(84 days)
Not Found
Not Found
No
The summary describes a standard optical laparoscope with working channels and instrument ports. There is no mention of any computational analysis, image processing beyond basic viewing, or any terms related to AI/ML. The performance studies focus on electrical safety and conformity to standards, not algorithmic performance.
No.
Explanation: The intended use states the device is for "viewing the interior of the patient" for "examination, diagnosis and / or therapy." While therapy is mentioned, the device description focuses on its use as an endoscope with an optic for viewing and working channels for accessories. This suggests it's primarily a diagnostic and access tool, not a therapeutic device itself. The mention of therapy is likely related to the use of endoscopic accessories in conjunction with the device, rather than the device performing the therapy directly.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "for examination, diagnosis and / or therapy".
No
The device description clearly describes a physical endoscope with working channels, optics, instrument ports, and the ability to be steam-sterilized. These are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states the device is an operating laparoscope used for "viewing the interior of the patient through surgically produced accesses; for examination, diagnosis and / or therapy". This involves direct visualization within the patient's body, not the analysis of samples outside the body.
The device is an in vivo diagnostic and therapeutic device, not an in vitro one.
N/A
Intended Use / Indications for Use
The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses: for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.
Product codes
GCJ
Device Description
The operating laparoscopes are endoscopes with working channels. The optic of the endoscopes is distortion-free. The instrument ports with automatic valves or insertion cocks are detachable and can be replaced by a laser coupler. The submitted laparoscopes are steam-sterilizable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Viewing the interior of the patient.
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
The devices conform to IEC 601-1 and IEC 601-2-18, and to the relevant provisions of European Device Directive 93/42/EEC. No clinical tests performed.
Key Metrics
Not Found
Predicate Device(s)
1 pre-enact.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488
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Image /page/0/Picture/2 description: The image shows the name "RICHARD WOLF" in bold, black, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The letters are evenly spaced and the overall composition is simple and clear.
MEDICAL INSTRUMENTS C
510(k) Summary of Safety and Effectiveness
| Date of Preparation: | May 18, 1999 |
|---|---|
| FDA establishment registration number: | 1418479 |
| 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 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Operating Laparoscopes |
|---|---|
| Model number: | 8912.402, 8914.402, 8915.402 and accessories |
| Common name: | Laparoscopes with working channel |
| Classification name: | Laparoscopes |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | 1 Operating Peritoneoscope 4937 | 1 Richard Wolf |
| 2 | 2 | 2 |
1.0 Description
The operating laparoscopes are endoscopes with working channels. The optic of the endoscopes is distortion-free. The instrument ports with automatic valves or insertion cocks are detachable and can be replaced by a laser coupler. The submitted laparoscopes are steam-sterilizable.
1
2.0 Intended Use
The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses: for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.
Technological Characteristics 3.0
- = distortion free
- autoclavable 134°C / 273°F
- = detachable instrument port with insertion cock
- detachable laser coupler for CO2 laser
4.0 Substantial Equivalence
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.
5.0 Performance Data
The devices conform to IEC 601-1 and IEC 601-2-18, and to the relevant provisions of European 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 instructions manual.
By: Ret Hassan
Robert L. Casarsa Quality Assurance Manager
Date: May 18,99
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 12 1999
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K991718
Trade Name: Laparoscopes Models 8912.402, 8914.402, and 8915.402 Regulatory Class: II Product Code: GCJ Dated: May 18, 1999 Received: May 20, 1999
Dear Mr. Casarsa:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 requirement, as set forth in the Quality System Regulation (OS) 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 devices 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 devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices 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 devices, 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/dsmamain.html".
Sincerely yours,
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
Indications for Use
| 510(k) Number (if known): | K991171 |
|---|---|
| --------------------------- | --------- |
Device Name:__________________________________________________________________________________________________________________________________________________________________ Operating Laparoscopes
Intended Use:
The operating laparoscopes are used for viewing the interior of the patient through surgically produced accesses; for examination, diagnosis and / or therapy in connection with endoscopic accessories for laparoscopy.
Combinations:
The laparoscopes are used in connection with light sources and flexible light cables, video cameras, or reflex cameras and objectives lenses, as well as accessories for endoscopic use (e.g. trocar sleeves, forceps, electrodes).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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(Division Sign-Off)
Division of General Restorative Devices K991718
510(k) Number
Prescription Use
Per 21 CFR 801.109
OR
Over-The Counter_