(52 days)
Not Found
No
The summary describes a mechanical device for surgical access and dilation, with no mention of AI, ML, image processing, or data analysis capabilities.
Yes
The device is indicated for "diagnosis and therapy" and is used to create a pneumoperitoneum and dilate surgical passages, which are therapeutic interventions.
Yes
The "Indications and field of use" section explicitly states that "The Veroscope and dilation tube systems are used for diagnosis and therapy".
No
The device description clearly outlines physical components such as a trocar sleeve, veress cannula, protection tube, endoscope, metal dilation sleeves, guide rod, plastic dilation tube, and trocars, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The VEROSCOPE and Dilation Tube System are used for surgical access and manipulation within the body. They are tools for creating passages, providing visual access (endoscopic view), and facilitating diagnosis and therapy in vivo (within the living body).
- Lack of Specimen Analysis: The description does not mention the device being used to analyze any specimens taken from the body. The endoscopic view is of the internal anatomy directly, not a processed sample.
The device is clearly intended for surgical and endoscopic procedures performed directly on the patient, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The VEROSCOPE is used percutaneously for penetrating the abdominal cavity under endoscopic control to safely reach a defined body region. It therefore also serves to create a pneumoperitoneum under visual control in the abdomen.
The Dilation Tube System and standard Dilation System is used for dilating surgically created passages in body cavities.
Indications and field of use: The Veroscope and dilation tube systems are used for diagnosis and therapy in conjunction with endoscopic accessories in various disciplines such as surgery, gynecology and urology.
Product codes (comma separated list FDA assigned to the subject device)
HET, GCJ
Device Description
The 'Veroscope' consists of an outer trocar sleeve with insufflation stopcock, a veress cannula rice + erosopo consisted brotection tube with a transparent blunt tip and an endoscope.
The 'Veroscope' is similar to a spring-loaded, blunt Veress needle that is used for penetrating tissue layers under endoscopic view.
The Standard Dilation System consists of metal dilation sleeves and a guide rod.
The Dilation Tube System 4760 consists of a plastic dilation tube and trocars with sleeves of various dimensions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal cavity, body cavities
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)
No performance standards are known.
No clinical tests performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962799, K971420, K003417, K942201, K983925, K012539
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
K041321 1 of 2
JUL 0 9 2004
Medical Instruments Corporation
353 Corporate Woods Parkway Vernon Hills, IL 60061 Phone: 847-913-1113 Customer Service: 800-323-WOLF www.richard-wolf.com
12.0 510(k) Summary of Safety and Effectiveness
| Submitter: | |
|---|---|
| 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: | IL 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | May 14, 2004 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | ( 847 ) 913 1113 |
| FAX number (include area code): | ( 847 ) 913 0924 |
Product Information:
| Trade name: | VEROSCOPE, Optical Veress Cannula and Dilation Tube System |
|---|---|
| Model number: | 8760.xxx, 4760.xxx, 8921.xxx, 8923.xxx |
| Common name: | Needle, pneumoperitoneum, spring loaded and Cannula and trocar, suprapubic |
| Classification name: | Endoscope and Accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 K962799 | 1 Set Laparoscopy, Veress Cannula spring loaded, Telescopes | 1 Richard Wolf |
| 2 K971420 | 2 Mini Laparoscopes, Veress Cannula spring loaded, Telescopes | 2 Richard Wolf |
| 3 K003417 | 3 Mini Fiber Laparoscope/ Hysteroscope Sets | 3 Richard Wolf |
| 4 K942201 | 4 Laparoscopy dilation system | 4 Richard Wolf |
| 5 not known | 5 Optical VERESS Pneumoperitoneum Needle | 5 Karl Storz |
| 6 K983925 | 6 EndoPath Ultra Veress Insufflation Needle | 6 Ethicon Endo-Surgery, Inc. |
| 7 K012539 | 7 VersaStep System | 7 U.S. Surgical (Tyco Health) |
1
K041321.
pg. 2 of 2
1.0 Definition
The 'Veroscope' consists of an outer trocar sleeve with insufflation stopcock, a veress cannula rice + erosopo consisted brotection tube with a transparent blunt tip and an endoscope.
The 'Veroscope' is similar to a spring-loaded, blunt Veress needle that is used for penetrating tissue layers under endoscopic view.
The Standard Dilation System consists of metal dilation sleeves and a guide rod.
The Dilation Tube System 4760 consists of a plastic dilation tube and trocars with sleeves of various dimensions.
Intended Use 2.0
The 'VEROSCOPE' is used percutaneously for penetrating tissue layers under endoscopic control to safely reach a defined body region. It also serves to create a pneumoperitoneum under visual control in the abdomen.
The Dilation Tube System and the Standard Dilation System is used for dilating surgically created passages in body cavities.
The Veroscope and the Dilation Tube Systems are used for diagnosis and therapy in conjunction rity veroscopic accessories in various disciplines such as surgery, gynecology and urology.
Technological Characteristics 3.0
With increased tissue resistance, which is the case in particular with boundary layers, for with the rased thead recording is pushed back against the force of the spring, the transparent tip springs back and the puncture site can be observed with the endoscope. By pressing the the brings on the veress cannula serves to block the spring-back action of the transparent tip.
Substantial Equivalence 4.0
The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing pre-enactment and 510(k)-devices sold by Richard Wolf, Karl Storz, Ethicon, Autosuture/Tyco and other competitors.
Performance Data 5.0
No performance standards are known.
Clinical Tests 6.0 No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual.
Robert L. Casarsa
Quality Assurance Manager
Date: May 14, 2004
By:
12-2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes that resemble human figures or faces, arranged in a cascading or flowing manner.
JUL 0 9 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, Illinois 60061
Re: K041321
Trade/Device Name: VEROSCOPE, Optical Veress Cannula Regulation Number: 21 CFR 884.1720, 876.1500 Regulation Name: Gynecologic laparoscope and accessories, Endoscope and accessories Regulatory Class: II Product Code: HET, GCJ Dated: May 14, 2004 Received: May 25, 2004
Dear Mr. Casarsa:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your be determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, aronerols 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 II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Mr. Robert L. Casarsa
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
Celia M. Witten, Ph.D., M.D.
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
VEROSCOPE, Optical Veress Cannula Device Name:
Indications For Use: The VEROSCOPE is used percutaneously for penetrating the abdominal cavity under endoscopic control to safely reach a defined body region. It therefore also serves to create a pneumoperitoneum under visual control in the abdomen.
The Dilation Tube System and standard Dilation System is used for dilating surgically created passages in body cavities.
Indications and field of use: The Veroscope and dilation tube systems are used for diagnosis and therapy in conjunction with endoscopic accessories in various disciplines such as surgery, gynecology and urology.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ghn Wh
(Division Sign Off)
Division of General, Restorative, and Neurological Devices
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
510(k) Number | C041321