What is the FDA product code for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

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

What is the regulatory pathway for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

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

What are the predicate devices for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

Sonicision Cordless Ultrasonic Dissection Device, SCD13 (K153371).

Who can help prepare an FDA 510(k) submission like Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

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.

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector

Q: Who is the manufacturer of Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector?

Surgical Instrument Service and Savings, Inc. filed the 510(k) submission for Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector (K173627).

K173627 · Surgical Instrument Service and Savings, Inc. · NLQ · Jul 12, 2018 · SU

Device Facts

Record ID	K173627
Device Name	Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector
Applicant	Surgical Instrument Service and Savings, Inc.
Product Code	NLQ · SU
Decision Date	Jul 12, 2018
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic, Pediatric

Intended Use

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Device model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device 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. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm diameter. The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

Device Story

Reprocessed single-use cordless ultrasonic dissector; attaches to reusable generator and battery pack (not included). Device features active ultrasonic blade and clamping jaw; surgeon-controlled via handle to grasp, coagulate, and dissect tissue. Used in OR for open/endoscopic procedures; operated by surgeons. Ultrasonic energy provides tissue effect; coagulates vessels up to 5 mm. Benefits include bleeding control and minimal thermal injury compared to traditional electrosurgery or steel scalpels.

Clinical Evidence

No human clinical data. Evidence includes bench testing (simulated use, grasping/pulling force, cutting effectiveness, drop test, device integrity, cutting/coagulation evaluation, tissue sticking, cleaning validation, biocompatibility, sterilization validation, product stability) and a 21-day chronic in vivo porcine study. Porcine study confirmed vessel sealing (up to 5 mm), hypertensive challenge, and gross pathology (no notable hemorrhage or injury to collateral structures).

Technological Characteristics

Sterile, single-use ultrasonic dissector. Features active blade vibrating at ultrasonic frequency and clamping jaw. Interfaces with reusable Sonicision generator and battery. Dimensions: 5 mm diameter, 13 cm shaft. Sterilization: validated process. No internal software/algorithm; device is a mechanical/ultrasonic instrument.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in general, plastic, pediatric, gynecologic, urologic, orthopedic (spine/joint space), and ENT procedures. Suitable for open and endoscopic use; coagulates isolated vessels up to 5 mm diameter.

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

Sonicision Cordless Ultrasonic Dissection Device, SCD13 (K153371)

Reference Devices

Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD391 and SCD 396 (K170955)

Related Devices

K141371 — SONICISION CORDLESS ULTRASONIC DISSECTOR · Covidien, Formerly Valleylab, A Division of Tyco H · Aug 7, 2014
K200427 — Sonicision Cordless Ultrasonic Dissector · Covidien, LLC · Jul 10, 2020
K143562 — Reprocessed Cordless Ultrasonic Dissection Device · Sterilmed, Inc. · May 20, 2015
K170955 — Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · Jul 3, 2017
K212301 — Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device · Covidien, LLC · Nov 15, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 12, 2018 Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) Ms. Stephanie Mays Regulatory Affairs Specialist Quality Assurance and Regulatory Affairs 1500 NE Hemlock Ave Redmond, Oregon 97756 Re: K173627 Trade/Device Name: Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Model SCD 13 Regulation Name: Unclassified Regulatory Class: Class II Product Code: NLQ Dated: May 10, 2018 Received: May 14, 2018 Dear Ms. Mays: 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 mav, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Binita S. Ashar -S 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K173627 Device Name Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 Indications for Use (Describe) The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device 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. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm diameter. The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | Device Model | Device Name | Original Manufacturer | |--------------|---------------------------------------------------------------------------------------------------|--------------------------| | SCD13 | Sonicision Cordless Ultrasonic Dissector (14.5-mm jaw and 5-mm diameter x 13-cm long shaft) | Covidien | Reprocessed Single-Use Device Model Included in Submission: {4}------------------------------------------------ ## K173627 Summary This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR § 807.92. | Submitter/ Owner | Surgical Instrument Service and Savings (dba Medline ReNewal) 1500 NE Hemlock Ave. Redmond, OR 97756 | | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Prepared by/Contact Name | Stephanie Boyle Mays Regulatory Affairs Specialist, Quality Assurance and Regulatory Affairs P: 541-516-4205 • F: 541-923-3375 • E: smays@medline.com | | | | | Date Prepared | May 14, 2018 | | | | | Device Name and Classification | Proprietary/Trade Name: | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Model SCD13 | | | | | Regulatory Name: | Scalpel, ultrasonic reprocessed | | | | | Regulatory Class | Unclassified | | | | | Product Code: | NLQ | | | | | Panel: | General & Plastic Surgery | | | | Predicate Device | 510(k) number: | K153371 | | | | | Proprietary/Trade Name: | Sonicision Cordless Ultrasonic Dissection Device, SCD13 | | | | | Regulatory Name: | Instrument, ultrasonic surgical | | | | | Classification: | Unclassified | | | | | Product Code: | LFL | | | | | Panel: | General & Plastic Surgery | | | | | Manufacturer | Covidien, 5920 Longbow Dr., Boulder, CO 80301 | | | | Reference Device | 510(k) number: | K170955 | | | | | Proprietary/Trade Name: | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD391 and SCD 396 | | | | | Regulatory Name: | Scalpel, ultrasonic reprocessed | | | | | Classification: | Unclassified | | | | | Product Code: | NLQ | | | | | Panel: | General & Plastic Surgery | | | | | Manufacturer | Surgical Instrument Service and Savings (dba Medline ReNewal), 1500 NE Hemlock Ave., Redmond, OR 97756 | | | | Device Description | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13, is a sterile, single-use component to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Device can coagulate vessels up to 5 mm in diameter. Furthermore, it is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically. | | | | | Indications for Use: | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Device model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are 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 (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm diameter. The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures. | | | | | Technological Characteristics | The technological characteristics and the fundamental scientific technology of the subject devices are identical to the predicate and reference devices. The proposed device is a reprocessed version of the predicate K153371 Sonicision Cordless Ultrasonic Dissector SCD13 device. The predicate and reference devices were used to support intended use, technological characteristics, and functional performance specifications. | | | | | | Predicate | Reference Medline | Proposed | Comparison | | Device Characteristics | Covidien Sonicision Cordless Ultrasonic Dissector | ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector | As Stated | | 510(k) | K153371 | K170955 | K173627 | Not applicable | | Model Number(s) | SCD13 | SCD391, SCD396 | SCD13 | As stated | | Indications for Use | The Sonicision Cordless Ultrasonic Dissection Device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are 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 (such | The Medline ReNewal Reprocessed Sonicision Cordless TM Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for | The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Device model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, | Proposed device same as predicate; proposed device same as reference except for additional ENT indications on proposed device | | Device Characteristics | Predicate | Reference | Proposed | Comparison | | Indications for Use concluded | as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter. The Sonicision 13 cm device is also indicated for use in otorhinolaryngologi c (ENT) procedures. | 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. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter. | urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm in diameter. The Sonicision 13- cm device is also indicated for use in otorhinolaryngologic (ENT) procedures. | | | Power Platforma | Sonicision Battery and Generator | Sonicision Battery and Generator | Sonicision Battery and Generator | Same…