SAPPHIRE INFUSION PUMP

K123049 · Q Core Medical , Ltd. · FRN · Oct 17, 2013 · General Hospital

Device Facts

• Record ID: K123049
• Device Name: SAPPHIRE INFUSION PUMP
• Applicant: Q Core Medical , Ltd.
• Product Code: FRN · General Hospital
• Decision Date: Oct 17, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Q Core Sapphire infusion pump is intended for the 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 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 ground transportation. The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

Device Story

Sapphire Infusion Pump is a single-channel, volumetric, linear peristaltic pump; delivers fluids (saline, TPN, lipids, blood, medications) via IV, subcutaneous, intra-arterial, or epidural routes. Operated by clinicians or patients in clinical, home, or pre-hospital transport settings. Features include multiple delivery modes (Continuous, Intermittent, TPN, PCA, Multi-step, Epidural) and a Drug Library. Pump monitors for occlusions, air-in-line, and battery status; provides alarms to alert users. Software-controlled operation ensures programmed dose delivery. Benefits include precise, controlled medication administration across various care environments, supporting patient mobility.

Clinical Evidence

Bench testing only. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), environmental (IEC 60601-1-11), mechanical (IEC 68-2), alarm testing (IEC 60601-1-8), pump accuracy (IEC 60601-2-24), and human factors. Administration sets underwent biocompatibility (ISO 10993), infusion/transfusion equipment testing (ISO 8536-4, ISO 1135-4), and sterilization validation (ISO 11135-1).

Technological Characteristics

Volumetric linear peristaltic infusion pump. Materials: non-DEHP, latex-free tubing. Connectivity: internal battery or external power. Software-controlled with user-defined delivery modes. Safety features: Anti-Free Flow Valve (AFFV) in administration sets, occlusion detection, and authorization levels. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-24, ISO 10993, ISO 8536-4, ISO 1135-4, ISO 11135-1.

Indications for Use

Indicated for patients requiring controlled delivery of saline, TPN, lipids, IV/epidural medications, blood, and blood products via intravascular, subcutaneous, intra-arterial, or epidural routes. Suitable for use by licensed healthcare professionals in clinical settings or by patients in ambulatory/home environments and pre-hospital ground transport.

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

• AP34 Multi-therapy Infusion pump (K082182)
• Spectrum Infusion Pump with Master Drug Library (K042121)
• CADD-Prizm Model 6101 Ambulatory Infusion Pump (K000842)
• Bodyguard Infusion Pump System (K060479)

Submission Summary (Full Text)

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K123049

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## 510(k) Summary

| Owner/Submitter | Q Core Medical Ltd.<br>29 Yad Haruzim St.<br>Netanya 4250529<br>ISRAEL | OCT 17 2013 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Rhona Shanker<br>FDA Regulatory Consultant to Q Core Medical Ltd<br>Ph: 301251-9570<br>Fax: [phone]<br>[e-mail] | |
| Date of Submission | 24 September 2012 | |
| Trade Name | Sapphire Infusion Pump System with Administration Sets | |
| Common Name | Infusion pump | |
| Classification Name | Infusion Pump 21 CFR 880.5725<br>Product Codes:<br>FRN - Infusion pump<br>MEA - Patient controlled analgesia (PCA) infusion pump<br>MRZ - Infusion pump accessories (administration sets) | |
| Predicate Device<br>Infusion Pump | AP34 Multi-therapy Infusion pump (K082182)<br>Spectrum Infusion Pump with Master Drug Library (K042121),<br>CADD-Prizm Model 6101 Ambulatory Infusion Pump<br>(K000842)<br>Bodyguard Infusion Pump System (K060479) | |
| Administration Sets | Q Core Administration Sets cleared under K082182 | |

## Device Description

The Q Core Sapphire infusion pump the result of modifications to the FDA cleared AP 34 Infusion pump (K082182). The modifications were changes to the user interface and additional functions that include new delivery modes and the Drug Library feature. There are no changes to the basic infusion pump technology. Like its predicates, the Sapphire is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular,

Image /page/0/Picture/6 description: The image shows the logo for QCORE medical. The logo consists of a stylized speech bubble with a dot inside a circle. Below the symbol is the text "QCORE" in a bold, sans-serif font, with the word "medical" in a smaller font directly underneath.

29 Yad Haruzim • St. P.O.Box 8639 • Netanya 4250529, ISRAEL Tel: [phone] • Fax: [phone] • [e-mail] • www.qcore.com

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subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alams for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and in pre-hospital medical ground transportation.

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

## Indications for Use

The O Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition, lipids, IV medication, epidural medication, blood and blood products.

The Sapphire 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. The Sapphire pump is designed to follow the patient through the various care areas, and in pre-hospital medical ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

#### Technological Characteristics

The Sapphire infusion pump is similar to the predicate devices in the following respects:

- All pumps are volumetric and software controlled. 1.
- All pumps are indicated for the controlled delivery of programmed doses of saline, TPN, 2. lipids, IV medication, epidural medication at selected rates and can be used in the hospital, pre-hospital medical ground transporation, and home environments.
- The Sapphire pump has six delivery modes: Continuous, Intermittent, Multi-step, PCA, 3. TPN, and Epidural. Each of the predicates includes at least three of these modes.
- The pump is substantially equivalent to the Spectrum Infusion Pump with Master Drug 4. Library (K042121) with respect to the delivery of blood and blood products.
- All pumps have similar safety features to prevent free flow, alarms for the detection of 5. upstream and downstream occlusions, low battery, end of infusion, and pump failure, and authorization levels to prevent misuse.

