(52 days)
Not Found
No
The summary describes a standard electrosurgical probe and its reprocessing, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
Explanation: The device is used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as hemostasis of blood vessels, all of which are therapeutic actions.
No
The device is described as a radio-frequency probe used for surgical procedures like resection, ablation, coagulation, and hemostasis, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly mentions physical components like an "energy-transferring cable" and "different tip configurations and suction probes," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used in electrosurgical procedures for resection, ablation, coagulation, and hemostasis of soft tissue and blood vessels during arthroscopic surgery. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details a radio-frequency probe with different tip configurations and suction capabilities, all designed for direct surgical intervention.
- Lack of IVD characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical tool used on the body during a procedure.
N/A
Intended Use / Indications for Use
The Reprocessed SERFAS Energy Probe is a disposable, radio-frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.
Product codes
NUJ
Device Description
The Reprocessed SERFAS Energy Probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, hip, elbow 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
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed SERFAS Energy Probes. This included the following tests:
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation.
Performance testing demonstrates that Reprocessed SERFAS Energy Probes perform as originally intended.
Key Metrics
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
K12/855
510(k) SUMMARY
AUG 16 2012
Submitter:
Stryker Sustainability Solutions 1810 W Drake Dr Tempe, Arizona 85283
Contact:
Eric Varty Vice President Research & Development 888-888-3433, ext. 5400 480.763.6078 (o) 480.496.1942(f) eric.varty@stryker.com
Date of preparation: 21 June 2012
Name of device:
| Trade/Proprietary Name: | Reprocessed SERFAS Energy Probe |
|---|---|
| Regulation Name: | Electrosurgical, Cutting & Coagulation Accessories, |
| Laparoscopic & Endoscopic, Reprocessed | |
| Regulation Number: | 21 CFR 878.4400 |
| Regulatory Class: | Class II |
| Product Code: | NUJ |
Predicate Device:
| Predicate Device | 510(k) Title | Manufacturer |
|---|---|---|
| K041810 | IMPULSE Energy System | Stryker Endoscopy |
| K991960 | SERFAS Energy System | Stryker Endoscopy |
Device Description:
The Reprocessed SERFAS Energy Probe includes an energy-transferring cable as well as several different tip configurations and suction probes which are capable of providing simultaneous fluid aspirations.
Indications for Use:
The Reprocessed SERFAS Energy Probe is a disposable, radio-frequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.
Technological Characteristics:
l
1
The design, materials, and intended use of Reprocessed SERFAS Energy Probe are identical to the predicate devices. The mechanism of action of the Reprocessed SERFAS Energy Probe is identical to the predicate devices in that the same standard mechanical design, materials, and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of SERFAS Energy Probes includes removal of adherent visible soil and decontamination. Each individual Probe is tested for appropriate function of its components prior to packaging and labeling operations. components prior to packaging and labeling operations.
Performance data:
Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed SERFAS Energy Probes. This included the following tests:
- � Biocompatibility
- . Validation of reprocessing
- Sterilization Validation .
- ◆ Function test(s)
- Packaging Validation .
Performance testing demonstrates that Reprocessed SERFAS Energy Probes perform as originally intended.
Conclusion:
Stryker Sustainability Solutions concludes that the modified devices (Reprocessed SERFAS Energy Probes) are safe, effective, and substantially equivalent to the predicate devices as described herein.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 16 2012
Stryker Sustainability Solutions % Mr. Eric Varty Vice President 1810 West Drake Drive Tempe, Arizona 85283
Re: K121855
Trade/Device Name: Reprocessed SERFAS Energy Probe Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accesories Regulatory Class: Class II Product Code: NUJ Dated: June 21, 2012 Received: June 25, 2012
Dear Mr. Varty:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Eric Varty
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K121855
Device Name: Reprocessed SERFAS Energy Probe
Indications For Use: The Reprocessed SERFAS Energy Probe is a disposable, radiofrequency probe used in electrosurgical procedures for resection, ablation, and coagulation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery for the knee, shoulder, ankle, hip, elbow and wrist.
Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diph
Der Xua Dr
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121855