Who is the manufacturer of REPROCESSED ULTRASONIC COAGULATING SHEARS?

Ascent Healthcare Solutions filed the 510(k) submission for REPROCESSED ULTRASONIC COAGULATING SHEARS (K093702).

What is the FDA product code for REPROCESSED ULTRASONIC COAGULATING SHEARS?

NLQ. as a Class U device in the SU panel.

What is the regulatory pathway for REPROCESSED ULTRASONIC COAGULATING SHEARS?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like REPROCESSED ULTRASONIC COAGULATING SHEARS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

REPROCESSED ULTRASONIC COAGULATING SHEARS

K093702 · Ascent Healthcare Solutions · NLQ · Mar 4, 2010 · SU

Device Facts

Record ID	K093702
Device Name	REPROCESSED ULTRASONIC COAGULATING SHEARS
Applicant	Ascent Healthcare Solutions
Product Code	NLQ · SU
Decision Date	Mar 4, 2010
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic, Pediatric

Intended Use

The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 coagulating shears; 18 cm length; 8.5 mm shaft diameter; 18 mm active blade. Features scissor handle with integrated hand control buttons (MIN/MAX power levels); audible/tactile closure mechanism. Device functions by cutting and coagulating vessels up to 5 mm diameter. Used in open surgical procedures; operated by surgeons. Requires connection to external Harmonic Generator 300 (GEN04) and Hand Piece (HP054). Reprocessing involves cleaning, decontamination, and functional testing of components. Provides surgeons with precise tissue management; reduces thermal injury compared to traditional electrosurgery.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

Ultrasonic energy-based surgical instrument. Consists of a scissor handle housing with hand controls. Dimensions: 18 cm length, 8.5 mm shaft diameter, 18 mm active blade. Operates with external Harmonic Generator 300 and Hand Piece. Reprocessing includes cleaning and decontamination. No changes to materials or mechanical design compared to predicate.

Indications for Use

Indicated for soft tissue incisions in patients requiring bleeding control and minimal thermal injury. Applicable for general, plastic, pediatric, gynecologic, urologic, and orthopedic exposure procedures. Used 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

Harmonic Wave Coagulating Shears with Scissor Handle and Hand Control, Model Wave18S (K062000)

Related Devices

K100537 — REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND GRIP ASSIST MODEL FCS9, TWBLUE, GABLUE · Ascent Healthcare Solutions · May 12, 2010
K111794 — REPROCESSED HARMONIC SCALPEL · Sterilmed, Inc. · Jan 11, 2012
K132566 — REPROCESSED HARMONIC SHEAR · Sterilmed, Inc. · Jun 14, 2014
K133672 — REPROCESSED HARMONIC ACE SHEARS WITHOUT ADAPTIVE TISSUE TECHNOLOGY · Stryker Sustainability Solutions · May 1, 2014
K083060 — REPROCESSED HARMONIC SCALPEL · Sterilmed, Inc. · Jan 9, 2009

Submission Summary (Full Text)

{0}------------------------------------------------ Page 1 of 2 # MAR - 4 2010 K093709 SECTION 5: 510(k) SUMMARY ﺎ ﻳﺎﺭ ﺍﻟﻌ : ・・ | Submitter: | Ascent Healthcare Solutions 10232 South 51st Street Phoenix, Arizona 85044 | | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------| | Contact: | Moira Barton-Varty Senior Director Regulatory Affairs 480.763.5300 (o) 480.763.5350 (f) mbarton@ascenths.com | | | Date of preparation: | November 30, 2009 | | | Name of device: | Trade/Proprietary Name: Reprocessed Ultrasonic Coagulating Shears Classification Name: Scalpel, Ultrasonic, Reprocessed | | | Predicate Device K062000 | 510(k) Title Harmonic Wave Coagulating Shears With Scissor Handle and Hand Control, Model Wave18S; Harmonic Disposable Torque Wrench | Manufacturer Ethicon Endo-Surgery, Inc. | | Device description: | The Ultrasonic Coagulating Shears is an instrument consisting of a scissor handle housing assembly with hand control buttons (MIN for minimum power level and MAX for maximum power level). An audible and tactile mechanism is integrated into the handle housing to indicate full closure. The Ultrasonic Coagulating Shears is 18 cm long, shaft diameter of 8.5 mm, with an active blade length of 18 mm. The blade and clamp arm are straight allowing them to function through an incision without the use of a trocar. The Ultrasonic Coagulating Shears allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. | | | | The Ultrasonic Coagulating Shears is designed to operate with the Harmonic TM Generator 300 (GEN04) and the Hand Piece (HP054). | | | | Note: Only the Ultrasonic Coagulating Shears 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. other related equipment are not included in the scope of this {1}------------------------------------------------ 093702 ﮩ Page 2 of ② Indications for Use: The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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. The design, materials, and intended use of Reprocessed Technological Ultrasonic Coagulating Shears are identical to the predicate characteristics: device. The mechanism of action of Ultrasonic Coagulating Shears 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 Coagulating Shears includes removal of adherent visible soil and decontamination. Each individual Ultrasonic Coaqulating Shear 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 Coaqulating Shears. This included the following tests: - Biocompatibility . - Validation of reprocessing . - . Sterilization Validation - Function test(s) ● - Packaging Validation . Performance testing demonstrates that Reprocessed Ultrasonic Coagulating Shears perform as originally intended. Ascent Healthcare Solutions concludes that the modified Conclusion: devices (Reprocessed Ultrasonic Coagulating Shears) 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a bird-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002 MAR - 4 2010 Ascent Healthcare Solutions % Ms. Moira Barton-Varty Senior Director of Regulatory Affairs 10232 South 51st Street Phoenix, Arizona 85044 Re: K093702 Trade/Device Name: Reprocessed Ultrasonic Coagulating Shears Regulatory Class: Unclassified Product Code: NLQ Dated: February 23, 2010 Received: February 24, 2010 Dear Ms. Barton-Varty: 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 {3}------------------------------------------------ Page 2 - Mr. 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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark N. Melkerson 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 93702 510(k) Number (if known): ## Device Name: Reprocessed Ultrasonic Coagulating Shears # Indications For Use: The Reprocessed Ultrasonic Coagulating Shears with Scissor Handle and Hand Control are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The shears 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 × (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) Neil RP Ogilvie for mxn (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093702 Page 12 {5}------------------------------------------------ | Reprocessor | Model Number | Description | |-----------------------------|--------------|-----------------------------------------------------------------------------------------| | Ascent Healthcare Solutions | Wave18S | Reprocessed Ultrasonic Coagulating Shears Scissor Handle with Hand Control | | | | 8.5 mm diameter / 18 cm long | Image /page/5/Picture/1 description: The image shows a medical device, specifically a Harmonic scalpel. The device has a long, thin shaft with a grasping mechanism at the end. The handle is white and has the words "I-harmonic wave" printed on it. Figure 1 Reprocessed Ultrasonic Coagulating Shears YhilRP Oglin for mxm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093702