(430 days)
Not Found
Not Found
No
The device description focuses on the mechanical and electrical components for tissue coagulation and does not mention any AI/ML capabilities or related concepts like image processing, training data, or performance metrics associated with AI/ML.
No
The device is used for tissue destruction through coagulation during surgical procedures, which is an intervention rather than a therapeutic treatment in itself.
No
Explanation: The device is described as performing tissue coagulation, specifically for female sterilization and other operative procedures, by destroying tissue with high temperatures. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines multiple hardware components (Forceps Body, Exterior tube, Interior tube, Electrodes, plugs, Cable) and describes a physical mechanism of action (directing high frequency electrical current through tissue). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is used for "Bipolar tissue coagulation" during surgical procedures. It directly interacts with and modifies tissue within the body using electrical current and heat.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It is a surgical tool used for treatment and modification of tissue in situ.
Therefore, the bissinger® detachable bipolar coagulation-forceps is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Bipolar tissue coagulation in: Gynecology and Laparascopic surgical procedures
Product codes
85HIN, 85HET, 78KNS
Device Description
The bissinger® detachable bipolar coagulation-forceps is comprised of several detachable components: a Forceps Body (grip), an Exterior tube, an Interior tube (sliding tube), electrodes of varying types (1mm Electrode (fluted bit), 3mm Electrode (tong-type bit), Hirsch-electrode (rippled bar)), and various plugs (Erbe-type plug, Martin/Berchtold-type plug, Codman-type plug, Valleylab-type plug) to connect to different current generators, as well as a connecting Cable. The Forceps Body serves as the attachment point for all other components. The exterior and interior tubes, along with the electrodes, are available in multiple working lengths (200mm, 340mm, 450mm). The plugs facilitate connection to specific brands of current generators. The device is supplied clean only and requires sterilization before each use, with steam autoclave sterilization being the recommended method.
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)
Not Found
Reference Device(s)
WISAP bipolar coagulators available from WISAP USA.
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
tv and
bissinger®
distribute btc
detachable bipolar coagulation-force
Medizintechnik GmbH
Premarket Notification, Section 510(k)
Medizintechnik, GmbH
Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92
- Device Name:
| Trade Name: | bissinger® detachable bipolar coagulation-forceps |
|---|---|
| Common Name: | Coagulation forceps |
| Classification Name: | Bipolar, Coagulator-Cutter, Endoscopic, Bipolar and Accessories |
2. Establishment Name & Registration Number:
| Name: | Medizintechnik, GmbH |
|---|---|
| Number: | Pending |
3. Classification:
& 884.4150 Bipolar endoscopic coagulator-cutter and accessories.
(a) Identification. A bipolar endoscopic coagulator-cutter is a device used to perform female sterilization and other operative procedures under endoscopic observation. It destroys tissue with high temperatures by directing a high frequency electrical current through tissue between two electrical contacts of a probe. This generic type of device may include the following accessories: an electrical generator, probes, and electrical cables. (b) Classification. Class III (premarket approval). (c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 884.3.
[45 FR 12684-12720, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987]
| Device Class: | Class III |
|---|---|
| Classification Panel: | OB/GYN |
| Product Code: | 85HIN |
4. Device Description:
| Cat. # | Description |
|---|---|
| xx123 | Forceps Body |
| xx789 | Exterior tube (3 lengths) |
| xx234 | Interior tube (3 lengths) |
| xx567 | 1mm Electrode (fluted bit) (3 lengths) |
| xx890 | 3mm Electrode (tong-type bit) (3 lengths) |
| xx345 | Hirsch-electrode (rippled bar) (3 lengths) |
| xx678 | Erbe-type plug |
| xx901 | Martin/Berchtold-type plug |
| xx012 | Codman-type plug |
| xx111 | Valleylab-type plug |
| xx222 | Cable |
1
Forceps Body (grip). The handle is the attachment point for the other elements of the coagulation forcep. The exterior tube, internal tube, electrode and the current cable (with or without addapter) attach here.
Exterior tube. Available in three working lengths, 200mm, 340mm and 450mm. Please refer to the graphic representations in Appendix II for additional information.
