(287 days)
KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.
KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures
KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.
The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.
The provided text is a 510(k) summary for the KLS Martin Electrosurgical Instruments. This document asserts substantial equivalence to predicate devices rather than providing a study that establishes performance against specific acceptance criteria. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing identical or very similar technological characteristics and intended use, rather than conducting a de novo clinical trial with defined acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, including details like sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is not present in this 510(k) summary.
Here's why and what can be inferred:
- No Acceptance Criteria or Performance Study: The document explicitly states, "The KLS Martin Electrosurgical Instruments are identical in design, manufacturing, material and operation to the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables (K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968)."
- This is the core of a substantial equivalence claim. It means the manufacturer is asserting that since the device is identical or substantially similar to previously cleared devices, it inherently meets the same performance and safety standards as those predicates. There is no new performance data presented because the performance is assumed to be equivalent to the predicates.
- No AI Component: The device is an electrosurgical instrument (physical surgical tools). There is no mention of any AI or software component in the device's functionality. Therefore, questions related to AI performance, human-AI collaboration, sample sizes for AI training/testing, or ground truth for AI algorithms are not applicable to this submission.
In summary, based on the provided text, a table of acceptance criteria and a study proving the device meets these criteria cannot be generated because the 510(k) submission model used here is based on substantial equivalence to predicate devices, not on a new performance study with explicit acceptance criteria.
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JUN 1 2 2009
510(K) SUMMARY
Submitter:
.
Contact Person:
Date of Summary:
Device Name:
Trade Name:
Common Name:
Classification Name and Number:
Regulatory Class:
Predicate Devices:
Intended Use:
KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: 904-641-7746 Fax: 904-641-7378
Tom Faucett Product Marketing Liaison
18 May 2009
Electrosurgical Instruments
KLS Martin Electrosurgical Instruments
Electrosurgical, Cutting & Coagulation & Accessories
Electrosurgical, Cutting & Coagulation & Accessories (CFR 878.4400)
ll
Claris Non-Stick Bipolar Forceps (K051429)
BiTech Bipolar Scissors (K042077)
POWERGRIP Bipolar Coagulation Forceps (K033177)
Bissinger Cables (K981919)
Detachable Bipolar Coaqulation Bissinger Forceps (K970968)
KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar
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Kof.ros
Page 2 of 83
coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.
KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures
KLS Martin Electrosurqical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurqical generator to a bipolar instrument.
The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.
Technological Characteristics:
Similarities to Predicate:
The KLS Martin Electrosurgical Instruments are identical in design, manufacturing, material and operation to the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables
Device Description:
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Page 3 of 3
(K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968).
Substantial Equivalence:
5.3
Due to identical operating aspects, the design, the ability to be utilized with multiple generators and the same manufacturing facility as the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables (K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968) and have the same indications for use leads to the decision that the KLS Martin Electrosurgical Instruments are substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized shapes resembling birds in flight, arranged in a descending order of size.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 2 2009
KLS Martin L.P. % Mr. Tom Faucett Product Marketing Liaison 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K082505
Trade/Device Name: KLS Martin Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: April 28, 2009 Received: May 21, 2009
Dear Mr. Faucett:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing
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Page 2-Mr. Faucett
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
F.A. Dalla
Mark N. Melkerson Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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082505
Indications for Use
K082505 510(k) Number (if known):
Device Name:
KLS Martin Electrosurgical Instruments
Indications For Use:
Indications For Use: KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.
KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gyneoology and laparoscopic surgical procedures.
KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.
KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.
KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures
KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.
Prescription Use (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)
urrence of CDRH, Office of Device Evaluation (ODE)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K082505
Page 1 of
§ 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.