PIEZOTOME CUBE

K172137 · Satelec - Acteon Group · DZI · May 3, 2018 · Dental

Device Facts

• Record ID: K172137
• Device Name: PIEZOTOME CUBE
• Applicant: Satelec - Acteon Group
• Product Code: DZI · Dental
• Decision Date: May 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the SATELEC PIEZOTOME CUBE is to supply utilities and to serve as a base for dental tools and accessories for use by qualified dental practitioners.

Device Story

PIEZOTOME CUBE is an ultrasonic surgical system for dental bone surgery. System comprises a console, multifunction footswitch, and reusable piezoelectric handpiece. Console contains motherboard and display; provides electrical signals to handpiece. Piezoelectric transducer in handpiece converts electrical signals into mechanical micro-vibrations transmitted to dental tips. Irrigation pump provides fluid to cool clinical site and rinse bone/tooth fragments. Used in dental clinics by qualified practitioners. Practitioner adjusts ultrasonic modes and irrigation flow via touch-sensitive front panel. Device facilitates precise bone cutting/drilling for reconstructive oral surgery. Benefits include controlled bone preparation for wires, pins, or screws.

Clinical Evidence

Bench testing only. Performance comparison confirmed similarity in piezoelectric output, frequency modulation, and irrigation flow rates to the predicate. Electrical safety (IEC 60601-1) and EMC (IEC 60601-1-2) testing performed. Sterilization (ISO 17665-1/2, AAMI ST55/TIR 30) and cleaning validation (FDA 2015 guidance) confirmed for reusable handpiece. Biocompatibility (ISO 10993-1) confirmed for patient-contact materials.

Technological Characteristics

Piezoelectric ultrasonic surgical system. Console features switch power supply and motherboard/display board with UL94-V0 fire-rated materials. Handpiece uses piezoelectric ceramic transducer. Patient-contact material: Polyphenylsulfone (PPSU). Connectivity: Wired handpiece and footswitch. Power: 100-230 VAC, 50/60 Hz. Sterilization: Autoclave (132°C/4 min). Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1.

Indications for Use

Indicated for intraoral surgery procedures, including osteotomy, osteoplasty, periodontics, and implantology, in patients requiring dental bone surgery.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• PIEZOTOME SOLO (K112188)
• PIEZOTOME SOLO LED (K112188)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

Satelec - Acteon Group Argie Zoubroulis Quality Manager 124 Gaither Drive Suite # 140 Mt. Laurel, New Jersey 08054 April 3, 2018

Re: K172137

Trade/Device Name: PIEZOTOME CUBE Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: Class II Product Code: DZI Dated: March 23, 2018 Received: April 3, 2018

Dear Argie Zoubroulis:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172137

Device Name PIEZOTOME CUBE

Indications for Use (Describe)

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### 510(k) Summary [As Required by 21 CFR 807.92.c] K172137

#### I - SUBMITTER

01.a. 510(k) Submitter:

SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex France 011-33-556-340-607 Telephone: [phone] Fax: [e-mail] email:

01.b. Contact Person:

Argie ZOUBROULIS SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 800-289-6367 Ext. 390 Telephone: [phone] Fax: [e-mail] Email:

8044015 1.c. Establishment Registration Number: 1.d. Date Prepared: May 2, 2018

- 1.e. Type of 510(k) submission:
- II DEVICE

02.a. Trade Name of Device:

02.b. Common Name of Device:

02.c. Classification Regulation:

02.d. Regulation Identification: Traditional 510(k) Submission.

PIEZOTOME CUBE

Piezoelectric Handpiece and Console

Classification Name : Bone Cutting Instrument and Accessories (21 CFR 872.4120)

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting Handpiece, and ACpowered bone saw.

02.e. Medical Device Class: ll

Image /page/3/Picture/20 description: The image shows the logo for Acteon. The logo consists of the word "ACTEON" in a bold, sans-serif font. The letters are dark gray. A blue curved line is below the word, starting from the left and extending upwards, partially encircling the word.

