(98 days)
The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.
The provided text describes the 510(k) summary for the Dornier Bipolar Cable. This is a submission for a medical device that does not involve Artificial Intelligence (AI). The submission focuses on demonstrating substantial equivalence to a predicate device through conventional engineering and safety testing.
Therefore, many of the requested categories related to AI performance, such as sample sizes for test and training sets, expert consensus, adjudication methods, and MRMC studies, are not applicable to this document.
Here's the information that can be extracted or deduced from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility | Found to be acceptable |
| Packaging | Found to be acceptable |
| Biocompatibility | Found to be acceptable |
| Electrical Safety Testing (IEC 60601-1-2:2014) | Limited to Radiated Emissions (EN 55011), Radiated and Conducted Immunity (EN 61000-4-3 and EN 61000-4-6). Found to be acceptable. |
| Electrical Safety Testing (ANSI/AAMI/IEC 60601-2-2: 2009) | ACTIVE ACCESSORY HF leakage, ACTIVE ACCESSORY HF dielectric strength, ACTIVE ACCESSORY mains frequency dielectric strength. Found to be acceptable. |
| Dimensional Tests | Found to be acceptable |
| Connector grip test | Found to be acceptable |
| Continuity test | Found to be acceptable |
| Cable insulation HF and Mains Dielectric Strength test | Found to be acceptable |
| Cable tensile strength tests | Found to be acceptable |
| Activation recognition and operation | Found to be acceptable |
| Insulation Resistance | Found to be acceptable |
| Endurance Test | Found to be acceptable |
| Connector pull force | Found to be acceptable |
| Surface temperature measurement test | Found to be acceptable |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the device is a physical electrosurgical cable and its evaluation did not involve a "test set" in the context of an AI algorithm or data analysis study. The testing performed was engineering and safety validation. The provenance of test data for physical components is not usually detailed in this manner for 510(k) submissions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. "Ground truth" in this context typically refers to the confirmed diagnostic or clinical reality for evaluating an AI model. For a physical medical device, the "ground truth" is established through adherence to engineering standards and validated test methods by qualified engineers and technicians, not through expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there was no test set requiring expert adjudication in the context of an AI system.
5. 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
This information is not applicable as the device is a physical electrosurgical cable and does not involve AI assistance for human readers or direct comparative effectiveness in that manner.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as there is no algorithm or AI component in this device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on meeting established engineering standards and validated test methods for its physical and electrical properties. This is typically determined by physical measurements, electrical tests, and adherence to regulatory standards (e.g., IEC 60601 series).
8. The sample size for the training set
This information is not applicable as there is no AI component or training set for this device.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI component or training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
May 19, 2021
Dornier MedTech America, Inc. John S. Hoffer Vice President Quality, Regulatory, Clinical 1155 Roberts Boulevard, Suite 100 Kennesaw, GA 30144
Re: K210394
Trade/Device Name: Dornier Bipolar Cable Regulation Number: 21 CFR§ 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: April 15, 2021 Received: April 16, 2021
Dear John S. Hoffer:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark J. Antonino, M.S. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210394
Device Name
Dornier Bipolar Cable
Indications for Use (Describe)
The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
Dornier Bipolar Cable
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Dornier MedTech America, Inc. 1155 Roberts Blvd., Suite 100 Kennesaw, GA 30144
Date Prepared: 02/05/2021
Contact Person: John Hoffer Phone: 770-514- 6163
Name/Address of Sponsor and Name of Device
Dornier MedTech America, Inc. 1155 Roberts Blvd. Kennesaw, GA 30144
| Trade Name: | Dornier Bipolar Cable |
|---|---|
| Common Name: | Electrosurgical accessory |
| Classification Name: | Endoscopic electrosurgical unit and accessories |
| Regulation Number: | 21 CFR 876.4300 |
| Regulatory Class: | II |
| Product Code: | FAS |
Predicate Device
Olympus Resection Electrodes with HF cable (K171965)
Purpose of the 510(k) Notice
The purpose of this submission is to obtain marketing clearance for the Dornier Bipolar Cable product line.
Intended Use/Indications for Use
The Dornier Bipolar Cable is indicated to be used with a compatible electrosurgical generator and an HF electrode for endoscopic treatment in urological applications: Cutting, ablation, resection, vaporization and coagulation with HF current.
Device Description
The Dornier Bipolar Cable is a sterile, single use, disposable device that allows connection of an electrosurgical generator to an HF electrosurgical resection and vaporization electrode. The outer body of the Dornier Bipolar Cables are constructed of a medical grade thermoplastic elastomer. The cable consists of a double wire zip cord with one plug end which has four (4) banana and one (1) straight pin, style of connector that is then attached to the generator. The other end is separated and has two (2) overmolded connectors, one male pin on a wire and one female pin on a wire which are compatible with the HF Electrode.
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K210394 Page 2 of 2
Technological Characteristics
The Dornier Bipolar Cable has similar technological characteristics as the predicate device, The Olvmpus Resection Electrodes with HF cable (K171965). It should be noted that this submission is for the connection cable only and does not contain an electrode. The subject and predicate cable device are based on the following technological elements:
- Similar indications for use
- Similar design features
- Similar technological features
- Provided sterile for single-use
The basic characteristics of the Dornier Bipolar Cable are substantially equivalent to the cable included within the predicate device submission.
Performance Data
The Dornier Bipolar Cable was subjected to the following tests to assure design and performance under the specified testing parameters:
Sterility Packaging Biocompatibility Electrical Safety Testing IEC 60601-1-2:2014 Testing limited to Radiated Emissions (EN 55011) Radiated and Conducted Immunity (EN 61000-4-3 and EN 61000-4-6)
ANSI/AAMI/IEC 60601-2-2: 2009 201.8.8.3.102 ACTIVE ACCESSORY HF leakage, 201.8.8.3.103 ACTIVE ACCESSORY HF dielectric strength, 201.8.8.3.104 ACTIVE ACCESSORY mains frequency dielectric strength
- Dimensional Tests Connector grip test Continuity test Cable insulation HF and Mains Dielectric Strength test Cable tensile strength tests Activation recognition and operation Insulation Resistance Endurance Test Connector pull force Surface temperature
measurement test
All testing was found to be acceptable and substantially equivalent to those of the predicate device.
Substantial Equivalence
A comparison of design characteristics has been performed and demonstrates that the proposed Dornier Bipolar Cable is substantially equivalent to the predicate device in terms of intended use, technological characteristics, type of materials and performance characteristics. Therefore, the proposed Dornier Bipolar Cable is as safe, as effective, and performs as well as the predicate device.
Conclusion
Based on the data and information comparing the Dornier Bipolar Cable and the predicate device we conclude they are substantially equivalent as they have the same intended use, basic design, principle of operation, technology, materials, and performance to the predicate. Any minor differences between the subject and predicate device do not raise any concerns regarding the overall safety or effectiveness. Thus, the Dornier Bipolar Cable is substantially equivalent to its predicate device.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).