(98 days)
To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.
Sutter Electrosurgical Cables are electrosurgical accessories designed to transfer electrosurgical power to monopolar and bipolar instruments from an electrosurgical generator. The cables are designed to fit standard monopolar/bipolar instruments and generator connectors. Sutter Electrosurgical Cables are supplied non-sterile, and can be reused after cleaning and steam sterilization.
This 510(k) summary is for electrosurgical cables, which are accessories for a medical device. The document states that the cables were validated through "testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the provided text does not contain Section 17, nor does it detail specific acceptance criteria or the reported device performance in a quantifiable manner. It primarily asserts substantial equivalence to predicate devices based on design concepts, technologies, and materials, and general safety and effectiveness claims.
Therefore, much of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The submission refers to "Standards mentioned in Section 17," which is not included.
- Reported Device Performance: Not explicitly stated in the provided text in a quantifiable manner (e.g., specific thresholds or measurements). The conclusion states: "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified. The submitter is "Sutter Medezintechnik GmbH, Tullastrasse 87, 79108 Freiburg Germany," suggesting the testing might have occurred in Germany, but this is not explicitly stated as the provenance of the test data. The submission also states the cables are "supplied non-sterile, and can be reused after cleaning and steam sterilization," which implies certain sterilization validation tests would have occurred, but details are not provided.
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)
- Not applicable/Not mentioned. This type of information is typically relevant for studies involving subjective interpretation of medical images or clinical outcomes, which is not the case for electrosurgical cables. Testing for such devices usually involves engineering and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not mentioned. This is typically used in clinical studies with human assessors.
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
- Not applicable. This is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device. This refers to the performance of the electrosurgical cables themselves in a simulated or actual use environment according to engineering standards. The document only generically states "testing," without providing specifics of whether it was standalone performance or involved human components of a system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the human interpretation sense. For electrosurgical cables, "ground truth" would likely refer to established engineering performance standards (e.g., electrical conductivity, insulation integrity, mechanical strength, biocompatibility, sterilization efficacy) as defined by the "Standards mentioned in Section 17." The document explicitly states "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission."
8. The sample size for the training set
- Not applicable. This is not an AI-enabled device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not an AI-enabled device that uses a "training set."
Summary of available information:
The provided 510(k) summary for Sutter Electrosurgical Cables primarily focuses on demonstrating substantial equivalence to predicate devices. It states that "Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission." However, the specific details of these standards, the acceptance criteria derived from them, and the quantitative performance results are not included in the provided text. The document asserts that "Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices."
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510(k) Premarket Notification Sutter Medizintechnik GmbH Electrosurgical Cables 510(k) Summary
MAR 1 7 2008
November 27, 2007
The 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the Sutter BipolarElectrosurgical Cable |
|---|---|
| Submitter: | Sutter Medezintechnik GmbHTullastrasse 8779108 Freiburg Germany |
| ProprietaryName: | Sutter Electrosurgical Cables |
| CommonName andClassification: | Electrosurgical Cutting and Coagulation Device and Accessories(79GEI, §878.4400, Class II) |
| DeviceDescription: | Sutter Electrosurgical Cables are electrosurgical accessories designed totransfer electrosurgical power to monopolar and bipolar instruments from anelectrosurgical generator. The cables are designed to fit standardmonopolar/bipolar instruments and generator connectors. Sutter ElectrosurgicalCables are supplied non-sterile, and can be reused after cleaning and steamsterilization. |
| Intended Use: | To electrically connect monopolar/bipolar electrosurgical instruments to anelectrosurgical generator. |
| TestDiscussion: | Sutter Electrosurgical Cables presented in this submission are substantiallyequivalent in design concepts, technologies and materials to their predicatedevices. Sutter Electrosurgical Cables were validated through testing thatsupports the compliance of the devices to the Standards mentioned in Section17 of this submission. |
| TestConclusion: | Sutter Electrosurgical Cables are substantially equivalent to their predicatedevices in design concepts, technologies and materials. Testing demonstratesthat these devices are as safe, as effective, and perform as well as or better thanthe legally marketed devices. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2008
Sutter Medizintechnik GMBH % Boone Interactive Mr. Thomas A. Boone Consultant 353 Loma Larga Road Corrales, New Mexico 87048
Re: K073450
Trade/Device Name: Sutter Monopolar and Bipolar Electrosurgical Cables Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: February 21, 2008 Received: February 29, 2008
Dear Mr. Boone:
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 forth in the quality systems (QS) 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 - Mr. Thomas A. Boone
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark M. Milkman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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1041 �.
Indications for Use
| 510(k) Number (if known): | K073450 |
|---|---|
| Device Name: | Sutter Monopolar and Bipolar Electrosurgical Cables |
| Indications for Use: | To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator. |
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nil R P Ogl for rkm
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number_4013450
§ 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.