(230 days)
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13, is a sterile, single-use component 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 Device can coagulate vessels up to 5 mm in diameter. Furthermore, it is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically.
The provided FDA 510(k) summary for the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, model SCD13 (K173627), does not contain information about acceptance criteria and the study that proves the device meets those criteria in the format requested, particularly for AI/ML-based devices. This submission is for a reprocessed surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through functional, performance, and biocompatibility testing, rather than presenting clinical study results with acceptance criteria typical for diagnostic or AI-powered devices.
However, I can extract information related to performance testing and the type of evidence used to support the substantial equivalence claim. Since this is not an AI/ML device, many of the requested fields (like effect size with/without AI, sample size for test set/training set for AI, number of experts for ground truth, adjudication method, etc.) are not applicable.
Here's an adaptation of the requested table and information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a reprocessed device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are implicitly that the reprocessed device performs comparably to the original predicate device across various functional and safety aspects. The reported performance aims to show this comparability.
| Acceptance Criteria (Implicit: Comparable to Predicate) | Reported Device Performance (Summary from K173627) |
|---|---|
| Functional Performance | |
| Simulated Use | Comparable performance to predicate device |
| Grasping/Pulling Force | Comparable performance to predicate device |
| Cutting Effectiveness/Functionality | Comparable performance to predicate device |
| Drop Test | Comparable performance to predicate device |
| Device Integrity | Comparable performance to predicate device |
| Cutting/Coagulation Evaluation (prolonged) | Comparable performance to predicate device |
| Tissue Sticking | Comparable performance to predicate device |
| Reprocessing Effectiveness | |
| Cleaning (Protein, Carbohydrates, Endotoxins) | Demonstrated effective cleaning |
| Sterilization Validation | Validated sterilization |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity) | Demonstrated biocompatibility |
| Safety and Clinical Function | |
| Acute ex vivo Vessel Sealing Verification (initial) | Effective sealing in arteries and veins (up to 5mm diameter vessels including Hypogastric, Short Gastric, Gastrosplenic, Ovarian Pedicle, Splenic, Renal) |
| ENT Morphometry Evaluation for Thermal Spread | Comparable thermal spread to predicate device |
| Other Histopathology | Performed (details not specified) |
| 21-day Chronic in vivo Study (Porcine Model) | Vessel sealing verification (initial), hypertensive challenge, gross pathology on necropsy showed no notable hemorrhage or injury in collateral structures. |
| Product Stability | Demonstrated stability |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of a "test set" for diagnostic performance, as this is a surgical instrument.
For the performance testing:
- Bench tests: The number of devices or trials tested for each bench criterion (e.g., simulated use, grasping force, cutting effectiveness, cleaning, drop test, device integrity, tissue sticking, prolonged cutting/coagulation evaluation, thermal spread) is not explicitly stated in the summary.
- Acute ex vivo: Tissue types and vessel sizes evaluated are listed (Hypogastric, Short Gastric, Gastrosplenic, Ovarian Pedicle for A/V Bundle, Splenic, Renal for Isolated Arteries or Veins, all up to 5mm diameter), but the number of vessels or tissue samples tested is not provided.
- Chronic in vivo: A single 21-day chronic in vivo study was conducted using a porcine model. The number of animals used is not specified.
Data Provenance: The studies are described as bench tests, ex vivo (tissue samples, likely animal or cadaveric), and in vivo (porcine model). The country of origin for these studies is not specified in the provided summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of "experts" establish a "ground truth" for a diagnostic test set, as this is related to a surgical instrument's functional performance and reprocessing safety. The evaluation would have been performed by qualified laboratory personnel and veterinary surgeons (for in vivo studies), but not "experts" in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic test requiring adjudication of interpretations.
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 device is a reprocessed surgical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The device's performance is standalone in the sense that its functional capabilities are evaluated independently, but it is ultimately used by a human surgeon.
7. The type of ground truth used
The "ground truth" for this type of device is established through:
- Direct measurement: For physical properties (e.g., grasping force, cutting effectiveness, device integrity, cleaning efficacy).
- Histopathology/Morphometry: For tissue effects like thermal spread and absence of injury in collateral structures.
- Direct observation and assessment: For simulated use and in vivo studies (e.g., visual assessment of vessel sealing, absence of hemorrhage).
- Laboratory assays: For biocompatibility (cytotoxicity, endotoxins).
- Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs as safely and effectively as the original, legally marketed predicate device.
8. The sample size for the training set
Not applicable. This device does not use machine learning or AI, and therefore has 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 for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 12, 2018
Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Ms. Stephanie Mays Regulatory Affairs Specialist Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K173627
Trade/Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Model SCD 13 Regulation Name: Unclassified Regulatory Class: Class II Product Code: NLQ Dated: May 10, 2018 Received: May 14, 2018
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 mav, 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 manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR
1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Binita S. Ashar -S
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) K173627
Device Name
Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13
Indications for Use (Describe)
The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device 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 Device can be used to coagulate isolated vessels up to 5 mm diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.
