Medline ReNewal Reprocessed Harmonic ACE+7 Shears

K193563 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · NLQ · Aug 19, 2020 · SU

Device Facts

• Record ID: K193563
• Device Name: Medline ReNewal Reprocessed Harmonic ACE+7 Shears
• Applicant: Surgical Instrument Service and Savings Inc.(Dba Medline Ren
• Product Code: NLQ · SU
• Decision Date: Aug 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

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.

Device Story

Reprocessed ultrasonic surgical shears; used for grasping, coagulating, and transecting soft tissue in open and laparoscopic procedures. Device connects to Ethicon GEN11 generator; energy delivery activated via hand-control buttons or optional foot switch. Mechanical trigger actuates jaws; shaft and tissue effector rotate 360 degrees. Reprocessing includes cleaning, sterilization, and integration of 'ReNewal Key' flex circuitry to enable additional use cycles beyond original single-use limit. Operated by surgeons in OR settings. Output is mechanical/thermal energy for tissue effect; provides hemostasis and cutting. Benefits include reduced thermal injury compared to traditional electrosurgery.

Clinical Evidence

Bench testing only. Evaluated via electrical safety (IEC 60601-1, 60601-1-2), simulated use, device integrity, handle operation, shaft rotation, device recognition, cutting time, thermal analysis, tissue sticking, burst pressure, histopathology, seal quality, cleaning validation (protein, carbohydrate, endotoxin), and biocompatibility (cytotoxicity, sensitization, irritation, materials-mediated pyrogen, acute systemic toxicity).

Technological Characteristics

Ultrasonic surgical instrument; 5-mm diameter; 23, 36, or 45-cm shaft lengths. 360-degree rotation. Energy source: Ethicon GEN11 generator. Connectivity: Handpiece connection to generator. Flex circuitry in handle for data storage/device recognition. Sterilization: Validated reprocessing cycle.

Indications for Use

Indicated for soft tissue incisions in general, plastic, pediatric, gynecologic, urologic, and thoracic surgery, including orthopedic structure exposure and lymphatic vessel sealing/transection. Suitable for open and endoscopic procedures requiring bleeding control and minimal thermal injury. Coagulates vessels up to 7 mm diameter.

Regulatory Classification

Identification

Single-use reprocessed versions of the ultrasonic devices used in surgical procedures either for fragmentation, emulsification and aspiration of soft tissue and hard tissue or for ligation of vessels (under product code “LFL”). Reprocessing validation data for this device type must be included in a 510(k) submission.. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).

