REPROCESSED HARMONIC SCALPEL

K083060 · Sterilmed, Inc. · NLQ · Jan 9, 2009 · SU

Device Facts

• Record ID: K083060
• Device Name: REPROCESSED HARMONIC SCALPEL
• Applicant: Sterilmed, Inc.
• Product Code: NLQ · SU
• Decision Date: Jan 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The reprocessed harmonic scalpels are indicated to be used for cutting of 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 and endoscopic procedures.

Device Story

Reprocessed ultrasonic surgical instrument; used with external hand piece, generator, and torque wrench; performs simultaneous soft tissue cutting and coagulation. Features scissor handle with MIN/MAX controls; integrated force-limiting mechanism for distal closure; 18 cm shaft; 8.5 mm diameter; 18 mm active blade; straight blade and clamp arm. Used by surgeons in OR settings for open and endoscopic procedures. Device functions as adjunct/substitute for electrosurgery, lasers, or steel scalpels. Benefits include precise hemostasis with reduced thermal injury. Subject device is a reprocessed version of the Ethicon Harmonic WAVE; reprocessed via validated cleaning and sterilization protocols to ensure functional equivalence.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including functional performance testing and validation of cleaning, sterilization, and packaging processes.

Technological Characteristics

Ultrasonic scalpel; utilizes mechanical vibration for cutting and coagulation. Features include scissor handle, MIN/MAX hand controls, and force-limiting mechanism. Dimensions: 18 cm shaft length, 8.5 mm shaft diameter, 18 mm active blade. Materials and construction identical to predicate. Device is non-sterile as received, reprocessed via validated cleaning and sterilization cycles.

Indications for Use

Indicated for cutting soft tissue and providing hemostasis in abdominal, pediatric, gynecologic, and orthopedic (spine/joint space) open and endoscopic procedures where control of bleeding and minimal thermal injury is desired.

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 WAVE (K083060)

Submission Summary (Full Text)

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510(K) PREMARKET NOTIFICATION SUBMISSION OCTOBER 10, 2008 For Reprocessed Harmonic Scalpel

### SUMMARY AND CERTIFICATION II.

#### 510(k) Summary A.

SterilMed, Inc. Submitter:

Contact Person:

Dennis Toussaint 11400 73rd Avenue North Maple Grove, MN 55369 Ph: 763-488-3410 Fax: [phone]

JAN. - 9 2009

883060

| Date Prepared: | October 10, 2008 |
|------------------------|----------------------------------|
| Trade Name: | Reprocessed Harmonic Scalpel |
| Classification Name: | Scalpel, Ultrasonic, Reprocessed |
| Classification Number: | Unclassified |
| Product Code: | NLQ |

| Predicate<br>Devices: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVETM<br>harmonic scalpels. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description: | SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator<br>and torque wrench and are intended to be used in soft tissue surgery for simultaneous cutting<br>and coagulation of vessels and tissue. The instrument has a scissor handle with hand control<br>capabilities consisting of MIN and MAX buttons. The handle housing has an integrated<br>mechanism for limiting the force that can be applied when closing the distal mechanism. The<br>instrument has an 18 cm shaft length, 8.5 mm shaft diameter, active blade length of 18 mm, and<br>utilizes a straight blade and clamp arm.<br>Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece,<br>generator, and any other related equipment are not included in the scope of this submission. |
| Intended Use: | The reprocessed harmonic scalpels are indicated to be used for cutting of soft tissue and<br>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<br>scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine<br>and joint space) and other open and endoscopic procedures. |
| Functional and<br>Safety Testing: | Representative samples of reprocessed harmonic scalpels were tested to demonstrate<br>appropriate functional characteristics. Process validation testing was performed to validate the<br>cleaning and sterilization procedures as well as device packaging. In addition, the<br>manufacturing process includes visual and validated functional testing of all products produced. |
| Conclusion: | The reprocessed harmonic scalpels are substantially equivalent to Ethicon Harmonic WAVE™<br>harmonic scalpels.<br>This conclusion is based upon the devices' similarities in functional design (principle of<br>operation), materials, indications for use and methods of construction. |

CONFIDENTIAL & PROPRIETARY INFORMATION OF STERILMED, INC.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the eagle. The eagle is black, and the text is also black.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SterilMed, Inc. % Mr. Dennis Toussaint Director of Regulatory Affairs 11400 73rd Avenue North Maple Grove, Minnesota 55369

Re: K083060

Trade/Device Name: Reprocessed Harmonic Scalpels Regulatory Class: Unclassified Product Code: NLQ, LFL Dated: October 10, 2008 Received: October 14, 2008

Dear Mr. Toussaint:

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.

JAN - 9 2009

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it ' may be subject to such 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); 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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## Page 2 - Mr. Dennis Toussaint

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Eyaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

#### 5 10(k) Number (if known):_ K083060

## Device Name: Reprocessed Harmonic Scalpels

## Indications for Use:

The reprocessed harmonic scalpels are indicated to be used for cutting of 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 and endoscopic 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)

Mark A. Milliken

(Division Sign-Of (Division Sign-Only Restorative, Division of Generative, Divisionogical Devices

510(k) Number

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# Devices included in this Premarket Notification Submission – 510(k) K083060

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