ||
| Street address: | FAX number (include area code): | ||
| 353 Corporate Woods Parkway | ( 847 ) 913 0924 | ||
| City: | State/Province: | Country: | ZIP / Postal Code: |
| Vernon Hills | Illinois | USA | 60061 |
| Contact name: | Mr. Ron Haselhorst | ||
| Contact title: | Quality Assurance / Regulatory Affairs Manager | ||
| Parent Company: | |||
| Company / Institution name: | FDA establishment registration | ||
| Richard Wolf GmbH | number: 96 111 02 | ||
| Street address: | Pforzheimer Str. 32 | ||
| City: | State/Province: | Country: | ZIP / Postal Code: |
| Knittlingen | Baden-Württemberg | Germany | 75438 |
| Product Information: | |||
| Trade name: | Model numbers: | ||
| The Richard Wolf ENDOCAM® Logic HD Camera System 5525 | 5525xxx. 85525xxx, 8526xxxx | ||
| Common name: | Classification name: | ||
| Endoscopic Video Camera System | 876.1500; FET - Endoscopic Video Imaging System / Component (Class 11) | ||
| Information on devices to which substantial equivalence is claimed: | |||
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
| 1 K080977 | 1 3 CCD ENDOCAM 5550 (Product Code: GCJ) | 1 Richard Wolf Medical Inst. Corp. | |
| 2 K023659 | 2 1 CCD ENDOCAM 5520 (Product Code: KOG) | 2 Richard Wolf Medical Inst. Corp. | |
| 3 K964173 | 3 C-mount objective lens, steam sterilizable | 3 Richard Wolf Medical Inst. Corp |
1
Device Description:
The Richard Wolf ENDOCAMB Logic HD Camera System 5525 is an endoscopic camera system for rigid and flexible endoscopes (e.g. Arthroscopes, Bronchoscopes, Hosteroscopes. Laparoscopes, Ureteroscopes, etc.). The Richard Wolf ENDOCAM® Logic HD Camera System 5525 allows the doctor to visualize the image of natural and artificial cavities through the endoscope by projecting images to a monitor for visual display and data storage during endoscopic diagnostic and therapeutic surgical procedures.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 consists of:
- ENDOCAM® Logic HD Controller(s) ﺎﻧ
- ENDOCAM & Logic HD Camera Head(s), and ﺬﺍ ﻳ
- ﺎ ﺗ Objective Lens (Coupler).
Devices are used in conjunction with other ancillary equipment such as endoscopes, light source, monitors, printers, recorders, required cabling, etc.
The Richard Wolf ENDOCAM® Logic HD Camera Head(s) use ICCD or 3CCD imaging systems to provide high definition (HD) visualization and quality images. The Richard Wolf ENDOCAM® Logic HD Camera Head cable connects to the ENDOCAM® Logic HD Controller, the ENDOCAM® Logic HD Controller relays the image from the endoscope with/without the use of an objective lens (coupler) to a video monitor; projection can be either analog or digital at the user's preference.
The Richard Wolf ENDOCAM® Logic HD Controller(s) is equipped with pre-programmed presets which can be selected via touch-screen, remote control, and/or keyboard. Self-made adjustments can be stored and individually named by user. Patient data and endoscopic images can be printed or stored directly onto USB flash drive.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is compatible and can be integrated with the Richard Wolf RiwoNet / Core operating room system.
Devices included in the Richard Wolf ENDOCAM® Logic HD Camera System 5525 are reusable and do not require sterilization before use because there is no direct patient contact. Methods of cleaning, disinfection, and sterilization are detailed in the Instruction for Use Manual: these instructions were developed by Richard Wolf using standards outlined in ANSI / AAMI ST:2004/(R) 2010 and FDA's Guidance "Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance. Office of Device Evaluation April 1996.
This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons.
Intended Use:
The ENDOCAM & Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapentions. The ENDOCAMO Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
2
Revision 04-02-2013 K130423
Pg. 30f4
Technological Characteristics:
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 similarities to the predicate devices are:
- Has the same intended use and Indications and field of application. ﺮ ﺍﻟﻤﺮﺍﺟﻊ
- : \ Incorporates the same basic design.
- , ﻟ Same operating principle.
- Are used in conjunction with other video equipment and endoscopic accessories. . ﺍ
- ﺗﺮ Can be integrated into the Richard Wolf operating room system.
- , l Reusable.
- . ﺍ Pre-programmed presets.
- Conforms to Safety Standards IEC 60601-1 and II:C 60601-1-2. ﺎﺀ
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 differences to the predicate devices are:
- Controller:
- Updated to allow for both digital and analog outputs. 0
- Updated to allow for both ICCD and 3CCD cameras, ০
- Is equipped with additional Input / Output Sockets and interfaces (e.g. HDMI. ಂ Service Interface. PIP module, etc.).
- Allows images to be stored and compressed. 0
- · Camera:
- Head can be angled or rotated. ্
- Cable is available in 3.0mm, 5.0mm. and 8.0mm lengths. 0
- Multipolar blade instead of Lemo. ੁ
-
Objective Lens:
- Snap on locking mechanism instead of locking collar. D
Performance Data:
Design verification testing demonstrates that the devices function as intended, and the performance did not raise any new issues of safety and effectiveness.
Voluntary Safety and Performance Standards: The Richard Wolf ENDOCAM@ Logic HD Camera System 5525 conforms to the following Sufety Standards:
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, 1988: ﺮ ﺃ Amendment 1, 1991-11, Amendment 2, 1995. (General)
- IEC 60601-1-2 Edition 3:2007-03. Medical electrical equipment Part 1-2: General . L requirements for basic safety and essential performance - Colluteral standard: Electromagnetic compatibility - Requirements and Test.
I esting was completed by Independent laboratories, certifications are on file.
Clinical Data: No clinical tests performed.
3
Rational for Substantial Equivalence:
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 shares the same general indications for use, has similar features and technological characteristics as the predicate devices, the minor difference(s) do not raise new questions for safety or effectiveness.
The Richard Wolf ENDOCAM® Logic HD Camera System 5525 was non-clinically tested to determine the safety and efficacy under the indications for use and meet aforementioned safety standards, same as the predicate devices.
For these reasons. The Richard Wolf ENDOCAM® Logic HD Camera System 5525 is substantially equivalent to the existing 510(k) cleared devices sold by: Richard Wolf Medical Instruments Corporation (K080977, K023659, and K964173).
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three wing-like shapes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the left side and top of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 3, 2013
Richard Wolf Medical Instruments Corporation % Mr. Ron Haselhorst Quality Assurance and Regulatory Affairs Manager 353 Corporate Woods Parkway VERNON HILLS IL 60061
Re: K130423
Trade/Device Name: The ENDOCAM® Logic HD Camera System 5525 Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FET Dated: February 15, 2013 Received: February 25, 2013
Dear Mr. Haselhorst:
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 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.
5
Page 2 - Mr. Ron Haselhorst
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 B 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
6
Indication for Use
510(k) Number (if known): K130423
Device Name: The ENDOCAM® Logic HD Camera System 5525
Intended Use:
The ENDOCAM® Logic HD Camera System 5525 has been designed for high-definition video endoscopy and can be used for both diagnostic and therapeutic interventions. The ENDOCAM® Logic HD Camera System 5525 is used in conjunction with other video equipment and endoscopic accessories.
Prescription use (Pari 21 CFR 801 Subpart D)
Friend of the comments of the state of the
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)
Benjamin R≡Eishe 2013.04.03 7 2 - 6:30 -04'00'
(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K130423 510(k) Number
Section / Page 4-10 of 108
Revision 02-15-2013