POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX

K033177 · Gunter Bissinger Medizintechnik GmbH · HET · Mar 11, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K033177
• Device Name: POWERGRIP BIPOLAR COAGULATION FORCEPS, MODEL 824XXXXX
• Applicant: Gunter Bissinger Medizintechnik GmbH
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 11, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.

Device Story

POWERGRIP coagulation forceps are manual surgical instruments for grasping, cutting, and bipolar coagulation in minimally invasive surgery. The device consists of a handle, shaft, electrode inserts, and cables. The handle uses a double-hinge mechanism to actuate the jaws; a small wheel on the handle allows 360-degree rotation of the electrode insert, which locks into place. The device is designed for both right and left-hand operation. During surgery, the physician compresses the handle to close the jaws and releases it to open them. The device is intended for use by surgeons in clinical settings. The modification improves handling control, accuracy, and facilitates faster disassembly/re-assembly for reprocessing. The device benefits patients by providing high-precision tissue coagulation and high pressure during grasping and cutting.

Clinical Evidence

No clinical data. Substantial equivalence is based on design validation, comparison of materials, and mechanical performance testing.

Technological Characteristics

Materials: PEEK, PTFE, stainless steels (301, 303, 304, 420), silicone. Principle: Bipolar electrosurgical coagulation. Form factor: Handheld forceps with shaft lengths of 200, 250, 340, 450 mm. Connectivity: None. Sterilization: Compatible with standard reprocessing (jaws remain open during cleaning). Compliance: UL-544, ISO 9001.

Indications for Use

Indicated for bipolar tissue coagulation during gynecologic and laparoscopic surgical procedures.

Regulatory Classification

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.

Predicate Devices

• Bissinger Detachable Bipolar Coagulation Forceps (K970968)

Reference Devices

• Bipolar Cables (K981919)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "K033177 page 1/6" in a handwritten style. Below this, the text "SPECIAL 510(k)" is printed in a bold, sans-serif font. The text appears to be part of a document or label, possibly related to a medical device or regulatory submission.

Guenter Bissinger Medizintechnik GmbH

MAR 1 1 2004

### 510(k) SUMMARY of Safety 2. and Effectiveness

As required by Section 807.92(c)

2.1 Submitter: [807.92 (a)(1)] Guenter Bissinger Medizintechnik GmbH Gottlieb-Daimler-Str. 5 Tel. [phone] [phone] Fax D-79331 Teningen eMail [e-mail] Germany Internet www.bissinger.com

2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International Tel [phone] Amstel 320-l 1017 AP Amsterdam Fax [phone] The Netherlands eMail bsi(@xs4all.nl

### 2.3 Date Summary Prepared: [807.92 (a)(1)] September 24, 2003

| 2.4 | Device Names: [807.92 (a)(2)] | | |
|-----|------------------------------------------------------------------|-------------------------------|--------------|
| | Proprietary | POWERGRIP Coagulation Forceps | |
| | Common | Coagulation Forceps | |
| | Classification Name | Prod. Code | CFR |
| | Laparoscope, Gynecologic<br>(& Accessories) | 85 HET | CFR 884.1720 |
| | Unit, Electrosurgical, Endoscopic,<br>(with/without Accessories) | 78 KNS | CFR 876.4300 |

#### 2.5 Reason for Submission:

Change in control mechanism of forceps jaws

- 2.6 Modification to Existing Device: 1807.92 (a)(3)] Bissinger Detachable Bipolar Coagulation K 970968 Forceps (Cleared 05/21/98)

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K033177 page 46
SPECIAL 510(k)

#### Device Description: {807.92(a)(4)+(6)] 2.7

The POWERGRIP coagulation forceps are designed for grasping, cutting and bipolar coagulation in minimally invasive surgery.

The POWERGRIP handle actuates the jaws of the electrode inserts by means of a double-hinge and serves as the point of attachment for accessories (shafts, inserts, cables).

### Reasons for Device Modification: [807.92 (d)] 2.8 Control Mechanism Change:

- To improve handling control with respect to direction 1. and accuracy of forceps during surgical procedures;
- To make disassembly and re-assembly easier, faster 2. and more effective for exchange of electrode jaws during procedure and for reprocessing.

#### 2.9 Intended Use: [807.92 (a)(5)]

Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.

