Predicate Devices

K 970968

Reference Devices

K 981919

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical surgical instrument for grasping, cutting, and bipolar coagulation, with no mention of AI or ML features.

Therapeutic

Yes
The device is described as "bipolar tissue coagulation" forceps used in surgical procedures, directly indicating its therapeutic function by modifying biological tissue.

Diagnostic

No
The device is described as surgical forceps for tissue coagulation, which is a therapeutic function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical instrument (forceps) with a handle, jaws, and electrode inserts, designed for grasping, cutting, and coagulation. This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures." This describes a surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body (like blood, urine, or tissue biopsy).
Device Description: The description details a surgical instrument used for grasping, cutting, and coagulation during surgery. This aligns with a surgical device, not an IVD.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a biological sample.
- Providing information about a patient's health status based on sample analysis.
- Using reagents or calibrators.

In summary, the POWERGRIP coagulation forceps are a surgical instrument used for direct intervention on tissue during surgery, which is distinct from the function of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.

Product codes

85 HET, 78 KNS

Device Description

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).

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

K 970968

Reference Device(s)

K 981919

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

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. +49-7641-91 43 30 +49-7641-5 49 84 Fax D-79331 Teningen eMail info@bissinger.com Germany Internet www.bissinger.com

2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International Tel +31-20-428 95 91 Amstel 320-l 1017 AP Amsterdam Fax +31-20-428 94 29 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
(& Accessories)	85 HET	CFR 884.1720
	Unit, Electrosurgical, Endoscopic,
(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)

1

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

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

2

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.

3

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

4

Guenter Bissinger Medizintechnik GmbH

1

:

·

. .

:

SPECIAL 510(k)

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

Signature:

Matthias Bissinger

Matthias Bissinger Director, Product Development & Production

Date:

September 26 , 2003

5

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

ignature:

Matthias Bissinger
Director, Product Development
& Production

6

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.

7

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (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 (800) 638-2041 or (301) 443-6597 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

8

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)