Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology

K151405 · Surgical Instrument Services and Savings(Dba Medline Renewal · NLQ · Jan 26, 2016 · SU

Device Facts

• Record ID: K151405
• Device Name: Medline ReNewal Reprocessed Harmonic ACE + Shears without Adaptive Tissue Technology
• Applicant: Surgical Instrument Services and Savings(Dba Medline Renewal
• Product Code: NLQ · SU
• Decision Date: Jan 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

Medline ReNewal Reprocessed Harmonic ACE+ Shears without 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, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

Device Story

Reprocessed ultrasonic surgical shears; originally manufactured by Ethicon Endo-Surgery. Device inputs: electrical energy converted to mechanical ultrasonic vibration. Device transforms energy to oscillate blade for simultaneous tissue cutting and coagulation. Used in OR by surgeons for open and endoscopic procedures. Output: mechanical cutting and thermal hemostasis. Benefits: reduced bleeding and thermal injury compared to traditional electrosurgery. Medline ReNewal cleans, refurbishes, tests, inspects, and re-sterilizes used devices for additional clinical use.

Clinical Evidence

Bench testing only. No clinical data. Performance evaluated via simulated use, grasping/pulling force, cutting effectiveness, device integrity, thermal analysis, vessel burst pressure, seal quality, histopathology, electrical safety (IEC 60601-1), cleaning validation (protein/carbohydrate/endotoxin levels), biocompatibility (cytotoxicity, sensitization, irritation, pyrogenicity, acute systemic toxicity), sterilization validation, and product stability.

Technological Characteristics

Ultrasonic scalpel; reprocessed single-use device. Sensing/actuation: ultrasonic vibration for cutting/coagulation. Connectivity: none. Sterilization: validated process. Electrical safety: IEC 60601-1 compliant. Materials: identical to original predicate device.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury. Used in general, plastic, pediatric, gynecologic, urologic, and orthopedic open and endoscopic procedures as an adjunct or substitute for electrosurgery, lasers, or steel scalpels.

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 ACE® Shears+ Adaptive Tissue Technology (K120729)

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

January 26, 2016

Surgical Instrument Services and Savings (dba Medline Renewal) Ms. Brandi Panteleon Director, Regulatory Affairs 2747 SW 6th St. Redmond, Oregon 97756

Re: K151405

Trade/Device Name: Medline Renewal Reprocessed Harmonic Ace + Shears without Adaptive Tissue Technology

Regulatory Class: Unclassified Product Code: NLO Dated: December 23, 2015 Received: December 28, 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 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

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,

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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| Device Model | Device Name | Device Size |
|--------------|----------------------------------------------------------------------------------|-------------|
| HAR23M | Medline ReNewal Reprocessed ACE+<br>Shears without Adaptive Tissue<br>Technology | 5 x 23 cm |
| HAR36M | Medline ReNewal Reprocessed ACE+<br>Shears without Adaptive Tissue<br>Technology | 5 x 36 cm |

Reprocessed Single-Use Device Models Included in Clearance:

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## Indications for Use

510(k) Number (if known) K151405

Device Name

Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive Tissue Technology

#### Indications for Use (Describe)

Medline ReNewal Reprocessed Harmonic ACE+ Shears without 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, 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is a vertical line, followed by the word "Renewal" in green and blue. Below the word "Renewal" is the phrase "Full Circle Reprocessing" in a smaller font.

# 510(k) Summary — K151405

| Submitter/<br>Owner | Medline ReNewal<br>2747 SW 6th St.<br>Redmond, OR 97756 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Names | Brandi Panteleon<br>Director, QA/RA<br>P: 541-923-3310<br>F: 541-923-3375<br>E: [e-mail] |
| Date Prepared | May 20, 2015 |
| Device Names | Proprietary Name: Medline ReNewal Reprocessed Harmonic ACE+ Shears<br>without Adaptive Tissue Technology, models HAR23M and HAR36M<br>Common Name: Unclassified/scalpel, ultrasonic reprocessed |
| Classification | Unclassified/scalpel ultrasonic, reprocessed<br>Product code: NLQ |
| Predicate<br>Device | K120729 Ethicon Endo-Surgery Harmonic ACE® Shears+ Adaptive Tissue<br>Technology |
| Device<br>Description | Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive<br>Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are<br>cleaned, refurbished, tested, inspected, packaged, and sterilized for an<br>additional clinical use. |
| Intended Use | Medline ReNewal Reprocessed Harmonic ACE+ Shears without Adaptive<br>Tissue Technology are indicated for soft tissue incisions when bleeding<br>control and minimal thermal injury are desired. The instruments can be<br>used as an adjunct to, or substitute for, electrosurgery, lasers and steel<br>scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to<br>orthopedic structures (such as spine and joint space) and other open and<br>endoscopic procedures. |
| Technological<br>Characteristics | The technological characteristics and the fundamental scientific technology<br>of the subject devices are identical to the predicate device. The proposed<br>devices are a reprocessed version of the predicate devices. |

•

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Image /page/5/Picture/0 description: The image contains the Medline Renewal logo. The word "Medline" is in blue, with a blue star-like symbol to the right. To the right of the Medline logo is the word "Renewal" in green and blue, with the words "Full Circle Reprocessing" in a smaller font below.

| | 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: | |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Performance<br>Testing | 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, seal quality and histopathology; electrical safety in accordance with IEC 60601-1; cleaning; protein, carbohydrates, and endotoxins and visual inspection; biocompatibility; cytotoxicity, sensitization, irritation; pyrogenicity, and acute systemic toxicity; performance qualification; sterilization validation; and product stability. | |
| Conclusion | Based on comparisons of the indications for use, intended use,<br>technological characteristics, and performance data to the predicate<br>devices, Medline ReNewal Reprocessed Harmonic ACE+ Shears without<br>Adaptive Tissue Technology are substantially equivalent to the predicate<br>devices. | |