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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| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| SCD13 | Sonicision Cordless Ultrasonic Dissector(14.5-mm jaw and 5-mm diameter x13-cm long shaft) | Covidien |
Reprocessed Single-Use Device Model Included in Submission:
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K173627 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 | |||
|---|---|---|---|---|
| Preparedby/ContactName | Stephanie Boyle MaysRegulatory Affairs Specialist, Quality Assurance and Regulatory AffairsP: 541-516-4205 • F: 541-923-3375 • E: smays@medline.com | |||
| Date Prepared | May 14, 2018 | |||
| Device NameandClassification | Proprietary/TradeName: | Medline ReNewal Reprocessed Sonicision CordlessUltrasonic Dissector, Model SCD13 | ||
| Regulatory Name: | Scalpel, ultrasonic reprocessed | |||
| Regulatory Class | Unclassified | |||
| Product Code: | NLQ | |||
| Panel: | General & Plastic Surgery | |||
| PredicateDevice | 510(k) number: | K153371 | ||
| Proprietary/TradeName: | Sonicision Cordless Ultrasonic Dissection Device,SCD13 | |||
| Regulatory Name: | Instrument, ultrasonic surgical | |||
| Classification: | Unclassified | |||
| Product Code: | LFL | |||
| Panel: | General & Plastic Surgery | |||
| Manufacturer | Covidien, 5920 Longbow Dr., Boulder, CO 80301 | |||
| ReferenceDevice | 510(k) number: | K170955 | ||
| Proprietary/TradeName: | Medline ReNewal Reprocessed Sonicision CordlessUltrasonic Dissector, Models SCD391 and SCD 396 | |||
| Regulatory Name: | Scalpel, ultrasonic reprocessed | |||
| Classification: | Unclassified | |||
| Product Code: | NLQ | |||
| Panel: | General & Plastic Surgery | |||
| Manufacturer | Surgical Instrument Service and Savings (dba MedlineReNewal), 1500 NE Hemlock Ave., Redmond, OR97756 | |||
| DeviceDescription | The Medline ReNewal Reprocessed Sonicision Cordless UltrasonicDissector model SCD13, is a sterile, single-use component to which theSonicision Reusable Generator and Reusable Battery Pack attach. (TheSonicision Reusable Generator and Reusable Battery Pack are not includedin this submission 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 Device can coagulate vessels upto 5 mm in diameter. Furthermore, it is designed to be inserted andextracted through a compatible 5 mm trocar, when used endoscopically. | |||
| Indications forUse: | The Medline ReNewal Reprocessed Sonicision Cordless UltrasonicDissection Device model SCD13 is indicated for soft tissue incisions whenbleeding control and minimal thermal injury are desired. The device can beused as an adjunct to or substitute for electrosurgery, lasers, and steelscalpels in general, plastic, pediatric, gynecologic, urologic, exposure toorthopedic structures (such as spine and joint space) and other open andendoscopic procedures. The Sonicision Cordless Ultrasonic DissectionDevice can be used to coagulate isolated vessels up to 5 mm diameter.The Sonicision 13-cm device is also indicated for use inotorhinolaryngologic (ENT) procedures. | |||
| TechnologicalCharacteristics | The technological characteristics and the fundamental scientific technologyof the subject devices are identical to the predicate and reference devices.The proposed device is a reprocessed version of the predicate K153371Sonicision Cordless Ultrasonic Dissector SCD13 device. The predicate andreference devices were used to support intended use, technologicalcharacteristics, and functional performance specifications. | |||
| Predicate | ReferenceMedline | Proposed | Comparison | |
| DeviceCharacteristics | CovidienSonicisionCordlessUltrasonicDissector | ReNewalReprocessedSonicisionCordlessUltrasonicDissector | Medline ReNewalReprocessedSonicisionCordlessUltrasonicDissector | As Stated |
| 510(k) | K153371 | K170955 | K173627 | Notapplicable |
| ModelNumber(s) | SCD13 | SCD391,SCD396 | SCD13 | As stated |
| Indications forUse | The SonicisionCordlessUltrasonicDissection Deviceis indicated for softtissue incisionswhen bleedingcontrol andminimal thermalinjury are desired.The device can beused as an adjunctto or substitute forelectrosurgery,lasers, and steelscalpels ingeneral, plastic,pediatric,gynecologic,urologic, exposureto orthopedicstructures (such | The MedlineReNewalReprocessedSonicisionCordless TMUltrasonicDissectionDevicesmodels SCD391 and SCD396 areindicated forsoft tissueincisions whenbleedingcontrol andminimalthermal injuryare desired.The devicescan be used asan adjunct to orsubstitute for | The MedlineReNewalReprocessedSonicision CordlessUltrasonicDissection Devicemodel SCD13 isindicated for softtissue incisionswhen bleedingcontrol and minimalthermal injury aredesired. The devicecan be used as anadjunct to orsubstitute forelectrosurgery,lasers, and steelscalpels in general,plastic, pediatric,gynecologic, | Proposeddevice sameas predicate;proposeddevice sameas referenceexcept foradditionalENTindicationson proposeddevice |
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
