(109 days)
No
The summary describes disposable infusion sets and their performance characteristics, with no mention of AI or ML.
No.
The device is used for delivering fluids, including blood and blood products, to a patient's vascular system or epidural space; it does not treat a disease or condition directly.
No
This device is for the delivery of fluids, including blood and blood products, to a patient's vascular system or epidural space. It is an infusion set, not a diagnostic device.
No
The device description explicitly lists various hardware components such as luer adapters, piercing pin connectors, cassettes, tubing, and valves, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the delivery of fluids (including blood and blood products) to a patient's vascular system or epidural space. This is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details components for fluid delivery and control, not for analyzing biological samples to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting analytes, or providing information for diagnosis.
- Performance Studies: The performance studies focus on material compatibility, leakage, tensile strength, coring, and flow rate accuracy – all related to the safe and effective delivery of fluids. There are no studies related to diagnostic accuracy or performance.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to deliver substances into the body, not to analyze substances from the body for diagnostic purposes.
N/A
Intended Use / Indications for Use
Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular.
Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Sapphire Epidural Set are indicated for the delivery of fluids to a patient's epidural space.
Product codes (comma separated list FDA assigned to the subject device)
MRZ
Device Description
Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets are comprised of various components including the following: male luer adapter with cap, female luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in-line adapter, injection site assembly, check valve, pressure activated valve and blood chamber. Sapphire sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, epidural space
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of non-clinical tests for determination of substantial equivalence:
All materials of construction for Q Core Sapphire Sets meet the applicable material test requirements for ISO 10993 as demonstrated in the predicate 510(k). All materials of construction for Sapphire Sets remain the same as the predicate product. Additional data has been generated demonstrating that Sapphire sets meet the applicable material test requirements for ISO 10993 as follows:
ISO Standard Biological Effect
10993-4 Hemocompatibility
10993-5 Cytotoxicity
10993-10 Sensitization
Intracutaneous Irritation
10993-11 Systemic Toxicity
Subacute Toxicity
Pyrogenicity
Performance testing for all Q Core Sapphire set components was conducted as indicated in the predicate 510(k) to ensure the device performs as intended in accordance with applicable standards. New performance data has been generated to ensure the Sapphire Sets perform as intended in accordance with:
ISO 8536-4. 6.1 Particulate Contamination
ISO 8536-4. 6.2/ Leakage
ISO 8536-8.6.3
ISO 8536-4.6.3 Tensile Strength
ISO 8536-4.6.4 Coring
ISO 8536-4.6.9 Flow Regulator
ISO 1135-4.5.8 Flow Regulator
Additionally, flow rate accuracy testing using the proposed Sapphire Sets and the Sapphire Infusion System has been conducted.
All testing is acceptable.
The product Sterility Assurance Level is 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of three human profiles facing right, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 25, 2017
ICU Medical Amy Giertych Vice President. Global Regulatory Affairs 600 North Field Drive Lake Forest, Illinois 60045
Re: K171346
Trade/Device Name: Sapphire Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: MRZ Dated: July 27, 2017 Received: July 27, 2017
Dear Amy Giertych:
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
1
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.
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 (DICE) at its toll-free 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" (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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv.
Tara A. Ryan -S
for Lori 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
Indications for Use
510(k) Number (if known)
Device Name Sapphire Set
Indications for Use (Describe)
Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's vascular.
Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Sapphire Epidural Set are indicated for the delivery of fluids to a patient's epidural space.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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 PRAStaff@fda.hhs.gov
"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."
3
510(k) Summary
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Sapphire Sets.
| Submitter Information | |
|---|---|
| Name | ICU Medical |
| Address | 600 North Field Drive |
| Lake Forest, IL. 60046 | |
| Phone number | (224)-212-4235 |
| Mobile number | (224)-507-8812 |
| Fax number | (224) 212-5221 |
| Establishment Registration | |
| Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Amy Giertych, Vice President Global Regulatory Affairs |
| Date prepared | 8/23/2017 |
| Name of device | |
| Trade or proprietary name | Sapphire Sets |
| Common or usual name | Accessories, Pump, Infusion |
| Classification name | Infusion Pump, 21 CFR 880.5725, Class II |
| Product Code(s) | Primary Code: MRZ |
| Legally marketed device(s) to which | |
| equivalence is claimed | Sapphire Infusion System - K123049 (Primary Predicate 510(k)) |
| Sapphire Sets - K160492 (Reference 510(k)) | |
| Plum Sets - K141789 (Reference 510(k)) | |
