(58 days)
Not Found
No
The document describes a bipolar forceps with a non-stick coating and does not mention any AI or ML capabilities.
Yes
The device is designed to coagulate tissue, which is a therapeutic function.
No
Explanation: The device is described as bipolar forceps used for grasping, manipulating, and coagulating tissue with an electrosurgical generator. Its function is to perform a surgical procedure (coagulation), not to diagnose a condition or disease.
No
The device description clearly describes a physical medical device (bipolar forceps) made of a specific material with thermal properties, not a software-only product.
Based on the provided information, the Bissinger CLARIS NON-STICK bipolar forceps is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "grasp, manipulate and coagulate selected tissue" during surgical procedures. This is an in vivo (within a living organism) application, not an in vitro (outside of a living organism) diagnostic test.
- Device Description: The description focuses on the physical properties of the forceps and its function in tissue coagulation. It does not describe any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Information: There is no mention of analyzing blood, urine, tissue samples, or any other biological material to provide diagnostic information about a patient's health status.
- Connection to Electrosurgical Generator: The device is connected to an electrosurgical generator, which is used for surgical procedures, not diagnostic testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Bissinger CLARIS NON-STICK bipolar forceps does not fit this description.
N/A
Intended Use / Indications for Use
The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.
The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.
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
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUL 2 9 2005
Image /page/0/Picture/1 description: The image is a logo for "bissinger". The logo is a black letter "b" inside of an eye. The word "bissinger" is written in lowercase letters below the eye.
CLARIS NON-STICK
510(k) Notification
Annex I, Page 1 of 3
K 051429
Page 1 of (3)
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS IN Accordance with SMDA of 1990
DATE: 2005-05-19
Submitted by:
Guenter Bissinger Medizintechnik GmbH Gottlieb-Daimler-Str. 5 D-79331 Teningen Germany Phone: +49 (7641) 914330 Fax: +49 (7641) 54984 Email: info@bissinger.com
Official Correspondent: Matthias Bissinger
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Page ② of ③
Image /page/1/Picture/1 description: The image shows a logo with the word "bissinger" in lowercase letters. Above the word, there is a stylized eye graphic. The pupil of the eye is shaped like the letter "b". The logo is simple and modern, with a focus on the word "bissinger" and the eye graphic.
510(k) Notification
CLARIS NON-STICK
Annex I, Page 2 of 3
K 051429
1. Device Name
CLARIS NON-STICK Bipolar Forceps Trade Name: Bipolar Forceps Common Name:
2. Classification
| Device: | Device, Electrosurgical, Cutting & Coagulation & Accessories |
|---|---|
| Device description: | Electrosurgical cutting and coagulation device and accesso- |
| ries. | |
| Medical Specialty: | Part 878, General & Plastic Surgery |
| Product Code: | GEI |
| Regulation Number: | 878.4400 |
| Device Class: | 2 |
3. Substantial Equivalence
CLARIS NON-STICK Bipolar Forceps are substantially equivalent to other legally marketed Bipolar Forceps from different manufacturers, e.g. Link Technology, Inc. / Silverglide Surgical Technologies, K992931.
4. Description of the Device
During the coagulation of tissue the coagulated tissue might stick to the tip of the forceps. This undesirable effect can almost completely be avoided by using the new CLARIS NON-STICK bipolar forceps. By applying a material with excellent thermal properties for the forceps, difficult and time-consuming cleaning of the forceps during an operation is no longer necessary and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. By using a suitable connecting cable, CLARIS NON-STICK bipolar forceps can be connected to all high-frequency electrosurgical generators generally used.
5. Intended Use
The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate and coagulate selected tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.
The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
6. Performance Standards
DIN EN 60601-1: Medical electrical equipment - Part 1: General requirements for safety (IEC 60601-1:1988 + A1:1991 + A2:1995); German version EN 60601-1:1990 + A1:1993 + A2:1995; Version: 01-Mar-1996;
2
Image /page/2/Picture/1 description: The image shows a logo with the word "bissinger" in lowercase letters. Above the word, there is a stylized eye graphic. The pupil of the eye is shaped like the letter "b". The logo is contained within a rectangular border.
510(k) Notification
CLARIS NON-STICK
Page 3 of 3
Annex I, Page 3 of 3
DIN EN 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (IEC 60601-2-2: 1998); German version EN 60601-2-2:2000; Version: 01-Aug-2001;
ANSI/AAMI HF18-2001: Electrosurgical Devices; Version: 01-May-2001.
7. Sterilization by User
BiTech Bipolar Scissors are delivered in non-sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.
Cleaning and Maintenance
Every surgical instrument should be disinfected and thoroughly cleaned after each use. Proper cleaning, inspection and maintenance will help ensure correct function of the surgical instrument. Clean, inspect and test each instrument carefully. Sterilise all instruments before surgery. A good cleaning and maintenance procedure will extend the useful life of the instrument.
Special attention must be paid to slots, stops, ends, hollow tubes and other highly inaccessible Opolar attention mation, cables and connectors for cuts, voids, cracks, tears, abrasions, etc.
Do not use damaged instruments.
Cleaning and rinsing must take place immediately after each use for best effect. Failure to clean promptly may result in adherent particles or dried secretions that may resist cleaning and complicate or resist future sterilisation.
Instruments must be completely cleaned and rinsed of all foreign matter.
Use warm water and a commercially available instrument pre-soak or cleaning agent. Enzymatic cleaners (such as Enzol™) must be used to remove protein deposits. Follow the enzymatic cleaner's instructions; rinse thoroughly.
- · Do not use corrosive cleaning agents (i.e. bleach). Cleaning solutions and rinses at or near a neutral pH (7.0) are best.
- · Do not use abrasive cleaners.
- · Only a soft bristle brush should be used.
- · Immerse the entire device in detergent and clean while soaking. Rinse with sterile deionized water. Can be disinfected in the washing machine up to 203°F (95°C).
- · Rinse thoroughly with distilled water.
- · Prepare for storage and/or sterilisation.
Sterilization
Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes has to be used.
(Note: Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilisation times.)
Caution: Autoclave temperatures should not exceed 280°F (137°C); handles, insulation or other non-metallic parts may be damaged
Do not sterilise with hot air.
Do not use 'Flash' autoclave procedures.
8. Conclusion
Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that Bissinger CLARIS NON-STICK bipolar forceps are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three horizontal lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 9 2005
Guenter Bissinger Medizintechnik GmbH c/o Ms. Christa Heitmann-Franke MEDAGENT, Inc. One Park Avenue, Suite #5G Hampton, New Hampshire 03842
Re: K051429
Trade/Device Name: CLARIS NON-STICK Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 27, 2005 Received: June 10, 2005
Dear Ms. Heitmann-Franke:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 (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.
4
Page 2- c/o Ms. Christa Heitmann-Franke
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 (240) 276-0115. 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,
Stipt Rhodes
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number: K_ 051429
Device Name: CLARIS NON-STICK Bipolar Forceps
Indications for Use:
. .
The Bissinger CLARIS NON-STICK bipolar forceps are designed to grasp, manipulate The bloomger of and tissue. It is to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current.
The Bissinger CLARIS NON-STICK bipolar forceps has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
Prescription Use X YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 SFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hupt Rurdis
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_K051429