(240 days)
The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.
This document is a 510(k) summary for the Medline ReNewal Reprocessed Harmonic ACE+7 Shears, which is a reprocessed medical device. It aims to demonstrate substantial equivalence to a legally marketed predicate device.
Acceptance Criteria and Device Performance (Based on the document):
The document primarily focuses on demonstrating substantial equivalence to the predicate device (Ethicon Harmonic ACE+7 Shears, K132612) through comparisons of various characteristics and performance testing. The "acceptance criteria" here implicitly refer to meeting the performance and safety profiles of the original device after reprocessing.
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance testing conducted to ensure equivalency after reprocessing. The acceptance criteria are implied to be achieving results comparable to or within acceptable ranges of the original, new device.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Summary from "Performance Testing" section) |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1 and 60601-1-2 | "Evaluated and found to be equivalent to the predicate devices in accordance with IEC 60601-1 and 60601-1-2" |
| Simulated Use | Equivalent performance during simulated surgical use | "Evaluated and found to be equivalent to the predicate devices" |
| Device Integrity | Maintenance of structural and functional integrity | "Evaluated and found to be equivalent to the predicate devices" |
| Handle Operation | Proper and equivalent handle functionality | "Evaluated and found to be equivalent to the predicate devices" |
| Shaft Knob Rotation | Smooth and effective shaft rotation | "Evaluated and found to be equivalent to the predicate devices" |
| Device Recognition | Proper recognition by the associated generator (Ethicon GEN11) | "Evaluated and found to be equivalent to the predicate devices" (Specifically, the ReNewal Key-integrated flex circuitry enables additional use, implying successful recognition for subsequent use). |
| Cutting Time | Comparable cutting efficiency/speed | "Evaluated and found to be equivalent to the predicate devices" |
| Thermal Analysis Characterization | Comparable thermal profiles to minimize thermal injury | "Evaluated and found to be equivalent to the predicate devices" |
| Tissue Sticking | Comparable minimal tissue sticking properties | "Evaluated and found to be equivalent to the predicate devices" |
| Burst Pressure | Maintenance of vessel sealing integrity/strength | "Evaluated and found to be equivalent to the predicate devices" |
| Histopathology | Comparable tissue effects related to coagulation and transection | "Evaluated and found to be equivalent to the predicate devices" |
| Seal Quality | Effective and consistent tissue sealing | "Evaluated and found to be equivalent to the predicate devices" |
| Cleaning (Protein, Carbohydrates, Endotoxin) | Demonstration of effective decontamination/sterilization from biological residue | All tests passed; specific levels not provided but implied to meet acceptable limits for reprocessing. |
| Biocompatibility (Cytotoxicity, Sensitization, Irritation, Materials-mediated Pyrogen, Acute Systemic Toxicity) | No unacceptable biological reactions from reprocessed materials | All tests passed; implied to meet acceptable standards for patient contact. |
| Performance Qualification | Overall device performance consistently meeting specifications | "Evaluated and found to be equivalent to the predicate devices" |
| Sterilization Validation | Device can be effectively sterilized for patient safety | Passed and achieved required sterility assurance levels. |
2. Sample Size Used for the Test Set and Data Provenance:
The document broadly states that the functional characteristics were "evaluated." It does not specify the exact sample sizes (N) for each of the performance tests listed. The data provenance is implied to be from prospective testing conducted by Medline ReNewal as part of their 510(k) submission process for the reprocessed device. There is no indication of country of origin for the testing, other than the submitting company being based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes technical and functional performance testing of a physical medical device, not an AI/algorithm-based diagnostic device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists, pathologists) for interpreting test results is not applicable in the same way as for diagnostic AI. The "ground truth" for the device's performance is established by the direct measurements and results of the physical and biological tests against established engineering and safety standards. The individuals conducting and analyzing these tests would be qualified engineers, technicians, and potentially toxicologists/biologists. The document doesn't specify how many or their exact qualifications.
