(113 days)
No
The document describes a standard electrosurgical probe and does not mention any AI or ML capabilities.
Yes
The device is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels, which are considered therapeutic actions.
No
The device is an electrosurgical probe intended for resection, ablation, and coagulation of soft tissue and hemostasis, which are therapeutic functions, not diagnostic ones.
No
The device is a physical electrosurgical probe, a hardware component, and not solely software.
Based on the provided information, the Stryker SERFAS 90-S Electrosurgical Probe is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is 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 (which is the definition of an in vitro diagnostic).
- Device Description: The device is described as an "electrosurgical device" used for "RF ablation". This is a type of surgical tool.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis.
Therefore, the Stryker SERFAS 90-S Electrosurgical Probe is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Stryker SERFAS 90-S 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 Electrosurgical Probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810, 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 Electrosurgical probe was tested for performance in accordance with internal design specification and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in this premarket notification:
- Aggressive Use: Determines if a probe can last its full lifetime without failure while being subjected to an extended activation period on tissue at the highest power setting. Results: Pass
- Tip Cantilever: Determines if the probe tip can withstand the normal, side, and back force required to permanently deform the lumen. Results: Pass
- Electrode Bend: Verifies the electrode can withstand a 7lb force for a worst case scenario. Results: Pass
- Thermal Expansion (Heat) Test: Verifies that the SERFAS probe tip assembly does not experience thermal expansion capable of causing catastrophic failure when subject to excessive heat. Results: Pass
- Leak: Verifies the condition of the ceramic-outer lumen assembly and the condition of the suction clamp of all styles of Stryker and non-Stryker RF ablation probes. Results: Pass
- System Compatibility: Verifies that the electrosurgical probe is compatible with Stryker's legally marketed consoles. Results: Pass
Biocompatibility was assessed in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and related collateral standards for patient contacting materials (see Section 15 -Biocompatibility).
Sterilization was assessed in accordance with ISO 11135:2014 - Sterilization of health-care products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. Sterilization residuals were assessed in accordance with ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (see Section 14 - Sterilization and Shelf Life).
Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. Test results obtained verified the safety and effectiveness of the device per design specifications and applicable standards (see Section 18 - Performance Testing - Bench).
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 3, 2016
Stryker Corporation Somi Ekwealor Regulatory Affairs Analyst 5900 Optical Court San Jose, California 95138
Re: K160050
Trade/Device Name: SERFAS 90-S Electrosurgical Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: April 1, 2016 Received: April 4, 2016
Dear Somi Ekwealor:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Jennifer R. Stevenson -A
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
| K160050 | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Page 1 of 1 | Page 19 of 681 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------|
| | Indications for Use | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. | |
| 510(k) Number (if known) | K160050 | | |
| Device Name | Stryker® SERFAS 90-S Electrosurgical Probe | | |
| Indications for Use (Describe) | The Stryker SERFAS 90-S 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. | | |
| Type of Use (Select one or both, as applicable) | | | |
| | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
| FORM FDA 3881 (8/14) | Page 1 of 1 | PSC Publishing Services (301) 443-6740 | EF |
|---|---|---|---|
| ---------------------- | ------------- | ---------------------------------------- | ---- |
189 ງຸງ 10 6 ໂ ລອງປີ 1
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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. Somi Ekwealor, MSRS, RAC |
| Regulatory Affairs Analyst | |
| Stryker Corporation | |
| Contact Information | Email: somi.ekwealor@stryker.com |
| Phone: (408) 754-2356 | |
| Fax: (408) 754-2507 | |
| Date Prepared | 08 Jan 2016 |
2. Device Identification
Proposed Device:
| Proprietary Name | Stryker® SERFAS 90-S 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 |
Predicate Device:
| Proprietary Name | SERFAS Energy System (probe only*) |
|---|---|
| Common Name | RF System, RF Generator, RF Probe, RF Footswitch |
| Premarket Notification | K041810 |
| Classification Name | Electrosurgical Cutting and Coagulation Device and Accessories |
| Regulation Number | 21 CFR 878.4400 |
| Product Code | GEI |
| Regulatory Class | II |
- The predicate device includes the entire energy system and accessories while the Proposed device includes the electrosurgical probe (90-S Redesign) only. This premarket notification refers to the SERFAS 90-S Redesign unless Original SERFAS 90-S is stated.
