(293 days)
No
The description details a mechanical, battery-powered syringe driver with a pressure-sensitive safety feature. There is no mention of AI or ML algorithms for decision-making, data analysis, or control beyond simple motor activation based on user input and pressure threshold.
No.
The device is an infiltration pump that administers local anesthetic for regional anesthesia, which is a procedure rather than the treatment of a disease or condition.
No
The SAFIRA system is an infiltration pump used to administer local anaesthetic, not to diagnose a condition. Its stated purpose in the "Intended Use / Indications for Use" is to "administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia."
No
The device description clearly outlines multiple hardware components including a syringe, driver, operator (foot pedal or palm operator), batteries, and a motor. It is a physical infiltration pump.
Based on the provided information, the Medovate SAFIRA system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "administer local anaesthetic below a specified pressure threshold to a target nerve bundle for regional anaesthesia." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as an "infiltration pump used to infuse local anesthetic drugs into the body." This further reinforces its function as a delivery system for medication within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) taken from the patient. IVD devices are specifically designed for in vitro (outside the body) examination of specimens.
Therefore, the Medovate SAFIRA system is a medical device used for administering medication during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
FRN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nerve bundle (for regional anaesthesia)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinicians / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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).
2
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
3
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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4
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
5
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.
6
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 |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Equivalence | | | |
| FDA
Classification
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
Panel | General Hospital Devices | General Hospital Devices | Identical |
| Common / Usual
Name | Infiltration Pump | Infiltration Pump | Identical |
| Manufacturer | Medovate Ltd | Medovate Ltd | Identical |
| Intended
Operator | Physician or another
qualified medical
professional | Physician or another
qualified medical
professional | Identical |
| Criteria | Predicate Device:
Unmodified SAFIRA | Proposed Device:
SAFIRA | Comments |
| | (As per 510(k) K153599) | (K230083) | |
| Intended Use | Syringe infusion pump
operated via a foot pedal
for the infusion of non-IV
fluids into the body. | Syringe infusion pump
operated via an operator
for the infusion of non-IV
fluids into the body. | Substantially Equivalent
The wording "Foot Pedal" has
been replaced by "Operator"
as the SAFIRA Palm
Operator has been added to
the proposed SAFIRA device.
The principle of operation,
indications for use and
intended purpose remain
unchanged. |
| Contraindicated
for IV Fluid
Delivery | Yes | Yes | Identical |
| Indications for
Use | The Concert Medical
Hands-Free Syringe is
indicated for general fluid
irrigation / infiltration. | The Medovate SAFIRA
System is intended for use
by trained clinicians to
administer local
anaesthetics below a
specified pressure
threshold to a target nerve
bundle for regional
anaesthesia. | Substantially Equivalent
The wording of the proposed
SAFIRA device has been
amended to be more specific
and provide an Indication for
Use which is in line with the
use of the device.
The use of the proposed
SAFIRA remains unchanged
from the predicate
unmodified SAFIRA device,
and both devices have the
same medical intention. |
| Criteria | Predicate Device:
Unmodified SAFIRA
(As per 510(k) K153599) | Proposed Device:
SAFIRA
(K230083) | Comments |
| Design and
Technology
Equivalence | | | |
| Sterile Device? | Sterile:
Syringe
Non-Sterile:
Driver
Operator | Sterile:
Syringes
Non-Sterile:
Driver
Operators | Identical |
| Single Use
Device? | Single Use:
Syringe
Reusable:
Driver
Operator | Single Use:
Syringes
Reusable:
Driver
Operators | Identical |
| Fundamental
Scientific
Technology | Non-IV fluids infused
into the body via a
needle/cannula through
the application of pressure
exerted on the syringe
plunger through motor-
driven motion. | Local anaesthetic fluids
infused into the body via
a needle/cannula through
the application of pressure
exerted on the syringe
plunger through motor-
driven motion. | Equivalent
SAFIRA has restricted its use
to Local Anesthetic in line
with its Indications for Use.
The Fundamental Technology
of the predicate unmodified
and proposed SAFIRA
devices remains unchanged. |
| Pump Type | Piston-Driven Syringe | Piston-Driven Syringe | Identical |
| Infusion Fluid
Reservoir | Syringe (20ml), filled by
user | Syringe (20ml), filled by
user | Identical |
| | Predicate Device:
Unmodified SAFIRA | Proposed Device:
SAFIRA | |
| Criteria | (As per 510(k) K153599) | (K230083) | Comments |
| Compatible
Needle Sets | B. Braun Stimuplex A
22G x 2"
B. Braun Ultra
22G x 3-1/8"
Pajunk Sonoflex Stim
22G x 50mm
Life-Tech EchoBright
22G x 50mm | Needle Gauge: >22G
Needle Length: