(82 days)
Not Found
No
The device description and intended use clearly define the device as simple electrical cords for connecting electrosurgical instruments to a generator. There is no mention of any computational or analytical functions, let alone AI/ML. The performance studies focus on electrical and mechanical properties, not algorithmic performance.
No.
The device is described as an accessory (cable/cord) for connecting electrosurgical instruments to a generator. It transmits current to the surgical instrument but does not directly provide therapy itself.
No
The device is described as an accessory (cautery cords) for connecting electrosurgical instruments to an electrosurgical generator for cutting and coagulation, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical cord with connectors, designed to transmit electrical current. The performance studies also involve physical testing (dimensional, mechanical, electrical safety). This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the cords are for connecting electrosurgical instruments to a generator for surgical cutting and coagulation. This is a therapeutic/surgical function performed on the patient, not a diagnostic test performed on a sample taken from the patient.
- Device Description: The description reinforces its role as an accessory for surgical instruments used during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely within the realm of surgical intervention.
N/A
Intended Use / Indications for Use
Intended Use: To connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.
Indications for Use: The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Product codes
GEI
Device Description
The Monopolar and Bipolar Cautery Cords have been designed as an accessory to electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments include scissors, forceps, and dissectors. The cord connects to the electrosurgical generator on one end and the active instrument on the other end. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generator-mating connector on the other end.
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)
Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and use in simulated surgical procedures.
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.
Olsen Medical Electrosurgical Cables/Adapters (K111262)
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
2014 JAN - 7
510(k) Summary
| 510(k) Owner: | Intuitive Surgical, Inc. |
|---|---|
| 1266 Kifer Road | |
| Sunnyvale, CA 94086 |
Contact:
Brandon Hansen Project Manager, Regulatory Affairs Phone Number: 408-523-7485 Fax Number: 408-523-8907 Email: Brandon.Hansen@intusurg.com
Date Summary Prepared: September 27, 2013
| Trade Name: | Monopolar and Bipolar Cautery Cord |
|---|---|
| Common Name: | Monopolar/Bipolar Electrosurgical Cord |
| Classification: | Class II |
| 21 CFR 878.4400, Electrosurgical Cutting and Coagulation | |
| Device and Accessories | |
| Product Codes: | GEI |
| Classification Advisory | |
| Committee: | General and Plastic Surgery |
| Predicate Device: | Olsen Medical Electrosurgical Cables/Adapters (K111262) |
Page 1
1
Device Description
The Monopolar and Bipolar Cautery Cords have been designed as an accessory to electrosurgical instruments where monopolar/bipolar electrosurgical cutting and coagulation is desired during surgery. Examples of such instruments include scissors, forceps, and dissectors. The cord connects to the electrosurgical generator on one end and the active instrument on the other end. The Monopolar and Bipolar Cautery Cords are insulated cords with an instrument-mating connector on one end and generatormating connector on the other end.
Intended Use:
To connect monopolar/bipolar electrosurgical instruments to an electrosurgical generator.
Indications for Use:
The Monopolar and Bipolar Cautery Cords are intended for connecting monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Technological Characteristics:
The Monopolar and Bipolar Cautery Cords are substantially equivalent to the predicate devices. Olsen Medical Electrosurgical Cables/Adapters (K11262) in terms of design, materials, technological characteristics, and intended use.
Performance Data:
Performance test data demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The testing conducted consisted of dimensional measurements, mechanical and functional verification, electrical safety, and use in simulated surgical procedures.
Summary:
Based on the intended use, indications for use, technological characteristics, and performance data, Monopolar and Bipolar Cautery Cords are substantially equivalent to the predicate devices, the Olsen Medical Electrosurgical Cables/Adapters
2
Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is arranged on a single line and appears to be a header or title. The font is a sans-serif typeface, and the overall impression is one of official documentation or signage.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2014
Intuitive Surgical, Inc. Mr. Brandon Hansen Project Manager, Regulatory Affairs 1266 Kifer Road Sunnyvale, California 94086
Re: K133167
Trade/Device Name: Monopolar and Bipolar Cautery Cords Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 6, 2013 Received: November 7, 2013
Dear Mr. Hansen:
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. 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. You must or any 1 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 (reporting of medical
3
Page 2 - Mr. Brandon Hansen
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director For Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number if known: K133167
Device Name: Monopolar and Bipolar Cautery Cords
INDICATION FOR USE:
for connecting The Monopolar and Bipolar Cautery Cords are intended monopolar/bipolar electrosurgical instruments to an electrosurgical generator to provide transmission of high frequency current from the electrosurgical generator to the surgical instrument.
Prescription Use _ X_
AND/OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 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)
Long H. Chen -A
for BSA
(Division Sign-off) Division of Surgical Devices 510(k) Number: K133167