Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)

K161086 · Sterilmed, Inc. · NUJ · Sep 20, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161086
• Device Name: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm)
• Applicant: Sterilmed, Inc.
• Product Code: NUJ · General, Plastic Surgery
• Decision Date: Sep 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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) and other open and endoscopic procedures.

Device Story

Hand-actuated surgical instrument for grasping, coagulating, and transecting soft tissue; used in open and laparoscopic procedures by surgeons. Device features shaft with rotatable tissue effector; energy delivery via hand activation or generator foot switch. Includes EEPROM memory chip storing device ID, usage tracking, and Adaptive Tissue Technology algorithm parameters. Generator reads EEPROM to modulate power output and provide audible feedback based on blade thermal conditions and tissue presence. Reprocessing involves cleaning, sterilization, and functional testing; limited to one use cycle for shears and five for torque wrench accessories. Benefits include reduced thermal injury and effective bleeding control during surgery.

Clinical Evidence

Bench testing only. No clinical data. Non-clinical testing included cleaning validation, sterilization verification, ethylene oxide residuals (ISO 10993-7), packaging (ASTM D4169, F88, F2096), shelf-life (ASTM 1980-07), and biocompatibility (ISO 10993-1). Functional performance testing included electrical safety, vessel seal burst pressure (static/burst), thermal spread, fluid ingress, pad retention, pad failure, and clamp force.

Technological Characteristics

Hand-actuated electrosurgical instrument with rotatable shaft and tissue effector. Features EEPROM memory chip for generator communication. Power modulation via Adaptive Tissue Technology algorithm. Biocompatibility per ISO 10993-1 for <24h blood contact. Sterilization via ethylene oxide. Packaging standards: ASTM D4169, ASTM F88, ASTM F2096. Shelf-life standard: ASTM 1980-07.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in general, plastic, pediatric, gynecologic, urologic, thoracic, and orthopedic (spine/joint) open and endoscopic procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Harmonic ACE Shears + Adaptive Tissue Technology (K121550)

Reference Devices

• Reprocessed Harmonic Shears (K132566)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a triple-line design representing the bodies.

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

September 20, 2016

Sterilmed, Inc. Ms. Neelu Gibson Senior Director, Regulatory Affairs 5010 Cheshire Parkway, Suite 2 Plymouth, Minnesota 55446

Re: K161086

Trade/Device Name: Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23cm) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NUJ Dated: August 19, 2016 Received: August 22, 2016

Dear Ms. Gibson:

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 device

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related adverse events) (21 CFR Part 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 Parts 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 [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

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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Christopher J. Ronk -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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### Indications for Use

510(k) Number (if known) K161086

#### Device Name

Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm)

Indications for Use (Describe)

The Reprocessed Harmonic Shears with Adaptive Tissue Technology 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) and other open and endoscopic 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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### K161086 Device Name and Model Numbers

| Device Name | Model Number |
|------------------------------------------------------------------------------------------------|--------------|
| Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 23cm Length, With Adaptive Tissue Technology | HAR23R |
| Reprocessed Harmonic ACE®+ Shears, 5 mm Diameter, 36cm Length, With Adaptive Tissue Technology | HAR36R |

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Image /page/4/Picture/0 description: The image shows the logo for STERILMED. The logo consists of a stylized green and blue circular arrow on the left, followed by the word "STERILMED" in black and light blue lettering. The first part of the word, "STERIL", is in black, while the "MED" is in a lighter blue color.

