(112 days)
The Select - Sutter Electrosurgical Forceps and Electrodes are reusable Electrosurgical Forceps and Electrodes which have applications in laparoscopic, general, Neurologic and Thoracic applications in laparosoppid are designed to provide surgeons with an electrosurgical technique for coagulation. The accessories provide a method for aiding in electrosurgical rie accessories provice a migues and medical literature relative procedures. Surgical techniques and medical to tache consulted procedered. Complications, and hazards are to be consulted proceded the performance of any surgical procedures.
The Select-Sutter Electrosurgical Instruments are reusable surgical instruments which have applications in but not limited to; laparoscopic, general, neurologic and thoracic procedures The Forcens and Hierrories are designed to provide surgeons with an electrosurgical technique for coagulation.
The provided text is a 510(k) premarket notification for an electrosurgical cutting and coagulation device. It primarily details the device's classification, material composition, intended uses, and lists various types of testing that "will be completed, reviewed and approved prior to release and distribution of this product."
However, it does not contain the results of these tests, nor does it define specific acceptance criteria against which device performance is measured. The document states that testing will be conducted, implying that at the time of this filing, the comprehensive performance data and their comparison to acceptance criteria were not yet available.
Therefore, I cannot provide the requested information from the given text. Specifically:
- A table of acceptance criteria and the reported device performance: Not available. The document lists types of tests but not criteria or results.
- Sample sized used for the test set and the data provenance: Not available.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no study results are presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an electrosurgical instrument, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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K972008
Sept. 19, 1997
972008
SAFETY & EFFECTIVENESS DATA SUMMARY
( instituation Name Electrosurgical Cutung and Coagulation Device and Accessories I ommord sual Name: Electrosurgical Forceps and Electrodes N/A at this ume Propretary Name
Classification: Class II Electrosurgical cutting and coagulation Device and Accessories # 79GEI Reg. # 878.4400 Electrosurgical Electrodes # 79JOS Reg. # 878.4400
Performance Standards: Devices are manufactured according to cGMP's. MIL-STD 105E. AAMI and ASTM requirements, IEC 601 (2-2) and applicable Harmonized Standards
Material Composition
Material Composition: Surgical grade Stainless Steel (CrNiMo-alloy) certified according IC ISO 3832/1 and ASTM 899. Tefinn and plastics are identical to the materials used on modicale devices All of our products are manufactured from medical grade materials.
All materials were selected because of their stability to withstand Steam sterilization.
Testing conducted to assure safety and effectiveness include but is not limited to:
Note: This testing will be completed. reviewed and approved prior to release and mistribution I this product.
Dimensional Venfication I Pak lesting Functional Testing Visual Inspection Bioburden Stress/desiructive testing Accelerated Aging - Shelf Life Sterilization
Intended Uses:
The Select-Sutter Electrosurgical Instruments are reusable surgical instruments which have applications in but not limited to; laparoscopic, general, neurologic and thoracic procedures The Forcens and Hierrories are designed to provide surgeons with an electrosurgical technique for coagulation.
Page 10
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ellen Henke-Knupp European Surgical, Inc. 73 Eagles Nest Road Duxbury, Massachusetts 02332
SEP 1 9 1997
K972008 Re: Trade Name: Electrosurgical Forceps and Electrodes Regulatory Class: II Product Code: GEI Dated: July 18, 1997 Received: July 24, 1997
Dear Ms. Henke-Knupp:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Ellen Henke-Knupp
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
focallfo
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 - of - 1
!0(k) Number (it known)
Electrosurgical Forceps and Electrodes Device Name
Indications For Use
The Select - Sutter Electrosurgical Forceps and Electrodes are reusable Electrosurgical Forceps and Electrodes which have applications in laparoscopic, general, Neurologic and Thoracic applications in laparosoppid are designed to provide surgeons with an electrosurgical technique for coagulation. The accessories provide a method for aiding in electrosurgical rie accessories provice a migues and medical literature relative
procedures. Surgical techniques and medical to tache consulted procedered. Complications, and hazards are to be consulted proceded the performance of any surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Picollo
of General Restorative D
Prescription Use
(21 CFR 801.109)
[✓]
ાર
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.