(90 days)
Richard Wolf endoscopes for use in plastic surgery, are designed to visualize anatomy through natural and recenture well and socked for ass ar processors) may be used to visualize subcuraneous tissue when the indicated application is endoscopic plastic/reconstructive surgery.
The Richard Wolf Endoscopes have 4mm, 7mm, and 10mm diameters with working lengths ranging from 190mm to 300 mm. They have a viewing direction of 0°, 25°, and 50°. The eyepieces are fixed or detachable, depending upon the specific model.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Panoview Telescopes:
Based on the provided 510(k) summary, there is no specific acceptance criteria or study that proves the device meets such criteria in the traditional sense of a performance study with quantitative results.
The document states: "These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual." However, it explicitly states "6.0 Clinical Tests None" and provides no performance data or detailed study information.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that Richard Wolf Medical Instruments Corp. is claiming their Panoview Telescopes are as safe and effective as devices already on the market (the predicate devices).
Therefore, I cannot populate most of the requested table and study-related information as it is not present in the provided text.
Here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall) are provided in this submission. The basis for clearance is substantial equivalence, not a direct performance study against defined criteria.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None explicitly stated as quantitative targets. The implied "acceptance" is that the device is substantially equivalent in terms of safety and effectiveness to predicate devices. | None explicitly stated as quantitative results. The submission relies on the assertion that the device design and testing, in conjunction with substantial equivalence to legally marketed devices, ensures safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No performance study with a test set was conducted or reported.
- Data Provenance: Not applicable. No performance data was generated from a test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No performance study with a test set requiring ground truth was conducted or reported.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No performance study with a test set requiring adjudication was conducted or reported.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states "6.0 Clinical Tests None."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
- Standalone Study: Not applicable. The device is an optical endoscope, not an AI algorithm. Its performance is inherent in its optical and mechanical design, which is assessed through substantial equivalence to existing devices, not through an "algorithm-only" study.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No performance study was conducted that would require a ground truth. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices based on their prior clearance and market history.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The device is an optical instrument, not a learning algorithm or AI. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.
Summary of Basis for Clearance (Based on Provided Text):
The Richard Wolf Panoview Telescopes received 510(k) clearance based on Substantial Equivalence to legally marketed predicate devices. The submission asserts that the devices are "designed and tested to guarantee the safety and effectiveness" but does not provide specific performance data or clinical test results to support this beyond the claim of equivalence to already-cleared devices. The key elements cited for substantial equivalence are:
- The devices have the same intended use.
- Similar technological characteristics (though not deeply detailed or compared quantitatively).
- No clinical tests were deemed necessary for this submission.
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son capitar in la sankar Vernon Hills, Illinois 60064 Phone: 847.943.1113 Fax: 847,913,1488
NOV - 6 1997
| RICHARD WOLFMEDICAL INSTRUMENTS CORPORATION | |||
|---|---|---|---|
| 510(k) Summary of Safety and Effectiveness | |||
| Submitter: | Date of Preparation:August 5, 1997 | ||
| 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 | ||
| Trade name: | Panoview Telescopes | Model number: | 8880.401, 8880.431, 8880.402,8880.403, 8933.441, 8933.401,8933.442, 8933.402, 8933.441,8933.421, 8934.442, 8934.422 |
| Common name: | Endoscopes | Classification name: | Laparoscope, Plastic andGeneral Surgery |
| Information on devices to which substantial equivalence is claimed: |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K951519 | WECO Endoscopic System w/ Fiber OpticLight | Wells EndoscopicCompany |
| 2 | Endoscope | Storz | |
| 3 | EndoPlastic™ Scope, 10mm | Snowden-Pencer | |
| 4 | K960400 | Diamond-View™ Non-AutoclavableEndoscopes, 10mm | Snowden-Pencer |
| 5 |
1.0 Description
파
The Richard Wolf Endoscopes have 4mm, 7mm, and 10mm diameters with working lengths ranging from 190mm to 300 mm. They have a viewing direction of 0°, 25°, and 50°. The eyepieces are fixed or detachable, depending upon the specific model.
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ResseS 10/97
2.0 Intended Use
Richard Wolf endoscopes for use in plastic surgery are designed to visualize anatomy through natural and man-made openings in body cavities. The endoscopes may be used to visualize subcutaneous tissue when the indicated application is endoscopic cosmetic surgery of the facial and forethead / breast aughertation, and endospopic absominal plasity procedures.
3.0 Technological Characteristics
· Removable and permanent eyepiece
Substantial Equivalence 4.0
The Richard Wolf Endoscopes for plastic surgery are substantially equivalent to:
- Snowden-Pencer .
- · Wells Endoscopy
- Karl Storz
- Storz (USA) .
All devices have the same intended use.
5.0 Performance Data
- 6.0 Clinical Tests None
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By: Robert Casaran
Robert L. Casarsa Quality Assurance Manager
Date: Aug 5, 92
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. The bottom half of the circle contains a stylized image of an eagle with its wings spread, with three human profiles incorporated into the design of the eagle's body. The overall design is simple and clean, with a focus on the text and the symbolic image of the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
NOV - 6 1997
Re: K972927 Trade Name: Panoview Telescopes Regulatory Class: II Product Code: GCJ Dated: August 5, 1997 Received: August 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. 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 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.
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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 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
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≤ 10(k) Number (if known):
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Endoscopes for Plastic Surgery Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Indications for Use:
Richard Wolf endoscopes for use in plastic surgery, are designed to visualize anatomy through natural and recenture well and socked for ass ar processors) may be used to visualize subcuraneous tissue when the indicated application is endoscopic plastic/reconstructive surgery.
Revised 10/31/97
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices K972927
510(k) Number
Prescription Use
Per CFR 21 CFR 801.109
OR
1 - 3
Over-The-Counter Use_
§ 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.