Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis

K161693 · Stryker Sustainability Solutions · NLQ · Feb 23, 2017 · SU

Device Facts

• Record ID: K161693
• Device Name: Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis
• Applicant: Stryker Sustainability Solutions
• Product Code: NLQ · SU
• Decision Date: Feb 23, 2017
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis 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, gynecologic, 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

Ultrasonic surgical instrument for soft tissue incision and coagulation; used in open and endoscopic procedures. Device features ergonomic handle with three hand-controlled activation buttons; provides audible and tactile feedback for full closure. Utilizes Adaptive Tissue Technology to monitor tissue and modulate generator power output. Operated by surgeons in clinical settings (OR). Reprocessing involves cleaning, decontamination, and functional testing of components. Benefits include precise hemostasis, reduced thermal injury, and vessel sealing up to 7 mm. Output is mechanical transection and coagulation of tissue.

Clinical Evidence

Bench and laboratory testing only. Included biocompatibility, sterilization validation, electrical safety (IEC 60601-1, IEC 60601-2-2), and electromagnetic compatibility (IEC 60601-1-2). Functional performance evaluated vessel sealing (up to 7mm), thermal spread, transection time, and burst pressure. Acute and chronic pre-clinical testing evaluated thermal spread and hemostasis efficacy.

Technological Characteristics

Ultrasonic scalpel; 5mm diameter; 23cm, 36cm, or 45cm shaft lengths. Features Adaptive Tissue Technology for power modulation. Includes PCB for generator communication. Reprocessed via cleaning and decontamination. Electrical safety per IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.

Indications for Use

Indicated for patients undergoing general, plastic, pediatric, gynecologic, thoracic, or orthopedic procedures requiring soft tissue incision, coagulation, or vessel sealing (up to 7 mm).

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 with Advanced Hemostasis (K132612)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 23, 2017

Stryker Sustainability Solutions Mr. Scott English Staff Regulatory Affairs Specialist 1810 W. Drake Dr. Tempe, Arizona 85283

Re: K161693

Trade/Device Name: Reprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced Hemostasis

Regulatory Class: Unclassified Product Code: NLQ Dated: January 24, 2017 Received: January 25, 2017

Dear Mr. English:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 [phone] or [phone] 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

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Sincerely yours,

# Jennifer R. Stevenson -S

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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K161693

#### Device Name

Reprocessed HARMONIC ACE® +7, 5mm Diameter Shears with Advanced Hemostasis

#### Indications for Use (Describe)

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis 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, gynecologic, urologic, 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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# K161693

# 510(k) SUMMARY

#### Submitter:

Stryker Sustainability Solutions 1810 W. Drake Drive Tempe, Arizona 85283

Contact: Mr. Scott English Staff Requlatory Affairs Specialist 480-763-5333 (o) 480-763-5310 (f) [e-mail]

Date of Preparation: January 23, 2017

Name of Device:

| | Trade/Proprietary Name: Reprocessed HARMONIC ACE® +7, 5mm Diameter Shears with<br>Advanced Hemostasis |
|-----------------------------|-------------------------------------------------------------------------------------------------------|
| Common Name: | Scalpel, Ultrasonic, Reprocessed |
| Classification Information: | Class: Unclassified<br>Unclassified Reason: Pre-Amendment<br>Product Code: NLQ |

#### Predicate Devices:

| Model<br>Number | 510(k)<br>Number | 510(k) Title | Original Manufacturer |
|----------------------------|------------------|-----------------------------------------------|-----------------------|
| HARH23<br>HARH36<br>HARH45 | K132612 | HARMONIC ACE+ Shears with Advanced Hemostasis | Ethicon Endo-Surgery |

#### Device Description:

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coaqulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an erqonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The only difference between the three (3) model numbers subject of this submission is the shaft length detailed in the table below.

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| Model<br>Number | Description | Size |
|-----------------|--------------------------------------------------------------|------------------------------------|
| HARH23 | Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis | 5mm Diameter,<br>23cm Shaft Length |
| HARH36 | Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis | 5mm Diameter,<br>36cm Shaft Length |
| HARH45 | Reprocessed HARMONIC ACE® +7 Shears with Advanced Hemostasis | 5mm Diameter,<br>45cm Shaft Length |

Each instrument is shipped with one sterile, single-use, disposable torque wrench.

## Intended Use:

The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis 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, gynecologic, 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.

### Summary of Technological Characteristics:

The design, materials, and intended use of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are equivalent to the predicate devices. The mechanism of action of the reprocessed device is identical to the predicate device in that the same standard mechanical design, materials, and sizes are utilized. The differences between the reprocessed device and predicate device include a substitute tissue pad, new scalpel rod blade coating, and replacement Printed Circuit Board (PCB). There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition, Stryker Sustainability Solutions' reprocessing of HARMONIC ACE® 7, 5 mm Diameter Shears with Advanced Hemostasis includes removal of adherent visible soil and decontamination. Each individual device is tested for appropriate function of its components prior to packaging and labeling operations.

#### Performance Data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis. This included the following tests:

- Biocompatibility
- Validation of Reprocessing ●
- Sterilization Validation ●
- Functional Performance Tests .
- Electrical Safety Testing
- Electromagnetic Compatibility Testing ●
- Software Validation
- Packaging Validation

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# K161693

The functional performance testing involved electrical safety and electromagnetic compatibility testing in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2, and verification/comparative testing (to the predicate device). The bench testing involved evaluation of the device's performance and ability to seal and divide vessels up to 7mm, including: thermal spread, transection time, burst pressure, device functionality, and device reliability.

Acute and chronic pre-clinical testing was conducted to evaluate thermal spread and the ability to achieve hemostasis of vessels and tissues.

The performance testing demonstrates that reprocessed devices are as safe and effective as the predicates and operate as originally intended.

#### Conclusion:

Stryker Sustainability Solutions concludes that the Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis is at least as safe and effective as the predicate device as described herein.