SAFIRA

K230083 · Medovate Limited · FRN · Oct 31, 2023 · General Hospital

Device Facts

• Record ID: K230083
• Device Name: SAFIRA
• Applicant: Medovate Limited
• Product Code: FRN · General Hospital
• Decision Date: Oct 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.

Device Story

SAFIRA is a battery-powered, motorized syringe driver for regional anesthesia procedures. It consists of a sterile, single-use 20mL syringe (polypropylene) and a reusable driver/operator. Clinicians fill the syringe with local anesthetic, lock it into the driver, and attach a needle set. The operator (foot pedal or palm-held) controls a DC motor that advances or retracts the syringe plunger. The device features an overpressure safety mechanism that stops plunger movement if pressure exceeds 17psi ±3psi. Used in clinical settings, it allows controlled infusion of anesthetic to target nerve bundles. The device benefits patients by providing a consistent, pressure-limited delivery of anesthetic, reducing risks associated with manual injection pressures.

Clinical Evidence

No clinical data. Evidence consists of bench-top system verification testing and a human factors study to validate design changes, including the new palm operator, NRFit syringe compatibility, and updated pressure limit. Performance met pre-determined acceptance criteria.

Technological Characteristics

Battery-powered, motorized piston-driven syringe pump. Materials: Polypropylene syringe body, silicone oil lubricant, isoprene synthetic rubber seal. Connectivity: None. Sterilization: Sterile single-use syringes; non-sterile reusable driver/operator. Standards: ISO 80369-7 (Luer), ISO 80369-6 (NRFit), ISO 14971:2019 (Risk Management).

Indications for Use

Indicated for trained clinicians to administer local anesthetic below a specified pressure threshold to a target nerve bundle for regional anesthesia.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• SAFIRA (K153599)

Reference Devices

• Dragon Heart Medical Devices syringes (K042547)

Submission Summary (Full Text)

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October 31, 2023

Medovate Limited % Pamela Papineau Delphi Medical Device Consulting, Inc. 5 Whitcomb Ave Ayer, Massachusetts 01432

Re: K230083

Trade/Device Name: Safira Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion pump Regulatory Class: Class II Product Code: FRN Dated: September 29, 2023 Received: September 29, 2023

Dear Pamela Papineau:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Jake K. Digitally signed by Jake K Lindstrom -S Lindstrom -S Date: 2023.10.31 16:23:58 -04'00"

Jake Lindstrom, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K230083

Device Name SAFIRA

Indications for Use (Describe)

The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.

Type of Use (Select one or both, as applicable)

| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------|
| <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) Summary

#### General Information 1

Owners Name

Contact Person 1:

Email address:

Email address:

Contact Person 2:

Telephone Number:

Telephone Number:

Medovate Limited The Workplace, Camboro Business Park Girton, Cambridge, CB3 0QH Alan Finnerty (Technology Director) [phone] [e-mail] Stuart Thomson (Managing Director) [phone] [e-mail]

| Date Prepared: | October 30, 2023 |
|-----------------------|------------------|
| Device Trade Name: | SAFIRA |
| Common/Usual Name: | Infusion Pump |
| Product Code: | FRN |
| Classification Name: | Infusion Pump |
| Device Regulation: | 21 CFR 880.5725 |
| Device Classification | Class II |

### Predicate Device:

Product Code:

Common/Usual Name:

Classification Name:

Device Classification

Device Regulation

Medovate Limited SAFIRA; K153599 Infusion Pump FRN Infusion Pump 21 CFR 880.5725 Class II

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#### Indications for Use: 1.1

The Medovate SAFIRA system is intended for use by trained clinicians to administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia.

#### Device Description: 1.2

The Medovate SAFIRA device is an infiltration pump used to infuse local anesthetic drugs into the body as part of a Regional Anaesthesia procedure.

The SAFIRA device consists of a sterile, single-use plastic Syringe (20mL capacity) fitted with a custom collar and plunger, a non-sterile reusable Driver, and a non-sterile reusable Operator. SAFIRA is a battery powered motorized syringe driver for use in delivering anaesthetic via injection during a Peripheral Nerve Block (PNB) Procedure.

The user fills the syringe with the fluid of choice, then locks the filled Syringe into the Driver, where the specially designed Syringe Plunger rack mates with the Driver Gear. When the SAFIRA Syringe is attached to the Driver, the collar locks the Syringe to the Driver housing, and the Plunger engages with the Driver Gear to advance or retract the Syringe Plunger.

The female Luer or NRFit connection of a sterile, single-use needle set (not supplied by Medovate) is attached to the standard male Luer or NRFit fitting on the SAFIRA Syringe. The Operator (Foot Pedal or Palm Operator) connector is plugged into the receptacle on the Driver, ready for use.

The Driver contains non-replaceable AAA batteries which power a small DC motor which in turn controls the movement of the Syringe Plunger.

