(14 days)
Not Found
No
The summary does not mention AI, ML, image processing, or any data-driven learning components. The device is described as an RF generator for coagulation, and the performance studies focus on substantial equivalence to a predicate device, which is typical for non-AI/ML devices.
Yes
The device is indicated for "coagulation of soft tissue," which is a therapeutic action.
No
Explanation: The "Intended Use / Indications for Use" states the device is "Indicated for coagulation of soft tissue," which is a treatment or surgical procedure, not a diagnostic one.
No
The device is described as an "RF Generator," which is a hardware component used in electrosurgery. The summary also mentions "Performance testing was done to validate its intended use," implying testing of a physical device. There is no mention of the device being solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation of soft tissue." This is a therapeutic procedure performed directly on a patient's body, not a diagnostic test performed on a sample taken from the body.
- Device Description: It's an "RF Generator," which is a piece of equipment used in electrosurgery for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to perform a surgical procedure.
N/A
Intended Use / Indications for Use
MSI S-500L RF Generator is intended for coagulation of soft tissue. These devices are intended for use by qualified medical personnel trained in the use of electrosurgery.
Product codes
GEI
Device Description
MSI S-500L RF Generator
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel trained in the use of electrosurgery.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was done to validate its intended use. The comparison and performance testing results in this 510(k) notification shows MSI S-500L RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K041980
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:
July 22, 2004
Name of the Device:
Trade / Proprietary Name: MSI S-500L RF Generator
Common / usual Name: Electrosurgical Generator and Accessories
Classification Name: Electrosurgical cutting and coagulation device (21CFR878.4400)
Predicate Devices:
MSI S-500 RF Generator (K033888)
Description:
MSI S-500L RF Generator
Statement of Intended Use:
MSI S-500L RF Generator 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 S-500L RF Generator 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 S-500L RF Generator is substantially equivalent to predicate device and is safe and effective in its intended use.
1
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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
Mr. Eric Kao Vice President of Quality and Regulatory Affairs MedSphere International, Inc. 48511 Warm Springs Boulevard, Suite 212 Fremont, California 94539
Re: K041980
Trade/Device Name: MSI S-500L RF Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 22, 2004 Received: July 23, 2004
Dear Mr. Kao:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enclosure) to regard change the Medical Device Amendments, or to commerce prior to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been rechasined in assee approval of a premarket approval application (PMA). allu Cosmetic 71ct (71ct) that do not see subject to the general controls provisions of the Act. The 1 ou may, dicierore, market are act recessful and requirements for annual registration, listing of general controls provisions 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 If your device is clusion (sovated with be major regulations affecting your device can Inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dr F 5 rocames a vour device complies with other requirements of the Act that I DA has made a determentlations administered by other Federal agencies. You must of any ireactal statutes and regulations and limited to: registration and listing (21 Comply with an the Act 810 cart 801); good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic fordt in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Eric Kao
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w you'ls ough finding of substantial equivalence of your device to a legally premaired notincation. The PDF Imaling or castion 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 If you desire specific arrious. Jose (301) 594-4659. Also, please note the regulation entitled, Comact the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response 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
fa Cclia 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
Indications for Use
| Applicant: | MedSphere International, Inc.
48511 Warm Springs Blvd., Suite 212
Fremont, CA 94539 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | K041980 |
| Device Name: | MSI S-500L RF Generator |
| 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. |
| Prescription Use | X OR Over-the-Counter Use |
| | (Per 21 CFR 801.109) |
| (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 | K041980 |
| (Optional format 1-2-06) | |