(48 days)
The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, and wrist.
The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes are single-use devices that have been cleaned, disinfected, inspected, refurbished, tested, packaged, labeled, and sterilized. All models can be operated with integrated finger switches on the device handle to control ablation, coagulation and power level. Each model also has a suction line that removes tissue and fluids from the surgical site. In addition, the models can be operated with foot switches, which offer another mode with which to control ablation, coagulation, and the power setting. The devices are connected to the appropriate generator by a connector cable. The generators and the foot switches are not included in the scope of this project, and they will not be reprocessed.
The provided document describes the acceptance criteria and study proving the device meets those criteria for the Medline ReNewal Reprocessed Stryker SERFAS Energy Probes.
1. Table of acceptance criteria and the reported device performance:
The document focuses on demonstrating substantial equivalence to the predicate device, the Stryker SERFAS Energy Probes. The acceptance criteria are implicitly tied to various performance tests aiming to show that the reprocessed device functions identically and safely as the original. The performance reported indicates that the device met these criteria, suggesting equivalence.
| Acceptance Criteria Category | Specific Tests/Evaluations | Reported Device Performance (Implied) |
|---|---|---|
| Safety and Functionality | - Sterilization Validation | Equivalent to predicate |
| - Biocompatibility (cytotoxicity, sensitization, irritation) | Equivalent to predicate | |
| - Pyrogenicity | Equivalent to predicate | |
| - Acute Systemic Toxicity | Equivalent to predicate | |
| - Electrical Testing (electromagnetic compatibility (IEC 60601-1-2), electrical safety (IEC 60601-1 and IEC 60601-2-2), basic safety (IEC 60601-1 and IEC 60601-2-2)) | Equivalent to predicate | |
| Performance Qualification | - Simulated Use | Equivalent to predicate |
| - Critical Function Bending Equivalence Test | Equivalent to predicate | |
| - Critical Function Suction Equivalence Test | Equivalent to predicate | |
| - Critical Function Thermal Tissue Damage Equivalence Test | Equivalent to predicate | |
| - Critical Function Drop Equivalence Test | Equivalent to predicate | |
| - Critical Function Device Equivalence Integrity | Equivalent to predicate | |
| - Product Stability | Equivalent to predicate | |
| Cleaning Effectiveness | - Cleaning: Protein | Equivalent to predicate |
| - Cleaning: Hemoglobin | Equivalent to predicate | |
| Overall Equivalence | "The functional characteristics of the proposed Medline ReNewal Reprocessed Stryker SERFAS Energy Probe have been evaluated and found to be equivalent to the Stryker SERFAS Energy Probe predicate devices based on the following tests:" (conclusion statement) | Substantially Equivalent |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test (e.g., number of reprocessed devices tested for "simulated use" or "electrical safety"). It mentions "reprocessed single-use device models" and lists specific model numbers, implying that tests were conducted on these reprocessed units.
- Sample Size: Not explicitly stated for individual tests. The testing covers specific reprocessed models (279-351-100, 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100).
- Data Provenance: The tests were conducted by Surgical Instrument Service and Savings (dba Medline ReNewal), indicating a prospective testing approach specific to their reprocessing methods. The country of origin for the data is not explicitly stated but is implied to be within the U.S. from the FDA submission context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable to this type of device submission. This document pertains to the reprocessing of a surgical instrument, not an AI/ML device requiring expert interpretation of medical images or data. The "ground truth" here is the established safety and performance profile of the original Stryker SERFAS Energy Probe, against which the reprocessed version is compared using objective engineering and performance tests.
4. Adjudication method for the test set:
Not applicable. As this is not an AI/ML device, there's no need for expert adjudication of outputs. The tests performed are objective, measurable performance validations against predetermined specifications or the predicate device's performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
The ground truth for this submission is the established safety and performance characteristics of the legally marketed predicate device (Stryker SERFAS Energy Probes). Medline ReNewal's reprocessed devices are evaluated against these known characteristics to demonstrate "substantial equivalence." This includes:
- Engineering specifications and operational parameters of the original device.
- Performance in specific functional tests (e.g., electrical, suction, bending).
- Cleaning effectiveness benchmarks.
- Biocompatibility and sterilization standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; therefore, there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it in this context. The "ground truth" for demonstrating substantial equivalence is based on the performance and safety of the predicate device as initially cleared by the FDA.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health and Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. Food & Drug Administration".
