The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.
The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.
Here's an analysis of the acceptance criteria and study information based on the provided text:
The document is a 510(k) premarket notification for a reprocessed medical device, specifically the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical effectiveness or superiority. Therefore, the testing described focuses on demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than establishing new performance benchmarks for all surgical devices.
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a direct table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it lists types of performance tests conducted to establish equivalence. The general acceptance criterion for all the tests is that the reprocessed device must demonstrate equivalence to the predicate device in terms of safety and effectiveness.
| Acceptance Criteria (General Description) | Reported Device Performance (Summary from document) |
|---|---|
| Equivalence to predicate device in functional characteristics | Found to be equivalent to the predicate devices based on various tests. |
| Grasping/Pulling Force | Evaluated (Found equivalent) |
| Cutting Effectiveness/Functionality | Evaluated (Found equivalent) |
| Drop Test | Evaluated (Found equivalent) |
| Device Integrity | Evaluated (Found equivalent) |
| Cutting/Coagulation Evaluation for Prolonged Period | Evaluated (Found equivalent) |
| Thermal Analysis Characterization | Evaluated (Found equivalent) |
| Tissue Sticking | Evaluated (Found equivalent) |
| Cleaning (Effectiveness of reprocessing) | Evaluated (Found equivalent) |
| Protein, Carbohydrates, and Endotoxins (Residuals after cleaning) | Evaluated (Found equivalent) |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation) | Evaluated (Found equivalent) |
| Pyrogenicity, and Acute Systemic Toxicity | Evaluated (Found equivalent) |
| Performance Qualification | Evaluated (Found equivalent) |
| Sterilization Validation | Evaluated (Found equivalent) |
| Product Stability | Evaluated (Found equivalent) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes (N numbers) used for each individual performance test. It only states that the functional characteristics "have been evaluated."
- Data Provenance: The data provenance is not explicitly stated. However, since this is a submission for a reprocessed device by Medline ReNewal, the testing would have been conducted by Medline ReNewal or their contracted testing facilities. Given the nature of performance testing for medical devices, it's generally done in a controlled laboratory environment. The origin of the reprocessed devices themselves would be from various healthcare facilities where they were originally used before being sent for reprocessing. The testing itself is prospective in the sense that Medline ReNewal performed these tests on their reprocessed devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (expert consensus, qualifications) is typically relevant for studies involving subjective interpretation, like imaging diagnostics or clinical endpoints, where human experts establish ground truth. For this submission, which is about the functional and safety equivalence of a reprocessed surgical instrument, the "ground truth" is established by direct physical and chemical testing against defined specifications or comparison to the performance of the new predicate device. Therefore, information about "experts establishing ground truth" in the clinical sense is not applicable or provided in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret cases and disagreements are resolved. This document pertains to performance testing of a reprocessed surgical instrument, which involves objective laboratory measurements and comparisons to predetermined specifications or predicate device performance. Therefore, an adjudication method in this context is not applicable and not mentioned.
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
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids, especially those involving AI interpretation, where human readers interact with a system to make diagnoses. The Medline ReNewal device is a surgical instrument, not an AI diagnostic tool.
- Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical surgical instrument, not an algorithm or software. Its performance is inherent to its mechanical, electrical, and material properties when used by a surgeon.
7. The type of ground truth used
The ground truth for evaluating the safety and effectiveness of the reprocessed device is established through:
- Comparison to the predicate device's known performance: The fundamental scientific technology and intended use are considered identical to the predicate.
- Pre-defined specifications and standards: Each performance test (e.g., grasping/pulling force, cutting effectiveness, cleaning, biocompatibility, sterilization) would have acceptance criteria based on established engineering standards, regulatory requirements, and the expected performance of a new device.
- Objective laboratory measurements: Physical, chemical, and biological tests are performed to directly measure different aspects of the device's function and safety.
Essentially, the "ground truth" is objective measurement against established requirements and comparison to the original device's performance.
8. The sample size for the training set
This concept of a "training set" is relevant for machine learning or AI models. Since this is a physical medical device and not an AI or software product, there is no training set in the traditional sense. The development and validation of the reprocessing procedure would involve internal process development and verification, but it's not a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
July 3, 2017 Surgical Instrument Services and Savings (dba Medline ReNewal) Ms. Stephanie Boyle Mays Regulatory Affairs Specialist, Regulatory Affairs 1500 NE Hemlock Avenue Redmond. Oregon 97756
Re: K170955
Trade/Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396 Regulatory Class: Unclassified Product Code: NLO Dated: June 6, 2017 Received: June 7, 2017
Dear Ms. Mays:
We have reviewed vour 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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, Jennifer R. Stevenson -53
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) TBD K170955
Device Name
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices SCD 391 and SCD 396
Indications for Use (Describe)
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.
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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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| SCD391 | Covidien Sonicision Cordless UltrasonicDissector(14.5-mm jaw and 5-mm diameter x 39-cm long shaft) | Covidien |
| SCD396 | Covidien Sonicision Cordless UltrasonicDissector(14.5-mm jaw and 5-mm diameter x 39-cm long shaft) | Covidien |
a
Reprocessed Single-Use Device Models Included in Clearance:
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Image /page/4/Picture/1 description: The image contains the Medline Renewal logo. 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 the word "Renewal" in green and blue letters, with the words "Full Circle Reprocessing" in blue letters below it.
