CompuFlo Epidural Computer Controlled Anesthesia System

K161883 · Milestone Scientific, Inc. · FMF · Jun 9, 2017 · General Hospital

Device Facts

• Record ID: K161883
• Device Name: CompuFlo Epidural Computer Controlled Anesthesia System
• Applicant: Milestone Scientific, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Jun 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The CompuFlo Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real time verification of needle tip placement in the lumbar epidural space in patients over the age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider. Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, Compuflo Epidural Computer Controlled Anesthesia System is disconnected and HCP continues with the medical procedure.

Device Story

Device provides real-time verification of epidural needle tip placement in lumbar epidural space; utilizes in-line fluid pressure sensor to measure pressure at needle tip; provides visual and audio feedback to clinician. System comprises primary unit, pneumatic foot pedal, AC power/battery, and single-use disposable kit (pressure sensor, 20mL syringe, tubing, ID adapter). Used in clinical settings (in-patient/out-patient) by healthcare providers. Clinician monitors LCD interface/audio cues to confirm needle entry into epidural space; device is disconnected once placement is verified. Benefits include objective, real-time confirmation of needle position compared to subjective loss-of-resistance techniques.

Clinical Evidence

Prospective, randomized, parallel group, multicenter pivotal study (COMPASS) with 400 subjects (240 chronic pain, 160 acute labor/delivery). 388 procedures performed. Primary endpoint: success rate of lumbar epidural space identification compared to loss-of-resistance (LOR) technique. Results met non-inferiority hypothesis with a 1% delta margin. Bench testing confirmed dose accuracy, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and alarm performance (IEC 60601-1-8).

Technological Characteristics

Injection-molded plastic housing; motor-driven piston syringe pump; internal force sensor; microprocessor; LCD screen. Connectivity: AC mains or internal battery. Disposables: EO-sterilized (ISO 11135-1) in-line fluid pressure sensor, 20mL syringe, tubing, ID adapter. Sensing principle: in-line fluid pressure measurement. Software developed per IEC 62304.

Indications for Use

Indicated for patients >18 years requiring epidural needle placement in the lumbar epidural space for medically necessary in-patient or out-patient procedures.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Exmoor Plastics Limited, Epidrum (K093863)

Reference Devices

• Milestone Scientific, Inc. CompuFlo Infusion Pump (K053554)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of human profiles facing right, with three overlapping faces suggesting community and connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 9, 2017

Milestone Scientific, Inc. Stephen Solomon Director, Engineering and Regulatory Affairs 220 South Orange Ave. Livingston, New Jersey 07039

Re: K161883

Trade/Device Name: CompuFlo Epidural Computer Controlled Anesthesia System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: April 28, 2017 Received: May 1, 2017

Dear Stephen Solomon:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number ( <i>if known</i> ) | K161883 |
| Device Name | CompuFlo Epidural Computer Controlled Anesthesia System |
| Indications for Use (Describe) | The CompuFlo Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real time verification of needle tip placement in the lumbar epidural space in patients over the age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider. Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, Compuflo Epidural Computer Controlled Anesthesia System is disconnected and HCP continues with the medical procedure. |
| Type of Use (Select one or both, as applicable) | |
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="0" y2="12"></line> <line style="stroke:rgb(0,0,0);stroke-width:2" x1="0" x2="12" y1="12" y2="0"></line> </svg> </span>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
| | <div> <span> <svg height="12" width="12"> <rect height="12" style="fill:lightgrey;stroke-width:1;stroke:rgb(0,0,0)" width="12"></rect> </svg> </span>Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

| FORM FDA 3881 (8/14) | Page 1 of 1 |
|----------------------|-------------|
|----------------------|-------------|

PSC Publishing Services [phone] EF

{3}------------------------------------------------

# 510(k) SUMMARY

# Milestone Scientifics' CompuFlo Epidural Computer Controlled Anesthesia System

# Submitter

Stephen Solomon Director Engineering and Regulatory Affairs Milestone Scientific 220 S. Orange Ave. Livingston NJ 07039 Phone: [phone] Fax: [phone] [e-mail]

Date Prepared: June 6, 2017

# Trade Name of Device

CompuFlo Epidural Computer Controlled Anesthesia System

# Sponsor:

Milestone Scientific, Inc. 220 S. Orange Avenue Livingston, New Jersey 07039

#### Contact Name:

Stephen Solomon Phone: [phone] Fax: [phone] [e-mail]

Common or Usual Name: Piston Syringe (21 CFR 880.5860, Product code: FMF)

#### Predicate Devices

- Primary predicate device: Exmoor Plastics Limited, Epidrum (K093863) ●
- . Reference device: Milestone Scientific, Inc. CompuFlo Infusion Pump (K053554)

#### Intended Use / Indications for Use

The CompuFlo® Epidural Computer Controlled Anesthesia System is intended for use with an epidural needle for the real-time verification of needle tip placement in the lumbar epidural space in patients over age of 18 who are required to have epidural needle placement as part of a medically necessary, in-patient or out-patient procedure, as established by their Health Care Provider.