Interior tube (sliding tube). Available in three working lengths, 200mm and 450mm. Please refer to the graphic representations in Appendix II for additional information.
1mm Electrode (fluted bit). Available in three working lengths, 200mm, 340mm and 450mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.
3mm Electrode (tong-type bit). Available in three working lengths, 200mm, 340mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.
Hirsch-electrode (rippled bar). Available in three working lengths, 200mm and 450mm to match the interior and exterior tube length selected. Please refer to the graphic representations in Appendix II for additional information.
Erbe-type plug. Used to connect the bissinger detachable bipolar coagulation-forceps to an Erbe brand current generator. Please refer to the graphic representations in Appendix II for additional information.
Martin/Berchtold-type plug. Used to connect the bissinger® detachable bipolar coagulationforceps to an Martin/Berchtold brand current generator Please refer to the graphic representations in Appendix II for additional information.
Codman-type plug. Used to connect the bissinger® detachable bipolar coagulation-forceps to a Codman brand current generator. Please refer to the graphic representations in Appendix II for additional information.
Valleylab-type plug. Used to connect the bissinger detachable bipolar coagulation-forceps to a Valleylab brand current generator. Please refer to the graphic representations in Appendix II for additional information.
Cable. Provides the flexible insulated cable to connect the instrument to the current generator.
5. Cleaning/Sterilization/Re-sterilization:
The surgical instruments required to properly use the device are supplied clean only and must be sterilized prior to each use. Remove all shipping and packaging materials before sterilization. Wash all instruments thoroughly prior to sterilization. For the instruments, the recommended method is steam autoclave sterilization. The recommended sterilization cycle is based on AAMI guidelines. The cycle is saturated steam at 270° F for 15 minutes.
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2
6. Equivalence:
Based on the materials, intended uses, design and clinical technique, the bissinger detactions bipolor coogulation-forceps are substantially equivalent to the referenced legally marketed WISAP bipolar coagulators available from WISAP USA.
7. Feature Comparison Table:
| FEATURE | bissinger® | WISAP - USA | SE? |
|---|---|---|---|
| Intended Use: | Yes | ||
| Materials: | PEEK, PTFE, stainless steel, | ||
| Silicone, Pa | Polyethylene, stainless | ||
| steel, | Yes | ||
| Length: | 200mm, 340mm & 450mm | 330mm & 450mm | Yes |
| Forcep Style: | 1mm Electrode (fluted bit) | ||
| 3mm Electrode (tong-type bit) | |||
| Hirsch-electrode (rippled bar) | WISAP - #7585, 7585-1 | ||
| WISAP - #7585, 7585-1 | |||
| WISAP - #7585-4, 7585-5 | Yes | ||
| Insulation Material: | PTFE | PTFE | Yes |
| UL Compliant: | UL-544 | UL-544 | Yes |
| ISO Compliant: | ISO-9001 | ISO-9001 | Yes |
| Manufacturer: | Medizintechnik, GmbH | WISAP USA | Yes |
| K-Number | Pending | Unknown | Yes |
952
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 21 lagg
Mr. David W. Schlerf Medizintechnik, GMBH c/o Buckman Company, Inc. 1000 Burnett Avenue, Suite 450 Concord, CA 94520
Re. K970968
Bissinger® Detachable Bipolar Forceps Dated: August 20, 1997 Received: February 20, 1998 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET 21 CFR 876.4300/Procode: 78 KNS
Dear Mr. Schlerf:
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, narket the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, issing 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 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 Admisstration (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
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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiliance at (301) 594-4613. Additioually, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (30) ) 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/dsmaldsmamain.html".
Sincerely vours,
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
Enclosure
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Page 1 __ of _ 1
K970968 510(k) Number:
Device Name: bissinger® detachable bipolar coagulation-foresps
Indications For Use:
Bipolar tissue coagulation in: Gynecology and Laparascopic surgical procedures
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thos h. Seymour
(Division Sign-Off) Division of Reproductive, Abdominal, ENT. and Radiological Devices 4776 510(k) Number
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Prescription Use ✓
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
(Per 21 CFR 801.109)
(Optional format 1-2-96)