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| 02.f. | Panel: | Dental |
|-------|---------------------------|----------------|
| 02.g. | Product Code: | DZI |
| 02-h. | Subsequent Product Codes: | Not Applicable |

## III - PREDICATE DEVICES

The Substantial Equivalence (SE) of PIEZOTOME CUBE is based on the Predicate Device identified in the Table 01.

| Trade Name | Manufacturer | Product Code | 510(k) number | Date Cleared |
|--------------------------------------|--------------|--------------|---------------|--------------|
| PIEZOTOME SOLO<br>PIEZOTOME SOLO LED | SATELEC | DZI | K112188 | Feb 03, 2012 |

#### Table 01 Identification of I egally Marketed Predicate Devices

#### IV -DEVICE DESCRIPTION

SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use.

PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece.

The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values).

The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving.

Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip.

The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.

Image /page/4/Picture/12 description: The image shows the logo for ACTEON. The logo is composed of the company name in a bold, sans-serif font, with the letters in a dark gray color. A curved, light blue line extends from the bottom left of the image, arching upwards and towards the left of the word ACTEON. The overall design is simple and modern.

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## V - INDICATION FOR USE

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

# VI - COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE (SUBSTANTIAL EQUIVALENCE)

A comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device is present in Table 02.

| | New Device | Predicate Device #1<br>(PD#1) | Impact of the differences<br>on Safety /<br>Effectiveness |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Trade /<br>Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Indication for Use | The PIEZOTOME CUBE<br>is an ultrasonic surgical<br>system that supply<br>utilities to and serve as a<br>base for dental tips. The<br>PIEZOTOME CUBE<br>consist of a control unit<br>and handpiece intended<br>for use in intraoral<br>surgery procedures,<br>including osteotomy,<br>osteoplasty, periodontics<br>and implantology. | The intended use of the<br>SATELEC PIEZOTOME<br>SOLO (or PIEZOTOME<br>SOLO LED available in<br>option) is to supply<br>utilities to and serve as a<br>base for dental tools and<br>accessories for use by<br>qualified dental<br>practitioners. | Similar to PD#1 - No Impact |
| Intended Use | The intended use of the<br>SATELEC PIEZOTOME<br>CUBE is to supply utilities<br>and to serve as a base for<br>dental tools and<br>accessories for use by<br>qualified dental<br>practitioners. | The intended use of the<br>PIEZOTOME SOLO is to<br>supply utilities to and<br>serve as a base for<br>dental tools and<br>accessories for use by<br>qualified dental<br>practitioners.<br>The<br>PIEZOTOME SOLO is a<br>device designed to<br>perform dental surgery<br>including osteotomies,<br>osteoplasties,<br>periodontal<br>and implant<br>surgery. | Similar to PD#1 - No Impact |
| Code Product | DZI | DZI | Identical to PD#1 - No Impact |
| Subsequent product | / | / | Identical to PD#1 - No Impact |
| Part | 872 - Dental devices | 872 - Dental devices | Identical to PD#1 - No Impact |
| Regulation Number | 21 CFR 872.4120 | 21 CFR 872.4120 | Identical to PD#1 - No Impact |

# Table 02 – Comparison Between SATELEC PIEZOTOME CUBE and the Predicate Device

Image /page/5/Picture/6 description: The image shows the word "ACTEON" in a bold, sans-serif font. The letters are dark gray, almost black. A curved, light blue line extends from the bottom left of the image, arching upwards and to the right, partially surrounding the word. The line adds a sense of motion or energy to the logo.

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#### 006 – 510(k) Summary (SMDA Requirements) S001 Additional Inform natio n

| Regulation Identification | A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The | A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a | Identical to PD#1 - No Impact |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|