{4}------------------------------------------------

Once Health Care Provider verifies the epidural needle placement in the lumbar epidural space, CompuFlo® Epidural Computer Controlled Anesthesia System is disconnected and the HCP continues with the medical procedure.

# Device Description

The device consists of: (1) the primary unit, (2) a pneumatic foot pedal control, (3) an AC power cord and (4) single-use disposable kit, which include an external in-line fluid pressure sensor, a 20 mL plastic syringe, plastic tubing and an ID Adapter. Operation of the device is allowed when powered by the AC mains or by the internal battery source. The epidural needle and solution is not supplied in the disposable Kit.

# Technological Characteristics

The CompuFlo® Epidural Computer Controlled Anesthesia System includes an injectionmolded plastic housing that contains the motor-driven piston syringe pumps and internal force sensor, syringe retainer, microprocessor, and LCD screen display. A foot pedal and power cord are also included; the user controls the epidural needle placement verification by use of the LCD user interface and optionally the foot pedal. The tray of single-use disposable supplies includes an external in-line fluid pressure sensor, a 20 mL plastic syringe, tubing set and an adapter that limits use of the disposables to a single use. Both the CompuFlo Epidural and the reference device, the CompuFlo Infusion Pump use the same technology to control the infusion according to the operator's preferences.

#### Performance Data

Testing of the CompuFlo Epidural device was carried out to meet elements of FDA's Draft Guidance Total Product Life Cycle: Infusion Pump-Premarket Notification [510(k]). Performance of the device and controlling software was evaluated via non-clinical testing, addressing such subjects as syringe plunger travel distance, volume dispensed, flow rates, and the accuracy of displays monitoring pressure at the needle tip. The results of these tests demonstrate that the device is as safe and as effective, and performs as well as, if not better than, the predicate device. Testing was conducted at various flow rates and head pressures to ensure that the instrument not only functions at nominal conditions but also at the extreme limits of the instrument's specifications. Bench data demonstrated that the CompuFlo Epidural has substantially equivalent performance as the predicate device.

A summary of the non-clinical testing is provided in table below.

| Non-Clinical | Standard / Bench Testing |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety | IEC 60601-1:2012, 3rd edition, Medical Electrical Equipment – Part 1 General<br>Requirements for Safety and found to meet all applicable causes. |
| EMC | IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1; General Requirements<br>for Safety - Section 2: Collateral Standard- Electromagnetic Compatibility -<br>Requirements and Tests and found to meet all applicable causes. |
| Non-Clinical | Standard / Bench Testing |
| Infusion Pump | IEC 60601-2-24:2012, Medical Electrical Equipment, Particular Requirements for the<br>Safety of Infusion Pumps and found to meet all applicable causes. |
| Alarms | IEC 60601-1-8:2012, Medical Electrical Equipment, Parts 1-8: General<br>Requirements for Safety-Collateral Standard - General Requirements, tests and<br>Guidance for Alarm Systems and found to meet all applicable causes. |
| Mechanical<br>Testing | Vibration and shock testing per MIL-STD 810G Method 514.6 Procedure 1 and<br>Method 516.6 Procedure 1 and found to meet all applicable causes. |
| Environmental<br>Testing | Altitude, Temperature and Humidity per Mil-STD 810G Method 500.5 Procedure 1;<br>Method 501.5 Procedure 1 and 2; Method 502.5 Procedure 2; and found to meet all<br>applicable causes. |
| Drop Test | Testing to confirm that the instrument can function and or not create a hazard under<br>an adverse condition of a 6 inch and 12 inch drop on a hard surface. |
| Software | Developed and maintained per IEC 62304 and conducted according to FDA<br>guidance titled "Guidance for the Content of Premarket Submissions for Software<br>Contained in Medical Devices (May 11, 2005)" |
| System<br>Integration Test | Conformance Verification. |
| Sterilization | External In-Line Fluid Pressure Sensor, tubing set and syringe are sterilized using a<br>validated 100% ethylene oxide (EO) sterilization process to SAL of six log reduction<br>according to ANNSI/AAMI/ISO 11135-1:2007 as previously cleared by FDA |
| Cybersecurity | Cybersecurity risk assessment and management was conducted according to FDA<br>guidance titled, "Content of Premarket Submissions for Management of<br>Cybersecurity in Medical Devices (October 2, 2014)". |
| Biocompatibility | The CompuFlo Epidural instrument does not come in direct contact with the patient.<br>Components that have indirect contact with the patient were previously cleared by<br>the FDA. Additional testing was conducted per ISO 10993-18 as part of an overall<br>risk analysis and found to meet applicable clauses. |
| Human Factors | Milestone conducted a human factors/usability study according to FDA guidance<br>document titled, "Applying Human Factors and Usability Engineering to Optimize<br>Medical Device Design (June 22, 2011)". Study results demonstrated that<br>participants were able to adequately use the device. |
| Dose Accuracy | Dose accuracy testing was conducted comparing the dose accuracy of CompuFlo<br>Epidural to the referenced CompuFlo (K053554) instrument. Six test points were<br>used to confirm the dose accuracy. The average variation between the reported and<br>actual fluid dispensed was 0.316% for the CompuFlo Epidural and 3.2% for the<br>CompuFlo (K053554). |
| Zero Pressure | The Zero Pressure test was conducted to demonstrate the system's ability to<br>compensate for vertical displacement by using the Zero Pressure button. |

