(60 days)
Indicated for coagulation of soft tissue
These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.
The provided text is a 510(k) summary for the MSI SA Electrodes, which is an electrosurgical device. This document focuses on demonstrating substantial equivalence to a predicate device based on intended use and technological characteristics, and therefore describes performance testing rather than a study with acceptance criteria in the context of clinical AI/ML device evaluation.
The 510(k) summary explicitly states: "Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI SA Electrode is substantially equivalent to predicate device and is safe and effective in its intended use."
However, it does not provide the specific details required for the requested table and study information, such as:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are listed.
- Sample size used for the test set and the data provenance: Not mentioned, as it primarily refers to performance testing, not a clinical study on a test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as there's no clinical ground truth determination described.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No indication of an MRMC study. The device is an electrosurgical tool, not an AI/ML diagnostic tool, so such a study would not be relevant in this context.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable; this is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable; the "ground truth" would likely be based on engineering specifications and physical performance tests for an electrosurgical electrode (e.g., coagulation efficacy, temperature accuracy, insulation integrity).
- The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided 510(k) document is for a physical electrosurgical device and focuses on demonstrating substantial equivalence through performance testing, which is a different type of validation than the one typically described for AI/ML-based medical devices with specific acceptance criteria, clinical test sets, and expert-established ground truths. Therefore, the requested information elements are largely not present or applicable in this context.
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030996
Section E - 510(k) Summary
Submitted by:
MedSphere International, Inc.
48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539
Fax: 510-656-8816 Tel: 510-656-8232
Contact Person:
Eric Kao, Vice President of Quality and Regulatory Affairs
Date Summary Prepared:
March 28, 2003
Name of the Device:
Trade / Proprietary Name: MSI SA Electrodes
Common / usual Name: Electrosurgical electrode
Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)
Predicate Devices:
MSI TA Electrodes
Description:
The MSI SA series of disposable electrodes are electrosurgical devices used for coagulation of soft tissue. These devices are designed for percutaneous, laparoscopic or intraoperative use. The device consists of a needle electrode and a handle. For temperature measurement model, the needle contains a thermocouple for monitoring tissue temperature. The needle electrode is housed in an insulated cannula. The handle incorporates an electrical connector for interconnecting to an electrosurgical generator.
Statement of Intended Use:
MSI SA Electrode is intended for coagulation of soft tissue
This device is intended for use by qualified medical personnel trained in the use of electrosurgery.
Comparison to Predicate Devices:
MSI SA Electrode has been compared to previously 510(k) cleared device with respect to intended use and technological characteristics. Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI SA Electrode is substantially equivalent to predicate device and is safe and effective in its intended use.
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Image /page/1/Picture/1 description: The image shows a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three overlapping faces or heads, and three curved lines above the heads.
Public Health Service
MAY 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Eric Kao Vice President of Quality and Regulatory Affairs MedSphere International, Inc. 48511 Warm Springs Boulevard, Suite 212 Fremont, California 94539
Re: K030996
Trade/Device Name: MSI SA Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 28, 2003 Received: March 31, 2003
Dear Mr. Kao:
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. Eric Kao
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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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,
l. Mark N. Milkman
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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Section D - Statement of Indications for Use K030996
Indications for Use
| Applicant: | MedSphere International, Inc. |
|---|---|
| 48511 Warm Springs Blvd., Suite 212, Fremont, CA 94539 | |
| 510(k) Number (if known): | |
| Device Name: | MSI SA Electrodes |
| Indications For Use: | Indicated for coagulation of soft tissue |
| These devices are intended for use by qualified medical personnel trained in the use of electrosurgery. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE, IF NEEDED)
(Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K030996 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR Over-the-Counter Use |
|---|---|
| (Per 21 CFR 801.109) |
(Optional format 1-2-06)
§ 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.