The Operator consists of 2 color-coded controls; when the user applies pressure to the appropriate control (green = infuse, yellow = aspirate), the motor activates the Plunger movement mechanism to move the Plunger forwards (infuse/inject) or backwards (aspirate).

The Driver is designed to deliver fluid at a maximum flow rate of 0.5mL/sec. The motor is designed with an overpressure safety feature, which causes the Plunger movement to stop if the pressure in the syringe exceeds 17psi ±3psi regardless of whether the "infuse" control of the operator is depressed.

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#### Substantial Equivalence: 1.3

The proposed SAFIRA device described in this 510(k) is substantially equivalent to the predicate SAFIRA device cleared in 510(k) K153599.

Substantial equivalence has been demonstrated by following the FDA Guidance: "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]", and accompanying text in the guidance.

The following table demonstrates a summary of the Substantial Equivalence between the Predicate Unmodified SAFIRA device (cleared in 510(k) K153599), and the proposed SAFIRA device.

| Criteria | Predicate Device:<br>Unmodified SAFIRA<br>(As per 510(k) K153599) | Proposed Device:<br>SAFIRA<br>(K230083) | Comments |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Equivalence | | | |
| FDA<br>Classification<br>Name | Infusion Pump | Infusion Pump | Identical |
| Product Code | FRN | FRN | Identical |
| Regulation | 21 CFR 880.5725 | 21 CFR 880.5725 | Identical |
| Device Class | II | II | Identical |
| Classification<br>Panel | General Hospital Devices | General Hospital Devices | Identical |
| Common / Usual<br>Name | Infiltration Pump | Infiltration Pump | Identical |
| Manufacturer | Medovate Ltd | Medovate Ltd | Identical |
| Intended<br>Operator | Physician or another<br>qualified medical<br>professional | Physician or another<br>qualified medical<br>professional | Identical |
| Criteria | Predicate Device:<br>Unmodified SAFIRA | Proposed Device:<br>SAFIRA | Comments |
| | (As per 510(k) K153599) | (K230083) | |
| Intended Use | Syringe infusion pump<br>operated via a foot pedal<br>for the infusion of non-IV<br>fluids into the body. | Syringe infusion pump<br>operated via an operator<br>for the infusion of non-IV<br>fluids into the body. | Substantially Equivalent<br>The wording "Foot Pedal" has<br>been replaced by "Operator"<br>as the SAFIRA Palm<br>Operator has been added to<br>the proposed SAFIRA device.<br>The principle of operation,<br>indications for use and<br>intended purpose remain<br>unchanged. |
| Contraindicated<br>for IV Fluid<br>Delivery | Yes | Yes | Identical |
| Indications for<br>Use | The Concert Medical<br>Hands-Free Syringe is<br>indicated for general fluid<br>irrigation / infiltration. | The Medovate SAFIRA<br>System is intended for use<br>by trained clinicians to<br>administer local<br>anaesthetics below a<br>specified pressure<br>threshold to a target nerve<br>bundle for regional<br>anaesthesia. | Substantially Equivalent<br>The wording of the proposed<br>SAFIRA device has been<br>amended to be more specific<br>and provide an Indication for<br>Use which is in line with the<br>use of the device.<br>The use of the proposed<br>SAFIRA remains unchanged<br>from the predicate<br>unmodified SAFIRA device,<br>and both devices have the<br>same medical intention. |
| Criteria | Predicate Device:<br>Unmodified SAFIRA<br>(As per 510(k) K153599) | Proposed Device:<br>SAFIRA<br>(K230083) | Comments |
| Design and<br>Technology<br>Equivalence | | | |
| Sterile Device? | Sterile:<br>Syringe<br><br>Non-Sterile:<br>Driver<br>Operator | Sterile:<br>Syringes<br><br>Non-Sterile:<br>Driver<br>Operators | Identical |
| Single Use<br>Device? | Single Use:<br>Syringe<br><br>Reusable:<br>Driver<br>Operator | Single Use:<br>Syringes<br><br>Reusable:<br>Driver<br>Operators | Identical |
| Fundamental<br>Scientific<br>Technology | Non-IV fluids infused<br>into the body via a<br>needle/cannula through<br>the application of pressure<br>exerted on the syringe<br>plunger through motor-<br>driven motion. | Local anaesthetic fluids<br>infused into the body via<br>a needle/cannula through<br>the application of pressure<br>exerted on the syringe<br>plunger through motor-<br>driven motion. | Equivalent<br>SAFIRA has restricted its use<br>to Local Anesthetic in line<br>with its Indications for Use.<br>The Fundamental Technology<br>of the predicate unmodified<br>and proposed SAFIRA<br>devices remains unchanged. |
| Pump Type | Piston-Driven Syringe | Piston-Driven Syringe | Identical |
