(56 days)
20230041, 20230043
Not Found
No
The description focuses on mechanical and optical functions (connecting endoscope to camera, focusing) and mentions no software, algorithms, or data processing that would suggest AI/ML.
No
The "Intended Use / Indications for Use" section states the lenses are used for "video-controlled diagnostics and therapy," but the device itself is a connecting lens, not a device that performs therapy. It facilitates the visualization that might be part of a therapeutic procedure, but it does not directly administer or perform therapy.
No
The C-Mount objective lenses serve to connect an endoscope to video cameras for video-controlled diagnostics and therapy. While they are used in a diagnostic context by helping to visualize internal structures, the lenses themselves are accessories that facilitate the use of other diagnostic tools (endoscopes and cameras) rather than performing diagnostic functions directly, such as analyzing images or providing a diagnosis.
No
The device description clearly describes physical objective lenses with a focus ring and clamping mechanism, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "connect endoscope to video cameras" for "video-controlled diagnostics and therapy." This describes a device used in vivo (within the body) during a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description focuses on the mechanical function of coupling a telescope to a camera and focusing the image. This aligns with an optical or imaging accessory used during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, detecting analytes, or providing diagnostic information based on laboratory tests.
Therefore, the C-Mount objective lenses described are accessories for endoscopic procedures, not IVD devices.
N/A
Intended Use / Indications for Use
The C-Mount objective lenses serve to connect endoscope to video cameras. The lenses with clamping mechanism are used for video-controlled diagnostics and therapy and allow quick adaptation and fixation of the standard telescopes with evepiece. The focus ring serves to focus an endoscopic image on the monitor.
Product codes
Not Found
Device Description
The C-Mount objective lenses allows a telescope to be coupled to a video camera. The focus ring on the objective lenses is rotatable to allow the camera to focus on the telescope to obtain the proper picture.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The devices have been tested to assure that there is no leakage or reduced optical quality when subjected to steam sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
1 pre-enact., 20230041, 20230043, 88-9714, 88-9715
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
DEC 1 3 1996
K94
173
8172
510(k) Summary of Safety and Effectiveness
| Submitter: | Date of Preparation: | |
|---|---|---|
| Company / Institution name: | October 17, 1996 | |
| RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | |
| Division name (if applicable): | 14 184 79 | |
| N.A. | Phone number (include area code): | |
| Street address: | ( 847 ) 913 1113 | |
| 353 Corporate Woods Parkway | FAX number (include area code): | |
| City: | ( 847 ) 913 0924 | |
| 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: | Model number: 85 261.172 85 261.212 | |
| C-Mount objective lenses, steam-sterilizable | 85 261.242 85 261.272 85 261.322 | |
| 85 261.382 85 261.452 | ||
| Common name: | Classification name: | |
| C-Mount objective lenses | Endoscope and/or accessories | |
| Information on devices to which substantial equivalence is claimed: | ||
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 pre-enact. | 1 RIWO lenses f = 15 mm, 30 mm, 60 mm, Model no. 5400/15, 5400/30, 5400/60 | 1 Richard Wolf M.I.C. |
| 2 | 2 C-mount lenses f = 25 mm, 38 mm, Model no. 20230041, 20230043 | 2 Karl Storz |
| 3 | 3 Coupler 28 mm, 35 mm, , Model no. 88-9714, 88-9715 | 3 Snowden Pencer |
| 4 | 4 | 4 |
| 5 | 5 | 5 |
| 6 | 6 | 6 |
1.0 Description
The C-Mount objective lenses allows a telescope to be coupled to a video camera.
The focus ring on the objective lenses is rotatable to allow the camera to focus on the telescope to obtain the proper picture.
1
2.0 Intended Use
proje
The C-Mount objective lenses serve to connect endoscope to video cameras.
The lenses with clamping mechanism are used for video-controlled diagnostics and therapy and allow quick adaptation and fixation of the standard telescopes with evepiece.
The focus ring serves to focus an endoscopic image on the monitor.
3.0 Technological Characteristics
The C-Mount objective lenses are redesigned for steam sterilization. The production method and function of the device mainly stayed the same.
Substantial Equivalence 4.0
These Devices are substantially equivalent to pre-enactment devices sold by Richard Wolf and to actual 510(k) devices sold by Karl Storz and Snowden Pencer. The differences do not affect safety or effectiveness of the device.
5.0 Performance Data
The devices have been tested to assure that there is no leakage or reduced optical quality when subjected to steam sterilization.
6.0 Clinical Tests
}
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to quarantee the safety and effectiveness. when used according to the instruction manual.
By: Robert L. Casares
Robert L. Casarsa Quality Assurance Manager
Date: 05/16/1996