(260 days)
No
The document describes a standard electrosurgical probe and its intended use, with no mention of AI or ML capabilities. The performance studies focus on mechanical and thermal properties, not algorithmic performance.
No.
A therapeutic device is one that treats a disease or condition. This device is an electrosurgical probe that resects, ablates, and coagulates soft tissue; this description does not indicate that it is treating a disease or condition for therapy.
No
The device is described as an electrosurgical probe intended for resection, ablation, and coagulation of soft tissue, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is an electrosurgical probe, which is a physical hardware component used in surgical procedures. It is an accessory to existing energy and arthroscopy systems, also hardware.
Based on the provided information, the Stryker SERFAS 90-S Max electrosurgical probe is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states the device is an electrosurgical probe used for "resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels" during surgical procedures. It directly interacts with tissue within the body.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze specimens taken from the body. Its function is to modify tissue in situ.
Therefore, the Stryker SERFAS 90-S Max electrosurgical probe is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The Stryker SERFAS 90-S Max electrosurgical probe 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 Stryker SERFAS 90-S Max electrosurgical probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810 and K160050, and the Crossfire Arthroscopy System, marketed through K071859, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Stryker SERFAS 90-S Max electrosurgical probe was tested for performance in accordance with internal design specifications and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted: Aggressive Use, Tip Cantilever, Torsion in a Slot, Bending Moment, Impact, Electrode Pull, Heat, Captured Tip, Leak, Heat Shrink, Mechanical Force, Shaft Compression, Thermal Damage. All tests passed. Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 26, 2018
Stryker Benjamin Krebs Quality Engineer 5900 Optical Court San Jose, California 95138
Re: K171391
Trade/Device Name: Stryker 90-S Max SERFAS Energy Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2017 Received: May 11, 2017
Dear Benjamin Krebs:
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, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
X171391 510(k) Number (if known)
Stryker SERFAS 90-S Max Electrosurgical Probe Device Name
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1. General Information
| 510(k) Sponsor | Stryker Corporation |
|---|---|
| Address | 5900 Optical Court |
| San Jose, CA 95138 | |
| FDA Registration Number | 2936485 |
| Correspondence Person | Mr. Benjamin Krebs |
| Quality Engineer | |
| Stryker Corporation | |
| Contact Information | Email: ben.krebs@stryker.com |
| Phone: (408) 754-2897 | |
| Fax: (408)-754-2969 | |
| Date Prepared | January 25, 2018 |
2. Device Identification
| Proposed Device: | |
|---|---|
| Proprietary Name | Stryker® SERFAS 90-S Max Electrosurgical Probe |
| Common Name | RF Probe |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |
Primary Predicate Device:
| Proprietary Name | Stryker® SERFAS 90-S Electrosurgical Probe |
|---|---|
| Common Name | RF Probe |
| Premarket Notification | K160050 |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |
4
| Reference Device: | |
|---|---|
| Proprietary Name | SERFAS Energy System |
| Common Name | RF Probe |
| Premarket Notification | K041810 |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |
Device Description
The Stryker SERFAS 90-S Max electrosurgical probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810 and K160050, and the Crossfire Arthroscopy System, marketed through K071859, which is intended for resection, ablation, and coagulation of soft tissue via radiofrequency (RF) ablation. RF ablation probes are the main tool used in most arthroscopic procedures for the removal of tissue and the coagulation of bleeding vessels. The Proposed device is a disposable single-use electrosurgical device provided sterile via Ethylene Oxide sterilization.
3. Indications for Use
The Stryker SERFAS 90-S Max electrosurgical probe 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.
4. Comparison of Technological Characteristics with the Predicate Device
The Stryker SERFAS 90-S Max electrosurgical probe is similar to the predicate device with respect to technological characteristics and design. The modifications of the Proposed device, listed below, are minor and testing confirms that these modifications do not raise any new questions of safety or effectiveness, therefore supporting that the SERFAS 90-S Max electrosurgical probe is substantially equivalent to the predicate device currently on the market.
The following differences exist between the Proposed device and the predicate device:
- Probe Tip (Electrode and Ceramic) Design ●
- . Outer Lumen Heat Shrink Material
5
5. Performance Testing
The Stryker SERFAS 90-S Max electrosurgical probe was tested for performance in accordance with internal design specifications and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in the table below:
| Test Name | Description | Results |
|---|---|---|
| Aggressive Use | Determines if a probe can last its full lifetime without | |
| failure | Pass | |
| Tip Cantilever | Determines if the probe tip can withstand the normal and | |
| side force | Pass | |
| Torsion in a Slot | Determines if the probe tip can withstand torsional forces | Pass |
| Bending Moment | Verifies failure mode while probe is used in prying | |
| manner | Pass | |
| Impact | Determines a probe can survive an impact of a hard object | Pass |
| Electrode Pull | Determines the force at which the electrode is pulled out of | |
| the probe tip assembly | Pass | |
| Heat | Determines if the probe tip can withstand extreme | |
| temperatures | Pass | |
| Captured Tip | Determines strength of probe tip assembly | Pass |
| Leak | Determines if probe will allow leakage. | Pass |
| Heat Shrink | Determines mechanical strength of heat shrink | Pass |
| Mechanical Force | Determines if the probe can withstand representative | |
| compressive force on shaft | Pass | |
| Shaft Compression | Determines if the probe can withstand representative | |
| compressive force on shaft | Pass | |
| Thermal Damage | Determines the thermal effect on tissue of the proposed | |
| device compared to the reference device. | Pass |
Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria.
6. Conclusion
Based on the intended use, technological characteristics, performance testing, and non-clinical testing in comparison to the predicate device, the Stryker SERFAS 90-S Max electrosurgical probe does not raise any new questions of safety and effectiveness, therefore demonstrating substantial equivalence.