Sapphire Infusion Pump

K161667 · Q Core Medical , Ltd. · FRN · Mar 27, 2017 · General Hospital

Device Facts

• Record ID: K161667
• Device Name: Sapphire Infusion Pump
• Applicant: Q Core Medical , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Mar 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Q Core Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation. The dedicated Q Core administration sets for the Sapphire Infusion Pump are intended for singleuse only.

Device Story

Single-channel, volumetric, linear peristaltic infusion pump; delivers fluids via intravascular, subcutaneous, intra-arterial, or epidural routes. Operates in continuous, intermittent, TPN, PCA, multi-step, and epidural modes. Used by clinicians in clinical environments or patients in ambulatory/home settings and pre-hospital air/ground transport. Features include optional preprogrammed drug library, WiFi connectivity (compatible with MedNet), and various accessories (lockboxes, bolus handles, mounting brackets). Microcomputer-controlled; provides real-time display, history logs, and multiple alarms (occlusion, air-in-line, battery, flow error). Healthcare providers program delivery parameters; device ensures controlled fluid administration to benefit patients requiring precise medication/fluid therapy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including system verification and validation, human factors evaluations, electrical safety (IEC 60601-1, IEC 60601-1-12), EMC testing (IEC 60601-1-2), software verification/validation, and cleaning/disinfection validation.

Technological Characteristics

Volumetric, linear peristaltic infusion pump. Microcomputer-controlled. Power: Rechargeable Li-Ion battery (7.4V/1960 mAh) or AC adapter (100-240V, 50-60 Hz). Connectivity: WiFi (optional). Dimensions: 143 x 96 x 49 mm. Weight: 518g. Compliant with IEC 60601-1 and IEC 60601-1-2. Software-controlled infusion modes.

Indications for Use

Indicated for controlled delivery of fluids (saline, TPN, lipids, IV/epidural meds, blood) via intravascular, subcutaneous, intra-arterial, and epidural routes. For use by licensed healthcare professionals in clinical settings and home users in ambulatory environments, including pre-hospital medical air and ground transport. Patient population includes adult and pediatric patients.

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

• Sapphire Infusion Pump (K141389)

Reference Devices

• CADD®-Solis VIP Ambulatory Infusion Pump (K111275)

Submission Summary (Full Text)

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

March 27, 2017

Q Core Medical Ltd. % Rhona Shanker President Z & B Enterprises, Inc. 12154 Darnestown Road, #236 Gaithersburg, Maryland 20878

Re: K161667

Trade/Device Name: Sapphire Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: FRN, MRZ Dated: February 24, 2017 Received: February 24, 2017

Dear Rhona Shanker:

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.

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

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,

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

Enclosure

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## Indications for Use

510(k) Number (if known) K161667

Device Name

Sapphire Infusion Pump

Indications for Use (Describe)

The Q Core Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.

The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.

The dedicated Q Core administration sets for the Sapphire Infusion Pump are intent use and singleuse only.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# K161667 510(K) SUMMARY

Manufacturer's Name:

O Core Medical Ltd. 29 Yad Haruzim St. Netanya 4250529 ISRAEL Ph: [phone] Fax: [phone].

| Corresponding Official: | Rhona Shanker<br>FDA Regulatory Consultant to Q Core Medical Ltd |
|-------------------------|------------------------------------------------------------------|
|-------------------------|------------------------------------------------------------------|

| Telephone Number: | 301-251-9570 |
|-------------------|----------------------------|
| E-mail: | [e-mail] |

Preparation Date:

Trade Name:

Common or Usual Name:

Infusion Pump

March 23, 2017

Sapphire Infusion Pump

| Regulation Name: | Infusion Pump |
|---------------------------|--------------------------------------------------------|
| Regulation Number: | 21 CFR 880.5725 |
| Product Code: | FRN - Infusion Pump<br>MRZ – Infusion Pump Accessories |
| Device Class: | Class II |
| Primary Predicate Device: | K141389 Sapphire Infusion Pump |
| Reference Device: | K111275 CADD®-Solis VIP Ambulatory Infusion Pump |

## Device Description

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products. The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire Infusion Pump is designed to follow the patient through the various care areas, and is suitable for use in the different settings.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are sterile and intended for single-patient use and single-use only.