4. Adjudication Method for the Test Set:
Not applicable in the context of this device's performance testing. Adjudication methods like 2+1 or 3+1 are typical for human interpretation of medical images or data, not for direct physical performance measurements. The results of the tests would be objectively measured and compared to predefined criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of an AI system on human reader performance in diagnostic tasks, which is not the subject of this 510(k) submission for a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical surgical instrument (Harmonic ACE+7 Shears), not an AI algorithm. Its performance is inherent to the reprocessed device itself.
7. The type of ground truth used:
The "ground truth" for this reprocessed device is established through various physical, electrical, mechanical, and biological measurements against established engineering specifications and safety standards for the original device and similar devices. This includes:
- Direct measurements of cutting time, burst pressure, and other functional parameters.
- Results from standardized cleaning and sterilization validation protocols.
- Outcomes of biocompatibility testing.
- Comparisons against the performance data of the original predicate device (implicitly serving as a benchmark for acceptable "ground truth" performance).
8. The sample size for the training set:
Not applicable. This device is a physical reprocessed medical instrument and does not involve AI or machine learning models that require training sets.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
August 19, 2020
Surgical Instrument Service and Savings, Inc. (dba Medline ReNewal) Gail Gassner Quality Assurance Specialist II 1500 NE Hemlock Ave Redmond, Oregon 97756
Re: K193563/S001
Trade/Device Name: Medline ReNewal Reprocessed Harmonic ACE+7 Shears Regulatory Class: Unclassified Product Code: NLQ Dated: July 20, 2020 Received: July 21, 2020
Dear Gail Gassner:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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K193563
Reprocessed Single-Use Device Models Included in Submission:
| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| HARH23 | Harmonic ACE+7 Shears(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears(5-mm diameter x 45-cm long shaft, 360° rotation) | Ethicon |
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193563
Device Name
Medline ReNewal Reprocessed Harmonic ACE+7 Shears (HARH23, HARH36, HARH45)
Indications for Use (Describe)
The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.
| 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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K193563
Reprocessed Single-Use Device Models Included in Submission:
| Device Model | Device Name | OriginalManufacturer |
|---|---|---|
| HARH23 | Harmonic ACE+7 Shears(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears(5-mm diameter x 45-cm long shaft, 360° rotation) | Ethicon |
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Image /page/5/Picture/2 description: The image contains the Medline Renewal logo. The Medline logo is on the left side of the image and is a blue square with a white cross inside. The word "MEDLINE" is written in white letters inside the blue square. To the right of the Medline logo is the word "Renewal" written in green and blue letters. Below the word "Renewal" is the phrase "Full Circle Reprocessing" written in smaller, gray letters.
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic AČE+7 Shears
5.0 510(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 | ||
|---|---|---|---|
| Contact/Prepared by | Gail GassnerQuality Assurance Specialist II, Quality Assurance/Regulatory AffairsP: 541-516-4193 • F: 541-923-3375 • E: ggassner@medline.com | ||
| Date Prepared | December 20, 2019 | ||
| Device NameandClassification | Proprietary/TradeName: | Medline ReNewal Reprocessed Harmonic ACE+7Shears models HARH23, HARH36, and HARH45 | |
| Common or UsualName | Reprocessed ultrasonic scalpel | ||
| RegulatoryName/Reference | Electrosurgical cutting and coagulation device andaccessories reprocessed, 21 CFR § 878.4400 | ||
| Regulatory Class | Unclassified | ||
| Product Code | NLQ | ||
| Panel | General & Plastic Surgery | ||
| PredicateDevice | 510(k) Number | K132612 | |
| Proprietary orTrade Name | HARMONIC ACE+ SHEARS 23 CM LENGTH WITHADVANCED HEMOSTASIS, HARMONIC ACE +LAPAROSCOPIC SHEARS 36 CM LENGTH WITHADVANCE | ||
| Common or UsualName | Ultrasonic surgical instrument | ||
