(66 days)
Olsen Electrosurgical Inc. Bipolar Cables, Valleylab Reusable Cords/Connectors
Not Found
No
The device description and intended use clearly define the device as a simple electrical cable for transmitting power, with no mention of AI or ML capabilities.
No
The device is a cable that transmits electrical power to a surgical instrument, not a device that directly treats a condition or disease.
No
Explanation: The device is described as an electrosurgical cable for transmitting electrical power from a generator to a surgical instrument, indicating its use in therapeutic procedures, not diagnostic ones.
No
The device description clearly states it is a "line of non-sterile, reusable bipolar foot activated cables," which are physical hardware components used to transmit electrical power.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrosurgical procedures to provide transmission of electrical power...to a bipolar foot-activated instrument." This describes a device used during a surgical procedure on a patient, not a device used to examine specimens outside of the body (which is the definition of an IVD).
- Device Description: The description reinforces its use in electrosurgery by mentioning it fits various electrosurgical units.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting diseases or conditions, or providing information about a patient's health status based on in vitro testing.
Therefore, the Bissinger bipolar cable/cord is a surgical accessory used in electrosurgical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes
GEI
Device Description
Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.
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
qualified medical personnel trained in the use of electrosurgery.
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)
Olsen Electrosurgical Inc. Bipolar Cables, Valleylab Reusable Cords/Connectors
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
0
છે નિર્દ 6 1998
Image /page/0/Picture/1 description: The image shows a close-up of an eye on the left side of the image. The eye has a dark pupil and a visible lower eyelid. On the right side of the image, there is a series of handwritten numbers that appear to be "1981919". The numbers are written in a cursive style and are slightly slanted.
510(k) Summary of Safety and Effective 2. Günter Bissinger Medizintechnik GmbH
As required by Section 807.92(c)
Submitted by:
Günter Bissinger Medizintechnik GmbH Tel. Gottlieb-Daimier-Straße 5 Fax D-79331 Teningen/ Baden eMail Germany
01149 (7641) 9 14 33 0 01149 (7641) 5 49 84 BissingerM@aol.com
Contact Person:
Dagmar Mäser FDA Liaison Amstel 320-l 1017 AP Amsterdam The Netherlands
01131 (20) 428-9591 Tel. 01131 (20) 428-9429 Fax bsi(@xs4all.nl eMail
Date Summary Prepared:
May 26, 1998
Name of the Device:
Bissinger Cables Proprietary Name: Bipolar Cable/Cord Common/Usual Name: Electrosurgical Cutting and Coagulation Classification Name: Device and Accessories (per 21 CFR 878.4400)
Description:
Bissinger cables are a line of non-sterile, reusable bipolar foot activated cables fitting Erbe, Martin, Valleylab, Aesculap GK50, Codman CMC II, and other ES units.
Intended Use:
The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Industry Standards:
Bissinger certifies to comply with the required IEC. ANSI, and AAMI standards for manufacture, cleaning, sterilization and for the validation of these processes.
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1
Image /page/1/Picture/0 description: The image shows a drawing of an eye on the left side of the image. The eye is drawn in black and white, and it is facing to the left. On the right side of the image, there is a signature. The signature is written in black ink.
Predicate Devices: g)
Olsen Electrosurgical Inc. Bipolar Cables Valleylab Reusable Cords/Connectors
Predicate Comparison: h)
ate Comparing the Bissinger Bipolar Cables to predicate devices is attached.
Bissinger Bipolar Cables Substantial Equivalence Comparison to Predicate Devices:
| Manufacturer | Bissinger | Olsen | Valleylab |
|---|---|---|---|
| Device | Bipolar cable | Bipolar cable | Bipolar cable |
| Model(s) | 80100xx | 870,871,872 | E0019 |
| Intended Use | Transmission of | ||
| electrical power from | |||
| an electrosurgical | |||
| generator to a bipolar | |||
| foot activated | |||
| instrument | Transmission of | ||
| electrical power from | |||
| an electrosurgical | |||
| generator to a bipolar | |||
| foot activated | |||
| instrument | Transmission of | ||
| electrical power from | |||
| an electrosurgical | |||
| generator to a bipolar | |||
| foot activated | |||
| instrument | |||
| Length of Cable | 3 meters, 5 meters | 10 foot (3.05m) | 12 foot (3.66m) |
| Material of Outer | |||
| Cable Insulation | Silicone | Silicone | Silicone |
| Reusable/Single | |||
| Use? | Reusable | Reusable | Reusable |
| Provided Sterile? | No | No | No |
| Connector Types | |||
| Instrument End | Two types: either for | ||
| instruments with | |||
| standard American | |||
| two-pin type plugs, or | |||
| for instruments with | |||
| the standard | |||
| European flat plug | Two types: either for | ||
| instruments with | |||
| standard American | |||
| two-pin type plugs, or | |||
| for instruments with | |||
| the standard | |||
| European flat plug | For instruments with | ||
| standard American | |||
| two-pin type plugs | |||
| Connector Types | |||
| Generator End | Martin, Erbe, | ||
| Valleylab, Aesculap | |||
| GK50, Codman CMC | |||
| II, standard type | |||
| fitting all generators | |||
| utilizing the standard | |||
| receivers for | |||
| "Banana" inserts | Martin (872), Eder | ||
| (872), Wolf (872), | |||
| standard type fitting | |||
| all generators utilizing | |||
| the standard | |||
| receivers for | |||
| "Banana" inserts | |||
| (870,871) | Valleylab |
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Ms. Dagmar S. Maser Günter Bissinger Medizintechnik GmbH FDA Liaison Business Support, International Amstel 320-I 1017 AP Amsterdam - The Netherlands
Re: K981919
Trade Name: Bissinger Cables, Catalog Number 801000XX Regulatory Class: II Product Code: GEI Dated: May 27, 1998 Received: June 1, 1998
Dear Ms. Maser:
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 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 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 II (Special Controls) or 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 (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 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Dagmar S. Maser
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) 594-4595. Additionally, for questions on the promotion 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,
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
4
Günter Bissinger Medizintechnik GmbH
510(k) Number:
K98/9/9
Device Name:
Bipolar Cable/Cord
Classification Name:
Electrosurgical Cutting and Coagulation Device & Accessories
Product Code:
79 GEI Class II 21 CFR 878.4400
INDICATIONS FOR USE:
The Bissinger bipolar cable/cord is intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar output of an electrosurgical generator to a bipolar foot-activated instrument.
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
(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. 1981919
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
V
(Optional Format 1-2-96)