(67 days)
pre-enactment
Not Found
No
The summary does not mention any AI or ML capabilities, image processing beyond basic visualization, or performance studies related to algorithmic analysis.
No.
The intended use explicitly states "For examination, diagnosis and/or therapy," but the "Device Description" and "Intended Use / Indications for Use" primarily describe its function for visualization to "visualize the inside of the patient." While it can be used during therapy, the device itself is for visualization/diagnosis rather than directly delivering a therapeutic effect.
Yes
The "Intended Use / Indications for Use" section explicitly states "For examination, diagnosis and/or therapy". Endoscopes are used for visual inspection, which aids in the diagnostic process.
No
The device description explicitly states it is an endoscope with specific diameters, which is a physical hardware device used for visualization.
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 intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The description clearly states the endoscope is used to "visualize the inside of the patient via natural or surgically generated access." This is an in vivo (inside the body) procedure.
- Intended Use: The intended use is for "examination, diagnosis and/or therapy" by directly visualizing internal structures, not by analyzing specimens outside the body.
Therefore, this endoscope falls under the category of a medical device used for direct visualization and intervention within the patient's body, not an IVD.
N/A
Intended Use / Indications for Use
The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.
For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT.
Product codes (comma separated list FDA assigned to the subject device)
78 FBP, 78 GCM
Device Description
An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies.
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
infants and babies
Intended User / Care Setting
personnel trained in the use of endoscopic instrumentation used in various medical disciplines, 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 performance standards are known. The devices conform to the relevant provisions of European Device Directive 93/42/EEC.
Clinical tests performed were not 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.
pre-enactment
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.
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553 Corporate Woods Vernon I lills, Illinois 6006 i Phone: 847.913.4443 Fax: $47.943.1488
510(k) Summary of Safety and Effectiveness
RICHARD WOLF
| Date of Preparation | December 23, 1998 |
|---|---|
| --------------------- | ------------------- |
| Submitter: | |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| FDA establishment registration number: | 14 184 79 |
| Division name (if applicable): | N.A. |
| Phone number (include area code): | (847) 913-1113 |
| Street address: | 353 Corporate Woods Parkway |
| FAX number (include area code): | (847) 913-0924 |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Endoscopes with Panoview Plus Optics |
|---|---|
| Model number: | 8672.xxx and 8686.xxx |
| Common name: | Endoscopes |
| Classification name: | Endoscopes |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | pre-enactment | Cysto-Urethrosocpe for children, Model 8670 and 8680 | Richard Wolf |
| 2 | 2 | 2 |
1.0 Description
An endoscope with 1.9 mm and 2.7 mm diameter, typically used in endoscopy in infants and babies.
2.0 Intended Use
The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.
1
K 984607 - pg r of r
Technological Characteristics 3.0
- · increased image size and greater brightness
- sharp, brilliant quality over the entire image .
- autoclavable 134°C / 273°C .
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
No performance standards are known. The devices conform to the relevant provisions of European Device Directive 93/42/EEC.
6.0 Clinical Tests
Clinical tests performed were not performed.
7.0 Conclusions Drawn
These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.
By: Robert L. Casares
Robert L. Casarsa Quality Assurance Manager
Date: Dec 23 98
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 5 1999
Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60061
Re: K984607
Thin Endoscopes with Panoview Plus Optics Dated: December 23, 1998 Received: December 28, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FBP & GCM
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 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 Requlations. 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.
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) 594-4613. 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 requlation 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,
APT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): __ K 98 46 07
Device Name: Thin Endoscopes with Panoview Plus Optics
Intended Use:
The endoscopes serve to visualize the inside of the patient via natural or surgically generated access.
Indications and Fields of Application:
For examination, diagnosis and/or therapy by personnel trained in the use of endoscopic instrumentation used in various medical disciplines, such as surgery, urology, gynecology, and ENT.
Contraindications:
There are no known contradindications directly related to the product. The attending physician must determine the appropriateness of the application while considering the general condition of the patient.
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
Prescription Use
Per 21 CFR 801.109
5 - 1
Over-The Counter