#### 2.10 System Components

The system consists of the following elements:

| POWERGRIP Bipolar Coagulation Forceps | | Detachable Bipolar<br>Coagulation Forceps<br>K 970968 | |
|----------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------|---------------------------------|
| Powergrip Handle | | SE | |
| Exterior Tube (Shaft, various lengths) | | SE | Interior Tube (various lengths) |
| Electrodes | Grasping Forceps<br>(large, small, Micro<br>France) (various types &<br>sizes) | SE | |
| " | Preparation Forceps<br>(various types & sizes) | SE | |
| " | Scissors Forceps | SE | |
| " | Dissecting Forceps (i.e.<br>Maryland) | SE | |
| Cables | | SE | |

K 981919 Bipolar Cables (GEI, Class II, CFR 878.4400), cleared 06/08/98

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K033177 page 3/6
SPECIAL 510(k)

#### Industry Standards: [807.92 (d)] 2.11

BISSINGER certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards.

- MRI Environment: [807.92 (d)] 2.12 Not applicable
#### Information Bearing on the Safety and Effectiveness: 2.13

[807.92 (b)(3)]

The Bissinger POWERGRIP Bipolar Coagulation Forceps have the same intended use as the previously cleared devices. There is no change in materials, classification or labeling. There is also no change in how the surgeon controls the device. The only change is the internal activation of the jaw movement.

THIS CHANGE DOES NOT AFFECT THE SAFETY OR EFFECTIVENESS OF THE DEVICE. Rather, the internal mechanical connection to the jaws improves the surgeon's control of the electrode jaws and assures well adjustable opening and closing of the jaws with very high pressure during grasping and cutting and high precision in tissue coagulation.

Like the predicate device, effective cleaning and sterilization are assured due to a built-in mechanism that keeps forceps jaws open during reprocessing.

There are no additional characteristics known that should adversely affect the safety and effectiveness of these devices.

The results of design validation raise no new issues of safety and effectiveness.

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K033177 page 4/6
SPECIAL 510(k)

# 2.14 C O M P A R I S O N of DESIGN + SAFETY and EFFECTIVENESS

| Device | POWERGRIP Bipolar<br>Coagulation Forceps | Detachable Bipolar<br>CoagulationForceps |
|-------------------|--------------------------------------------------------------------------------------|------------------------------------------|
| Catalog # | 824 xxxxx | 855 xxxxx |
| Intended Use | Bipolar tissue coagulation in<br>gynecologic and laparoscopic<br>surgical procedures | Identical |
| Length | 200, 250, 340, 450 mm | 200, 340, 450 mm |
| Materials | PEEK, PTFE, Stainless Steels<br>301, 303, 304, 420, Silicone | Identical |
| Forceps<br>Styles | Grasping jaws, small &<br>curved scissors, Micro<br>France, preparation forceps | Substantially Equivalent |

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## Guenter Bissinger Medizintechnik GmbH

1

:

·

. .

:

:

### SPECIAL 510(k)

| Design<br>Comparison | Bissinger Powergrip Bipolar<br>Coagulation Forceps are<br>designed to provide concentrated<br>cutting force with surgeon's hand<br>control. | The Bissinger Detachable Bipolar<br>Coagulation Forceps are<br>designed to provide concentrated<br>cutting force with surgeon's hand<br>control. |
|-------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Compressing the handle, closes<br>electrode jaws and gently<br>releasing it, opens them. | Compressing the handle, moves<br>an inner tube forward to close the<br>jaws. The tube recedes when<br>compression is released to open |
| | Jaw position can be changed<br>360° by moving small wheel at<br>handle with index finger and<br>locks into place during surgical<br>procedure, reducing hand<br>discomfort/fatigue.<br>The device is designed for right<br>and left-hand operation. The<br>overall design is substantially | them again.<br>The position of the jaws is<br>regulated by turning a wheel at<br>the top rear of the handle. An<br>internal locking mechanism<br>assures that position during<br>surgical procedure and reduces<br>hand discomfort/fatigue. |
| | equivalent to previously cleared | The instrument is designed for<br>both right and left hand use. |
| Safety &<br>Effectiveness<br>of Operating<br>Principle<br>Change<br>[807.92 (b)(1)] | and competitive devices.<br>The change in jaw activation<br>improves the surgeon's control<br>over the closing and opening<br>action of the bipolar jaws. The<br>indications for use, materials, and<br>general operating instructions<br>remain identical. The different<br>inserts can be exchanged in | |
| | seconds during surgical<br>procedures. | |
| | The POWERGRIP dismantles<br>into three parts for thorough and<br>reliable reprocessing and to<br>facilitate repairs/replacement of<br>defective parts. | |
| | The device modification<br>introduces no new risk for patient<br>or surgeon and enhances device<br>safety and effectiveness when<br>compared to the predicate. | |
| | Careful attention must be paid to<br>Bissinger's user instructions. | |

