The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures.

The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.

Device Description

The DORO® Non-Stick Bipolar Forceps are for use in general surgical procedures. These devices are connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. The forceps are designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

During the coagulation of tissue, the coagulated tissue may stick to the forceps. This undesirable effect can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver allov tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations.

Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators.

The DORO® Bipolar Reusable Cables are non-sterile, reusable bipolar cables of 3 and 5 meters. They are designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch. The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twinpin connectors (2-banana plug). The cables are comprised of silicone (outer insulation), PTFE or FEP (core insulation), and Cu-wire poreless silver plated (wire).

The cable consists of a twin-pin connector (2-banana plug) that is comprised of silver plated bronze and insulated with silicone. The connector cable at the forceps end is comprised of bronze or brass - silver or nickel plated, Stainless Steel 1.4310, PP (Polypropylene or TPE).

AI/ML Overview

Here's an analysis of the provided text regarding the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables, focusing on acceptance criteria and study information:

Analysis:

The provided 510(k) Notification (K070997) does not contain a study that proves the device meets specific performance acceptance criteria in the manner typically seen for AI/ML or diagnostic devices.

Instead, this submission seeks substantial equivalence for the DORO® devices based on their similarity to legally marketed predicate devices and compliance with recognized performance standards for electrosurgical equipment. The "performance" discussed primarily relates to safety and functional standards, not to a measurement of diagnostic accuracy or clinical effectiveness against a set of predefined acceptance metrics for a novel technology.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this type of device and submission.

Detailed Breakdown based on the provided text:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance/Statement
General Safety and Effectiveness (Implicit)	Substantial equivalence to predicate devices (K51429, K992931 for forceps; K061835, K051429 for cables).
"Non-Stick" Property (for Forceps)	"This undesirable effect [tissue sticking] can be eliminated by the non-stick properties of the unique solid silver alloy tip forceps of the DORO line. The solid silver alloy tip provides excellent thermal properties and eliminates the difficult and time-consuming of the forceps during a procedure. The non-stick properties are permanent since it is not a coating and the non-stick properties are retained through repeated and frequent sterilizations." (This is a descriptive claim, not a quantitative performance metric with a defined acceptance threshold within this document).
Compatibility (for Cables)	"The cable fittings are compatible for use with: Erbe, Martin, Valleylab, Aesculap and other ES Generator Units with twin-pin connectors (2-banana plug)."
Sterilization (by user)	"The user may sterilize these devices by using a validated and applicable sterilization process." "Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes should be used." (Implicit acceptance is that the device withstands this process and remains functional and sterile.)
Compliance with Recognized 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 + 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: Electrosurgical Devices: Version: 01-May-2001. (The device's performance is implicit in meeting these standards, but specific criteria and test results are not detailed in this summary.)
Functionality (Forceps)	"designed to grasp and manipulate selected tissues. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch."
Functionality (Cables)	"designed to transport electrical power from a high-frequency electrosurgical generator by a foot-activated switch."
Limitations (Forceps)	"The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures." (This is a contraindication/limitation, not a performance metric itself.)

Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The submission focuses on substantial equivalence to existing devices and compliance with recognized standards rather than a clinical or performance study with a test set of data. The "tests" would have been conducted against the standards themselves (e.g., electrical safety, mechanical durability, sterilization validation), but the details of those internal test sets are not in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Ground truth establishment by experts is not relevant for this type of device submission where safety and functional compliance to standards are primarily demonstrated.
Adjudication method for the test set:
- Not applicable / Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/ML device, nor a diagnostic device that involves human readers interpreting results.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used:
- Not applicable. For this type of device, the "ground truth" would be the successful demonstration of compliance with the specified engineering and safety standards (e.g., electrical resistance within limits, mechanical strength, material biocompatibility, successful sterilization cycles), rather than clinical outcomes or expert consensus.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this traditional medical device submission.
How the ground truth for the training set was established:
- Not applicable.

Summary of the Study (or lack thereof, in the context of typical "device performance studies"):

The 510(k) K070997 for the DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables relies on a Substantial Equivalence pathway. This means that no specific clinical or performance study (in the sense of a trial with a defined 'test set' against a 'ground truth' for an AI/ML or diagnostic device) is presented within this summary.

