(197 days)
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No
The summary describes a standard electrosurgical instrument system for manual operation and does not mention any AI or ML capabilities.
No
The device is used to dissect, grasp, manipulate, and cauterize tissues during surgery, which are actions commonly associated with surgical tools rather than devices designed to provide therapy.
No
The device is described as an Electrosurgical, Cutting & Coagulation system used to dissect, grasp, manipulate and/or cauterize tissues during surgical procedures, not to diagnose conditions.
No
The device description clearly indicates a "Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories," which are physical hardware components used in surgery. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used during surgical procedures to dissect, grasp, manipulate, and cauterize tissues. This is a direct interaction with the patient's body for treatment and manipulation, not for analyzing samples outside the body.
- Device Description: The description confirms it's a system of laparoscopic instruments for electrosurgical cutting and coagulation. This aligns with surgical tools, not diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on surgical intervention and manipulation of tissues in situ.
N/A
Intended Use / Indications for Use
The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.
Product codes
GEI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Surgical Innovations PLC % Mr. Paul Birtles Clayton Wood House 6 Clayton Wood Bank Leeds. West Yorkshire United Kingdom LS16 6ZQ
JAN 2 6 2012
Re: K111986
Trade/Device Name: Logic Laparoscopic Instrument System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories
Regulatory Class: Class II Product Code: GEI Dated: January 6, 2012 Received: January 10, 2012
Dear Mr. Birtles:
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
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Page 2 – Mr. Paul Birtles
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 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 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/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 yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Attachment 2
Indications for Use Statement K11986 510(k) Number Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Device Name Coagulation & Accessories Indications for Use The Logic Laparoscopic Instrument System, Electrosurgical, Cutting & Coagulation & Accessories is designed to dissect, grasp, manipulate and/or cauterise various tissues during manual operations in minimally invasive surgery and general endoscopic/laparoscopic procedures.
Prescription Use _X (Per 21 CFR 801.109) OR
Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of DFRH, Office of Device Evaluation (ODE)
signature
(Division ign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111986