(56 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No leakage after steam sterilization | Not explicitly stated as "no leakage," but the devices "have been tested to assure that there is no leakage... when subjected to steam sterilization." This implies the tests passed the leakage criteria. |
| No reduced optical quality after steam sterilization | Not explicitly stated as "no reduced optical quality," but the devices "have been tested to assure that there is... no reduced optical quality when subjected to steam sterilization." This implies the tests passed the optical quality criteria. |
| Designed and tested to guarantee safety | "These devices are designed and tested to quarantee the safety and effectiveness." |
| Designed and tested to guarantee effectiveness | "These devices are designed and tested to quarantee the safety and effectiveness." |
| Function of the device mainly stayed the same | "The production method and function of the device mainly stayed the same." |
| Allowing telescope to be coupled to video camera | This is a fundamental function described: "The C-Mount objective lenses allows a telescope to be coupled to a video camera." |
| Focus ring rotatable to allow camera focus on telescope | This is a fundamental function described: "The focus ring on the objective lenses is rotatable to allow the camera to focus on the telescope to obtain the proper picture." |
| Serve to connect endoscope to video cameras | This is an intended use described: "The C-Mount objective lenses serve to connect endoscope to video cameras." |
| Used for video-controlled diagnostics and therapy | This is an intended use described: "The lenses with clamping mechanism are used for video-controlled diagnostics and therapy." |
| Allow quick adaptation and fixation of standard telescopes with eyepiece | This is an intended use described: "The lenses with clamping mechanism... allow quick adaptation and fixation of the standard telescopes with evepiece." |
| Focus ring serves to focus an endoscopic image on the monitor | This is an intended use described: "The focus ring serves to focus an endoscopic image on the monitor." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "The devices have been tested," but does not quantify how many devices or how many cycles of sterilization were performed.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. It implies internal company testing ("The devices have been tested").
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The testing described appears to be technical performance testing (leakage, optical quality, function) rather than requiring expert consensus for a "ground truth" in clinical interpretation.
4. Adjudication Method
Not applicable. The testing described is technical performance, not involving subjective interpretation requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical tests performed." The purpose of this submission is for a medical device (C-Mount objective lenses), which are hardware components, and the evaluation focuses on their physical and functional integrity, especially after steam sterilization.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
No, a standalone (algorithm only) performance study was not done. This device is a passive optical component and does not involve an algorithm or AI.
7. Type of Ground Truth Used
The ground truth used was based on technical performance specifications for leakage and optical quality after steam sterilization, and the expected functional performance of the device (e.g., proper focusing, coupling function). It is not clinical "ground truth" in the sense of disease diagnosis or outcomes.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
{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
§ 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.