(384 days)
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.
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, 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.
This document, K123049, is a 510(k) summary for the Q Core Sapphire Infusion Pump System. It details the device description, indications for use, technological characteristics, and pre-clinical testing performed to establish substantial equivalence to predicate devices. The document does not contain acceptance criteria for specific performance metrics or detailed study results that "prove the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with defined sensitivity/specificity targets.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a series of pre-clinical tests and comparisons of technical characteristics.
Here’s a breakdown of the information based on your request, highlighting what is (and isn't) present in this 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported performance values in terms of specific sensitivity, specificity, accuracy, or similar quantitative metrics for a diagnostic claim. The "performance" is demonstrated through compliance with recognized standards and comparison to predicate devices, rather than a direct measurement against a predefined criterion table.
The preclinical testing section lists the types of tests performed and the standards they adhere to. These standards implicitly contain acceptance criteria that the device must meet, but the specific numerical results of these tests (e.g., how accurate the pump was in terms of percentage deviation) are not included in this summary.
| Acceptance Criteria Category (Implied by Standards) | Reported Device Performance (Summary Statement) |
|---|---|
| Electrical Safety (per IEC 60601-1) | Met (Testing performed) |
| EMC Testing (per IEC 60601-1-2) | Met (Testing performed) |
| Environmental Testing (per 60601-1-11) | Met (Testing performed) |
| Mechanical Testing (per IEC 68-2) | Met (Testing performed) |
| Alarm Testing (per IEC 60601-1-8) | Met (Testing performed) |
| Software Verification & Validation (FDA Guidance) | Met (Testing performed) |
| Pump Accuracy (per IEC 60601-2-24) | Met (Testing performed) |
| Human Factors Testing | Met (Testing performed) |
| Biocompatibility (per ISO 10993) | Met (Testing performed) |
| Infusion Equipment Testing (ISO 8536-4) | Met (Testing performed) |
| Transfusion Equipment Testing (ISO 1135-4) | Met (Testing performed) |
| Sterilization Validation (per ISO 11135-1) | Met (Testing performed) |
| Sterile Packaging Validation | Met (Testing performed) |
| Shelf Life | Met (Testing performed) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes the types of preclinical tests performed (e.g., electrical safety, pump accuracy), but does not detail sample sizes for these tests or the provenance of any data used. This is typical for submissions focused on mechanical/electronic device performance and compliance with a standard, rather than clinical efficacy studies.
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)
This information is not applicable and therefore not provided. This 510(k) summary is for an infusion pump, which is a hardware device for drug delivery, not a diagnostic device that requires expert adjudication for ground truth (e.g., medical imaging analysis). The performance evaluation relies on engineering tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. As explained above, this is not a diagnostic device involving expert consensus.
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
This information is not applicable and therefore not provided. An infusion pump does not involve human readers interpreting data, nor does it incorporate AI in a way that would lead to an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and therefore not provided. The device is a physical pump, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests mentioned (e.g., pump accuracy, electrical safety) would be established by the specifications and criteria outlined in the respective IEC and ISO standards. For example, for pump accuracy, the ground truth would be the expected flow rate vs. the measured flow rate within acceptable deviations defined by IEC 60601-2-24. This is a technical specification compliance model, not a clinical "ground truth" derived from patient data or expert consensus.
8. The sample size for the training set
This information is not applicable and therefore not provided. The Q Core Sapphire Infusion Pump is not an AI/ML-driven device that utilizes a training set in the conventional sense.
9. How the ground truth for the training set was established
This information is not applicable and therefore not provided, as there is no training set for this type of device.
{0}------------------------------------------------
Page 1 of 4
510(k) Summary
| Owner/Submitter | Q Core Medical Ltd.29 Yad Haruzim St.Netanya 4250529ISRAEL | OCT 17 2013 |
|---|---|---|
| Contact Person | Rhona ShankerFDA Regulatory Consultant to Q Core Medical LtdPh: 301251-9570Fax: 301-251-9571Rhonashanker07@verizon.net | |
| 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 880.5725Product Codes:FRN - Infusion pumpMEA - Patient controlled analgesia (PCA) infusion pumpMRZ - Infusion pump accessories (administration sets) | |
| Predicate DeviceInfusion Pump | 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) | |
| 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: +972.73.238888 • Fax: +972.73.2388800 • info@qcore.com • www.qcore.com
{1}------------------------------------------------
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: +972.73.238888 • Fax: +972.73.2388800 • info@qcore.com • www.qcore.com
{2}------------------------------------------------
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.
-
- 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
{3}------------------------------------------------
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
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized human figure embracing a globe, representing the department's mission to protect the health of all Americans. The logo is in black and white.
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.
{5}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
{6}------------------------------------------------
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)
Image /page/6/Picture/13 description: The image shows the logo for the Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a stylized font. The letters are bold and have a slightly distressed or textured appearance. Below the letters, there is some smaller text, but it is not legible in the image.
Richard C. Chapman 2013.10.17 12:32:36 -04'00'
§ 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).