# Table 1: Summary of Non-clinical Testing

{5}------------------------------------------------

# Clinical Study

CompuFlo Epidural was evaluated in a prospective, randomized, parallel group, multicenter, pivotal study. The purpose of this pivotal study was to demonstrate the performance of the CompuFlo® Epidural Computer Controlled System for the epidural

{6}------------------------------------------------

space verification when compared to the loss of resistance technique (LOR). The primary objective of the COMPASS study was to determine whether the success rate of performance of lumbar epidural anesthesia with the CompuFlo Epidural to identify the epidural space is equivalent to performance of lumbar epidural anesthesia with the LOR technique. A total of 400 subjects were enrolled at 6 US clinical centers, of which two-hundred-forty subjects (240) required epidural procedure as part of the chronic pain management and one-hundredsixty (160) required epidural procedure for acute pain management during labor and delivery. Twelve (12) subjects (3% of the total population enrolled) did not have epidural procedure performed, so total of 388 procedures were performed as part of the study. The study data demonstrated the performance of the CompuFlo Epidural space verification. The primary outcome hypothesis that the Experimental Procedure Group (EPG) is noninferior to the Standard Care Group (SCG) with respect to the primary endpoint of successful performance of lumbar epidural procedure, where the non-inferiority margin (delta) is an absolute difference of 1 percent has been met.

Based on the nonclinical and clinical tests conducted, it was demonstrated that the CompuFlo Epidural device is as safe, as effective and performs as well as or better than the legally marketed device identified above.

# Substantial Equivalence

The CompuFlo Epidural Computer Controlled Anesthesia System is substantially equivalent to the Exmoor Plastics Limited's Epidrum cleared under K093863.

| Feature | Subject Device:<br>Milestone CompuFlo Epidural | Primary Predicate Device:<br>Exmoor Plastics Limited<br>Epidrum (K093863) | Reference Device:<br>Milestone<br>CompuFlo Infusion<br>Pump (K053554) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for<br>Use | The CompuFlo® Epidural<br>Computer Controlled Anesthesia<br>System is intended for use with<br>an epidural needle for the real-<br>time verification of needle tip<br>placement in the lumbar epidural<br>space in patients over age of 18<br>who are required to have<br>epidural needle placement as<br>part of the medically necessary,<br>in-patient or out-patient<br>procedure, as established by<br>their Health Care Provider.<br><br>Once Health Care Provider<br>Computer Controlled Anesthesia<br>System verifies the epidural<br>needle placement in the lumbar<br>epidural space, CompuFlo®<br>Epidural is disconnected and the<br>HCP continues with the medical<br>procedure. | The Epidrum is intended for use,<br>in conjunction with an epidural<br>needle, to verify the needle tip<br>placement in the epidural space. | The CompuFlo is<br>intended for use in<br>delivering medication<br>and other<br>fluids in a controlled<br>manner. The<br>CompuFlo is<br>indicated for use in<br>adults for the<br>continuous or<br>intermittent delivery<br>of medications and<br>other fluids through<br>intravenous, intra-<br>arterial,<br>subcutaneous,<br>epidural and enteral<br>routes. |

| | Table 2: Comparison between Milestone CompuFlo Epidural and Predicate device |
|--|------------------------------------------------------------------------------|
|--|------------------------------------------------------------------------------|

