(293 days)
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.
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.
The provided text describes the Medovate SAFIRA device, an infiltration pump for administering local anesthetic during regional anesthesia. It details the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than explicitly listing acceptance criteria for a new performance study of the exact same metrics. However, it does highlight key performance aspects and differences between the proposed device (SAFIRA, K230083) and the predicate device (unmodified SAFIRA, K153599).
The "Performance Equivalence" section of the table on page 6 effectively serves as a comparison of performance parameters.
| Criteria | Predicate Device (Unmodified SAFIRA - K153599) | Proposed Device (SAFIRA - K230083) | Comments |
|---|---|---|---|
| Maximum Infusion Flow Rate | 0.5ml/sec (30mL/min) using 22G needle set | 0.5ml/sec (30ml/min) using compatible needle set | Identical |
| Maximum Infusion Pressure | 13psi (±2psi) | 17psi (±3psi) | Difference to predicate. The pressure limit has been increased, however there is no impact on safety and no new risks have been introduced. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The text mentions "system verification testing" and a "Human Factors Study" as part of the performance testing. However, it does not specify the sample size used for these test sets, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature of the data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The provided text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted. The device is an infusion pump, not an AI-assisted diagnostic tool, so such a study would not be applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device described is a physical infusion pump with a user interface, not software or an algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply. The device's operation inherently involves human interaction (filling the syringe, attaching the needle, operating the controls).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Maximum Infusion Pressure" and "Maximum Infusion Flow Rate," the ground truth would be based on engineering specifications and measurements from instruments calibrated to measure fluid pressure and flow rate. For the Human Factors Study, the ground truth would likely be established by expert observations of user interaction and predefined usability metrics rather than medical outcomes.
8. The sample size for the training set
The provided text does not mention a training set in the context of machine learning or AI. The SAFIRA device is a hardware-based infusion pump, not an AI model.
9. How the ground truth for the training set was established
Since there is no mention of a training set for machine learning, this question is not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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) +44 (0)1223 901991 alan.finnerty@medovate.co.uk Stuart Thomson (Managing Director) +44 (0)1223 901991 stuart.thomson@medovate.co.uk
| 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:Unmodified SAFIRA(As per 510(k) K153599) | Proposed Device:SAFIRA(K230083) | Comments |
|---|---|---|---|
| RegulatoryEquivalence | |||
| FDAClassificationName | 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 |
| ClassificationPanel | General Hospital Devices | General Hospital Devices | Identical |
| Common / UsualName | Infiltration Pump | Infiltration Pump | Identical |
| Manufacturer | Medovate Ltd | Medovate Ltd | Identical |
| IntendedOperator | Physician or anotherqualified medicalprofessional | Physician or anotherqualified medicalprofessional | Identical |
| Criteria | Predicate Device:Unmodified SAFIRA | Proposed Device:SAFIRA | Comments |
| (As per 510(k) K153599) | (K230083) | ||
| Intended Use | Syringe infusion pumpoperated via a foot pedalfor the infusion of non-IVfluids into the body. | Syringe infusion pumpoperated via an operatorfor the infusion of non-IVfluids into the body. | Substantially EquivalentThe wording "Foot Pedal" hasbeen replaced by "Operator"as the SAFIRA PalmOperator has been added tothe proposed SAFIRA device.The principle of operation,indications for use andintended purpose remainunchanged. |
| Contraindicatedfor IV FluidDelivery | Yes | Yes | Identical |
