REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE

K100537 · Ascent Healthcare Solutions · NLQ · May 12, 2010 · SU

Device Facts

• Record ID: K100537
• Device Name: REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE
• Applicant: Ascent Healthcare Solutions
• Product Code: NLQ · SU
• Decision Date: May 12, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device 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 and other open procedures.

Device Story

Reprocessed ultrasonic surgical instrument; consists of scissor handle housing with hand control buttons (MIN/MAX power); 9cm working length; 16mm curved blade; clamp arm. Operates with Harmonic Generator 300 (GEN04) and Harmonic Blue Hand Piece (HPBLUE). Used in open surgical procedures (general, plastic, pediatric, gynecologic, urologic, orthopedic) by surgeons to cut and coagulate vessels up to 5mm. Device transforms electrical energy from generator into mechanical ultrasonic vibration at blade tip; vibration creates friction/heat for tissue cutting and vessel coagulation. Reprocessing involves cleaning, decontamination, and functional testing of previously used devices to restore to original performance specifications.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, and functional component testing.

Technological Characteristics

Ultrasonic surgical instrument; 9cm working length; 16mm curved blade; clamp arm; scissor handle housing with MIN/MAX power control buttons. Operates via ultrasonic energy (requires external generator and handpiece). Reprocessed device; materials and mechanical design identical to predicate.

Indications for Use

Indicated for soft tissue incisions in patients undergoing general, plastic, pediatric, gynecologic, urologic, or orthopedic open procedures where bleeding control and minimal thermal injury are 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

• Harmonic Focus Curved Shears and Torque Wrench (K063192)

Submission Summary (Full Text)

{0}------------------------------------------------

K 100 537

·

《: ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・

Page 1 of 2

# SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | MAY 12 2010 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Contact: | Ramona Kulik<br>Regulatory Affairs Engineer<br>480.763.5300 (o)<br>480.763.2952 (f)<br>[e-mail] | |
| Date of preparation: | February 24, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Ultrasonic Curved<br>Shears with torque wrench and grip assist | |
| | Classification Name: Scalpel, Ultrasonic, Reprocessed | |
| Predicate Device<br>K063192 | 510(k) Title<br>Harmonic Focus Curved Shears and<br>Torque Wrench | Manufacturer<br>Ethicon Endo-Surgery,<br>Inc. |
| Device description: | The Ultrasonic Curved Shears is an instrument consisting of a<br>scissor handle housing assembly with hand control buttons (MIN<br>for minimum power level and MAX for maximum power level).<br>The instrument has a working length of 9cm, an active blade<br>length of 16mm, and utilizes a curved blade and clamp arm. The<br>Ultrasonic Curved Shears device allows for the cutting and<br>coagulation of vessels up to and including 5mm in diameter. | |
| | The Reprocessed Ultrasonic Curved Shears with torque wrench<br>and grip assist are designed to operate with the Harmonic™<br>Generator 300 (GEN04) and Harmonic™ Blue Hand Piece<br>(HPBLUE). | |
| | Note: Only the Ultrasonic Curved Shears with torque wrench<br>and grip assist is the subject of this submission, the reusable<br>hand piece, generator, and any other related equipment are not<br>included in the scope of this submission. | |
| Indications for Use: | The Reprocessed Ultrasonic Curved Shears is indicated for soft<br>tissue incisions when bleeding control and minimal thermal<br>injury is desired. The device can be used as an adjunct to or<br>substitute for electrosurgery, lasers, and steel scalpels in<br>general, plastic, pediatric, gynecologic, urologic, exposure to<br>orthopedic structures and other open procedures. | |

{1}------------------------------------------------

K1 00 537

Page 2 of (2)

#### Technological characteristics:

The design, materials, and intended use of Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are identical to the predicate device. The mechanism of action of Ultrasonic Curved Shears with torque wrench and grip assist is identical to the predicate device in that the same standard mechanical design, size, and materials are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. In addition. Ascent Healthcare Solutions' reprocessing of Ultrasonic Curved Shears with torque wrench and grip assist includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Curved Shear with torque wrench and grip assist is tested for appropriate function of its components prior to packaging and labeling operations.

Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed Ultrasonic Curved Shears. This included the following tests:

- Biocompatibility �
- Validation of reprocessing .
- Sterilization Validation ●
- Function test(s) �
- Packaging Validation .

Performance testing demonstrates that Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist perform as originally intended.

Conclusion:

Ascent Healthcare Solutions concludes that the Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist are safe, effective, and substantially equivalent to the predicate device as described herein.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

MAY 1 2 2010

Ascent Healthcare Solutions % Ms. Ramona Kulik Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044

Re: K100537

Trade/Device Name: Reprocessed Ultrasonic Curved Shears with Torque Wrench And Grip Assist

Regulatory Class: Unclassified Product Code: NLQ Dated: February 24, 2010 Received: February 25, 2010

Dear Ms. Kulik:

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

{3}------------------------------------------------

Page 2 - Ms. Ramona Kulik

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.

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark A. Millman

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

Enclosure

{4}------------------------------------------------

### SECTION 4: INDICATIONS FOR USE STATEMENT

#### K100 537 510(k) Number (if known):

Device Name: Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist

#### Indications For Use:

The Reprocessed Ultrasonic Curved Shears is indicated for soft tissue incisions when bleeding control and minimal thermal injury is desired. The device 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 and other open procedures.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Detkrogh for max

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100537

{5}------------------------------------------------

| Reprocessor | Model Number | Description |
|-----------------------------|--------------|------------------------------------------------------------------------------|
| Ascent Healthcare Solutions | FCS9 | Reprocessed Ultrasonic Curved<br>Shears (9cm long/16mm blade<br>length) with |
| | TWBLUE | Torque wrench |
| | GABLUE | Grip Assist |

Image /page/5/Picture/1 description: The image shows a Harmonic Focus scalpel. The scalpel is white and has a black handle. The scalpel is lying on a table. The scalpel has the words "Harmonic Focus" printed on the side.

Figure 1 Reprocessed Ultrasonic Curved Shears with torque wrench and grip assist

Neil R. Ode for man
(Division Sign-Off)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100537