(77 days)
Not Found
Not Found
No
The summary describes a standard laparoscopic telescope with smaller dimensions and does not mention any AI or ML capabilities, image processing, or data analysis features typically associated with AI/ML in medical devices.
No
The device is described for "visualization," "examination," and "diagnostics," and is used for "smaller interventions," but the primary stated uses are diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "examination, diagnostics, and/or therapy." The "Device Description" also mentions it is "particularly suitable for diagnostics."
No
The device description clearly describes physical hardware components (telescopes, endoscopes, lens, outer diameter) and their function in providing visualization inside the patient. It does not mention any software-only components or functions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device provides "visualization inside the patient via natural or surgical generated access." This is an in vivo (within the living body) procedure, not an in vitro (in glass/outside the body) test.
- Intended Use: The intended use is for "examination, diagnostics, and/or therapy" by visualizing internal structures, not by analyzing samples taken from the body.
Therefore, the MINI Laparoscopes described are surgical instruments used for visualization during procedures performed directly on the patient, not for testing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The MINI laparoscopes provide visualization inside the patient by natural or surgically generated access.
Product codes
GCJ
Device Description
The PANOVIEW PLUS telescopes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and outpatient and pediatric laparoscopy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside the patient
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons who are trained and qualified in the use of endoscopically used accessories from various medical specialties, such as surgery, urology, gynecology, and ENT.
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)
No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
1 pre-enactment, 2, 3
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 Vernen Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.943.1488
NOV 2 4 1997
NOV 24 1981
K973359 RICHARD WOLF
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: | September 4, 1997 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Trade name: | PANOVIEW PLUS telescopes 3.5 mm |
| Model number: | 8379.401, .402, .403 |
| Common name: | MINI Laparoscopes |
| Classification name: | Laparoscopes |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enactment | 1 Lumina Telescope | 1 Richard Wolf |
| 2 | 2 Pediatric Laparoscopes | 2 Karl Storz |
| 3 | 3 Laparoscopes | 3 Jarit |
| 4 | 4 | 4 |
1.0 Description
트
The PANOVIEW PLUS telescopes are part of the MICRO and MINI instrument set for laparoscopic microsurgery. They are particularly suitable for diagnostics, smaller interventions, and outpatient and pediatric laparoscopy.
.
方
1
2.0 Intended Use
The MINI laparoscopes provide visualization inside the patient by natural or surgically generated access.
3.0 Technological Characteristics
The endoscopes design and biocompatability of materials is comparable to earlier Richard Wolf devices. The outer diameter of the submitted devices are smaller and provide minimally invasive laparoscopy. The smaller diameter of the lens results in a smaller endoscopic puncture.
4.0 Substantial Equivalence
The devices are substantially equivalent to existing pre-enactment devices and 510(k) devices sold by Richard Wolf, Karl Storz, and Jarit.
5.0 Performance Data
No know FDA performance standards exist.
Clinical Tests 6.0
No clinical tests performed.
7.0 Conclusions Drawn
The devices are designed and tested to guarantee the safety and effectiveness when used according to the instruction manual.
By: Robert H. Casasa
Robert L. Casarsa Quality Assurance Manager
Date: Sept 3, 97
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2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HL AN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 2 4 1997
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K973359
Trade Name: Mini Laparoscopes/PanoView PLUS telescopes 3.5 Regulatory Class: II Product Code: GCJ Dated: September 4, 1997 Received: September 8, 1997
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 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. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions 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
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 a legally marketed predicate device 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_
973359 510(k) Number (if known):
PANOVIEW PLUS telescope, 3.5 mm Device Name:
Intended Use:
The MINI Laparoscopes provide visualization inside the patient via natural or surgical generated access.
Indication:
For examination, diagnostics, and/or therapy for use by surgeons who are trained and qualified in the use of endoscopically used accessories from various medical specialties, such as surgery, urology, gynecology, and ENT.
Contraindications:
There are no know contraindications directly related to the product. The attending physician must consider the general condition of the patient when determining if the application is appropriate.
Combinations:
The endoscopes are used in connection with light sources and flexible light cables, video cameras or reflex cameras and objective lenses, as well as accessories for endoscopic use, e.g., trocar sleeves, forceps, electrodes.
Signature
510k) Numb
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Prescription Use Per 21 CFR 801.109
Over-The Counter