(162 days)
Bipolar tissue coagulation in gynecologic and laparoscopic surgical procedures.
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).
The provided text is a 510(k) summary for the Guenter Bissinger Medizintechnik GmbH POWERGRIP Bipolar Coagulation Forceps. It's a regulatory document for a medical device and describes modifications to an existing device, rather than a study proving performance against acceptance criteria in the typical sense of a clinical trial or performance study.
Based on the document, here's what can be extracted and what information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not contain a table of acceptance criteria or reported device performance in the way a clinical study report would. Instead, it makes claims of substantial equivalence to a predicate device and states that modifications improve handling and do not affect safety or effectiveness.
| Acceptance Criteria (Implied) | Reported Device Performance (Claimed) |
|---|---|
| Safety and Effectiveness not adversely affected by modification | "THIS CHANGE DOES NOT AFFECT THE SAFETY OR EFFECTIVENESS OF THE DEVICE." |
| Improved handling control for direction and accuracy | "To improve handling control with respect to direction and accuracy of forceps during surgical procedures" |
| Easier, faster, more effective disassembly and re-assembly for exchange and reprocessing | "To make disassembly and re-assembly easier, faster and more effective for exchange of electrode jaws during procedure and for reprocessing." |
| Surgeon's control of electrode jaws improved | "the internal mechanical connection to the jaws improves the surgeon's control of the electrode jaws" |
| Well-adjustable opening and closing of jaws | "assures well adjustable opening and closing of the jaws with very high pressure during grasping and cutting and high precision in tissue coagulation." |
| No new risk for patient or surgeon | "The device modification introduces no new risk for patient or surgeon and enhances device safety and effectiveness when compared to the predicate." |
| Compliance with industry standards | "BISSINGER certifies compliance with all appropriate industry standards and the validation of methods and processes covered by these standards." |
| UL Compliant (implied acceptance criteria from predicate) | UL-544 |
| ISO Compliant (implied acceptance criteria from predicate) | ISO 9001 |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or a study involving a particular sample size of cases/patients. The submission is for a modification to an existing device and relies on showing substantial equivalence to a predicate device and that the change does not adversely affect safety or effectiveness. There's no mention of country of origin or whether hypothetical data would be retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document does not describe a study involving experts to establish ground truth. The claims made are based on design rationale and comparison to a predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no test set or study with expert ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done or described in this document. The submission is a regulatory filing for a device modification, focusing on substantial equivalence and design changes, not a comparative clinical effectiveness study.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical medical device (coagulation forceps), not an algorithm or AI.
7. Type of Ground Truth Used
Not applicable. No ground truth in the context of a performance study is mentioned. The "ground truth" for this regulatory submission is the substantial equivalence to the predicate device and the engineering/design justification that the modifications do not compromise safety or effectiveness.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set mentioned or relevant.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is mentioned.
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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. +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)
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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 BipolarCoagulation ForcepsK 970968 | ||
|---|---|---|---|
| Powergrip Handle | SE | ||
| Exterior Tube (Shaft, various lengths) | SE | Interior Tube (various lengths) | |
| Electrodes | Grasping Forceps(large, small, MicroFrance) (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
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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 BipolarCoagulation Forceps | Detachable BipolarCoagulationForceps |
|---|---|---|
| Catalog # | 824 xxxxx | 855 xxxxx |
| Intended Use | Bipolar tissue coagulation ingynecologic and laparoscopicsurgical procedures | Identical |
| Length | 200, 250, 340, 450 mm | 200, 340, 450 mm |
| Materials | PEEK, PTFE, Stainless Steels301, 303, 304, 420, Silicone | Identical |
| ForcepsStyles | Grasping jaws, small &curved scissors, MicroFrance, preparation forceps | Substantially Equivalent |
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Guenter Bissinger Medizintechnik GmbH
1
:
·
. .
:
:
SPECIAL 510(k)
| DesignComparison | Bissinger Powergrip BipolarCoagulation Forceps aredesigned to provide concentratedcutting force with surgeon's handcontrol. | The Bissinger Detachable BipolarCoagulation Forceps aredesigned to provide concentratedcutting force with surgeon's handcontrol. |
|---|---|---|
| Compressing the handle, closeselectrode jaws and gentlyreleasing it, opens them. | Compressing the handle, movesan inner tube forward to close thejaws. The tube recedes whencompression is released to open | |
| Jaw position can be changed360° by moving small wheel athandle with index finger andlocks into place during surgicalprocedure, reducing handdiscomfort/fatigue.The device is designed for rightand left-hand operation. Theoverall design is substantially | them again.The position of the jaws isregulated by turning a wheel atthe top rear of the handle. Aninternal locking mechanismassures that position duringsurgical procedure and reduceshand discomfort/fatigue. | |
| equivalent to previously cleared | The instrument is designed forboth right and left hand use. | |
| Safety &Effectivenessof OperatingPrincipleChange[807.92 (b)(1)] | and competitive devices.The change in jaw activationimproves the surgeon's controlover the closing and openingaction of the bipolar jaws. Theindications for use, materials, andgeneral operating instructionsremain identical. The differentinserts can be exchanged in | |
| seconds during surgicalprocedures. | ||
| The POWERGRIP dismantlesinto three parts for thorough andreliable reprocessing and tofacilitate repairs/replacement ofdefective parts. | ||
| The device modificationintroduces no new risk for patientor surgeon and enhances devicesafety and effectiveness whencompared to the predicate. | ||
| Careful attention must be paid toBissinger'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 &InsulationMaterial | PTFE jaws are Insulated up tothe end of the grasping or cuttingzone to avoid inadvertentcoagulation | Substantially Equivalent | |
| Control ofjaw position | 350° rotation of electrode insertby moving star-shaped wheelwith Index finger jaw positionremains stable with opening andclosing to ensure precise work.when dissecting, cutting,grasping and coagulating | Substantially Equivalent | |
| Sterile | No | No | |
| DesignComparison | The Bissinger Powergrip BipolarCoagulation Forceps is designedto provide concentrated/cuttingforce with surgeon's handcontrolCompressing the handle, closeselectrode jaws and gentlyreleasing it, opens themJaw position can be changed330° by moving small wheel athandle with index finger andlocks into place during surgicalprocedure. This reduces handdiscomfort/fatigue.The device is designed for rightand left-hand operation. Theoverall design is substantiallyequivalent to previously clearedand competitive devices. | The Bissinger Detachable BipolarCoagulation Forceps is designedto provide concentrated/cuttingforce with surgeon's handcontrol.Compressing the handle, movesan inner tube forward to close thejaws. The tube recedes whencompression is released to openthem again.The position of the jaws isregulated by turning a wheel atthe top rear of the handle. AnInternal locking mechanismassures that position duringsurgical procedure and reduceshand discomfort/fatigue.The instrument is designed forboth right and left hand use. | |
| UL Compliant | UL-544 | Identical | |
| ISO Compliant | ISO 9001 | Identical | |
| Safety &Effectivenessof OperatingPrincipleChange[807.92 (b)(1)] | The Jaw activation changeimproves the surgeon's controlover the closing and openingaction of the bipolar Jaws. Theindications for use, materials, andgeneral operating instructionsremain identical. The designchanges facilitate dis- andreassembly before and afterreprocessing. The changeintroduces no new risk for patientor surgeon and rather enhancesdevice safety and effectivenesswhen compared to the predicate.Careful attention must be paid toBissinger's user instructions. | ||
| Signature: | Date: September 26, 2003 | ||
| Matthias BissingerDirector, Product Development& 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 | (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
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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)
§ 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.