| Indications forUse concluded | as spine and jointspace) and otheropen andendoscopicprocedures. TheSonicisionCordlessUltrasonicDissection Devicecan be used tocoagulate isolatedvessels up to 5mm in diameter.The Sonicision 13cm device is alsoindicated for use inotorhinolaryngologic (ENT)procedures. | electrosurgery,lasers, andsteel scalpelsin general,plastic,pediatric,gynecologic,urologic,exposure toorthopedicstructures(such as spineand jointspace) andother open andendoscopicprocedures.The SonicisionCordlessUltrasonicDissectionDevices can beused tocoagulateisolatedvessels up to 5mm diameter. | urologic, exposureto orthopedicstructures (such asspine and jointspace) and otheropen andendoscopicprocedures. TheSonicision CordlessUltrasonicDissection Devicecan be used tocoagulate isolatedvessels up to 5 mmin diameter.The Sonicision 13-cm device is alsoindicated for use inotorhinolaryngologic(ENT) procedures. | |
| PowerPlatforma | Sonicision Batteryand Generator | SonicisionBattery andGenerator | Sonicision Batteryand Generator | Same |
| TechnologicalCharacteristics | The SonicisionCordlessUltrasonicDissector is asterile single-usedevice thatincludes thefollowing features:•Active blade thatvibrates atultrasonicfrequency anddelivers the energythat provides thetissue effect.•Clamping jaw thatthe surgeon usesto providepressure tovessels, tissues, or | The MedlineReNewalReprocessedSonicisionCordlessUltrasonicDissectorsSCD 391 andSCD 396 areused tocoagulateisolatedvessels up to 5mm indiameter.Device featuresinterface withthe Sonicisionbattery andgenerator. | The MedlineReNewalReprocessedCordless UltrasonicDissector modelSCD13 is a sterilesingle-use devicethat includes thefollowing features:•Active blade thatvibrates atultrasonic frequencyand delivers theenergy thatprovides the tissueeffect.•Clamping jaw thatthe surgeon uses toprovide pressure tovessels, tissues, or | Same aspredicate |
| DeviceCharacteristics | Predicate | Reference | Proposed | Comparison |
| vascular bundlesas needed todeliver the desiredtissue effect.•Controls foractivating thedelivery ofultrasonic energyand for openingand closing theclamping jaw;•Features thatinterface with theSonicisiongenerator and theSonicision battery. | vascular bundles asneeded to deliverthe desired tissueeffect.•Controls foractivating thedelivery ofultrasonic energyand for opening andclosing theclamping jaw;•Features thatinterface with theSonicisiongenerator and theSonicision battery. | |||
| 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 -Bench | The functional characteristics of the proposed devices were compared tothe performance of the primary predicate device in several bench andanimal tests (see below list). The results of this testing showed comparableperformance between the proposed and predicate devices.• simulated use;• grasping/pulling force;• cutting effectiveness/functionality;• drop test;• device integrity;• cutting/coagulation evaluation for a prolonged period of time;• tissue sticking;• cleaning;o protein, carbohydrates, and endotoxins;• biocompatibility;o cytotoxicity, sensitization, irritation; pyrogenicity, and acutesystemic toxicity;• performance qualification;• sterilization validation;• product stability;• acute ex vivoo vessel sealing verification (initial)o ENT morphometry evaluation for thermal spread as compared topredicate device; ando other histopathology | |||
| PerformanceTesting –Chronic in vivo | Performance of the device was also established in a 21-day chronic in vivostudy with a porcine model. Testing included:o vessel sealing verification (initial);o hypertensive challenge ando gross pathology on necropsy (no notable hemorrhage or injuryin collateral structures) |
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K173627 Medline ReNewal
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Image /page/7/Picture/0 description: The image shows the Medline Renewal logo. The word "Renewal" is written in a combination of green and blue colors, with "Re" in green and "newal" in blue. Below "Renewal" is the text "Full Circle Reprocessing" in a smaller font size. To the left of the word "Renewal" is the Medline logo, which consists of the word "MEDLINE" in blue and a blue star-like symbol.
K173627 Medline ReNewal
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Image /page/8/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 in green and blue, and the words "Full Circle Reprocessing" are below the Renewal logo.
| Tissue/Vessel Name | Vessel Size Range (mm) |
|---|---|
| A/V Bundle | |
| Hypogastric | 2.0 - 5.0 |
| Short Gastric | 2.0 - 5.0 |
| Gastrosplenic | Up to 5.0 |
| Ovarian Pedicle | 3.0 - 5.0 |
| Isolated Arteries or Veins | |
| Splenic | Up to 5.0 |
| Renal | 4.0 - 5.0 |
| Conclusion Based on comparisons of the indications for use, intended use, technological characteristics, and performance bench and perfomance chronic data to the predicate device, Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Device, model SCD13 is substantially equivalent to the predicate devices. |
Tissue types and vessles evaluated to show effective sealing in arteries and in
veins included:
N/A