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| | New Device | Predicate Device #1<br>(PD#1) | Impact of the differences on<br>Safety / Effectiveness |
|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Trade /<br>Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| | device includes the<br>manual bone drill and<br>wire driver, powered<br>bone drill, rotary bone<br>cutting handpiece, and<br>AC-powered bone saw | wire, pin, or screw. The<br>device includes the<br>manual bone drill and<br>wire driver, powered<br>bone drill, rotary bone<br>cutting handpiece, and<br>AC-powered bone saw | |
| Regulation Name | Bone Cutting Instrument<br>and Accessories | Bone Cutting Instrument<br>and Accessories | Identical to PD#1 - No Impact |
| Regulatory Class | II | II | Identical to PD#1 - No Impact |
| | Principle of operation | | |
| Principle | An electrical signal emitted by the medical device is<br>supplied to the dental piezo-ultrasonic Handpiece. It<br>comprises a piezoelectric ceramic transducer, which<br>converts the electrical signal into ultrasonic<br>vibrations. Mechanical vibrations are transmitted to a<br>tip attached to the end of the ultrasonic Handpiece | | Identical to PD#1 - No Impact |
| | Dimensions of the Console | | |
| Height (mm) | 160 | 136 | No Impact |
| Depth (mm) | 271 | 306 | No Impact |
| Width (mm) | 251 | 378 | No Impact |
| Weight (kg) | 3.5 | 3.7 | No Impact |
| Mounting Unit | Table Top | Table Top | Identical to PD#1 - No Impact |
| | Power Supply | | |
| Supply Voltage (VAC) | 100 VAC to 230 VAC | 100 VAC to 230 VAC | Identical to PD#1 - No Impact |
| Frequency (Hz) | 50 Hz / 60 Hz | 50 Hz / 60 Hz | Identical to PD#1 - No Impact |
| Power Consumption (VA) | 150 | 150 | Identical to PD#1 - No Impact |
| | Electrical Safety Classification | | |
| Equipment Classification | Class 1 | Class 1 | Identical to PD#1 - No Impact |
| Electrical Type | BF Type | BF Type | Identical to PD#1 - No Impact |
| | Applied Parts on the Console | | |
| Quantity of connectors for<br>Applied Parts | 1 | 1 | Identical to PD#1 - No Impact |
| Localization | Front Panel of the<br>Device | Front Panel of the<br>Device | Identical to PD#1 - No Impact |
| | Internal constitution of the Console | | |
| Power supply | Switch Power Supply | Switch Power Supply | Identical to PD#1 - No Impact |
| Mother Board Fire aspects | UL94-V0 (self-<br>extinguishing material) | UL94-V0 (self-<br>extinguishing material) | Identical to PD#1 - No Impact |
| Display Board Fire<br>aspects | UL94-V0 (self-<br>extinguishing material) | UL94-V0 (self-<br>extinguishing material) | Identical to PD#1 - No Impact |
| External constitution of the Console | | | |
| Fire aspects (for Casing) | UL94-V0 (self-<br>extinguishing material) | UL94-V0 (self-<br>extinguishing material) | Identical to PD#1 - No Impact |
| Pictures | | | |
| Picture of the Console | Image: Picture of the Console | Image: Picture of the Console | No impact |
| | New Device | Predicate Device #1<br>(PD#1) | Impact of the differences on<br>Safety / Effectiveness |
| Trade /<br>Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Picture of the Footswitch | Image: footswitch | Image: footswitch | Identical to PD#1 - No Impact |
| Piezoelectric Performances for Dental Bone Surgery | | | |
| Technology | SATELEC PIEZOTOME<br>topology | SATELEC PIEZOTOME<br>topology | Identical to PD#1 - No Impact |
| Output<br>Ultrasonic<br>frequency (kHz) | 28 to 36 | 28 to 36 | Identical to PD#1 - No Impact |
| Available modes | D1/ D2 / D3 / D4 | D1/ D2 / D3 / D4 | Identical to PD#1 - No Impact |
| Nominal specification for<br>Output Current Value in<br>D1 mode (mA) | 215.3 | 215.3 | Identical to PD#1 - No Impact |
| Nominal specification for<br>Output Current Value in<br>D2 mode (mA) | 171.2 | 171.2 | Identical to PD#1 - No Impact |
| Nominal specification for<br>Output Current Value in<br>D3 mode (mA) | 123.9 | 123.9 | Identical to PD#1 - No Impact |
| Nominal specification for<br>Output Current Value in<br>D4 mode (mA) | 120.8 | 120.8 | Identical to PD#1 - No Impact |
| Frequency Modulation for<br>D1 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for<br>D2 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for<br>D3 mode (Hz) | 60 | 60 | Identical to PD#1 - No Impact |
| Frequency Modulation for<br>D4 mode (Hz) | 30 | 30 | Identical to PD#1 - No Impact |
| Irrigation Performances | | | |
| Irrigation Pump(s) | 1 | 1 | Identical to PD#1 - No Impact |
| Off Irrigation (ml/min) | 0 | 0 | Identical to PD#1 - No Impact |
| Minimum Irrigation Flow<br>Rate (nominal) (ml/min) | 10 | 10 | Identical to PD#1 - No Impact |
| Maximum Irrigation Flow<br>Rate (nominal) (ml/min) | 120 | 120 | Identical to PD#1 - No Impact |
| Localization of the Mains Power Switch | | | |
| Power-On / Power-Off | Mains switch localized at<br>the rear of the Device | Mains switch localized<br>at the rear of the Device | Identical to PD#1 - No Impact |
| User Interface for setting | | | |
| User interface for<br>information on settings | LED (Light Emitted<br>Diode) | Monochrome LCD | No Impact |
| Ultrasonic Power Setting<br>keys | Sensitive areas on front<br>panel | Keys on front panel | No Impact |
| Irrigation Flow Setting<br>keys | Sensitive areas on front<br>panel | Keys on front panel | No Impact |
| Footswitch | | | |
| Type of Footswitch | Multifunction | Multifunction | Identical to PD#1 - No Impact |
| Number of actuators on<br>Footswitch | 2 Functions | 2 Functions | Identical to PD#1 - No Impact |
| Environmental | | | |
| | New Device | Predicate Device #1<br>(PD#1) | Impact of the differences on<br>Safety / Effectiveness |
| Trade /<br>Device Name | PIEZOTOME CUBE | PIEZOTOME SOLO | |
| Knumber | K172137 | K112188 | |
| Where used | Usable in all medical<br>premises<br>Except Operating<br>theater / outdoor | Usable in all medical<br>premises<br>Except Operating<br>theater / outdoor | Identical to PD#1 - No Impact |
| Operating<br>Temperature<br>(°C) | +10 to +30 | +10 to +30 | Identical to PD#1 - No Impact |
| Storage Temperature (°C) | 0 to +50 | -20 to +70 | No Impact |
| Maximum<br>Operating<br>Altitude (m) | 2000 | 2000 | Identical to PD#1 - No Impact |
| Anatomical site | Bones in the oral sphere | Bones in the oral<br>sphere | Identical to PD#1 - No Impact |
| | | Handpieces | |
| Dental<br>Bone<br>Surgery<br>Handpiece | CUBE LED Handpiece | PIEZOTOME SOLO<br>Handpiece | No Impact |
| Type of Applied Part | Ultrasonic Handpiece | Ultrasonic Handpiece | Identical to PD#1 - No Impact |
| Technology<br>used<br>for<br>Handpieces | Piezoelectric technology | Piezoelectric technology | Identical to PD#1 - No Impact |
| | | Dimensions of the Dental Bone Surgery Handpieces | |
| Length (mm) | 130 | 130 | Identical to PD#1 - No Impact |
| Maximum Diameter (mm) | 23 | 23 | Identical to PD#1 - No Impact |
| | | Irrigation Tubing | |
| Length (mm) | 2550 | 2550 | Identical to PD#1 - No Impact |
| Principle of irrigation | Peristaltic tape | Peristaltic tape | Identical to PD#1 - No Impact |
| | | Dimensions of the Footswitch | |
| Width (mm) | 173 | 173 | Identical to PD#1 - No Impact |
| Height (mm) | 140 | 140 | Identical to PD#1 - No Impact |
| Depth (mm) | 176 | 176 | Identical to PD#1 - No Impact |
| Ingress Protection Rating<br>(IPxx) | IPX1 | IPX1 | Identical to PD#1 - No Impact |
| | | Cleaning | |
| Dental<br>Bone<br>Ultrasonic<br>Handpiece | Re-usable, Cleanable | Re-usable, Cleanable | Identical to PD#1 - No Impact |
| Unit Casing | Re-usable, Cleanable | Re-usable, Cleanable | Identical to PD#1 - No Impact |
| | | Sterilization / Sterile State | |
| Dental<br>Bone<br>Ultrasonic<br>Handpiece | Sterilizable<br>132°C / 4 min | Sterilizable<br>132°C / 4 min | Identical to PD#1 - No Impact |
| Irrigation Tubing | Provided under Sterile<br>State - Single Use | Provided under Sterile<br>State - Single Use…