VERSASTAT MULTIPOLAR SCISSORS AND CABLES
Device Facts
| Record ID | K974250 |
|---|---|
| Device Name | VERSASTAT MULTIPOLAR SCISSORS AND CABLES |
| Applicant | Pilling Weck, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Feb 11, 1998 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
To coagulate and transect vascular tissue simultaneously; to perform spot coagulation of bleeding vessels; to be used in open surgical procedures.
Device Story
VersaStat Multipolar Scissors are reusable, insulated surgical instruments designed for open surgery. Device inputs include electrical energy from compatible electrosurgical generators (Valley Lab, Codman, Bircher, Conmed, Wolf, Erbe) delivered via proprietary multipolar cables. The device features a three-pole connector shaft allowing monopolar or bipolar current flow to one or both blades, controlled by a switch on the cable. Surgeons operate the device to simultaneously coagulate and transect vascular tissue or perform spot coagulation. Activation is controlled via a foot pedal. The device provides hemostasis, reducing the need for grounding pads due to its multipolar design. Benefits include efficient tissue management and reduced bleeding during open procedures. Healthcare providers visually inspect the surgical site to confirm hemostasis post-activation.
Clinical Evidence
No clinical data provided. Bench testing only, including electrical functionality verification via saline-soaked gauze pad testing to confirm circuit completion, steam generation, and sparking.
Technological Characteristics
Reusable insulated surgical scissors with three-pole connector shaft. Compatible with monopolar/bipolar electrosurgical generators. Sterilization: Steam autoclave (AAMI ST8-113) or ETO (AAMI ST41-113). No software or electronic processing components.
Indications for Use
Indicated for use in open surgical procedures for simultaneous coagulation and transection of vascular tissue and spot coagulation of bleeding vessels. Not indicated for contraceptive coagulation of fallopian tubes, though may be used for hemostasis following fallopian tube transection.
Regulatory Classification
Identification
An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.
Submission Summary (Full Text)
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Image /page/0/Figure/3 description: This image contains the title "REFERENCE 3 510(K) SUMMARY OF SAFETY & EFFICACY". The image also contains the number K974250. The logo for Pilling Weck is also present. The date FEB 11 1998 is also included in the image.
## Versa Stating MULTIPOLAR SCISSORS AND CABLES: INSTRUCTIONS FOR USE
# Please read all information carefully. Fuller to property follow instructions may loss to clectrical fajury and result in improper functioning of device.
Important: This pelage intent is designed to provide instructions for we of the VersaStations MULTIPOLAR Sciences and Cables. It is not a reference to electrosurgical techniques.
#### Indications:
To congulate and transect vascular tissue simulaneously, to perform spot coagulation of bleeding vessels; to be used in open surgical procedures.
#### Description:
The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface.
The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.
#### Directions For Use:
Read all instructions carefully. Failure to peoply follow instructions may lead to clectical or thermal injury and one invester finctioning of the device. These instructions are recommended for general use of the device. Variations in use may occur in specific procedures due to individual technique and patient matomy.
- Verify commetibility of this device and its accessories with other equipment needed to conduct the surgical � procedure. The following electronical generators are compatible with the VersaStat™ cable: Valley Lab, Codman, Bircher, Conmed, Wolf, and Erbe.
- To be used in the dissection and transction of vascular tissue with the added feature of simultaneous � congulation of a bleeding vessel via a bipolar or monopolar current
- Insert the three comnector posts on the VersaStat™ MULTIPOLAR Scissors into the connector ports of cither � the bipolar or the monopolar VersaStat™ Cable. Due to this unique design, a grounding pad is not Decessary.
Caution: If the connection appears loose, inspect the scissor posts for any damage. If posts are damaged, do not use the scissors.
- Connect the VersaStat™ MULTIPOLAR Cable to the appropriate bipolar or monopolar output of the � electrosurgical generator. Refer to the electrosury cal generator manual for indications and instructions in making this connection.
- Set the electronization to bipolar or monopolar output. Adjust the power as low as possible to achieve . adequate hemostasis.
- � To congulate the tissue between the blades of the device, activate the bipolar or monopolar clostrosurgical generator by depressing the foot pedal.
- � Once coagulation is complete, inspect the surgical area to costre adequate hemostasis.