| Indications forUse | The Concert MedicalHands-Free Syringe isindicated for general fluidirrigation / infiltration. | The Medovate SAFIRASystem is intended for useby trained clinicians toadminister localanaesthetics below aspecified pressurethreshold to a target nervebundle for regionalanaesthesia. | Substantially EquivalentThe wording of the proposedSAFIRA device has beenamended to be more specificand provide an Indication forUse which is in line with theuse of the device.The use of the proposedSAFIRA remains unchangedfrom the predicateunmodified SAFIRA device,and both devices have thesame medical intention. |
| Criteria | Predicate Device:Unmodified SAFIRA(As per 510(k) K153599) | Proposed Device:SAFIRA(K230083) | Comments |
| Design andTechnologyEquivalence | |||
| Sterile Device? | Sterile:SyringeNon-Sterile:DriverOperator | Sterile:SyringesNon-Sterile:DriverOperators | Identical |
| Single UseDevice? | Single Use:SyringeReusable:DriverOperator | Single Use:SyringesReusable:DriverOperators | Identical |
| FundamentalScientificTechnology | Non-IV fluids infusedinto the body via aneedle/cannula throughthe application of pressureexerted on the syringeplunger through motor-driven motion. | Local anaesthetic fluidsinfused into the body viaa needle/cannula throughthe application of pressureexerted on the syringeplunger through motor-driven motion. | EquivalentSAFIRA has restricted its useto Local Anesthetic in linewith its Indications for Use.The Fundamental Technologyof the predicate unmodifiedand proposed SAFIRAdevices remains unchanged. |
| Pump Type | Piston-Driven Syringe | Piston-Driven Syringe | Identical |
| Infusion FluidReservoir | Syringe (20ml), filled byuser | Syringe (20ml), filled byuser | Identical |
| Predicate Device:Unmodified SAFIRA | Proposed Device:SAFIRA | ||
| Criteria | (As per 510(k) K153599) | (K230083) | Comments |
| CompatibleNeedle Sets | B. Braun Stimuplex A22G x 2"B. Braun Ultra22G x 3-1/8"Pajunk Sonoflex Stim22G x 50mmLife-Tech EchoBright22G x 50mm | Needle Gauge: >22GNeedle Length: <120mm | Minor DifferenceThe unmodified predicateSAFIRA device limited itsuse to 4 specific regionalnerve block needles.The proposed SAFIRA devicelimits use to a range of needlesizes which include thepreviously specified needles. |
| Power Source | Battery | Battery | Identical |
| Materials | |||
| Fluid PathMaterials | Syringe Body:Polypropylene | Syringe Body:Polypropylene | Identical |
| Syringe Body Lubricant:Silicone oil | Syringe Body Lubricant:Silicone oil | ||
| Seal:Isoprene Synthetic rubber | Seal:Isoprene Synthetic rubber | ||
| Note:Materials are identical tothose contained in theDragon Heart MedicalDevices syringes clearedin K042547 | Note:Materials are identical tothose contained in theDragon Heart MedicalDevices syringes clearedin K042547 | ||
| Criteria | Predicate Device:Unmodified SAFIRA(As per 510(k) K153599) | Proposed Device:SAFIRA(K230083) | Comments |
| PerformanceEquivalence | |||
| MaximumInfusion FlowRate | 0.5ml/sec (30mL/min)using 22G needle set | 0.5ml/sec (30ml/min)using compatible needleset | Identical |
| MaximumInfusion Pressure | 13psi (±2psi) | 17psi (±3psi) | Difference to predicate.The pressure limit has beenincreased, however there is noimpact on safety and no newrisks have been introduced. |
| User InterfaceEquivalence | |||
| User Interface | User fills the sterilesyringe with infusionfluid, places the syringe inthe pump mechanism(Driver), attaches thesterile infusion tubing andneedle (not provided byMedovate) and attachesthe Foot Pedal to thepump mechanism.User initiates fluidinfusion or aspiration bypressing on the FootPedal. | User fills the sterilesyringe with localanaesthetic, places theSyringe in the pumpmechanism (Driver),attaches the sterileinfusion tubing andneedle (not provided byMedovate) and attachesthe Operator to the pumpmechanism.User initiates fluidinfusion or aspiration bypressing on the Operatorcontrol. | Difference to predicate.'Foot Pedal' replaced by'Operator' due to theadditional Palm Operatorvariant which has been addedto the proposed SAFIRAdevice.The principle of operationremains the same. |
| Criteria | Predicate Device:Unmodified SAFIRA(As per 510(k) K153599) | Proposed Device:SAFIRA(K230083) | Comments |
| SyringeConnection | Luer Syringe(ISO 80369-7) | Luer Syringe(ISO 80369-7)NRFit Syringe(ISO 80369-6) | Minor Difference to PredicateAn NRFit Syringe has beendeveloped and added to theproposed SAFIRA device.The introduction of the NRFitSyringe to the SAFIRAdevice has not affected deviceuse and allows the user /facility to choose a syringe tomatch the needle type theyalready use for regionalblocks. |
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.
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).