(98 days)
Not Found
Not Found
No
The device description and intended use are purely focused on the electrical connection function of cables, with no mention of any computational or analytical capabilities that would involve AI/ML. The "Not Found" entries for AI/ML mentions and performance study details further support this.
No
The device is an accessory that connects electrosurgical instruments to a generator to transfer power, it does not directly provide therapy itself.
No
Explanation: The device is an electrosurgical cable that transfers power from a generator to instruments; it does not gather or analyze data to identify a disease, condition, or provide information for diagnosis. Its function is to facilitate a therapeutic procedure.
No
The device description explicitly states it is a physical cable designed to transfer electrosurgical power, indicating it is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator." This describes a device used during a surgical procedure to deliver energy to tissue, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces this by stating the cables "transfer electrosurgical power" and are used with "electrosurgical instruments."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
Therefore, the Sutter Electrosurgical Cables are accessories used in electrosurgery, which is a medical procedure performed on a patient, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
To electrically connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sutter Electrosurgical Cables presented in this submission are substantially equivalent in design concepts, technologies and materials to their predicate devices. Sutter Electrosurgical Cables were validated through testing that supports the compliance of the devices to the Standards mentioned in Section 17 of this submission.
Sutter Electrosurgical Cables are substantially equivalent to their predicate devices in design concepts, technologies and materials. Testing demonstrates that these devices are as safe, as effective, and perform as well as or better than the legally marketed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Bipolar
Electrosurgical Cable |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sutter Medezintechnik GmbH
Tullastrasse 87
79108 Freiburg Germany |
| Proprietary
Name: | Sutter Electrosurgical Cables |
| Common
Name and
Classification: | Electrosurgical Cutting and Coagulation Device and Accessories
(79GEI, §878.4400, Class II) |
| Device
Description: | 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. |
| Intended Use: | To electrically connect monopolar/bipolar electrosurgical instruments to an
electrosurgical generator. |
| Test
Discussion: | Sutter Electrosurgical Cables presented in this submission are substantially
equivalent in design concepts, technologies and materials to their predicate
devices. Sutter Electrosurgical Cables were validated through testing that
supports the compliance of the devices to the Standards mentioned in Section
17 of this submission. |
| Test
Conclusion: | Sutter Electrosurgical Cables are substantially equivalent to their predicate
devices in design concepts, technologies and materials. Testing demonstrates
that these devices are as safe, as effective, and perform as well as or better than
the legally marketed devices. |
1
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.
2
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
3
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