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

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The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

The Q Core Sapphire Infusion Pump includes Wiff functionality that is compatible with MedNet. The WiFi feature can be turned on or off, via an authorized Technician. As such, the Sapphire Infusion Pump is available with and without the WiFi functionality.

Sapphire Infusion Pump accessories include the mini cradle, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.

## Intended Use

The Q Core Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products.

The Sapphire Infusion Pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.

The dedicated Q Core administration sets for the Sapphire Infusion Pump are intended for singleuse only.

## Substantial Equivalence Discussion

The Sapphire Infusion Pump (pump and accessories) covered by this submission is the result of modifications to the FDA cleared Sapphire Infusion Pump (K141389). The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.

The table below includes a comparison of the technological characteristics between the new device and those of the predicate device:

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| Attribute | Predicate Device - K141389<br>Sapphire Infusion Pump | Subject Device - K161667<br>Sapphire Infusion Pump | Comparison | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|--|
| Indications for use | The Q Core Sapphire infusion<br>pump is intended for the controlled<br>delivery through intravascular,<br>subcutaneous, intra-arterial and<br>epidural routes. The pump is<br>designed to deliver saline, Total<br>Parenteral Nutrition (TPN), lipids,<br>IV medication, epidural medication,<br>blood and blood products.<br>The Sapphire pump includes the | The Q Core Sapphire Infusion Pump<br>is intended for controlled delivery<br>through intravascular, subcutaneous,<br>intra-arterial and epidural routes. The<br>pump is designed to deliver saline,<br>Total Parenteral Nutrition (TPN),<br>lipids, IV medication, epidural<br>medication, blood and blood<br>products.<br>The Sapphire Infusion Pump | The subject<br>device includes<br>the addition of<br>use in the air<br>environment | |
| | following infusion modes for all<br>intended uses: Continuous,<br>Intermittent, TPN, PCA, Multi-<br>step, and Epidural. | includes the following infusion<br>modes for all intended uses:<br>Continuous, Intermittent, TPN, PCA,<br>Multi-step, and Epidural. | | |
| | The pump is intended to be used by<br>both licensed health care<br>professionals in a clinical<br>environment, and home users in an<br>ambulatory environment and in pre<br>hospital medical ground<br>transportation. | The pump is intended to be used by<br>both licensed health care<br>professionals in a clinical<br>environment, and home users in an<br>ambulatory environment and in pre-<br>hospital medical air and ground<br>transportation. | | |
| | The dedicated Q Core<br>administration sets for the Sapphire<br>pump are intended for single-patient<br>use and single-use only. | The dedicated Q Core administration<br>sets for the Sapphire Infusion Pump<br>are intended for single-patient use<br>and single-use only. | | |
| Type of Pump | Volumetric | Same | - | |
| Operating Principle | Linear Peristaltic | Same | - | |
| Patient population | Adult and pediatric | Same | - | |
| Delivery Modes | Continuous, Intermittent, Multi-<br>step, PCA, TPN, and Epidural | Same | - | |