Signature:

Matthias Bissinger

Matthias Bissinger Director, Product Development & Production

Date:

September 26 , 2003

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| Guenter Bissinger Medizintechnik GmbH | | | |
|-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| | | | K033177, page |
| | | SPECIAL 510(k) | |
| Insulation &<br>Insulation<br>Material | PTFE jaws are Insulated up to<br>the end of the grasping or cutting<br>zone to avoid inadvertent<br>coagulation | Substantially Equivalent | |
| Control of<br>jaw position | 350° rotation of electrode insert<br>by moving star-shaped wheel<br>with Index finger jaw position<br>remains stable with opening and<br>closing to ensure precise work.<br>when dissecting, cutting,<br>grasping and coagulating | Substantially Equivalent | |
| Sterile | No | No | |
| Design<br>Comparison | The Bissinger Powergrip Bipolar<br>Coagulation Forceps is designed<br>to provide concentrated/cutting<br>force with surgeon's hand<br>control<br>Compressing the handle, closes<br>electrode jaws and gently<br>releasing it, opens them<br>Jaw position can be changed<br>330° by moving small wheel at<br>handle with index finger and<br>locks into place during surgical<br>procedure. This reduces hand<br>discomfort/fatigue.<br>The device is designed for right<br>and left-hand operation. The<br>overall design is substantially<br>equivalent to previously cleared<br>and competitive devices. | The Bissinger Detachable Bipolar<br>Coagulation Forceps is designed<br>to provide concentrated/cutting<br>force with surgeon's hand<br>control.<br>Compressing the handle, moves<br>an inner tube forward to close the<br>jaws. The tube recedes when<br>compression is released to open<br>them again.<br>The position of the jaws is<br>regulated by turning a wheel at<br>the top rear of the handle. An<br>Internal locking mechanism<br>assures that position during<br>surgical procedure and reduces<br>hand discomfort/fatigue.<br>The instrument is designed for<br>both right and left hand use. | |
| UL Compliant | UL-544 | Identical | |
| ISO Compliant | ISO 9001 | Identical | |
| Safety &<br>Effectiveness<br>of Operating<br>Principle<br>Change<br>[807.92 (b)(1)] | The Jaw activation change<br>improves the surgeon's control<br>over the closing and opening<br>action of the bipolar Jaws. The<br>indications for use, materials, and<br>general operating instructions<br>remain identical. The design<br>changes facilitate dis- and<br>reassembly before and after<br>reprocessing. The change<br>introduces no new risk for patient<br>or surgeon and rather enhances<br>device safety and effectiveness<br>when compared to the predicate.<br>Careful attention must be paid to<br>Bissinger's user instructions. | | |
| Signature: | | Date: September 26, 2003 | |
| | Matthias Bissinger<br>Director, Product Development<br>& Production | | |
| | | | 2-5 |

ignature:

Matthias Bissinger
Director, Product Development
& Production

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 1 2004

Gunter Bissinger Medizintechnik GMBH % Mr. Dagmar Masër Official Correspondent Business Support International Amstel 320-I, 1017 AP, Amsterdam THE NETHERLANDS

Re: K033177

Trade/Device Name: POWERGrip Bipolar Coagulation Forceps Regulation Number: 21 CFR 884.1720 Regulation Name: Gyneclogical Laparoscope and Accessories Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: II Product Code: 85 HET and 78 KNS Dated: February 5, 2004 Received: February 9, 2004

Dear Mr. Masër:

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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 one of the following numbers, based on the regulation number at the top of the letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogden

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k): Device Modification

| 510(k) Number | K033177 |
|---------------|---------|
|---------------|---------|

POWERGRIP Bipolar Coagulation Forceps Device Name

# INDICATION FOR USE

Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number k033177

Prescription Use
(Per CFR 801 109)

ાર

Over-The-Counter Use __

(Optional Pormat 1-2-96)