(15 days)
For the simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, variable output and volume controls/indicators, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and audible tones to indicate activation of the instrument heating element.
The provided text is a 510(k) premarket notification summary and an FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). This document type, particularly a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and the results of a dedicated study to prove it.
Here's why the requested information cannot be fully provided from the given text:
- Type of Device: The Starion Instruments Universal Power Supply (UPS) is an AC powered unit intended for use with cautery instruments for simultaneous cutting and cauterization of soft tissue. This is a hardware device, not an AI/ML-driven device or a diagnostic tool that would typically have the kind of performance metrics (sensitivity, specificity, AUC) and ground truth methodologies associated with the requested table criteria.
- 510(k) Process: The 510(k) pathway for medical devices (Class II in this case) primarily requires demonstrating "substantial equivalence" to a legally marketed predicate device. This is often achieved through performance testing that confirms the new device meets established safety and performance standards for its type, and that its technological characteristics do not raise new questions of safety or effectiveness compared to the predicate. It does not typically involve the elaborate "study" structure implied by the questions, especially those related to AI algorithm performance evaluation.
Therefore, the document does not contain information on:
- A table of acceptance criteria and reported device performance (in the context of sensitivity/specificity/accuracy for an AI algorithm).
- Sample size, data provenance, or ground truth for a test set.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study, human reader improvement with AI, or effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
What the document does provide regarding "acceptance" implicitly:
- Intended Use: "For the simultaneous cutting and cauterization of soft tissue during surgery."
- Substantial Equivalence: The primary "acceptance criterion" met is demonstrating substantial equivalence to the predicate device (Starion Instruments Universal Power Supply, K043155) in terms of intended use, target population, energy output, and principles of operation.
- Device Features: The device features (on/off switch, LED, variable output/volume, outlets, audible tones) are described, implying these functionalities were tested to ensure they operate as intended and safely.
- Safety and Effectiveness: The 510(k) process is about ensuring safety and effectiveness. The FDA's clearance indicates they were satisfied that the device meets these general criteria based on the submitted information and comparison to the predicate.
In summary, the provided text describes a basic medical device (a power supply for cautery instruments) cleared through the 510(k) pathway, which focuses on substantial equivalence rather than the detailed performance study characteristics typically associated with AI/ML devices or diagnostic assays implied by your questions.
{0}------------------------------------------------
Summary - 510(k) _ KD 70871 Subject:
Product: Starion Instruments Universal Power Supply (UPS)
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 Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery. The Food and Drug Administration has classified thermal cautery units as Class II devices (21 CFR 886.4115).
The Starion Instruments Universal Power Supply (UPS) is substantially equivalent in terms of intended use, target population, energy output, and principles of operation to the Starion Instruments Universal Power Supply, a legally marketed predicate device which has been granted marketing clearance via K043155.
The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, variable output and volume controls/indicators, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and audible tones to indicate activation of the instrument heating element.
Bina Si
Brian Grigsby - Submitter/Contact Person Vice President of Quality, Regulatory Affairs and Operations Starion Instruments Corporation 775 Palomar Avenue Sunnyvale, CA 94085 Phone (408) 522-5200 Fax (408) 522-5201
3/28/07
Date
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Starion Instruments % Mr. Brian Grigsby VP of Quliaty, Regulatory Affairs & Operations 775 Palomar Avenue Sunnyvale, California 94085
APR 1. 3 2007
Re: K070871
Trade/Device Name: Universal Power Supply (UPS) Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: II Product Code: HQO Dated: March 28, 2007 Received: March 30, 2007
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
{2}------------------------------------------------
Page 2 - Mr. Brian Grigsby
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.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
K070871
Device Name: Universal Power Supply (UPS)
Indications For Use:
For the simultaneous cutting and cauterization of soft tissue during surgery.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number LO7084
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.