October 18, 2017
Surgical Instrument Service and Savings (dba Medline ReNewal) Ms. Stephanie Boyle Mays Regulatory Specialist, Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave. Redmond, Oregon 97756
Re: K172608
Trade/Device Name: Medline ReNewal Reprocessed Stryker SERF AS Energy Probes (Models:279-351-100, 279-351-230, 279-351-250, 279-351-300,279-351-400, and 279-401-100) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 30, 2017 Received: August 31, 2017
Dear Ms. Mays:
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 device-related adverse events) (21 CFR 803); good
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manufacturing practice requirements as set forth in 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 (DICE) 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 (DICE) 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.
Jennifer R. Stevenson -S3
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
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Indications for Use
510(k) Number (if known) K172608
Device Name
Medline ReNewal Reprocessed Stryker SERFAS Energy Probes (models: 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100)
Indications for Use (Describe)
The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is a disposable, radio frequency probe used in electrosurgical procedures for resection, ablation of soft tissue, as well as the hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, hip, elbow, 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) |
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| DeviceModel | Device Name | OriginalManufacturer |
|---|---|---|
| 279-351-100 | 90-S SERFAS Energy Suction Probe3.5 mm | Stryker |
| 279-351-230 | 30-S SERFAS Energy Suction Probe3.5 mm | Stryker |
| 279-351-250 | 50-S SERFAS Energy Suction Probe3.5 mm | Stryker |
| 279-351-300 | Super 90-S SERFAS Energy Suction Probe3.5 mm | Stryker |
| 279-351-400 | 90-S Accelerator SERFAS Energy Suction Probe3.5 mm | Stryker |
| 279-401-100 | 90-S MAX SERFAS Energy Suction Probe4.0 mm | Stryker |
Reprocessed Single-Use Device Models Included in Clearance:
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Image /page/4/Picture/1 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue symbol to the left of it. To the right of "Medline" is a vertical line, followed by the word "Renewal" in green and blue. Below "Renewal" is the phrase "Full Circle Reprocessing" in blue.
510(k) Summary
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92.
| Submitter/Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)1500 NE Hemlock Ave.Redmond, OR 97756 |
|---|---|
| Date Prepared | August 30, 2017 |
| ContactName/Preparedby | Stephanie Boyle MaysRegulatory Affairs Specialist, Regulatory AffairsP: 541-516-4205/F: 541-923-3375E: smays@medline.com |
| Device NameandClassification | Propriety/Trade Name:Medline ReNewal Reprocessed StrykerSERFAS Energy Probes, models: 279-351-100,279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100Common Name:Electrosurgical cutting and coagulation deviceand accessoriesClassification:Class IIRegulation Number:21 CFR § 878.4400Product Code:NUJPanel:General & Plastic Surgery |
| 510(k) Number | K041810 |
| Propriety/Trade Name:Stryker SERFAS Energy Probes, models: 279-351-100, 279-351-230, 279-351-250, 279-351-300, 279-351-400, and 279-401-100 | |
| PredicateDevice andClassification | Common Name:Electrosurgical cutting and coagulation deviceand accessoriesClassification:Class IIRegulation Number:21 CFR § 878.4400Product Code:GEIPanel:General & Plastic SurgeryManufacturer:Stryker Endoscopy, 5900 Optical Ct., San Jose,CA 95138 |
| Intended Use | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probe is adisposable, radio frequency probe used in electrosurgical procedures forresection, ablation, and coagulation of soft tissue, as well as thehemostasis of blood vessels in patients undergoing arthroscopic surgery ofthe knee, shoulder, ankle, hip, elbow, and wrist. |
| ProductDescription | The Medline ReNewal Reprocessed Stryker SERFAS Energy Probes aresingle-use devices that have been cleaned, disinfected, inspected,refurbished, tested, packaged, labeled, and sterilized. All models can beoperated with integrated finger switches on the device handle to controlablation, coagulation and power level. Each model also has a suction linethat removes tissue and fluids from the surgical site. In addition, the modelscan be operated with foot switches, which offer another mode with which to |
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Image /page/5/Picture/1 description: The image shows the Medline Renewal logo. The Medline logo is on the left, with the word "MEDLINE" in blue and a blue star symbol. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in blue below it.