Predicate Devices

• HARMONIC ACE+ SHEARS 23 CM LENGTH WITH ADVANCED HEMOSTASIS, HARMONIC ACE + LAPAROSCOPIC SHEARS 36 CM LENGTH WITH ADVANCE (K132612)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 | Original<br>Manufacturer |
|--------------|----------------------------------------------------------------------------|--------------------------|
| HARH23 | Harmonic ACE+7 Shears<br>(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears<br>(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears<br>(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) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> 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 | Original<br>Manufacturer |
|--------------|----------------------------------------------------------------------------|--------------------------|
| HARH23 | Harmonic ACE+7 Shears<br>(5-mm diameter x 23-cm long shaft, 360° rotation) | Ethicon |
| HARH36 | Harmonic ACE+7 Shears<br>(5-mm diameter x 36-cm long shaft, 360° rotation) | Ethicon |
| HARH45 | Harmonic ACE+7 Shears<br>(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/<br>Owner | Surgical Instrument Service and Savings (dba Medline ReNewal)<br>1500 NE Hemlock Ave., Redmond, OR 97756 | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Contact/<br>Prepared by | Gail Gassner<br>Quality Assurance Specialist II, Quality Assurance/Regulatory Affairs<br>P: 541-516-4193 • F: 541-923-3375 • E: [e-mail] | | |
| Date Prepared | December 20, 2019 | | |
| Device Name<br>and<br>Classification | Proprietary/Trade<br>Name: | Medline ReNewal Reprocessed Harmonic ACE+7<br>Shears models HARH23, HARH36, and HARH45 | |
| | Common or Usual<br>Name | Reprocessed ultrasonic scalpel | |
| | Regulatory<br>Name/Reference | Electrosurgical cutting and coagulation device and<br>accessories reprocessed, 21 CFR § 878.4400 | |
| | Regulatory Class | Unclassified | |
| | Product Code | NLQ | |
| | Panel | General & Plastic Surgery | |
| Predicate<br>Device | 510(k) Number | K132612 | |
| | Proprietary or<br>Trade Name | HARMONIC ACE+ SHEARS 23 CM LENGTH WITH<br>ADVANCED HEMOSTASIS, HARMONIC ACE +<br>LAPAROSCOPIC SHEARS 36 CM LENGTH WITH<br>ADVANCE | |
| | Common or Usual<br>Name | Ultrasonic surgical instrument | |
| | Regulatory<br>Name/Reference | Electrosurgical cutting and coagulation device and<br>accessories reprocessed, 21 CFR § 878.4400 | |
| | Regulatory Class | Unclassified | |
| | Product Code | LFL | |
| | Panel | General & Plastic Surgery | |
| | Manufacturer | Ethicon Endo-Surgery, LLC<br>4545 Creek Road, Cincinnati, OH 45242 | |
| Device<br>Description | The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models<br>HARH23, HARH36, and HARH45) are used for coagulation and<br>mechanical transection of soft tissue during laparoscopic and open<br>procedures. The devices allow the surgeon to grasp, coagulate, and<br>transect soft tissue with a single instrument. The devices are hand-actuated<br>with a shaft and tissue effector that can be rotated. The energy delivery can<br>be activated with hand activation or with an optional generator foot switch. | | |
| Indications for<br>use | The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft<br>tissue incisions when bleeding control and minimal thermal injury are<br>desired. The instruments can be used as an adjunct to or substitute for<br>electrosurgery, lasers and steel scalpels in general, plastic, pediatric, | | |
| Technological<br>Characteristics | The technological characteristics and the fundamental scientific technology<br>of the subject devices are equivalent to the predicate device. The proposed<br>devices are a reprocessed version of the predicate devices. K132612<br>Ethicon Harmonic ACE+7 Shears was used as the primary predicate to<br>support intended use, technological characteristics, and functional<br>performance specifications. | | |
| Performance<br>Testing | The functional characteristics of the proposed devices have been evaluated<br>and found to be equivalent to the predicate devices based on the following<br>tests:<br>• electrical safety and electromagnetic compatibility in accordance<br>with IEC 60601-1 and 60601-1-2;<br>• simulated use;<br>• device integrity;<br>• handle operation;<br>• shaft knob rotation;<br>• device recognition;<br>• cutting time;<br>• thermal analysis characterization;<br>• tissue sticking;<br>• burst pressure;<br>• histopathology;<br>• seal quality;<br>• Cleaning:<br>o protein,<br>o carbohydrates,<br>o endotoxin;<br>• Biocompatibility:<br>o cytotoxicity,<br>o sensitization,<br>o irritation,<br>o materials-mediated pyrogen, and<br>o acute systemic toxicity;<br>• performance qualification; and<br>• sterilization validation. | | |
| | Summary Table: Predicate and Medline ReNewal Reprocessed Harmonic ACE+7 Shears<br>device comparison chart. | | |
| | Predicate | Proposed | Comparison |
| Device<br>Characteristics | Ethicon Harmonic ACE+7<br>Shears with Advanced<br>Hemostasis | Medline ReNewal<br>Reprocessed Harmonic<br>ACE+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,<br>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 for<br>Use | The Ethicon Harmonic ACE+<br>7 Shears with Advanced<br>Hemostasis are indicated for<br>soft tissue incisions when<br>bleeding control and minimal<br>thermal injury are desired. The<br>instruments can be used as an<br>adjunct to or substitute for<br>electrosurgery, lasers and<br>steel scalpels in general,<br>plastic, pediatric, gynecologic,<br>urologic, thoracic, exposure to<br>orthopedic structures (such as<br>spine and joint space), sealing<br>and transection of lymphatic<br>vessels, and other open and<br>endoscopic procedures. The<br>instruments allow for the<br>coagulation of vessels up to<br>and including 7 mm in<br>diameter using the Advanced<br>Hemostasis hand control<br>button. | The Medline ReNewal<br>Reprocessed Harmonic ACE+<br>7 Shears with Advanced<br>Hemostasis are indicated for<br>soft tissue incisions when<br>bleeding control and minimal<br>thermal injury are desired. The<br>instruments can be used as an<br>adjunct to or substitute for<br>electrosurgery, lasers and<br>steel scalpels in general,<br>plastic, pediatric, gynecologic,<br>urologic, thoracic, exposure to<br>orthopedic structures (such as<br>spine and joint space), sealing<br>and transection of lymphatic<br>vessels, and other open and<br>endoscopic procedures. The<br>instruments allow for the<br>coagulation of vessels up to<br>and including 7 mm in<br>diameter using the Advanced<br>Hemostasis hand control<br>button. | 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 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device<br>Characteristics | Ethicon Harmonic ACE+7<br>Shears with Advanced<br>Hemostasis | Medline ReNewal<br>Reprocessed Harmonic<br>ACE+7 Shears | As stated |
| Power Platforma | • HARH23 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11<br>• HARH36 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11<br>• HARH45 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11 | • HARH23 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11<br>• HARH36 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11<br>• HARH45 = Ethicon Endo-<br>Surgery Generator G11,<br>model GEN11 | Same |
| Technological<br>Characteristics | The Harmonic ACE+7 Shears<br>works in conjunction with the<br>Ethicon GEN11 generator.<br>The device connects to the<br>GEN11 with a handpiece and<br>can be operated using finger<br>switches on the handle or with<br>a foot pedal. Communication<br>with the GEN11 is facilitated<br>and data is stored by flex<br>circuitry in the device handle.b<br>A mechanical trigger actuates<br>the jaws. | The Harmonic ACE+7 Shears<br>works in conjunction with the<br>Ethicon GEN11 generator.<br>The device connects to the<br>GEN11 with a handpiece and<br>can be operated using finger<br>switches on the handle or with<br>a foot pedal. Communication<br>with the GEN11 is facilitated<br>and data is stored by<br>ReNewal Key-integrated flex<br>circuitry in the device handle.<br>A mechanical trigger actuates<br>the jaws. | As stated |
| a The Ethicon Endo-Surgery Generator G11, model GEN11 generator was cleared under<br>K101990. The generator will not be reprocessed by Medline ReNewal. It is not a part of this<br>submission.<br>b The flex circuitry in the OEM Harmonic ACE+7 Shears limits the device to a single use. The<br>ReNewal Key-integrated flex circuitry in the reprocessed Harmonic ACE+7 Shears enables<br>an additional use. | | | |
| Based on comparisons of the indications for use, intended use, technological<br>characteristics, and performance data to the predicate devices, Medline<br>Conclusion<br>ReNewal Reprocessed Harmonic ACE+7 Shears models HARH23, HARH36,<br>and HARH45 are substantially equivalent to the predicate devices. | | | |