# K161086

## 510(k) SUMMARY

| Submitter and<br>Manufacturer: | Sterilmed, Inc.<br>5010 Cheshire Parkway N, Suite 2<br>Plymouth, MN 55446<br>www.sterilmed.com |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official<br>Correspondent: | Neelu Gibson<br>Sr. Director, Regulatory Affairs (RAC)<br>Sterilmed, Inc.<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date of<br>Submission: | 15 March 2016 |
| Trade Name: | Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm),<br>Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm) |
| Common Name: | Reprocessed Harmonic Shears with Adaptive Tissue Technology |
| 510(k) Number: | K161086 |
| Device<br>Classification: | Name: Electrosurgical cutting and coagulation device and accessories.<br>Regulation: 21CFR 878-4400<br>Pro Code: NUJ<br>Class: Class II |
| Predicate Device: | Harmonic ACE Shears + Adaptive Tissue Technology (K121550). |
| Device<br>Description: | The Reprocessed Harmonic Shears with Adaptive Tissue Technology are<br>used for coagulation and mechanical transection of soft tissue during<br>laparoscopic and open procedures. The devices allow the surgeon to<br>grasp, coagulate and transect soft tissue with a single instrument. The<br>devices are hand-actuated with shaft and tissue effector that can be rotated.<br>The energy delivery can be activated with hand activation or with an<br>optional generator foot switch.<br>The device includes a torque wrench as an accessory piece (the torque<br>wrench is designed to ensure that the hand piece is properly secured to the<br>device. |
| Indications<br>for Use: | The Reprocessed Harmonic Shears with Adaptive Tissue Technology are<br>indicated for soft tissue incisions when bleeding control and minimal<br>thermal injury are desired. The instruments can be used as an adjunct to<br>or substitute for electrosurgery, lasers and steel scalpels in general, plastic,<br>pediatric, gynecologic, urologic, thoracic, exposure to orthopedic<br>structures (such as spine and joint space) and other open and endoscopic<br>procedures. |
| Technological<br>Characteristics: | The reprocessed Harmonic Shears with Adaptive Tissue Technology have<br>the same technological and performance characteristics as the predicate<br>devices, K121550. The reprocessed Harmonic Shears with Adaptive<br>Tissue Technology incorporate an ergonomic handle and tapered blade<br>geometry. Similar to the predicate models, each of these reprocessed<br>devices includes an EEPROM memory chip that stores device<br>identification, usage tracking, and operating parameters for use by the<br>Ethicon Endo-Surgery, Inc. Generator 11 generator that provides power<br>for the devices. |
| | Adaptive Tissue Technology refers to the power output algorithm that is<br>utilized by the devices. During use, the Adaptive Tissue Technology<br>algorithm parameters stored on the device EEPROM are read by the<br>generator and used to reduce the power (current) to the instrument and<br>provide a secondary, higher pitched generator activation tone when there<br>is little or no tissue between the instrument blade and tissue pads. To do<br>this the generator monitors the thermal condition of the blade during<br>device activation. |
| Functional<br>and Safety<br>Testing: | Representative samples of reprocessed devices were tested to<br>demonstrate appropriate functional characteristics. Process validation<br>testing was performed to validate the cleaning and sterilization<br>procedures as well as device packaging. In addition, the manufacturing<br>process includes visual and validated functional testing of all products<br>produced. Where appropriate prior validation testing of previously<br>cleared Reprocessed Harmonic Shears (K132566) was utilized for the<br>same reprocessing procedures, equipment, and sterilization processing.<br>The Reprocessed Harmonic Shears with Adaptive Tissue Technology are<br>reprocessed no more than one (1) time. The torque wrench accessories<br>are reprocessed no more than five (5) times. Each device and accessory<br>is marked and tracked through the reprocessing cycle. After the device<br>or torque wrench has reached the maximum number of reprocessing<br>cycles, one and five, respectively, it is rejected from further reprocessing. |
| Summary of<br>Non-Clinical<br>Tests Conducted: | Specific non-clinical tests performed included: cleaning validation,<br>sterilization verification, ethylene oxide residual testing (ISO 10993-7),<br>packaging validation (ASTM D4169, ASTM F88, ASTM F2096), and<br>shelf-life validation (ASTM 1980-07). In addition, validation of<br>functional performance (bench testing) was performed through simulated Electrical Safety Device Functionality Vessel Seal Burst (Static and Burst Pressure) Vessel Seal Thermal Spread Drop Fluid Ingress Pad Retention Pad Failure Clamp Force |
| | Performance testing shows the reprocessed Harmonic Shears with<br>Adaptive Tissue Technology to perform as originally intended.<br>In addition, the device was tested for biocompatibility per ISO 10993-<br>1 for short duration contact with blood (<24 hours). Biocompatibility<br>testing included:<br>Cytotoxicity Sensitization Irritation/Intracutaneous Reactivity Acute Systemic Toxicity Hemocompatability Chemical Pyrogens Hemolysis Immune Response |
| Conclusion: | Sterilmed conducted performance testing (described above) for the<br>Reprocessed Harmonic Shears with Adaptive Tissue Technology (23 cm<br>and 36 cm) against the OEM predicate devices, Harmonic ACE Shears +<br>Adaptive Tissue Technology, Models HAR23 and HAR36 (K121550).<br>Results demonstrated substantial equivalence to the predicate devices<br>with respect to safety and effectiveness.<br>Sterilmed therefore concludes that the Reprocessed Harmonic Shears with<br>Adaptive Tissue Technology (23 cm, 36 cm) are safe, effective, and<br>substantially equivalent to the predicate devices, Harmonic ACE Shears +<br>Adaptive Tissue Technology, Models HAR23 and HAR36 (K121550) |

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