The Q Core Administration Sets are similar to the predicate sets cleared under K082182 in the

Image /page/1/Picture/16 description: The image shows the logo for QCORE medical. The logo consists of a stylized letter Q with a circle around it, and the text "QCORE" above the word "medical". The logo is black and white.

29 Yad Haruzim • St. P.O.Box 8639 • Netanya 4250529, ISRAEL Tel: [phone] • Fax: [phone] • [e-mail] • www.qcore.com

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following respects:

- All sets are dedicated for use with Q Core infusion pumps. 1.
- All sets are indicated for intravenous infusion. 2.
- All sets can be used only by or under the order of a licensed medical practitioner. 3.
- 4. All sets consist of standard, conventional components such as Luer locks, PVC tubing, Y connector, tubing clamp.
- ર . All sets use materials with the same characteristics (biocompatible, non-DEHP, latex free).
- All sets have the same means to protect against free flow (cassette with an Anti-Free 6. Flow Valve [AFFV]).
- All sets are provided sterile, non-pyrogenic, intended for single patient use and single 7. use.
- All sets are intended for either hospital or home use. 8.

## Pre-Clinical Testing

Preclinical testing included in the submission to demonstrate that the Sapphire Infusion Pump is safe and performs as intended involved the following:

Electrical Safety per IEC 60601-1

EMC testing per IEC 60601-1-2

Environmental Testing per 60601-1-11

Mechanical Testing per IEC 68-2

Alarm testing per IEC 60601-1-8

Software Verification and Validation per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005

Pump accuracy per IEC 60601-2-24: Particular requirements for Safety of Infusion Pumps and Controllers

Human Factors testing

Testing of the Administration Sets involved:

Biocompatibility testing per ISO 10993 Testing per ISO 8536-4, Infusion Equipment for Medical Use, Part 4 Testing per ISO 1135-4, Transfusion Equipment for Medical Use Sterilization Validation per ISO 11135-1 Sterile Packaging Validation Shelf life

# Conclusion

The Sapphire Infusion Pump is substantially equivalent to the AP34 Multi-therapy Infusion pump (K082182) (primary predicate) with respect to the indications for use, the target

Image /page/2/Picture/24 description: The image shows the logo for QCore Medical. The logo consists of a stylized letter "Q" with a small circle attached to the upper right side, resembling a speech bubble. Below the symbol, the word "QCORE" is printed in a bold, sans-serif font, and underneath that, the word "medical" is printed in a smaller, lighter font.

29 Yad Haruzim • St. P.O.Box 8639 • Netanya 4250529, ISRAEL

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population, and the locations of use. The Sapphire is also substantially equivalent to the Spectrum Infusion Pump with Master Drug Library (K042121), the CADD-Prizm Model 6101 Ambulatory Infusion Pump (K000842) and the Bodyguard Infusion Pump System (K060479) with respect to the basic indications for use (i.e., infusion pump that administers controlled doses of medications and parenteral nutritional feedings), additional delivery modes, additional products (blood and blood products), administration sites, target populations and locations of use.

The Sapphire Infusion Pump incorporates the same operating principle (linear peristaltic infusion pump) as the AP 34 Infusion Pump, the Spectrum Infusion Pump, and the CADD Prizm Model 6101 Infusion Pump. The Pump has delivery modes (Continuous, Intermittent, Multi-step, PCA, TPN and Epidural) that are also provided by the predicate devices, and has alarms for occlusions, air in the line, administration set installment issues, and internal battery issues. The Q Core Administration Sets that are to be used with the Sapphire pump are substantially equivalent to those cleared under K082182.

In summary, the Sapphire Infusion Pump and its dedicated Administration Sets are substantially equivalent to its predicates with respect to indications for use, target populations, types of infusions, delivery modes, technological characteristics and safety features.

Image /page/3/Picture/4 description: The image shows the logo for QCORE medical. The logo consists of a stylized letter "Q" with a smaller circle inside the "Q", resembling a speech bubble. Below the symbol, the word "QCORE" is written in a bold, sans-serif font, and the word "medical" is written in a smaller font size directly below "QCORE".

29 Yad Haruzim • St. P.O.Box 8639 • Netanya 4250529, ISRAEL

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

October 17, 2013

O Core Medical LTD C/O Rhona Shanker Regulatory Consultant 12154 Darnestown Road, #236 GAITHERSBURG, MD 20878

Re: K123049

Trade/Device Name: Sapphire Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 15, 2013 Received: October 15, 2013

Dear Ms. 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.

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 device-related 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/5/Picture/6 description: The image shows the text "Mary St.Runner -S" in a stylized font. The words "St.Runner" are contained within a decorative border. The text is black against a white background.

Kwame Ulmer M.S. Acting Division 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): K123049

Device Name: Sapphire Infusion Pump System

Indications for Use:

The Q Core Sapphire infusion pump is intended for the 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 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 ground transportation.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Richard C. Chapman 2013.10.17 12:32:36 -04'00'