Instead, the "study" is an assertion of equivalence and adherence to established regulatory and engineering standards. The key elements for proving acceptance were:

Predicate Device Comparison: The devices are compared to previously cleared, legally marketed bipolar forceps and reusable cables (e.g., Günter Bissinger Medizintechnik GmbH (K51429), e.g. Link Technology, Inc. (K992931) for forceps; Stryker Silverglide Bipolar Forceps Reusable Cables (K061835) and CLARIS bipolar forceps (K051429) for cables). The claim is that the DORO devices have the same intended use, similar technological characteristics (e.g., material for non-stick properties, cable construction, connectivity), and raise no new questions of safety or effectiveness.
Compliance with Recognized Standards: The devices are stated to comply with several international and national standards for medical electrical equipment and electrosurgical devices (DIN EN 60601-1, DIN EN 60601-2-2, ANSI/AAMI HF18-2001). This compliance implicitly means they have undergone testing to meet the safety and performance requirements outlined in these standards.
Sterilization Validation (by user): The document specifies a validated steam-sterilization process, implying that the device was tested to withstand and allow for effective sterilization by the end-user.

In essence, the "proof" is the argument for substantial equivalence and adherence to existing safety and performance standards for electrosurgical accessories, rather than a novel study demonstrating a new type of performance metric.

Summary

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K070997

510(k) Notification

DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories

APPENDIX I: Summary

1. Device Name

Trade Name:	DORO® Non-Stick Bipolar ForcepsDORO® Bipolar Reusable Cables
Common Name:	Bipolar ForcepsBipolar Reusable Cables

2. Classification

The DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables of pro med instruments GmbH can be classified according following Device Names and Product Codes:

Device	Device, Electrosurgical, Cutting & Coagulation & Accessories
Device description	Electrosurgical cutting and coagulation device and accessories
Medical Specialty	Part 878, General & Plastic Surgery
Product Code	GEI
Regulation Number	878.4400
Device Class	2
Description acc. 21 CFR 878.4400:	PART 878--GENERAL AND PLASTIC SURGERY DEVICESSubpart E--Surgical DevicesSec. 878.4400 Electrosurgical cutting and coagulation device and accessories.(c) Identification. An electrosurgical cutting and coagulationdevice and accessories is a device intended to remove tissue and controlbleeding by use of high-frequency electrical current.(d) Classification: Class II.

3. Substantial Equivalence

(a) DORO® Non-Stick Bipolar Forceps:

The DORO® Non-Stick Bipolar Forceps are substantially equivalent to other legally marketed Bipolar Forceps from different manufacturers, Günter Bissinger Medizintechnik GmbH (product: CLARIS NON-STICK bipolar forceps, K51429), e.g. Link Technology, Inc. (product: Silverglide Surgical Technologies, K992931).

Reusable Standard two-pin round connector cables are designed to work with all foot-switching bipolar electrosurgical generators.

pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax: 011-49-761 441510

MAY 16 2007

APPENDIX I, Page 2

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510(k) Notification

DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories

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APPENDIX I: Summary

(b) DORO® Bipolar Reusable Cables

The DORO® Bipolar Reusable Cables are equivalent to the Stryker Silverglide Bipolar Forceps Reusable Cables (K061835) and nearly equivalent to CLARIS bipolar forceps (K051429) except small changes of the material.

5. Intended Use

(a) DORO® Non-Stick Bipolar Forceps

The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended for use in general surgical procedures. They are connected through a suitable bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation is achieved using electrosurgical energy generated by the electrosurgical generator unit and activated by a footswitch.

The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterliization or tubal coagulation for sterilization procedures and should not be used for these procedures.

(b) DORO® Bipolar Reusable Cables

The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.

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 + 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: Electrosurgical Devices: Version: 01-May-2001.

APPENDIX I, Page 3

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510(k) Notification

DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories

Image /page/2/Picture/2 description: The image shows a logo with the letters 'rmi' stacked vertically. To the right of the letters, there is some smaller text that is difficult to read due to the image quality. The letters are in a bold, sans-serif font, and the overall design is simple and modern. The logo appears to be for an organization or company with the initials 'rmi'.

