(90 days)
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.
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.
This document is a 510(k) summary for the Richard Wolf Medical Instruments Corp. 1 CCD Endocam 5502 and 3 CCD Endocam 5507. It declares substantial equivalence and does not detail a study proving specific acceptance criteria in the manner you've requested for a medical device's performance metrics. Instead, it focuses on general safety and effectiveness through compliance with regulatory standards and comparison to predicate devices.
Therefore, many of the requested fields cannot be directly populated from the provided text. I will explain why each field cannot be filled if the information is missing.
Here's the breakdown based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Compliance with specified standards: IEC601-1, IEC601-1-2, IEC1-1-2, IEC1-2-18, UL2601-1 (5507: UL pending) | "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)." |
| Conformity to Medical Device Directive 93/42/EEC | "Camera systems 5502 and 5507 conform to the relevant provisions of Medical Device Directive 93/42/EEC." |
| Camera head classified as Cardiac Floating (CF) equipment | "The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current." |
| Leakage current less than 10uA for cardiac visualization procedures | "The camera head is classified as Cardiac Floating (CF) equipment with less than 10uA of leakage current." |
| Designed and tested to guarantee safety and effectiveness when used according to instruction manual | "These devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific "test sets" for performance evaluation in the way requested for a clinical or AI-based device study. Instead, it refers to regulatory compliance testing performed by "Independent laboratories." Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document describes compliance testing against standards, not a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. The document refers to engineering and safety standard compliance testing, not a clinical study with image interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable and not provided. The device is an endoscopic video camera system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The device is hardware (camera system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the device's acceptance is based on adherence to specified international and national electrical and medical device safety standards (e.g., IEC601-1, UL2601-1) and the Medical Device Directive 93/42/EEC, rather than clinical outcomes or expert consensus on diagnostic performance.
8. The sample size for the training set:
This information is not applicable and not provided. The device is a physical camera system, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As above, no training set for an algorithm is mentioned.
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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.
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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
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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.
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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,
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
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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_
§ 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.