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The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures. The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.

The ReNew XR Handpiece with Reference Markings is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this submission). It is indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic procedures and it is also indicated for reference length measurement of tissue during endoscopic surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece with Reference Markings is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece with Reference Markings does not produce energy but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece with Reference Markings delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a handheld active electrosurgical generator through a return electrode attached to the patient is part of the electrical circuit. The Relew XR Handpiece with Reference Markings can be used with a legally marketed third party electro-surgical high frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use. Like the predicate device, the subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly. Variations of the subject devices include varying handle length and presence of a ratcheting mechanism.

The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway. This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time. The subject devices are made of ten (10) primary components which includes the following: - Front Hub - Overmolded Back Hub - Disc Spring - Yoke - Yoke Pin - Crimp Pin - Short Blade - Long Blade - Surgislip Lubricant - Heat Shrink with Adhesive Polymer There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates. The subject devices are supplied as sterile. In accordance to 21 CFR § 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.

The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

The ReNew XR Handpiece is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, and dissectors (all of which are outside of the scope of this submission), to cut, grasp, and dissect various tissues for use in endoscopic, including laparoscopic, surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece does not produce energy, but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a hand-held active electrode and travels back to the electrosurgical generator through a return electrode attached to the patient, so that the patient is part of the electrical circuit. The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use. The subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly. Variations of the subject devices include varying handle length, presence of a ratcheting mechanism, and single-piece vs. modular (three piece) instruments. The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.

Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The subject device ReNew V Handpiece Laparoscopic Instruments is a modification to its legally marketed predicate device ReNew Laparoscopic Instruments (K962119). The predicate device ReNew Laparoscopic Instruments (K962119) included the Reusable Hand Piece and the Disposable and Reusable Scissor Tips. The incremental modifications declared in this Traditional 510(k) Submission apply to the subject device ReNew V Handpiece Laparoscopic Instruments which is a Reusable Handpiece (Handle/Shaft) Assembly only. There are no changes to the predicate Disposable and Reusable Scissor Tips (K962119). The subject device ReNew V Handpiece Laparoscopic Instruments feature a 5mm diameter shaft for use when introduced with 5, 10/11, and 12mm instrument ports of a laparoscope or a cannula. The subject device is made of five (5) primary components, which include: Handle, Contact Pin Assembly, Turning Knob, Shaft Assembly and Flushing Port. The subject device includes variable configurations of 25cm, 34cm, and 42cm lengths; and it will be available in two optional configurations as a non-ratcheted or ratcheted Handpiece. The subject device ReNew V Handpiece Laparoscopic Instruments can be used to deliver Monopolar High-Frequency (HF) electrical current through the active electrode contacting the patient for cutting or coagulation, dispersing energy through the patient to an inactive patient return electrode and back to the High-Frequency (HF) Generator. The subject device can be used with a U.S. FDA cleared Electrosurgical High-Frequency (HF) Generator which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements. The subject device will be marketed with two (2) accessories, which include; Ring Inserts, and Cautery Post. In accordance to 21 CFR § 801.109, Subpart D, the subject device labeling is intended for Prescription use (Rx) only.

Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used. The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" length , 4.31" width, and 1.22" height , in dimensional measurements, as intended load during the transport, sterilization and storage between their intended use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use. The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors,Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacuum cycle parameters are as follows: time: 4 minutes at temperature 132 °C, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 °C with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 °C with a dry time of 20 minutes.

Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (Graspers, Dissectors, and Scissors) devices during its transportation, and storage purposes. Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) consist of a base, a lid and device holding brackets. The lid can be fastened to the base by means of a locking tab, which is designed as a part of the lid. The brackets are constructed from biomedical grade silicone material. These brackets are used to secure the intended devices during their transport, sterilization and storage purpose. The ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to be used for ReNew Tips sterilization purpose which are non-porous devices including graspers, dissectors, and scissors.

Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization tray (Catalog# 3706) is maintained until used. The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses. The ML-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.

Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure the M/L-10 Clip Applier device during its transportation, sterilization, and storage purposes. The subject device ML - 10 Clip Applier Sterilization #3706) consists of a case, a cover and brackets. The MIL-10 Clip Applier Sterilization Tray (Catalog #3706) Lid is 19.875" (Width) x .450" (Height); and the Base is 19.875" (Length) x 5.50" (Width) x 1.450" (Height) in dimensions. The ML-10 Clip Applier Sterilization Tray (Catalog #3706) cover and lid (case) are constructed of Stainless Steel material, which could be reused with Steam Sterilization method. The brackets are constructed from Aluminum, Stainless Steel, and biomedical grade Silicone. The ML-10 Clip Applier Sterilization Tray surface is coated with Nylon Coating Powder. The sterilization tray cover is secured to the case by means of assembled hardware and a locking tab, designed as part of the case and cover have an evenly distributed hole pattern in relation to the tray size to support the steam sterilization process. The brackets are designed to secure the ML-10 Clip Applier for sterilization purpose. The subject device MIL-10 Clip Applier Sterilization Tray is non-patient and non-blood/fluid contact during its intended use. The ML - 10 Clip Applier Sterlization Tray (Catalog #3706) is a metal tray and packaged in bubble wrap, single wall, 32 lbsfinch edge, crushed corrugated brown cardboard shipping box, which does not need any special handling requirements during shipment.

The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.

The Microline Flexible Ligating Shears system consists of the following: Microline Flexible Ligating Shears Microline Universal Power Supply Single or multiple access port device such as the TransEnterix SPIDER Single Port. The Microline Flexible Ligating Shears are designed to provide thermal ligation and division during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears consist of a sterile single patient use handpiece. The device has heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The Microline Universal Power Supply is designed to allow the surgeon control of the heating element power of the device in order to accommodate for individual patient anatomy. An instrument cord is attached to the handpiece and is plugged into the dedicated Microline Universal Power Supply. The Microline Flexible Ligating Shears are designed to be used with an Introducer such as the SPIDER Single Port Device. The Microline Flexible Ligating Shears are supplied sterile in a Tyvek/Mylar sterilization pouch on a mounting card and thermoformed tray, placed in a fiberboard carton. The device is intended to be used by a trained physician for a single patient use during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears power cable is attached to the instrument handpiece and connects to the Microline Universal Power Supply. The Universal Power Supply is supplied nonsterile for reusable use outside the sterile field. The Microline Flexible Ligating Shears incorporates Hi and Low heating modes that are used to cauterize and cut soft tissue. The heating elements in the tip are activated by a physician controlled finger switch located on the handpiece of the device. The Microline Flexible Ligating Shears is intended to provide general purpose cauterization, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.

The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.

The MiSeal Reposable Thermal Ligating Shears system consists of the following: MiScal Reusable Handpiece, MiScal Thermal Ligating Shears Kit, Universal Power Supply 200-006R. The MiSeal Reposable Thermal Ligating Shears are designed to provide thermal ligation and division in various surgical procedures. The MiSeal Reposable Thermal Ligating Shears consist of a reusable handpiece with heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The MiSeal Reposable Thermal Ligating Shears are designed to allow the surgeon control of the heating element power of the device in order to accommodate the individual patient anatomy. An instrument cord connects the handpiece to the dedicated Microline Surgical Universal Power Supply K070871. The MiSeal Reposable Handpiece is supplied non-sterile in a foam cavity placed in a fiberboard carton and is for multiple patient uses following cleaning and steam sterilization procedures performed per the provided Instructions for Use. The handpiece can be used multiple times if cleaning and sterilization procedures are followed. The MiSeal Disposable Kit (the functional instrument Tip and power cable portion of the applied part of the system) is supplied sterile in a die-cut chipboard Packaging Insert and Tyvek/Mylar pouch and is labeled for single use only. The tip is intended to be used by a trained physician for a single patient use in open general surgery, open vascular surgery, and laparoscopic surgical procedures. The MiSeal single use power cable is connected to the instrument handpiece and terminates at the electrical connection of the Universal Power Supply. The system power supply is supplied non-sterile for reusable use outside the sterile field. The MiSeal device incorporates Hi and Low heating modes that are used to coagulate and cut soft tissue. The heating elements in the disposable tip are activated by a physician controlled finger switch located on the handpiece of the device. The MiSeal device is intended to provide general purpose dissection, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.