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 | March 30, 2017 | ||
| Contactperson: | Ms. Stephanie Boyle Mays, BARegulatory Affairs Specialist, Regulatory AffairsPhone: 541-516-4205Fax: 541-923-3375E-mail: smays@medline.com | ||
| Device NamesandClassification: | Propriety/Trade Name: | Medline ReNewal Reprocessed SonicisionCordless Ultrasonic Dissection Devices, modelsSCD391 and SCD396 | |
| Common Name: | Scalpel, ultrasonic reprocessed | ||
| Classification: | Unclassified | ||
| Product Code: | NLQ | ||
| Panel: | General & Plastic Surgery | ||
| PredicateDevice: | 510(k) Number: | K101797 | |
| Propriety/Trade Name: | Sonicision Cordless Ultrasonic DissectionDevice, models SCD391 and SCD396 | ||
| Common Name: | Cordless ultrasonic surgical device | ||
| Classification: | Instrument, ultrasonic surgical | ||
| Product Code: | LFL | ||
| Panel: | General & Plastic Surgery | ||
| Manufacturer: | Covidien, formerly Valleylab, a division of TycoHealthcare: 5920 Longbow Dr., Boulder, CO80301 | ||
| DeviceDescription: | The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 andSCD396, are sterile, single-use components to which the SonicisionReusable Generator and Reusable Battery Pack attach. (The SonicisionReusable Generator and Reusable Battery Pack are not included in thissubmission and will not be reprocessed by Medline ReNewal.) Thiscomponent provides control for device functions such as selecting powerlevels, blade placement and position, grasping, coagulating and dissectingtissue. The Cordless Ultrasonic Dissection Devices can coagulate vesselsup to 5 mm in diameter. Furthermore, they are designed to be inserted andextracted through a compatible 5 mm trocar when used endoscopically. |
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Image /page/5/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is in a larger font than the word "Medline". The word "Re" is in green, and the word "Newal" is in blue. Underneath the word "Renewal" is the phrase "Full Circle Reprocessing".
| IntendedUse/Indicationsfor Use: | The Medline ReNewal Reprocessed Sonicision Cordless UltrasonicDissection Devices, models SCD391 and SCD396, are indicated for softtissue incisions when bleeding control and minimal thermal injury aredesired. The devices can be used as an adjunct to or substitute forelectrosurgery, lasers, and steel scalpels in general, plastic, pediatric,gynecologic, urologic, exposure to orthopedic structures (such as spine andjoint space) and other open and endoscopic procedures. The SonicisionCordless Ultrasonic Dissection Devices can be used to coagulate isolatedvessels up to 5 mm diameter. |
|---|---|
| TechnologicalCharacteristics: | The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate device. The proposeddevices are a reprocessed version of the predicate K101797 SonicisionCordless Ultrasonic Dissector Devices. The predicate device was used tosupport intended use, technological characteristics, and functionalperformance specifications. |
510(k) Substantial Equivalence Chart
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| DeviceCharacteristics | CovidienSonicision CordlessUltrasonic Dissector | Medline ReNewalSonicision CordlessUltrasonic Dissector | As stated |
| 510(k) | K101797 | K170955 | Not Applicable |
| Model Numbers | SCD391, SCD396 | SCD391, SCD396 | Not Applicable |
| IntendedUse/Indicationsfor Use | The Sonicision TMCordless UltrasonicDissection Device isindicated for soft tissueincisions when bleedingcontrol and minimal thermalinjury are desired. Thedevice can be used as anadjunct to or substitute forelectrosurgery, lasers, andsteel scalpels in general,plastic, pediatric,gynecologic, urologic,exposure to orthopedicstructures (such as spineand joint space) and otheropen and endoscopicprocedures. The SonicisionCordless UltrasonicDissection Device can beused to coagulate isolatedvessels up to 5 mm indiameter. | The Medline ReNewalReprocessed SonicisionCordless™ UltrasonicDissection Devices modelsSCD 391 and SCD 396 areindicated for soft tissueincisions when bleedingcontrol and minimal thermalinjury are desired. Thedevices can be used as anadjunct to or substitute forelectrosurgery, lasers, andsteel scalpels in general,plastic, pediatric,gynecologic, urologic,exposure to orthopedicstructures (such as spineand joint space) and otheropen and endoscopicprocedures. The SonicisionCordless UltrasonicDissection Devices can beused to coagulate isolatedvessels up to 5 mmdiameter. | Same |
| Predicate | Proposed | Comparison | |
| DeviceCharacteristics | CovidienSonicision CordlessUltrasonic Dissector | Medline ReNewalSonicision CordlessUltrasonic Dissector | |
| Power Platforma | Sonicision Battery andGenerator | Sonicision Battery andGenerator | Same |
| TechnologicalCharacteristics | The Sonicision CordlessUltrasonic Dissectors isused to coagulate isolatedvessels up to 5 mm indiameter. Device featuresinterface with the Sonicisionbattery and generator. | The Medline ReNewalReprocessed SonicisionCordless UltrasonicDissectors SCD 391 andSCD 396 are used tocoagulate isolated vesselsup to 5 mm in diameter.Device features interfacewith the Sonicision batteryand generator. | Same |
| a The Sonicision Battery and Generator are not part of this submission and will not bereprocessed by Medline ReNewal. The battery and generator were cleared in K153371(cleared March 3, 2016) and K101797 (cleared February 24, 2011). | |||
| PerformanceTesting: | The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests:simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; cleaning; protein, carbohydrates, and endotoxins; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. | ||
| Conclusion: | Based on comparisons of the indications for use, intended use,technological characteristics, and performance data to the predicatedevices, Medline ReNewal Sonicision Cordless Ultrasonic DissectionDevices, models SCD391 and SCD396 are substantially equivalent to thepredicate devices. |
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Image /page/6/Picture/0 description: The image contains the Medline Renewal logo. The Medline logo is on the left, and the Renewal logo is on the right. The Renewal logo is in green and blue, and the text "Full Circle Reprocessing" is below the Renewal logo.
510(k) Substantial Equivalence Chart (concluded)
N/A