(168 days)
Not Found
No
The document describes a standard electrosurgical system and does not mention any AI or ML components or capabilities.
Yes
The device is used for resection, ablation, coagulation of soft tissue, and hemostasis of blood vessels, which are therapeutic medical interventions.
No
The device is described as an electrosurgical system intended for "resection ablation and coagulation of soft tissue and hemostasis of blood vessels," which are therapeutic rather than diagnostic functions.
No
The device description explicitly states it is comprised of an electrosurgical generator, disposable probes, and a footswitch, which are all hardware components.
Based on the provided information, the SERFAS Energy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "resection ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints". This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The description of the system components (generator, probes, footswitch) aligns with a surgical electrosurgical system, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests to diagnose a condition, or providing information about a patient's health status based on sample analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The SERFAS Energy System's function is to perform surgical procedures.
N/A
Intended Use / Indications for Use
The SERFAS Energy System is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.
Product codes
GEI
Device Description
The SERFAS Energy System is a bipolar high frequency electrosurgical system comprised of an electrosurgical generator, a series of disposable, single use, probe styles, and a footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
joints such as the knee, shoulder, elbow, hip, ankle, and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K991960, K001588, K011634, K020832, K032504, K011083, K013463, K020557, K030551, K033584, K974022
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
DEC 2 1 2004
5900 Optical Court San Jose, CA 95138 t: 408 754 2000 f: 408 754 2505 www.stryker.com
stryker
Endoscopy
041810
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
December 2, 2004 Date
Device Name
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR 878.4400) |
|------------------------|-------------------------------------------------------------------------------------|
| Common and Usual Name: | RF System |
| Proprietary Name: | SERFAS Energy System |
Product Description
The SERFAS Energy System is a bipolar high frequency electrosurgical system comprised of an electrosurgical generator, a series of disposable, single use, probe styles, and a footswitch.
Intended Use
The SERFAS Energy System is indicated for resection ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle and wrist.
Predicate Devices
Stryker Endoscopy Radio Frequency Ablation System (SERFAS): K991960 ArthroCare System: K001588, K011634, K020832, K032504 ArthroCare ArthroWands: K011083, K013463, K020557, K030551, K033584 Mitek VAPR System: K974022
Substantial Equivalence
When compared to the predicated devices listed above the SERFAS Energy System has the same intended use and the technological differences do not raise new questions of safety and effectiveness. Therefore, the SERFAS Energy System is substantially equivalent to the predicate marketed devices.
Contact
Christopher Earley Senior Design Engineer Stryker Endoscopy
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 21 2004
Stryker Endoscopy c/o Mr. Nishith Desai TÜV Rheinland of North America, Inc. 12 Commerce Road Newtown, Connecticut 06470
Re: K041810
Trade/Device Name: SERFAS Energy System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 13, 2004 Received: December 15, 2004
Dear Mr. Desai:
We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becerer of 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 encreativent of the enactment date of the Medical Device Amendments, or to commerce prior to rial 2011-12-12 in accordance with the provisions of the Federal Food, Drug, de neces may been require approval of a premarket approval application (PMA). and Cosmotion Free (110) and the device, subject to the general controls provisions of the Act. The r ou may, cherefore, mailes of the Act include requirements for annual registration, listing of general voltable profice, 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 exassinou (tional 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 or any x 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.
2
Page 2 - Mr. Nishith Desai
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
3
Indications for Use
510(k) Number (if known): K041810
Device Name: SERFAS Energy System
Indications for Use:
The SERFAS Energy System is indicated for resection, ablation and coagulation of soft tissue and hemostasis of blood vessels in orthopedic and arthroscopic procedures of joints such as the knee, shoulder, elbow, hip, ankle, and wrist.
Prescription Use _ X (Per 21 CFR 801.109) OR
Over-The-Counter-Use__________________________________________________________________________________________________________________________________________________________
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Misiam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
K041810 510(k) Number___