(64 days)
Arthrocare System 2000, Mitek VAPR System
Not Found
No
The 510(k) summary describes a standard electrosurgical system and makes no mention of AI, ML, or related concepts.
Yes
The device is intended for "ablation and coagulation of soft tissues, and hemostasis of blood vessels" in surgical applications, which are therapeutic actions.
No
The device description clearly states its purpose is for "ablation and coagulation of soft tissues, and hemostasis of blood vessels" as an electrosurgical system, not for diagnosing conditions.
No
The device description explicitly lists hardware components such as a generator, cable, probes, and a footswitch, indicating it is not a software-only device.
Based on the provided information, the SERFAS RF system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is designed for surgical use involving the ablation and coagulation of soft tissues and hemostasis of blood vessels within the body (in vivo).
- Device Description: The description confirms it's an electrosurgery system used for tissue modification in the presence of an irrigant during surgery.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. The SERFAS system does not perform any such analysis of specimens.
Therefore, the SERFAS RF system is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The SERFAS RF system is an electrosurgical system designed for general surgical use, including orthopedic and arthroscopic applications of ablation and coagulation of soft tissues, and hemostasis of blood vessels. The system is intended for use in arthroscopic surgery of the joints such as knee, shoulder, elbow, ankle, hip and wrist. The system is intended for use in saline solution, Ringer's lactate or other conductive solution as an irrigant.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Stryker SERFAS is a bipolar electrosurgery system for ablation and coagulation of tissue in presence of a conductive irrigant. The SERFAS system includes a generator, a cable, probes with a variety of tip configurations and a footswitch. The probes are packaged sterile and the generator, cable and footswitch are packaged non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Joints such as knee, shoulder, elbow, ankle, hip 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The SERFAS system is tested to the following voluntary consensus standards for electrosurgical devices (IEC 60601-2-2 and EN-60601-1). The software in the system conforms to IEC 601-1-4.
The parts of SERFAS contacting the patient are constructed of materials which are tested for biocompatibility per ISO-10993 and General Program Memorandum #G95-1. Sterilization of the SERFAS probes is per EN 550 (EtO) or EN 552 (Irradiation) and sterility is validated for a minimum sterility assurance level of 10°.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Arthrocare System 2000, Mitek VAPR System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/1 description: The image shows the logo for Stryker Endoscopy. The word "Stryker" is in a bold, sans-serif font, with the "S" slightly larger than the other letters. There is a registered trademark symbol to the right of the "r". Below "Stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font.
N 991960
SUMMARY OF SAFETY AND EFFECTIVENESS
Device Name
| Classification Name: | Electrosurgical Cutting and Coagulation Device and
Accessories (21 CFR 878.4400) |
|------------------------|----------------------------------------------------------------------------------------------------------------|
| Common and Usual Name: | RF System, RF Generator, RF Console, RF Probe, RF
Cable, RF Footswitch |
| Proprietary Name: | SERFAS System, SERFAS Generator, SERFAS
Console, SERFAS Probe, SERFAS Handpiece Cable,
SERFAS Footswitch |
This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.
The Stryker SERFAS is a bipolar electrosurgery system for ablation and coagulation of tissue in presence of a conductive irrigant. The SERFAS system includes a generator, a cable, probes with a variety of tip configurations and a footswitch. The probes are packaged sterile and the generator, cable and footswitch are packaged non-sterile.
The SERFAS system is tested to the following voluntary consensus standards for electrosurgical devices (IEC 60601-2-2 and EN-60601-1). The software in the system conforms to IEC 601-1-4.
The parts of SERFAS contacting the patient are constructed of materials which are tested for biocompatibility per ISO-10993 and General Program Memorandum #G95-1. Sterilization of the SERFAS probes is per EN 550 (EtO) or EN 552 (Irradiation) and sterility is validated for a minimum sterility assurance level of 10°.
The SERFAS is equivalent in safety and effectiveness to a variety of devices currently marketed including the Arthrocare System 2000 and the Mitek VAPR System. These devices use high frequency current to achieve the intended clinical purpose.
This device does not raise new issues when compared to its predicate devices or uses. Therefore, it is considered substantially equivalent to those devices.
Contact:
Date: June 3, 1999
N. Mani Prakash, Ph.D. Senior Design Engineer Stryker Endoscopy
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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 features a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 13 1999
N. Mani Prakash, Ph.D. Senior Design Engineer Stryker® Endoscopy 2590 Walsh Avenue Santa Clara, California 95051
Re: K991960
Trade Name: Stryker® Endoscopy Radio Frequency Ablation System (SERFAS) Regulatory Class: II Product Code: GEI Dated: June 3, 1999 Received: June 10, 1999
Dear Dr. Prakash:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - N. Mani Prakash, Ph.D.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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June 3, 1999
510(k) Number if known:_______________________________________________________________________________________________________________________________________________________
INDICATION FOR USE:
The SERFAS RF system is an electrosurgical system designed for general surgical use, including orthopedic and arthroscopic applications of ablation and coagulation of soft tissues, and hemostasis of blood vessels. The system is intended for use in arthroscopic surgery of the joints such as knee, shoulder, elbow, ankle, hip and wrist. The system is intended for use in saline solution, Ringer's lactate or other conductive solution as an irrigant.
(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 Devices | K99/960 |
| 510(k) Number |
| Prescription Use | X | OR | Over-the-Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) |
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