| RegulatoryName/Reference | Electrosurgical cutting and coagulation device andaccessories reprocessed, 21 CFR § 878.4400 | ||
| Regulatory Class | Unclassified | ||
| Product Code | LFL | ||
| Panel | General & Plastic Surgery | ||
| Manufacturer | Ethicon Endo-Surgery, LLC4545 Creek Road, Cincinnati, OH 45242 | ||
| DeviceDescription | The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (modelsHARH23, HARH36, and HARH45) are used for coagulation andmechanical transection of soft tissue during laparoscopic and openprocedures. The devices allow the surgeon to grasp, coagulate, andtransect soft tissue with a single instrument. The devices are hand-actuatedwith a shaft and tissue effector that can be rotated. The energy delivery canbe activated with hand activation or with an optional generator foot switch. | ||
| Indications foruse | The Medline ReNewal Harmonic ACE+7 Shears are indicated for softtissue incisions when bleeding control and minimal thermal injury aredesired. The instruments can be used as an adjunct to or substitute forelectrosurgery, lasers and steel scalpels in general, plastic, pediatric, | ||
| TechnologicalCharacteristics | The technological characteristics and the fundamental scientific technologyof the subject devices are equivalent to the predicate device. The proposeddevices are a reprocessed version of the predicate devices. K132612Ethicon Harmonic ACE+7 Shears was used as the primary predicate tosupport intended use, technological characteristics, and functionalperformance specifications. | ||
| PerformanceTesting | The functional characteristics of the proposed devices have been evaluatedand found to be equivalent to the predicate devices based on the followingtests:• electrical safety and electromagnetic compatibility in accordancewith IEC 60601-1 and 60601-1-2;• simulated use;• device integrity;• handle operation;• shaft knob rotation;• device recognition;• cutting time;• thermal analysis characterization;• tissue sticking;• burst pressure;• histopathology;• seal quality;• Cleaning:o protein,o carbohydrates,o endotoxin;• Biocompatibility:o cytotoxicity,o sensitization,o irritation,o materials-mediated pyrogen, ando acute systemic toxicity;• performance qualification; and• sterilization validation. | ||
| Summary Table: Predicate and Medline ReNewal Reprocessed Harmonic ACE+7 Shearsdevice comparison chart. | |||
| Predicate | Proposed | Comparison | |
| DeviceCharacteristics | Ethicon Harmonic ACE+7Shears with AdvancedHemostasis | Medline ReNewalReprocessed HarmonicACE+7 Shears | As Stated |
| 510(k) | K132612 | K193563 | N/A |
| Model Numbers | HARH23, HARH36, HARH45 | HARH23, HARH36, HARH45 | Same |
| Common Name | Instrument, Ultrasonic Surgical | Scalpel, Ultrasonic,Reprocessed | As Stated |
| Regulation No. | 21 CFR § 878.4400 | 21 CFR § 878.4400 | Same |
| Regulatory Class | Unclassified | Unclassified | Same |
| Product Code | LFL | NLQ | As stated |
| Indications forUse | The Ethicon Harmonic ACE+7 Shears with AdvancedHemostasis are indicated forsoft tissue incisions whenbleeding control and minimalthermal injury are desired. Theinstruments can be used as anadjunct to or substitute forelectrosurgery, lasers andsteel scalpels in general,plastic, pediatric, gynecologic,urologic, thoracic, exposure toorthopedic structures (such asspine and joint space), sealingand transection of lymphaticvessels, and other open andendoscopic procedures. Theinstruments allow for thecoagulation of vessels up toand including 7 mm indiameter using the AdvancedHemostasis hand controlbutton. | The Medline ReNewalReprocessed Harmonic ACE+7 Shears with AdvancedHemostasis are indicated forsoft tissue incisions whenbleeding control and minimalthermal injury are desired. Theinstruments can be used as anadjunct to or substitute forelectrosurgery, lasers andsteel scalpels in general,plastic, pediatric, gynecologic,urologic, thoracic, exposure toorthopedic structures (such asspine and joint space), sealingand transection of lymphaticvessels, and other open andendoscopic procedures. Theinstruments allow for thecoagulation of vessels up toand including 7 mm indiameter using the AdvancedHemostasis hand controlbutton. | Same |
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Image /page/6/Picture/2 description: The image contains the Medline and Renewal logos. The Medline logo is on the left and consists of a blue square with a white star-like symbol and the word "MEDLINE" in white letters. To the right of the Medline logo is the Renewal logo, with the word "Renewal" in green and the words "Full Circle Reprocessing" in blue below it. The Renewal logo also has a trademark symbol.