APPENDIX I: Summary

7. Sterilization by User

DORO® Non-Stick Bipolar Forceps and DORO® Bipolar Reusable Cables 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. Sterilize 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, voids, cracks, 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 sterlization.

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 sterilization.

Sterilization

Only a validated steam-sterilization process according DIN EN 554 / ISO 11134 that uses a sterilization cycle of 137°C / 280°F, 3 bar, for min. 15 minutes should be used.

(Note: Contact the manufacturer of your steam autoclave to confirm appropriate temperatures and sterilization times.)

Caution: Autoclave temperatures should not exceed 280°F (137°C); handles, insulation or other non-metallic parts may be damaged

Do not sterilize with hot air.

Do not use 'Flash' autoclave procedures.

8. Conclusion

Based on the available 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that DORO® Non-Stick Bipolar Forceps are substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pro Med Instruments GmbH % Pro Med Instruments, Inc. Mr. Edgar Schuele Managing Director 5450 Lee Street, Suite 1 Lehigh Acres, Florida 33971

MAY 16 2007

Re: K070997

Trade/Device Name: DORO® Non-Stick Bipolar Forceps DORO® Bipolar Reusable Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: April 5, 2007 Received: April 13, 2007

Dear Mr. Schuele:

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 such 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

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Page 2 - Mr. Edgar Schuele

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.

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 (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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Molkerson

Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Notification K070997 DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories APPENDIX II: Indication Of Use Statement

Image /page/5/Picture/1 description: The image shows a black and white graphic of the letter 'i'. The letter is stylized with a dot above a wavy line that forms the body of the letter. To the right of the letter, there is some text that is too blurry to read. The letter 'i' is oriented vertically in the image.

pro med instruments GmbH Company: 510 (K) Number (if known): K070997 DORO® Bipolar Reusable Cables Device Name: Electrosurgical Cutting and Coagulation Device & Accessories Classification Name: GEI, Class II 21 CFR 878.4400 Product Code:

INDICATION OF USE

The DORO® Bipolar Reusable Cables are designed to conduct electrical power from the output of a high frequency electrosurgical generator to the instrument.

(Division Sign-Off)

Division of General, Restorative,
(Division Sign-off)
and Neurological Devices
Division of General, Restorative,
and Neurological Devices
510(K)Numbe510(k)997Number

1070997

PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE AN ANOHTER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801 Subpart D) or

Over-The Counter Use (Per 21 CFR 801 Subpart C)

pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax.: 011-49-761 441510

APPENDIX II Page 2

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510(k) Notification K070997

DORO® Non-Stick Bipolar Forceps, DORO® Bipolar Reusable Cables and Accessories

APPENDIX II: Indication Of Use Statement

Company:	pro med instruments GmbH
510 (K) Number (if known):	K070997
Device Name:	DORO® Non-Stick Bipolar Forceps
Classification Name:	Electrosurgical Cutting and Coagulation Device & Accessories
Product Code:	GEI, Class It 21 CFR 878.4400

INDICATION OF USE

The DORO® Non-Stick Bipolar Forceps are designed to grasp, manipulate and coagulate selected tissue and are intended i ne DONO Nort Online Spotar - Shopp are connected through a suitable bipolar cable with the bipolar output of an electrofor dse in generator. Bipolar probation may are used with bipolar coagulation is achieved using electrosurgical generated. Elipolar for sope mebological generator unit and activated by a footswitch.

The DORO® NON-STICK Bipolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

(Division Sign-off)

Division of General, Restorative, and Neurological Devices

510(K)Number K070997

PLEASE DO NOT WRITE BELOW THIS LINE --CONTINUE AN ANOHTER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

X Prescription Use (Per 21 CFR 801 Subpart D) or

Over-The Counter Use (Per 21 CFR 801 Subpart C)

pro med instruments GmbH, Bötzinger Str. 38, 79111 Freiburg / Germany Phone: 011-49-761 441545, Fax : 011-49-761 441510

APPENDIX II Page 1

Regulation Number and Section

§ 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.