(86 days)
Not Found
No
The summary describes a mechanical surgical instrument with electrical coagulation capabilities, with no mention of AI or ML.
Yes
The device is used for cutting, dissecting, and coagulating tissue during surgical procedures, which are therapeutic actions.
No
The device is described as a surgical tool for dissecting, cutting, and coagulating tissue during general surgical procedures, not for diagnosing conditions.
No
The device description clearly describes a physical surgical instrument (scissors) with electrical components for bipolar coagulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dissecting, cutting and bipolar coagulation of tissue during general surgical procedures." This describes a surgical instrument used directly on the patient's tissue, not a device used to examine specimens in vitro (outside the body).
- Device Description: The description details a surgical tool with scissor blades and electrical contacts for coagulation. This aligns with a surgical instrument, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any process that would be performed in vitro to diagnose a condition.
Therefore, the BiTech bipolar scissors are a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors 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
BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.
A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.
*Patented: US 6,355,035, EPO 99107816.3.
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
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): 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
OCT 27 2004
Image /page/0/Picture/1 description: The image contains three text boxes. The first text box contains the logo "bissinger". The second text box contains the text "510(k) Notification" and "BiTech Bipolar Scissors". The third text box contains the text "Annex I, Page 2 of 4".
1. Device Name
| Trade Name: | BiTech Bipolar Scissors |
|---|---|
| Common Name: | Bipolar Scissors |
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
BiTech Bipolar Scissors are substantially equivalent to other legally marketed Bipolar Scissors from different manufacturers, e.g.
4. Description of the Device
BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.
A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.
*Patented: US 6,355,035, EPO 99107816.3.
5. Intended Use
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.
1
Image /page/1/Picture/0 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 uses a bold, sans-serif font.
510(k) Notification
BiTech Bipolar Scissors
Annex I, Page 3 of 4
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;
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; Electrosuraical 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 areas. Check insulation, cables and connectors for cuts, 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.
Sterilisation
Only a validated steam-sterilization process according DIN EN 554 that uses a sterlization 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.
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Image /page/2/Picture/0 description: The image shows three boxes with text inside. The first box contains the word "bissinger" and a logo. The second box contains the text "510(k) Notification" and "BiTech Bipolar Scissors". The third box contains the text "Annex I, Page 4 of 4".
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 BiTech Bipolar Scissors are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird with three curved lines representing its wings.
Public Health Service
OCT 2 7 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Guenter Bissinger Medizintechnik GmbH c/o Mr. Franz Menean Managing Director MEDAGENT GmbH & Co. KG 47. Griesweg Muehlheim, Baden-Wuerttemberg Germany 78570
Re: K042077
Trade/Device Name: BiTech Bipolar Scissors Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 26, 2004 Received: August 11, 2004
Dear Mr. Menean:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becament in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass based in 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, do noos mat have been that do not require approval of a premarket approval application (PMA). and Oosmeter For (1 roy that 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 may or cable for 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 - Mr. Franz Menean
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and in your finding of substantial equivalence of your device to a legally promated notification " 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 11 you dome 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 other general mornational 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,
Miriam C. Provost
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
5
Indications for Use
510(k) Number (if known): K042077
Device Name: BiTech Bipolar Scissors
Indications for Use:
BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or the Bircon Elipola. Other its and should not be used for these procedures.
Prescription Use __ 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)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number Kc42077
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