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Image /page/7/Picture/2 description: The image contains the logo for "ReNewal Full Circle Reprocessing". On the left side of the logo is a blue square with the word "MEDLINE" written in white letters. To the right of the square is the word "ReNewal" written in green letters. Below the word "ReNewal" is the phrase "Full Circle Reprocessing".
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic ÀĆE+7 Shears
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Image /page/8/Picture/2 description: The image contains the Medline Renewal Full Circle Reprocessing logo. The Medline logo is on the left side of the image and is a blue square with a white cross in the center. The Renewal Full Circle Reprocessing logo is on the right side of the image. The word "Renewal" is in green and the words "Full Circle Reprocessing" are in blue.
Traditional 510(k) Notification K193563 Medline ReNewal Reprocessed Harmonic ÀĆE+7 Shears
Summary Table: Predicate and Medline ReNewal Reprocessed Harmonic ACE+7 Shears device comparison chart (concluded).
| Predicate | Proposed | Comparison | |
|---|---|---|---|
| DeviceCharacteristics | Ethicon Harmonic ACE+7Shears with AdvancedHemostasis | Medline ReNewalReprocessed HarmonicACE+7 Shears | As stated |
| Power Platforma | • HARH23 = Ethicon Endo-Surgery Generator G11,model GEN11• HARH36 = Ethicon Endo-Surgery Generator G11,model GEN11• HARH45 = Ethicon Endo-Surgery Generator G11,model GEN11 | • HARH23 = Ethicon Endo-Surgery Generator G11,model GEN11• HARH36 = Ethicon Endo-Surgery Generator G11,model GEN11• HARH45 = Ethicon Endo-Surgery Generator G11,model GEN11 | Same |
| TechnologicalCharacteristics | The Harmonic ACE+7 Shearsworks in conjunction with theEthicon GEN11 generator.The device connects to theGEN11 with a handpiece andcan be operated using fingerswitches on the handle or witha foot pedal. Communicationwith the GEN11 is facilitatedand data is stored by flexcircuitry in the device handle.bA mechanical trigger actuatesthe jaws. | The Harmonic ACE+7 Shearsworks in conjunction with theEthicon GEN11 generator.The device connects to theGEN11 with a handpiece andcan be operated using fingerswitches on the handle or witha foot pedal. Communicationwith the GEN11 is facilitatedand data is stored byReNewal Key-integrated flexcircuitry in the device handle.A mechanical trigger actuatesthe jaws. | As stated |
| a The Ethicon Endo-Surgery Generator G11, model GEN11 generator was cleared underK101990. The generator will not be reprocessed by Medline ReNewal. It is not a part of thissubmission.b The flex circuitry in the OEM Harmonic ACE+7 Shears limits the device to a single use. TheReNewal Key-integrated flex circuitry in the reprocessed Harmonic ACE+7 Shears enablesan additional use. | |||
| Based on comparisons of the indications for use, intended use, technologicalcharacteristics, and performance data to the predicate devices, MedlineConclusionReNewal Reprocessed Harmonic ACE+7 Shears models HARH23, HARH36,and HARH45 are substantially equivalent to the predicate devices. |
N/A