REPROCESSED HARMONIC SCALPEL

K111794 · Sterilmed, Inc. · NLQ · Jan 11, 2012 · SU

Device Facts

• Record ID: K111794
• Device Name: REPROCESSED HARMONIC SCALPEL
• Applicant: Sterilmed, Inc.
• Product Code: NLQ · SU
• Decision Date: Jan 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Device Story

Reprocessed ultrasonic surgical instrument; used with external hand piece, generator, torque wrench, and grip assist. Features scissor handle with MIN/MAX hand controls; integrated force-limiting mechanism for distal closure. Working length 9 cm; 16 mm active curved blade with clamp arm. Used in open surgical procedures (abdominal, pediatric, gynecologic, orthopedic) by surgeons. Device enables simultaneous cutting and coagulation of vessels up to 5 mm diameter. Reprocessing restores device to original functional specifications; intended as adjunct/substitute for electrosurgery, lasers, or steel scalpels. Benefits include precise tissue management with reduced thermal injury.

Clinical Evidence

Bench testing only. Validation included cleaning and sterilization efficacy, biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging integrity (ASTM D4169, F88, F1929, F2096), and shelf life (ASTM 1980-07). Functional performance verified via simulated use on beef tissue, visual inspection, and fatigue testing (repeated cycling and maximum power testing).

Technological Characteristics

Ultrasonic scalpel; curved blade and clamp arm; 9 cm length. Materials consistent with predicate. Energy source: external ultrasonic generator. Connectivity: mechanical interface to hand piece. Sterilization: ethylene oxide. Standards: ISO 11135, ISO 10993, ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096, ASTM 1980-07.

Indications for Use

Indicated for cutting soft tissue and providing hemostasis in patients undergoing abdominal, pediatric, gynecologic, or orthopedic open procedures where control of bleeding and minimal thermal injury is required.

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 Harmonic FOCUS™ Curved Shears (K063192)

Submission Summary (Full Text)

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## II. SUMMARY AND CERTIFICATION

| SUMMARY AND CERTIFICATION | | | JAN 11 2012 |
|---------------------------|------------------------|-------------------------------------------------------------------------------------------------------------|-------------|
| A. | 510(k) Summary | K111794 | |
| | Submitter: | SterilMed, Inc. | |
| | Contact Person: | Onya Dendinger<br>11400 73rd Avenue North<br>Maple Grove, MN 55369<br>Ph: 763-488-3410<br>Fax: [phone] | |
| | Date Prepared: | June 24, 2011 | |
| | Trade Name: | Reprocessed Harmonic Scalpel | |
| | Classification Name: | Scalpel, Ultrasonic, Reprocessed | |
| | Classification Number: | Unclassified | |
| | Product Code: | NLO | |

| Predicate<br>Devices: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears<br>(510(k) K063192). |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench<br>and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of<br>vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and<br>MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when<br>closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and<br>utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and<br>including 5 mm in diameter.<br>Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission. |
| Intended<br>Use: | The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting<br>soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.<br>The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in<br>abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other<br>open procedures. |
| Functional<br>and Safety<br>Testing: | Representative samples of reprocessed harmonic scalpels were tested to demonstrate appropriate functional<br>characteristics. Process validation testing was performed to validate the cleaning and sterilization procedures as<br>well as device packaging. In addition, the manufacturing process includes visual and validated functional testing<br>of all products produced. |
| Summary of<br>Non-clinical<br>Tests<br>Conducted: | Specific non-clinical tests performed included: cleaning validation, sterilization validation (ISO 11135, USP<br><71>), biocompatibility testing (ISO 10993-1), ethylene oxide residual testing (ISO 10993-7), packaging<br>validation (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life validation (ASTM 1980-<br>07). In addition, validation of functional performance (bench testing) was performed through simulated use on<br>beef tissue, visual inspection, fatigue testing (including repeated cycling and maximum power testing), and<br>function testing (including system checks). Performance testing shows the Reprocessed Harmonic Scalpels to<br>perform as intended. |
| Conclusion: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic FOCUS™ Curved Shears.<br>This conclusion is based upon the devices' similarities in functional design (principles of operation), materials,<br>indications for use and methods of construction. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circle around the eagle.

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

JAN 1 1 2012

SterilMed, Inc. % Ms. Onya Dendinger 11400 73td Avenue North Maple Grove, Minnesota 55369

Re: K111794

Trade/Device Name: Reprocessed Harmonic Scalpel Regulatory Class: Unclassified Product Code: NLQ Dated: December 29, 2011 Received: December 30, 2011

Dear Ms. Dendinger:

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

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Page 2 – Ms. Onya Dendinger

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

E. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/3/Picture/0 description: The image shows the logo for SterilMed, INC. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name, there is smaller text that reads "Medical Device Reprocessing" and "Small Equipment & Instrument Repair."

## Indications for Use

KIII 794 510(k) Number (if known):

Device Name: Reprocessed Harmonic Scalpel

Indications for Use:

The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired.

The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111794