| DeviceCharacteristics | Predicate | Proposed | Comparison |
|---|---|---|---|
| 510(k) | Stryker SERFAS EnergyProbes | Medline ReNewalReprocessed StrykerSERFAS Energy Probes | As Stated |
| 510(k) | K041810 | TBD | Not applicable |
| Model Numbers | • 279-351-100• 279-351-230• 279-351-250• 279-351-300• 279-351-400• 279-401-100 | • 279-351-100• 279-351-230• 279-351-250• 279-351-300• 279-351-400• 279-401-100 | Same |
| Intended Use | The SERFAS EnergyProbe is a disposable,radio frequency probe usedin electrosurgicalprocedures for resection,ablation, and coagulationof soft tissue, as well asthe hemostasis of bloodvessels in patientsundergoing arthroscopicsurgery of the knee,shoulder, ankle, hip, elbow,and wrist.The probe includes anenergy-transferring cableas well as several differenttip configurations andsuction probes which arecapable of providingsimultaneous fluidaspirations | The Medline ReNewalReprocessed SERFASEnergy Probe is adisposable, radiofrequency probe used inelectrosurgical proceduresfor resection, ablation, andcoagulation of soft tissue,as well as the hemostasisof blood vessels in patientsundergoing arthroscopicsurgery of the knee,shoulder, ankle, hip, elbow,and wrist.The probe includes anenergy-transferring cableas well as several differenttip configurations andsuction probes which arecapable of providingsimultaneous fluidaspirations. | Same |
| 510(k) Substantial Equivalence Chart (concluded) | |||
| Predicate | Proposed | Comparison | |
| DeviceCharacteristics | Stryker SERFAS EnergyProbes | Medline ReNewalReprocessed StrykerSERFAS Energy Probes | As Stated |
| ProductDescription | The Stryker SERFASEnergy Probes are single-use devices. All modelscan be operated withintegrated finger switcheson the device handle tocontrol ablation,coagulation and powerlevel. Each model also hasa suction line that removestissue and fluids from thesurgical site. In addition,the models can beoperated with footswitches, which offeranother mode with which tocontrol ablation,coagulation, and the powersetting. The devices areconnected to theappropriate generator by aconnector cable. | The Medline ReNewalReprocessed StrykerSERFAS Energy Probesare single-use devices thathave been cleaned,disinfected, inspected,refurbished, tested,packaged, labeled, andsterilized. All models canbe operated with integratedfinger switches on thedevice handle to controlablation, coagulation andpower level. Each modelalso has a suction line thatremoves tissue and fluidsfrom the surgical site. Inaddition, the models canbe operated with footswitches, which offeranother mode with which tocontrol ablation,coagulation, and the powersetting. The devices areconnected to theappropriate generator by aconnector cable. Thegenerators and the footswitches are not includedin the scope of this project,and they will not bereprocessed. | As stated |
| Power Platform | Stryker SERFAS● Energy SystemStryker Crossfire● System | Stryker SERFAS● Energy SystemStryker Crossfire● System | Same |
| TechnologicalCharacteristics | The technological characteristics and the fundamentalscientific technology of the subject devices are identicalto the predicate device. The proposed devices are areprocessed version of the predicate K041810 StrykerSERFAS Energy Probes. The predicate devices wereused to support intended use, technologicalcharacteristics, and functional performancespecifications. | Same |
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Image /page/6/Picture/0 description: The image shows the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is green and blue, and the words "Full Circle Reprocessing" are below it.
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Image /page/7/Picture/1 description: The image is a logo for Medline Renewal Full Circle Reprocessing. The Medline logo is on the left, and the Renewal logo is on the right. The Medline logo is a blue star with the word "MEDLINE" in blue letters. The Renewal logo is in green and blue letters, and the words "Full Circle Reprocessing" are in smaller blue letters below the Renewal logo. The logo is clean and professional.
| PerformanceTesting | The functional characteristics of the proposed Medline ReNewalReprocessed Stryker SERFAS Energy Probe have been evaluated andfound to be equivalent to the Stryker SERFAS Energy Probe predicatedevices based on the following tests: |
|---|---|
| sterilization validation; | |
| biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; | |
| electrical testing electromagnetic compatibility (in accordance with IEC 60601-1-2); electrical safety (in accordance with IEC 60601-1 and IEC 60601-2-2); and basic safety (in accordance with IEC 60601-1 and IEC 60601-2-2) | |
| performance qualification: simulated use; critical function bending equivalence test; critical function suction equivalence test; critical function thermal tissue damage equivalence test; critical function drop equivalence test; critical function device equivalence integrity; and product stability | |
| cleaning; protein, and hemoglobin. | |
| Conclusion |
§ 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.