(67 days)
For the simultaneous cutting and cauterization of soft tissue during surgery.
Cutting of natural or synthetic, non-metallic, sutures during surgery.
The Starion Instruments Thermal Ligating Shears are a single use, handheld surgical instrument intended for simultaneous cutting and cauterization of soft tissue during surgery. The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a switch, which activates heating element(s) in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Starion Instruments Thermal Ligating Shears:
The provided text does not contain specific acceptance criteria or an analytical study report demonstrating the device meets those criteria. This document is a 510(k) summary and FDA clearance letter, which focuses on establishing substantial equivalence to a predicate device rather than detailing performance studies with specific metrics.
Therefore, many of the requested fields cannot be filled from the given information.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states the device is "substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments Thermal Cautery Grasper/Dissector." This implies performance is expected to be similar, but specific quantitative acceptance criteria or performance metrics are not given. | Not provided in the document. While the device is intended for "simultaneous cutting and cauterization of soft tissue," no specific performance data (e.g., cutting time, seal strength, temperature reached, tissue necrosis depth) is reported. |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified. (The document is a regulatory submission, not a study report.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set
- Adjudication method: Not specified.
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
- MRMC study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used
- Type of ground truth: Not applicable/Not specified. For a surgical instrument like this, "ground truth" would typically relate to objective tissue effects (e.g., proper hemostasis, clean cut, minimal thermal spread) rather than diagnostic accuracy. No such ground truth methodology is described.
8. The sample size for the training set
- Sample size: Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Ground truth establishment: Not applicable. As above, there is no training set for this type of device.
Summary of what the document does provide regarding device evaluation:
The document indicates that the Starion Instruments Thermal Ligating Shears obtained 510(k) clearance based on substantial equivalence to a predicate device, the Starion Instruments Thermal Cautery Grasper/Dissector (K002547). This means the FDA determined that the new device is as safe and effective as the legally marketed predicate device, without needing to demonstrate new performance metrics outside of comparative testing (which wouldn't be detailed in this summary). The basis for this equivalence is stated as "intended use, target population, energy source, and principles of operation."
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OCT 1 0 2006
Summary - 510(k) Subject:
Starion Instruments Thermal Ligating Shears 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 Ligating Shears are 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 Ligating Shears are substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments Thermal Cautery Grasper/Dissector, a legally marketable predicate device which has been granted marketing clearance via K002547.
The Starion Instruments Thermal Ligating Shears allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a switch, which activates heating element(s) in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and 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
OCT 1 0 2006
Starion Instruments % Mr. Brian Grigsby 20665 4" Street Saratoga, California 95070
Re: K062257
Trade/Device Name: Starion Instruments Thermal Ligating Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 18, 2006 Received: September 20, 2006
Dear Mr. Grisby:
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KO62257 510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
For the simultaneous cutting and cauterization of soft tissue during surgery.
Cutting of natural or synthetic, non-metallic, sutures during surgery.
Prescription Use X (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 Devies Evaluation (ODE)
R. R. R.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K062257 Page 1 of 1
§ 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.