(52 days)
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.
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.
The provided text describes the 510(k) summary for the Reprocessed SERFAS Energy Probe (K121855). This submission is for a reprocessed device, and as such, the performance data focuses on demonstrating that the reprocessed device performs as originally intended, rather than establishing novel clinical efficacy or accuracy for a new AI algorithm.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a reprocessed device, the "acceptance criteria" are generally that the reprocessed device functions identically to the original predicate device and meets safety standards for reprocessing. The "reported device performance" reflects tests done to ensure this equivalence.
| Acceptance Criteria Category | Specific Test/Performance Goal | Reported Device Performance |
|---|---|---|
| Safety & Biocompatibility | Biocompatibility (cytotoxicity, sensitization, irritation, etc.) | Testing conducted to demonstrate performance. |
| Reprocessing Effectiveness | Validation of Reprocessing (cleaning, decontamination, integrity) | Testing conducted to demonstrate performance. |
| Sterilization Assurance | Sterilization Validation (achieve sterility assurance level) | Testing conducted to demonstrate performance. |
| Functional Equivalence | Function Test(s) (mechanical, electrical, energy transfer capabilities) | Testing conducted to demonstrate performance; each individual probe tested for appropriate function. |
| Packaging Integrity | Packaging Validation (maintain sterility and device integrity) | Testing conducted to demonstrate performance. |
| Overall Equivalence | "Perform as originally intended" | Performance testing demonstrates that Reprocessed SERFAS Energy Probes perform as originally intended. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for an AI algorithm. Instead, it refers to performance testing on the reprocessed devices.
- Test Set Sample Size: Not specified. The document states "Each individual Probe is tested for appropriate function of its components prior to packaging and labeling operations," implying a form of 100% inspection for functional integrity during reprocessing. However, for validation studies (biocompatibility, sterilization, reprocessing validation), the specific sample sizes used are not detailed in this summary.
- Data Provenance: Not applicable in the context of clinical data. The performance data is derived from bench and laboratory testing of the reprocessed devices themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The device is a reprocessed electrosurgical probe, not an AI diagnostic device that requires expert consensus for establishing ground truth on medical images or patient conditions. Ground truth for its performance is based on established engineering and biological standards for device function, material integrity, sterility, and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable. There is no "adjudication method" in the context of expert review for this type of device. Performance is assessed against predefined technical specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not applicable to a reprocessed electrosurgical probe.
6. If a Standalone Performance Study Was Done
Yes, in a sense, a "standalone" performance evaluation was done for the reprocessed device. The "Bench and laboratory testing" described, which includes biocompatibility, reprocessing validation, sterilization validation, function tests, and packaging validation, assesses the performance of the reprocessed probe itself against established safety and functional standards, independent of human interaction or a clinical trial. This is a standalone evaluation of the device's physical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for the Reprocessed SERFAS Energy Probe's performance is based on a combination of:
- Engineering Specifications: The original design and functional specifications of the predicate device.
- Regulatory Standards: ISO standards for biocompatibility (e.g., ISO 10993), sterilization (e.g., ISO 11135/11137), and reprocessing (e.g., AAMI TIR12, AAMI ST79).
- Established Test Methods: Standardized laboratory assays and bench tests to evaluate material properties, electrical performance, and mechanical integrity.
8. The Sample Size for the Training Set
This information is not applicable. This device does not use an "AI algorithm" in the conventional sense, and therefore, there is no "training set" of data for machine learning. The "training" for this device involved the development and validation of the reprocessing procedures.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8. The "ground truth" for the reprocessing process itself would have been established through extensive validation studies demonstrating the efficacy and safety of each step (cleaning, disinfection, sterilization, functional testing) in restoring the device to its "as-new" state, adhering to design specifications and regulatory guidelines.
{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
§ 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.