| Intended for intravenous,<br>intra-arterial and<br>subcutaneous use | Yes | Same | - | |
| Intended for<br>intravascular, intra-<br>peritoneal and epidural<br>routes of infusion. | Yes | Same | - | |
| System delivery<br>accuracy (nominal) | $\pm2.50%$ | Same | - | |
| System Components/Features | | | | |
| WiFi function | Yes | Same | - | |
| Real-time display | Yes | Same | - | |
| Microcomputer<br>controlled pump | Yes | Same | - | |
| Internal clock | Yes | Same | - | |
| Administration Set | Yes | Same | - | |
| Air-in-line sensor | Yes | Same | - | |
| Occlusion sensor | Yes | Same | - | |
| Temperature Sensor | Yes | Same | - | |
| Number of Channels | 1 | Same | - | |
| History Log | Yes | Same | - | |
| Pump Alarms and Messages | | | | |
| Battery/Low, Depleted | Yes | Same | - | |
| Pump in stop mode<br>(unattended) | Yes | Same | - | |
| High pressure<br>(Upstream/<br>Downstream Occlusion) | Yes | Same | - | |
| Pump Fault | Yes | Same | - | |
| Low volume in<br>medication reservoir | Yes | Same | - | |
| Cassette detachment<br>/misplaced/door open | Yes | Same | - | |
| Air-in-line | Yes | Same | - | |
| Flow Error | Yes | Same | - | |
| Key stuck | Yes | Same | - | |
| End-of-Infusion | Yes | Same | - | |
| Programmable End-of-<br>Infusion alarm | Yes | Same | - | |
| Programming Functions | | | | |
| High Internal<br>Temperature | Yes | Same | - | |
| Delivery Mode | Yes | Same | - | |
| Infusion Options | Yes | Same | - | |
| Security and/or Lock<br>Levels | Yes | Same | - | |
| Demand Dose Lockout | Yes | Same | - | |
| Delivery Limit | Yes | Same | - | |
| Maximum Rate | Yes | Same | - | |
| Minimum Rate | Yes | Same | - | |
| Occlusion pressure | Yes | Same | - | |
| Air Detection | Yes | Same | - | |
| Piggy back/Secondary | Yes | Same | - | |
| Bolus | Yes | Same | - | |
| Delayed Start | Yes | Same | - | |
| Infusion Specifications | | | | |
| Minimum Continuous<br>Delivery Rate | 0.1 mL/hr | Same | - | |
| Minimum Intermittent<br>Delivery Rate | 0.1 mL/hr | Same | - | |
| Maximum Intermittent<br>Delivery Rate | 999 mL/hr | Same | - | |
| Minimum PCA Delivery<br>Rate | 0 mL/hr | Same | - | |
| Maximum PCA Delivery<br>Rate | 99.9 mL/hr | Same | - | |
| Minimum TPN Delivery<br>Rate | 0.1 mL/hr | Same | - | |
| Maximum TPN Delivery<br>Rate | 600 mL/hr | Same | - | |
| Minimum Epi Delivery<br>Rate | 0.1 mL/hr | Same | - | |
| Maximum Epi Delivery<br>rate | 200 mL/hr | Same | - | |
| Patient Demand Dose | Yes | Same | - | |
| Maximum Patient<br>Demand Dose | 20 mL | Same | - | |
| Clinician Bolus | Yes | Same | - | |
| Maximum Clinician<br>Bolus | 20 mL | 30 mL | Supported by<br>literature and<br>CADD®-Solis<br>VIP Ambulatory<br>Infusion Pump<br>(K111275) | |
| Maximum Epidural<br>Hourly Volume | 40 mL | 60 mL | Supported by<br>literature<br>references | |
| Maximum Boluses per<br>Hour | 60 per hour / 60 per 4 hours | Same | - | |
| KVO | Yes | Same | - | |
| KVO Rate | 0 - 20 mL/hr or the actual rate,<br>whichever is lower | Same | - | |
| Reservoir volume | 0.1 to 9999 mL | Same | - | |
| Dose lockout time | Yes | Same | - | |
| Dose per Hour Limit | Yes | Same | - | |
| Delivery Limit | Yes | Same | - | |
| Programmable<br>Maximum Delivery Rate<br>(Continuous Rate and<br>Bolus) | Yes | Same | - | |
| <b>Accessories</b> | | | | |
| Administration sets | Yes - Q Core supplied<br>administration sets | Same | cleared under<br>(K082182,<br>K123049 and<br>K141389) | |
| AC adapter | Yes | Same | - | |
| Remote Dose Cord | Yes | Same…