4
Device Description
The Stryker SERFAS 90-S Electrosurgical Probe (hereafter referred to as "Proposed device") is an accessory to the SERFAS Energy System, marketed through K041810, 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. Indication for Use
The Stryker SERFAS 90-S 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 electrosurgical probe and predicate device are similar in technological characteristics and design. The predicate device includes the entire SERFAS Energy system while the Proposed device includes the probe only.
The differences between the Proposed device and the predicate are minor and raise no new questions of safety and effectiveness, therefore supporting that the SERFAS 90-S electrosurgical probe is substantially equivalent to the predicate device currently on the market. The following differences exist between the Proposed and predicate device:
- 트 Ceramic and Electrode Key Feature Design
- Electrode Face Suction Path
- 트 Handle Design
Ceramic and Electrode Key Feature Design
Both the Proposed device and predicate device ceramic raw materials are identical but the devices have slightly different dimensional specifications. The intent of this change is to increase the mechanical robustness of the probe's tip and thereby address the failure mode of tip breakage. This difference is not critical to the intended surgical use of the device and does not impact the effectiveness of the device when used as labeled, however the safety of this product will be improved as a result of this change given the reduction in occurrence of tip breakage.
5
This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.
Electrode Face Suction Path
The Proposed device contains minor electrode face suction path design differences compared to the predicate device. Both the Proposed device and predicate device electrode raw materials are identical but the devices have slightly different dimensional specifications.
This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.
Handle Design
The patient contacting raw materials of the Proposed device and predicate device handle are identical. The Proposed device has a slightly different design specification for improved safety. This difference is not critical to the intended surgical use of the device and does not affect the effectiveness of the device when used as labeled. however the safety of this product will be improved as a result of this change because the occurrence of unintentional activation will be decreased.
This minor difference in the Proposed device does not introduce additional risks and raises no new questions of safety or effectiveness and is substantially equivalent to the predicate device.
5. Performance Testing
The Stryker SERFAS 90-S Electrosurgical probe was tested for performance in accordance with internal design specification and with the applicable performance standards, which established the substantial equivalence determination. The following non-clinical tests were conducted and are summarized in this premarket notification:
| Test Name | Description | Results |
|---|---|---|
| Aggressive Use | Determines if a probe can last its full lifetime without failure | |
| while being subjected to an extended activation period on | ||
| tissue at the highest power setting. | Pass | |
| Tip Cantilever | Determines if the probe tip can withstand the normal, side, | |
| and back force required to permanently deform the lumen | Pass |
6
| Test Name | Description | Results |
|---|---|---|
| Electrode Bend | Verifies the electrode can withstand a 7lb force for a worst | |
| case scenario. | Pass | |
| Thermal | ||
| Expansion (Heat) | ||
| Test | Verifies that the SERFAS probe tip assembly does not | |
| experience thermal expansion capable of causing catastrophic | ||
| failure when subject to excessive heat | Pass | |
| Leak | Verifies the condition of the ceramic-outer lumen assembly | |
| and the condition of the suction clamp of all styles of Stryker | ||
| and non-Stryker RF ablation probes. | Pass | |
| System | ||
| Compatibility | Verifies that the electrosurgical probe is compatible with | |
| Stryker's legally marketed consoles | Pass |
Biocompatibility was assessed in accordance with ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process" and related collateral standards for patient contacting materials (see Section 15 -Biocompatibility).
Sterilization was assessed in accordance with ISO 11135:2014 - Sterilization of health-care products - Ethylene Oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. Sterilization residuals were assessed in accordance with ISO 10993-7 - Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (see Section 14 - Sterilization and Shelf Life).
Bench performance testing was conducted to ensure that the device functioned as intended and met design specifications and acceptance criteria. Test results obtained verified the safety and effectiveness of the device per design specifications and applicable standards (see Section 18 - Performance Testing - Bench).
6. Conclusion
Based on the intended use, technological characteristics, performance testing, and nonclinical testing in comparison to the predicate device, the Stryker SERFAS 90-S Electrosurgical Probe does not introduce additional risks and raises no new questions of safety and effectiveness, thus demonstrating substantial equivalence.