(79 days)
Not applicable
Not Found
No
The summary describes a mechanical surgical instrument (Verres Needle and Cannula) and does not mention any software, algorithms, or AI/ML terms.
No
The device is described as a 'Verres Needle and Cannula' and its intended use is to establish pneumoperitoneum and provide access for instrumentation in minimally invasive surgical procedures, which are interventional steps, not therapeutic outcomes.
No
Explanation: The device is described as providing access for operative and diagnostic instrumentation, but the device itself is not performing a diagnostic function. It creates pneumoperitoneum and provides access.
No
The device description explicitly states "Verres Needle and Cannula," which are physical surgical instruments, not software.
Based on the provided information, the Verres Needle and Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for establishing pneumoperitoneum and providing access for surgical instrumentation during minimally invasive surgical procedures. This is an in-vivo (within the living body) application.
- Device Description: The description is of a surgical instrument used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body, which is the core function of an IVD.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. The Verres Needle and Cannula is a surgical tool used for access during surgery, not for analyzing biological samples.
N/A
Intended Use / Indications for Use
Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Verres Needle and Cannula 1s intended for use in laparoscopic surgery that utilizes minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Product codes
85 HET
Device Description
The "Verres Needle and Cannula" is described as being made of Stainless Steel, featuring a Spring-Loaded Needle, and having a diameter range of 2.0 - 5.0mm.
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
multiple surgical specialties that utilize minimally invasive surgical procedures, physician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Gynescope Trocar and Sleeves, Marlow Verres Needle
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
SUMMARY OF SAFETY AND EFFECTIVENESS VERRES NEEDLE AND CANNUI
The Summary of Safety and Effectiveness on Laparoscopic surgery and the instruments used reflects data available and presented at the the submission was prepared, but caution should be exercised in interpreting the data. The results of future studies may require alterations of the conclusions or recommendations set forth.
Intended Use
Verres Needle and Cannula is intended for use in multiple surgical specialties that utilize minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.
Substantial Equivalency Information
The Verres Needle Cannula is similar to the Gynescope Trocar and Sleeves and the Marlow Verres Needle.
| | Gynescope
Trocar and
Sleeves | Marlow
Verres
Needle | Verres Needle
and Cannula |
|----------|------------------------------------|----------------------------|------------------------------|
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle | N/A | Spring-Loaded | Spring-Loaded |
| Diameter | 5.0 - 11.5mm | 2.0 mm | 2.0 - 5.0mm |
The intended use and technological characteristics of these devices do not vary significantly. The safety and effectiveness of the Verres Needle and Cannula are comparable to that of the Gynescope Trocar and Sleeves and the Marlow Verres Needle.
1
Image /page/1/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 1997
Ms. Debra A. Pekar Manager of Quality Assurance and Regulatory Affairs CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484
Re: K971837
VerreScope Verres Needle and Cannula . Dated: May 16, 1997 Received: May 19, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET
Dear Ms. Pekar
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device 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 Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 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 question and advertising of your device, 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
Sincerely yours,
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Page 9 ર 3 of
510(k) Number (if known):
Verres Needle / Cannula Device Name: _
Indications For Use:
Verres Needle and Cannula 1s intended for use in laparoscopic surgery that utilizes minimally invasive surgical procedures to establish pneumoperitoneum and to provide access for operative and diagnostic instrumentation.
CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.
(PLEASE DO NOT WRITE:BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) productive, Abdominal, ENT, Prescription lise > Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (Per 21 CFR 801.109)
(Optional Format 1-2-96)