{7}------------------------------------------------

| Feature | Subject Device:<br>Milestone CompuFlo Epidural | Primary Predicate Device:<br>Exmoor Plastics Limited<br>Epidrum (K093863) | Reference Device:<br>Milestone<br>CompuFlo Infusion<br>Pump (K053554) |
|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| User<br>Population | 18 years of age and older | Adults | Adults |
| Principal of<br>Operation /<br>Technological<br>Differences | The CompuFlo Epidural uses an<br>in-line fluid pressure sensor to<br>accurately measure the pressure<br>at the needle which provide<br>visual and audio indication that<br>the needle has entered the<br>epidural space | The Epidrum comprises a small<br>chamber, featuring<br>a female Luer inlet port and a<br>male Luer exit port on<br>opposing sides, with an<br>expandable membrane as<br>one of the sides between the<br>podts | CompuFlo Infusion<br>uses an in-line fluid<br>pressure technology<br>to deliver fluids with<br>pressure monitoring<br>and integral alarms |
| Disposables | • Commercial syringe, 20 ml<br>sizes, provided by Milestone<br>• Commercially available<br>needles provided by clinician<br>• Tubing Set provided by<br>Milestone<br>• ID Adaptor provided by<br>Milestone | • User-provided, commercially<br>available disposable<br>supplies, such as off-the-<br>shelf vials and off-the-shelf<br>needles<br>• Disposable hand piece and<br>tubing | • Commercially<br>available syringes<br>of various sizes<br>provided by<br>clinician<br>• Commercially<br>available needles<br>provided by<br>clinician<br>• Commercially<br>available hand<br>piece provided by<br>Milestone |

Milestone's CompuFlo Epidural Computer Controlled Anesthesia System and the primary predicate Epidrum have the same intended use of verifying the placement of the epidural needle in the epidural space. The CompuFlo Epidural Controlled Anesthesia System additionally achieves the primary intended use in real-time whereas Epidrum, the predicate device does not. In addition, CompuFlo Epidural Controlled Anesthesia System is specifically indicated for patients over the age of 18 years old, which was established based on the COMPASS Clinical study, whereas the Epidrum was indicated for use in adults. The aforementioned difference is not critical to the intended therapeutic or diagnostic use of the device and the differences do not affect the safety and effectiveness of the device when used as labeled.

Both devices also have similar technological characteristics of using pressure sensing based on the well-known and widely used loss of resistance technique;difference between CompuFlo Epidural Controlled Anesthesia System and Epidrum is technology that is used the provide visual and audio indication that the needle has entered the epidural space CompuFlo Epidural Controlled Anesthesia System uses computer controlled objective measurement of the pressure changes at the tip of the needle, whereas Epidrum relies on the subjective audio and visual indication of the pressure changes. As stated above, differences are not critical to the intended therapeutic or diagnostic, use of the device, and the differences do not raise different questions of safety and effectiveness of the device when used as labeled. Furthermore once Health Care Provider (HCP) verifies the epidural needle placement in the lumbar epidural space, the CompuFlo® Epidural is disconnected and the HCP continues with the medical procedure. The Epidrum indications for use does not

{8}------------------------------------------------

address this step, however from the labeling/instructions for use that step is also completed with the Epidrum, thus there is no difference.

The CompuFlo Epidural uses an in-line fluid pressure sensor to accurately measure the pressure at the needle, which provides visual and audio indication that the needle has entered the epidural space. In comparison, the Epidrum uses a small pressure chamber that provides a visual indication that the needle has entered the epidural space. Although the method of pressure sensing is different, both provide feedback to the user regarding the loss of pressure as the needle enters the epidural space. The pressure sensor in the CompuFlo Epidural provides an objective and accurate pressure measurement to the user. In addition, FDA has cleared similar pressure sensing technology in the company's reference CompuFlo device (K053554). As such, any differences in technological characteristics do not raise different questions of safety or effectiveness. Furthermore, bench testing and clinical study data have demonstrate substantially equivalent performance. Accordingly, the CompuFlo Epidural is substantially equivalent to the primary predicate Epidrum.