| Infusion Fluid<br>Reservoir | Syringe (20ml), filled by<br>user | Syringe (20ml), filled by<br>user | Identical |
| | Predicate Device:<br>Unmodified SAFIRA | Proposed Device:<br>SAFIRA | |
| Criteria | (As per 510(k) K153599) | (K230083) | Comments |
| Compatible<br>Needle Sets | B. Braun Stimuplex A<br>22G x 2"<br>B. Braun Ultra<br>22G x 3-1/8"<br>Pajunk Sonoflex Stim<br>22G x 50mm<br>Life-Tech EchoBright<br>22G x 50mm | Needle Gauge: >22G<br>Needle Length: <120mm | Minor Difference<br>The unmodified predicate<br>SAFIRA device limited its<br>use to 4 specific regional<br>nerve block needles.<br>The proposed SAFIRA device<br>limits use to a range of needle<br>sizes which include the<br>previously specified needles. |
| Power Source | Battery | Battery | Identical |
| Materials | | | |
| Fluid Path<br>Materials | Syringe Body:<br>Polypropylene | Syringe Body:<br>Polypropylene | Identical |
| | Syringe Body Lubricant:<br>Silicone oil | Syringe Body Lubricant:<br>Silicone oil | |
| | Seal:<br>Isoprene Synthetic rubber | Seal:<br>Isoprene Synthetic rubber | |
| | Note:<br>Materials are identical to<br>those contained in the<br>Dragon Heart Medical<br>Devices syringes cleared<br>in K042547 | Note:<br>Materials are identical to<br>those contained in the<br>Dragon Heart Medical<br>Devices syringes cleared<br>in K042547 | |
| Criteria | Predicate Device:<br>Unmodified SAFIRA<br>(As per 510(k) K153599) | Proposed Device:<br>SAFIRA<br>(K230083) | Comments |
| Performance<br>Equivalence | | | |
| Maximum<br>Infusion Flow<br>Rate | 0.5ml/sec (30mL/min)<br>using 22G needle set | 0.5ml/sec (30ml/min)<br>using compatible needle<br>set | Identical |
| Maximum<br>Infusion Pressure | 13psi (±2psi) | 17psi (±3psi) | Difference to predicate.<br>The pressure limit has been<br>increased, however there is no<br>impact on safety and no new<br>risks have been introduced. |
| User Interface<br>Equivalence | | | |
| User Interface | User fills the sterile<br>syringe with infusion<br>fluid, places the syringe in<br>the pump mechanism<br>(Driver), attaches the<br>sterile infusion tubing and<br>needle (not provided by<br>Medovate) and attaches<br>the Foot Pedal to the<br>pump mechanism.<br>User initiates fluid<br>infusion or aspiration by<br>pressing on the Foot<br>Pedal. | User fills the sterile<br>syringe with local<br>anaesthetic, places the<br>Syringe in the pump<br>mechanism (Driver),<br>attaches the sterile<br>infusion tubing and<br>needle (not provided by<br>Medovate) and attaches<br>the Operator to the pump<br>mechanism.<br>User initiates fluid<br>infusion or aspiration by<br>pressing on the Operator<br>control. | Difference to predicate.<br>'Foot Pedal' replaced by<br>'Operator' due to the<br>additional Palm Operator<br>variant which has been added<br>to the proposed SAFIRA<br>device.<br>The principle of operation<br>remains the same. |
| Criteria | Predicate Device:<br>Unmodified SAFIRA<br>(As per 510(k) K153599) | Proposed Device:<br>SAFIRA<br>(K230083) | Comments |
| Syringe<br>Connection | Luer Syringe<br>(ISO 80369-7) | Luer Syringe<br>(ISO 80369-7)<br>NRFit Syringe<br>(ISO 80369-6) | Minor Difference to Predicate<br><br>An NRFit Syringe has been<br>developed and added to the<br>proposed SAFIRA device.<br><br>The introduction of the NRFit<br>Syringe to the SAFIRA<br>device has not affected device<br>use and allows the user /<br>facility to choose a syringe to<br>match the needle type they<br>already use for regional<br>blocks. |

## Table 1: General Substantial Equivalence Comparison

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#### Non-Clinical Performance Testing: 1.4

Performance data demonstrated that SAFIRA has met the pre-determined acceptance criteria and is substantially equivalent to the predicate SAFIRA device. The risks associated with the proposed SAFIRA device were found to be acceptable when evaluated in accordance with ISO 14971:2019.

Performance testing included in this 510(k) application consists of system verification testing to verify the changes made to the SAFIRA device, including the injection pressure limit, inclusion of the NRFit Syringe and Palm Operator. This 510(k) submission includes an Infusion Pump Safety Case and the results of a Human Factors Study to validate the above changes.

#### 1.5 Conclusion:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The SAFIRA is substantially equivalent to the predicate unmodified SAFIRA cleared under K153599 with respect to the indications for use, target populations, treatment method, and technological characteristics.