(24 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, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.
The provided text is a 510(k) summary and FDA clearance letter for the Starion Instruments Universal Power Supply (UPS). It indicates that the device is a Class II medical device (thermal cautery unit) and has been found substantially equivalent to a legally marketed predicate device (Starion Instruments Surgical Power Supply, K000893).
The details requested in your prompt (acceptance criteria, study results, sample sizes, ground truth establishment, expert qualifications, etc.) are typically found in a 510(k) submission's detailed safety and effectiveness section, sometimes within a "Special Controls" document, or in the Design History File of the device manufacturer. The provided public summary and clearance letter do not contain this level of detail regarding specific performance studies or acceptance criteria beyond stating substantial equivalence.
Therefore, based only on the provided text, I cannot fill in most of the requested table and study details.
Here's what can be inferred from the provided text, and what cannot:
Information Available from the Text:
- Device Name: Starion Instruments Universal Power Supply (UPS)
- Intended Use: Simultaneous cutting and cauterization of soft tissue during surgery.
- Predicate Device: Starion Instruments Surgical Power Supply (K000893)
- Regulatory Classification: Class II, Product Code HOO, Regulation Number 21 CFR 886.4115 (Thermal cautery unit)
- Basis for Clearance: Substantial Equivalence to a predicate device.
Information NOT Available from the Text:
- Specific quantitative acceptance criteria for performance.
- Results of concrete performance tests to demonstrate these criteria are met.
- Details of any specific studies (other than the implicit substantial equivalence comparison).
- Sample sizes for test sets or training sets.
- Data provenance for any hypothetical test sets.
- Number/qualifications of experts, adjudication methods.
- Whether MRMC or standalone studies were performed.
- Type of ground truth used or how it was established for any test/training data.
Why this information is not present in the provided text:
For a 510(k) submission relying on substantial equivalence to a predicate device, the primary "study" is often a comparison to the predicate device demonstrating that the new device has the same technological characteristics, intended use, and performs as safely and effectively as the predicate. While internal testing (e.g., electrical safety, EMC, functional performance) is conducted by the manufacturer, the detailed summary provided to the FDA and then released publicly for a simple Class II device like a power supply often focuses on the comparison to the predicate rather than extensive new clinical or performance studies with defined acceptance criteria in the same way a novel, high-risk device might.
The FDA's finding of "substantial equivalence" means they deemed the device to be as safe and effective as the predicate based on the information provided by the manufacturer, which would have included performance data, but this data is not detailed in the publicly available summary you've provided.
Therefore, the table and study description will largely be empty or state "Not specified in the provided document."
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Not Specified) | Reported Device Performance (Not Specified) |
|---|---|---|
| Functional/Safety | e.g., Output Power Tolerance | e.g., Meets +/- X% of nominal |
(Specific performance metrics for a power supply like output voltage stability, current delivery, overload protection, thermal performance, EMI/EMC compliance would be relevant but are not detailed in the provided text). | Substantially equivalent to predicate device (K000893) regarding intended use, target population, energy output, and principles of operation. | Not explicitly stated with quantitative metrics. The FDA's clearance implies the device's performance is deemed equivalent to the predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided document.
- Data Provenance: Not specified regarding any specific test sets. The clearance is based on comparison to a predicate device and likely internal design verification/validation testing conducted by the manufacturer (Starion Instruments Corporation, Saratoga, CA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The 510(k) summary focuses on substantial equivalence to a predicate device for an electrical medical device power supply. This type of device typically relies on engineering and electrical safety testing against recognized standards rather than expert consensus on a "test set" of clinical data in the way an AI diagnostic device would.
4. Adjudication method for the test set
- Not applicable/Not specified. See point 3.
5. 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
- No. This is not applicable to a universal power supply for cautery instruments. MRMC studies are specific to diagnostic devices, particularly those involving image interpretation by human readers, often comparing human performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a power supply, not an algorithm or an AI system. Its function is to power cautery instruments used by a surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified in the context of clinical "ground truth." For a power supply, "ground truth" would relate to its electrical and functional performance meeting engineering specifications and safety standards, as compared to the predicate.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
In summary: The provided 510(k) content is for an electrical power supply device cleared via substantial equivalence. It does not involve the types of studies (MRMC, standalone algorithm performance, AI training sets with expert-established ground truth) that your questions are designed to uncover for more complex diagnostic or AI-enabled medical devices. The "study" here is the manufacturer's demonstration to the FDA that their new UPS is as safe and effective as their previously cleared predicate device.
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DEC - 9 2004
Summary - 510(k) __ | < 043155 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 Surgical Power Supply, a legally marketed predicate device which has been granted marketing clearance via K000893.
The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.
Ri. Si
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
11/12/04
Date
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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three horizontal lines above it, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 9 2004
Mr. Brian Grigsby Vice President of Quality, Regulatory Affairs and Operations Starion Instruments Corporation 20665 Fourth Street Saratoga, California 95070
Re: K043155
Trade/Device Name: Starion Instruments Universal Power Supply (UPS) Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: II Product Code: HOO Dated: November 12, 2004 Received: November 26, 2004
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/dsma/dsmamain.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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Page 1 of 1
510(k) NUMBER (IF KNOWN): K043155
DEVICE NAME: _ AC Powered Thermal Cautery Unit
INDICATIONS FOR USE:
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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)
iriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_Ko4 3155
§ 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.