(17 days)
For the simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.
The provided text is a 510(k) summary for the Starion Instruments Thermal Cautery Probe, which describes its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested table and details because the information is not present in the given document.
The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence based on the device's intended use, target population, energy source, and principles of operation being similar to the predicate device. It does not include a technical performance study with quantitative results against specific acceptance criteria.
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FEB 2 5 2005
Summary - 510(k)_K050308 Subject:
Starion Instruments Thermal Cautery Probe Product:
Summary:
This summary of 510(k) safety and effectiveness data is being submitted in accordance with the requirements of 21 CFR 807.92.
The Starion Instruments Thermal Cautery Probe is a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Food and Drug Administration has classified electrosurgical cutting and coagulating devices as Class II devices (21 CFR 878.4400).
The Starion Instruments Universal Thermal Cautery Probe is substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments Thermal Cautery Hook, a legally marketable predicate device which has been granted marketing clearance via K000296.
The Starion Instruments Thermal Cautery Probe allows the surgeon to position the probe in the region of tissue to be cauterized. The Thermal Cautery Probe features a handle, a finger/footswitch control and power cord for connection to a Starion Instruments power supply.
Binay Lim
Brian Grigsby - Submitter/Contact Person Vice President of Quality, Regulatory Affairs and Operations Starion Instruments Corporation 20665 Fourth Street Saratoga, CA 95070 Phone (408) 741-8773 Fax -(408) 741-8774
2/1/05
Date
Date
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.
FEB 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Grigsby Vice President of Quality, Regulatory Affairs and Operations Starion Instruments Corporation 20665 Fourth Street Saratoga, California 95070
Re: K050308
Trade/Device Name: Starion Instruments Thermal Cautery Regulation Number: 21 CFR 886.4100 Regulation Name: Radiofrequency electrosurgical cautery apparatus Regulatory Class: II Product Code: HQR Dated: February 4, 2005 Received: February 9, 2005
Dear Mr. Grigsby:
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.
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Page 2 - Mr. Brian Grigsby
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Miriam C Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN): __ K OS O 3 O 8
DEVICE NAME: ________ Thermal Cautery Probe
INDICATIONS FOR USE:
For the simultaneous cutting and cauterization of soft tissue during surgery.
Prescription Use (Per 21 CFR 901.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number 650308 Page 1 of 1
§ 886.4100 Radiofrequency electrosurgical cautery apparatus.
(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.