Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

K150524 · Surgical Instrument Services and Savings, Inc. · NLQ · Dec 16, 2015 · SU

Device Facts

• Record ID: K150524
• Device Name: Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology
• Applicant: Surgical Instrument Services and Savings, Inc.
• Product Code: NLQ · SU
• Decision Date: Dec 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Story

Reprocessed ultrasonic surgical shears; used for soft-tissue incision and coagulation. Device functions by converting electrical energy into mechanical ultrasonic vibration at the blade tip; vibration denatures proteins to create coagulum for hemostasis while cutting tissue. Used in open surgical procedures (general, ENT, plastic, pediatric, gynecologic, urologic, orthopedic) by surgeons. Device is a reprocessed version of original Ethicon Harmonic FOCUS+ Shears; Medline ReNewal cleans, refurbishes, tests, and re-sterilizes used devices for additional clinical use. Output is mechanical cutting and thermal coagulation of tissue; provides alternative to electrosurgery or lasers. Benefits include reduced thermal injury and effective bleeding control.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing: simulated use, grasping/pulling force, cutting effectiveness, drop test, device integrity, thermal analysis, tissue sticking, vessel burst pressure, electrical safety (IEC 60601-1), cleaning validation (protein, carbohydrates, hemoglobin, endotoxins), biocompatibility (sensitization, irritation, acute systemic toxicity), and sterilization validation.

Technological Characteristics

Ultrasonic scalpel; converts electrical energy to mechanical vibration. Dimensions: 9 cm length, 16 mm active blade. Materials: identical to original Ethicon device. Electrical safety: IEC 60601-1. Sterilization: validated re-sterilization process. Connectivity: none (standalone).

Indications for Use

Indicated for soft-tissue incisions requiring bleeding control and minimal thermal injury in general, ENT, plastic, pediatric, gynecologic, urologic, and orthopedic open procedures.

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

• Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive Tissue Technology (K133314)

Reference Devices

• MEDISISS Reprocessed Ultrasonic Instrument (K124033)
• Ethicon Endo-Surgery Harmonic FOCUS Shears (K100597)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines above and below them, resembling a bird in flight.

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

Surgical Instrument Service and Savings (dba Medline ReNewal) Ms. Brandi Panteleon Director, Quality Assurance and Regulatory Affairs 2747 Southwest 6th Street December 16, 2015 Redmond, Oregon 97756

Re: K150524

Trade/Device Name: Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology Regulatory Class: Unclassified

Product Code: NLQ Dated: December 4, 2015 Received: December 7, 2015

Dear Ms. Panteleon:

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-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours. Joshua C. Mipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. For Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Device Models Subject to Clearance:

| Model Number | Device Description | Device Length | Active Blade Length |
|--------------|---------------------------------------------------------------------------------------------|---------------|---------------------|
| HAR9FM | Medline ReNewal Reprocessed<br>Harmonic FOCUS+ Shears without<br>Adaptive Tissue Technology | 9 cm | 16 mm |

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## Indications for Use

510(k) Number (if known) K150524

Device Name

Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

#### Indications for Use (Describe)

Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is indicated for softtissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/4/Picture/0 description: The image contains the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star-like symbol. To the right of the Medline logo is the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.

K150524/S001 Traditional 510(k) Notification Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

(replacement page 25 of 88)

# 5.0 510(k) Summary

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon<br>Director, Regulatory Affairs<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | May 5, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Harmonic FOCUS+ Shears without<br>Adaptive Tissue Technology<br>Common Name: scalpel, ultrasonic, reprocessed |
| Classification | Unclassified/Scalpel, Ultrasonic, Reprocessed<br>Product Code: NLQ |
| Predicate<br>Device | K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive<br>Tissue Technology |
| Reference<br>Devices | K124033 – MEDISISS Reprocessed Ultrasonic Instrument<br>K100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears |
| Device<br>Description | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without<br>Adaptive Tissue Technology (originally manufactured by Ethicon Endo-<br>Surgery) are cleaned, refurbished, tested, inspected, packaged, and<br>sterilized for an additional clinical use. |
| Intended Use | Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without<br>Adaptive Tissue Technology is indicated for soft-tissue incisions when<br>bleeding control and minimal thermal injury are desired. The instrument can<br>be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel<br>scalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic,<br>pediatric, gynecologic, urologic, exposure to orthopedic structures (such as<br>spine and joint space) and other open procedures. |

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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "MEDLINE" is in blue and to the left of a blue star shape. To the right of the Medline logo is the word "Renewal" in green and blue. Underneath "Renewal" is the phrase "Full Circle Reprocessing" in blue.

K150524/S001 Traditional 510(k) Notification Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology

### (replacement page 26 of 88)

The technological characteristics and the fundamental scientific technology of the subject device are identical to the predicate and reference devices:

| Technological<br>Characteristics | K133314 - Ethicon Endo-Surgery Harmonic FOCUS Shears + Adaptive Tissue Technology; used as the primary predicate to support intended use, technological characteristics, and functional performance specifications; K124033 - MEDISISS Reprocessed Ultrasonic Instrument; used as a reference predicate to support cleaning, biocompatibility, and product stability of the reprocessed device, and K100597 - Ethicon Endo-Surgery Harmonic FOCUS Shears; used as a reference predicate to identify design progression of the original device. |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance<br>Testing | The functional characteristics of the subject device have been evaluated and found to be substantially equivalent to the predicate device based on the following tests: simulated use; grasping/pulling force; cutting effectiveness/functionality; drop test; device integrity; cutting/coagulation evaluation for a prolonged period of time; thermal analysis characterization; tissue sticking; vessel burst pressure; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, hemoglobin, and endotoxins; biocompatibility; sensitization, irritation, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. |
| Conclusion | Based on the information provided, the Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology are substantially equivalent to the predicate device. |