- Using the cable switch, select either blade or both for the coagulating function. �
#### Pretest to verify complete electrical activity:
- 1. Soak a 4" x 4" gauze pad with saline.
- 2. With device slightly open, firmly press the tips of the blades on the gauze pad. Make sure that the electrodes touch the pad.
- 3. Activate the bipolar mode foot pedal connected to the generator.
r - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
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Image /page/1/Picture/3 description: The image shows a logo with a stylized letter "W" on the left and the text "Pilling Weck" on the right. The "W" is a bold, geometric shape with a diamond-like element above it. The text "Pilling Weck" is in a bold, sans-serif font, with each letter clearly defined and spaced.
- Steam generation from the pad or sparking from the blades indicates active power and a complete circuit. The 4 device is ready to be used.
- If there is no steam or sparking: verify power switch is on and in bigolar mode. Ensure generator is functioning 5 property. Verify proper connections to generator and scissors. Add more salinc to ped. Ensure all electrodes are in contact with saline soaked rad. Decrease amount of pad surface contacting two blades. Turn power up in small increments.
## Contraindications:
The Versa States MULTIPOLAR Scieters are not indicated for contraceptive congulation of the failogian tubes, but may be used to achieve hemostatis following transection of the failopian tubes.
# Warnings and Precautions:
- A thorough understanding of the principles and techniques associated with electrosurgical procedures is . essential to avoid shock and burn hazards to both patient and medical personnel and damage to the device or other medical ingruments. Ensure that electrical issiation or grounding is not compromised.
- The Versa Stat™ MULTIPOLAR Sciesors are only competible with the VersaStat™ MULTIPOLAR Cable. �
- These acissors are not intended to be sharpened or repaired in any way. This may damage the electrodes. ◆
- Do not use abrasive cleaning tools or solutions on this device. �
- Never touch active blades of the scissors while energized. This may result in burns. .
- Do not touch the blades of the VersaStat™ Scissors to any staples or clips, �
- For custing and congraistica, lease the voltage/power as low as possible to actieve the desired effect. This is . needed due to inadvertent burning and increased potential for capacitance coupling at high powers.
## Cleaning and Sterilization Recommendations:
VersaStat™ Multipolar Scissors and Reusable Cables:
- Immediately after cach use soak theroughly in an enzyme cleaner approgriate for surgical instruments. Mix ◆ with warm tap water (100°F - 120°F) for approximately 5 minutes.
- Clean theroughly with a soft brush to loosen any congulum or dried blood. Be careful not to scratch the sufface � of the scissors. Do not disassemble the scissors.
- . Rinse thoroughly with warm water. Towel dry, treat with instrument licincant per hospital practice.
- Steam autoclave sterilization at a minimum temperature of 250° F for 15 minutes in accordance with ◆ AAMI/American National Standard ST8-113, Hospital Steam Sterilizers.
- May be ETO (ezs) sterilized in accordance with AAMI Recommended Practice/American National Standard � ST41-113. Good Hospital Practice: Ethylene Oxide Sterilization and Sterlity Assurance.
#### Caution:
Federal (USA) law restricts this device to sale by or on the order of a physician.
# CE 0120
Pilling Weck Inc. 420 Delaware Drive Fort Washington, PA 19034 (800) 523 - 2579 Customer Service (800) 523 - 6507 Made in USA
EU Authorized Representative: David Ball One Juno House Calleva Park Aldermaston, Berkshire England RG78RA
Rev. 11/97
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Richard G. Jones Vice President of Regulatory Affairs 420 Delaware Drive P.O. Box 7514 Fort Washington, Pennsylvania 19034
FEB 1 1 1998
Re: K974250 Trade Name: Versastat Multipolar Scissors and Cables Regulatory Class: II Product Code: GEI Dated: November 11, 1997 Received: November 13, 1997
Dear Mr. Jones:
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 (OS) 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. 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. Jones
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,
fo ceefs
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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Page of
510(k) Number (if known): K974250
VersaStatTM Multipolar Scissors and Cables Device Name:
Indications For Use: -
- to coagulate and transect vascular tissue simultaneously; .
- to perform spot coagulation of bleeding vessels; -
, i
- to be used in open. surgical procedures; -
(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
510(k) Number K974250
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Optional Formal 1-2-96)