| Reason for 510(k) submission | New IV administration sets to be used with Q Core Medical Ltd.'s Sapphire Infusion System. |
| Device description | Sapphire Sets are intended for use with the Sapphire Infusion System. Sapphire sets are |
| comprised of various components including the following: male luer adapter with cap, female | |
| luer with cap, piercing pin connector, sapphire cassette, tubing, flow control device, filter, in- | |
| line adapter, injection site assembly, check valve, pressure activated valve and blood chamber. | |
| Sapphire sets are configured to ensure the intended use of the device is met. The sets are | |
| disposable devices for single patient use. | |
| Intended Use of Device | Sapphire sets are intended for use with the Sapphire Infusion System to deliver fluids from a |
| container to a patient's vascular system. | |
| Indication for use | Sapphire Primary Sets are indicated for the delivery of fluids from a container to a patient's |
| vascular system. | |
| Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood | |
| and blood products to a patient's vascular system. | |
| Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's | |
| epidural space. |
4
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Predicate 510(k) | Proposed Device |
| 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. The Sapphire 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 pump are intended for single-patient use and single-use only. | Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system. | |
| Sapphire Blood Sets are indicated for the delivery of fluids including but not limited to blood and blood products to a patient's vascular system. | ||
| Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. | ||
| Characteristic | Predicate/Reference 510(k) | Proposed Device |
| Design and Materials of Construction | The design and materials of construction of all components for the sets, are as cleared under predicate/reference 510(k) noted below for each set component. | The design and materials of construction for all set components listed below have been previously cleared under the associated predicate/reference 510(k) |
| Piercing Pin | Piercing Pin | |
| new | 75-0704 | |
| K160492 (reference 510(k)) | 85-0143 | |
| K160492 (reference 510(k)) | 85-0142 | |
| K160492 (reference 510(k)) | 85-0288 | |
| K160492 (reference 510(k)) | 67-1760 | |
| K160492 (reference 510(k)) | 90-5710 | |
| Female Adapter | Female Adapter | |
| K160492 (reference 510(k)) | 90-9674 | |
| Male Adapter | Male Adapter | |
| K160492 (reference 510(k)) | 85-0250 | |
| Cap/Hood | Cap/Hood | |
| K160492 (reference 510(k)) | 75-0042 | |
| K160492 (reference 510(k)) | 75-0735 | |
| K160492 (reference 510(k)) | 75-2322 | |
| K160492 (reference 510(k)) | 90-9664 | |
| Characteristic | Predicate/Reference 510(k) | Proposed Device |
| K160492 (reference 510(k)) | 90-9665 | |
| Cassette | Cassette | |
| K160492 (reference 510(k)) | 85-0239 | |
| K160492 (reference 510(k)) | 67-2115 | |
| Tubing | Tubing | |
| K160492 (reference 510(k)) | 75-0322 | |
| K160492 (reference 510(k)) | 75-0324 | |
| K160492 (reference 510(k)) | 75-0364 | |
| K141789 (reference 510(k)) | 75-0941 | |
| K160492 (reference 510(k)) | 75-5236 | |
| Flow Control | Flow Control | |
| K141789 (reference 510(k)) | 67-1942 | |
| K160492 (reference 510(k)) | 75-1004 | |
| K160492 (reference 510(k)) | 75-1099 | |
| K160492 (reference 510(k)) | 96-4509 | |
| K141789 (reference 510(k)) | 96-4882 | |
| In-Line Adapter | In-Line Adapter | |
| K141789 (reference 510(k)) | 75-4967 | |
| K160492 (reference 510(k)) | 90-6979 | |
| Injection Site | Injection Site | |
| K160492 (reference 510(k)) | 67-2060 | |
| Check Valve | Check Valve | |
| K160492 (reference 510(k)) | 67-1042 | |
| K160492 (reference 510(k)) | 67-1589 | |
| Filter | Filter | |
| K141789 (reference 510(k)) | 67-1659 | |
| K141789 (reference 510(k)) | 67-1721 | |
| PAV | PAV | |
| K123049 (predicate 510(k) | 67-2098 | |
| Blood Chamber | Blood Chamber | |
| K141789 (reference 510(k)) | 85-0189 | |
| Bonding Agents | Bonding Agents | |
| K160492 (reference 510(k)) | 52-0010 | |
| K160492 (reference 510(k)) | 52-0013 | |
| K160492 (reference 510(k)) | 52-0166 |
5
6
| Summary of non-clinical tests
for determination of substantial
equivalence | All materials of construction for Q Core
Sapphire Sets meet the applicable material
test requirements for ISO 10993 as
demonstrated in the predicate 510(k). | All materials of construction for Sapphire Sets
remain the same as the predicate product.
Additional data has been generated
demonstrating that Sapphire sets meet the
applicable material test requirements for ISO
10993 as follows:
ISO Standard Biological Effect 10993-4 Hemocompatibility 10993-5 Cytotoxicity 10993-10 Sensitization
Intracutaneous Irritation 10993-11 Systemic Toxicity
Subacute Toxicity
Pyrogenicity | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| Performance testing for all Q Core
Sapphire set components was conducted as
indicated in the predicate 510(k) to ensure
the device performs as intended in
accordance with applicable standards. | | New performance data has been generated to
ensure the Sapphire Sets perform as intended
in accordance with:
ISO 8536-4. 6.1 Particulate Contamination ISO 8536-4. 6.2/ Leakage ISO 8536-8.6.3 ISO 8536-4.6.3 Tensile Strength ISO 8536-4.6.4 Coring ISO 8536-4.6.9 Flow Regulator ISO 1135-4.5.8 Flow Regulator Additionally, flow rate accuracy testing using
the proposed Sapphire Sets and the Sapphire
Infusion System has been conducted. | | | | | | | | | | | | | | |
| All testing is acceptable. | | All testing is acceptable. | | | | | | | | | | | | | | |
| The product Sterility Assurance Level is
10-6. | | The product Sterility Assurance Level
is 10-6 | | | | | | | | | | | | | | |
Conclusion
Sapphire Sets meet the functional claims and intended use as described in the product labeling. Sapphire Sets are substantially equivalent to the predicate device.