(37 days)
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.
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).
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:
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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.) |
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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.
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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.
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Adjudication method for the test set:
- Not applicable / Not provided.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
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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.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of this traditional medical device submission.
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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.
§ 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.