(90 days)
Not Found
No
The summary describes standard video processing and does not mention any AI/ML terms or functionalities.
Yes
The device is described as being used for both diagnostic and therapeutic interventions, indicating its role in treatment applications.
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 states that the system includes a camera controller and a camera head, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "video endoscopy and video microscopy" for "diagnostic and therapeutic interventions." This describes a device used to visualize internal structures of the body, which is an in vivo (within the living body) procedure, not an in vitro (outside the living body) procedure.
- Device Description: The description focuses on the camera system, camera head, and controller used for displaying images from endoscopic procedures. This aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which are hallmarks of IVD devices.
The device is clearly intended for direct visualization within the body, making it an in vivo diagnostic and therapeutic tool, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.
The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.
Product codes
FWF
Device Description
The endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.
The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.
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
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 (5507: UL pending).
Camera systems 5502 and 5507 conform to the relevant provisions of Medical Device Directive 93/42/EEC.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
NOV 23 K
.
353 Corporate Woods Parkway Vernon Hills, Illinois 60064 Phone: 847.913.1113 Fax: 847.913.1488
K 98296
MEDICAL INSTRUMENTS CORPORATION
510(k) Summary of Safety and Effectiveness
| Company / Institution name: | Richard Wolf Medical Instruments Corp. |
|---|---|
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP/Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | August 24, 1998 |
| FDA establishment regulation number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Product Information: | |
| Trade name: | 1 CCD Endocam and 3 CCD Endocam |
| Model number: | 5502 and 5507 |
| 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 endoscopic video camera systems include a camera controller and a small camera head which is connected by a camera cable to the controller. Endoscopic procedures are displayed with the objective lenses attached to the camera head and the video monitors connected to the camera controller.
The camera heads are CF Equipment (cardiac floating) according to UL2601-1 / IEC601-1.
1
Image /page/1/Picture/4 description: The image contains a black square with a white letter 'A' inside. The 'A' is stylized with a serif font, giving it a classic or formal appearance. The contrast between the black background and the white letter makes the 'A' stand out prominently.
2.0 Intended Use
The 1 CCD Endocam 5502 and 3 CCD Endocam 5507 are designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.
The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current. This permits its use for cardiac visualization procedures when used in conjuction with the proper instrumentation for entry into the cardiac system.
3.0 Technological Characteristics
The 1 CCD Endocam 5502 has a CCD image converter with mosaic color filter.
The 3 CCD Endocam 5507 has three CCD image converter for red, green and blue colors. separated by a prism. The light that falls onlo the sensor generates a signal which is processed in the camera controller to a standard NTSC video signal.
The camera head is insulated from earth (Type CF-Fquipment, 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.
રું.......................................................................................................................................................................... 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 (5507: UL pending).
Camera systems 5502 and 5507 conform 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: 9-4-98
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
NOV 2 3 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K982965
Trade Name: 1 CCD Endocam 5502 and 3 CCD Endocam 5507 with CF Camera Heads Regulatory Class: II Product Code: FWF Dated: August 24, 1998 Received: August 25, 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 (QS) 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.
3
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,
llydo
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
TO
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K982965
Device Name: _________________________________________________________________________________________________________________________________________________________________
Intended Use:
The 1 CCD Endocam 5.502 and 3 CCD Endocam 5.507 arc designed for video endoscopy and video microscopy and can be used for both diagnostic and therapeutic interventions.
The camera head is classified as Cardiac Hoating (CF) equipment with less than 10pA of leakage current. This permits its use for cardiac visualization procedures when used in conjunction with the proper instrumentation for entry into the cardiac system.
(11 J.ASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANCITHER PAGE IF NEEDELIJ
Concurrence of CDRH Office of Device Evaluation (ODDE)
boell
of General Restorative I
Prescription Use
Per 21 CRF 801.109
Over-The Counter_