(288 days)
No
The summary describes a standard infusion set with mechanical components and does not mention any AI/ML capabilities or related performance metrics.
No
This device is for fluid delivery, not for treating a disease or condition.
No
The device is indicated for the delivery of fluids from a container to a patient's vascular system, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly lists multiple hardware components (male luer adapter, female luer, piercing pin connector, sapphire cassette, tubing, flow control device, etc.) and describes it as a disposable device for single patient use, 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 is "for the delivery of fluids from a container to a patient's vascular system." This describes a device used for administering substances directly into the body, not for testing samples taken from the body.
- Device Description: The components listed (tubing, luer adapters, cassette, etc.) are all consistent with an infusion set used for delivering fluids, not for performing diagnostic tests on biological samples.
- No mention of testing biological samples: There is no indication that this device is used to analyze blood, urine, tissue, or any other biological sample for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of fluids.
N/A
Intended Use / Indications for Use
Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
MRZ
Device Description
Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira 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, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira 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
patient's vascular system
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)
All materials of construction for Hospira Sapphire Sets remain the same as the predicate product. Additional data has been generated demonstrating that Hospira Sapphire sets, which are comprised of a combination of Hospira IV set components with the Sapphire Cassette, meet the applicable material test requirements for ISO 10993 as follows:
ISO Standard Biological Effect
10993-4 Hemocompatibility
10993-5 Cytotoxicity
10993-10 Sensitization
10993-11 Intracutaneous Irritation
Systemic Toxicity
Subacute Toxicity
Pyrogenicity
New performance data has been generated to ensure the Hospira Sapphire Sets, a combination of Hospira IV set components with the Sapphire Cassette, perform as intended in accordance with:
ISO 8536-4, 6.1 Particulate Contamination
ISO 8536-4, 6.2 Leakage
ISO 8536-4, 6.3 Tensile Strength
ISO 1135-4, 5.3 Tensile Strength
Additionally, flow rate accuracy testing using the proposed Hospira 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.
Q Core Medical Sapphire Sets - K123049
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.
Hospira Plum Sets - K141789, Life Care PCA Infusion System - K043256
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Hospira, Inc. David Blonski Director Regulatory Affairs 375 North Field Drive Lake Forest, Illinois 60045
Re: K160492
Trade/Device Name: Hospira Sapphire Sets Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MRZ Dated: December 1, 2016 Received: December 2, 2016
Dear David Blonski:
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.
1
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 (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 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.
Sincerely yours,
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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
2
Indications for Use
510(k) Number (if known) K160492
Device Name Hospira Sapphire Set
Indications for Use (Describe)
Hospira Sapphire sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized representation of a plant or a medical symbol. The logo is presented in grayscale.
Section 5 510(k) Summary: K160492
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Hospira Sapphire Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3 |
| 375 North Field Drive | |
| Lake Forest, IL. 60046 | |
| Phone number | 24-212-5010 |
| Mobile number | 224-515-6807 |
| Fax number | (224) 212-5401 |
| Establishment Registration | |
| Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | 2/19/2016 |
| Name of device | |
| Trade or proprietary name | Hospira Sapphire Sets |
| Common or usual name | Infusion pump accessory |
| Classification name | Infusion Pump, 21 CFR 880.5725, Class II |
| Product Code(s) | MRZ |
| Legally marketed device(s) to which | |
| equivalence is claimed | Q Core Medical Sapphire Sets - K123049 (Predicate 510(k)) |
| Hospira Plum Sets - K141789 (reference 510(k) for technological characteristics) | |
| Life Care PCA Infusion System - K043256 (reference 510(k) for technological characteristics) | |
| Reason for 510(k) submission | New IV administration sets to be used with Q Core Medical Ltd.'s Sapphire Infusion System. |
| Device description | Hospira Sapphire Sets are intended for use with the Sapphire Infusion System. Hospira |
| 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, in-line adapter, injection site assembly, check valve, and burette chamber. Hospira | |
| 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 | Hospira Sapphire sets are intended for use with the Sapphire Infusion System to deliver fluids |
| from a container to a patient's vascular system. Hospira Sapphire Sets are indicated for the | |
| delivery of fluids from a container to a patient's vascular system. | |
| Indication for use | Hospira Sapphire Sets are indicated for the delivery of fluids from a container to a patient's |
| vascular system. |
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Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines converging at the top, resembling a stylized plant or a modern architectural element. The logo is presented in grayscale.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Predicate | 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, 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. | Hospira Sapphire Sets are indicated for the | |
| delivery of fluids from a container to a | ||
| patient's vascular system. | ||
| Discussion of change in | ||
| indication for use | The differences between the predicate and proposed indications for use stated above are not | |
| critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the proposed | ||
| device. The predicate indication for use stated above is primarily related to use of the | ||
| Sapphire Infusion pump with an inclusionary statement that the Q Core administration sets | ||
| for the Sapphire pump are intended for single-patient use and single-use only. The Hospira | ||
| Sapphire sets are intended for use with the Sapphire pump and as such are a component of | ||
| the predicate device system. The proposed sets are also intended for single patient use and | ||
| single-use only. The proposed Hospira Sapphire sets have the same intended use, and as | ||
| indicated below are tested to the same performance standards as the predicate sets and | ||
| therefore do not affect the safety and effectiveness predicate device system. | ||
| Design and Materials of | ||
| Construction | The design and materials of construction of | |
| all components for the set, with the | ||
| exception of the Sapphire Cassette, are as | ||
| cleared under the 510(k)s K141789 and | ||
| K043256 which are reference 510(k)s for | ||
| technological characteristics. | ||
| The design and materials of construction of | ||
| the Sapphire Cassette are as cleared under | ||
| the predicate Q Core Medical Ltd. 510(k) | ||
| K123049. | The design and materials of construction for | |
| all components of the sets remain the same | ||
| as the predicate product. | ||
| Summary of non-clinical tests | ||
| for determination of substantial | ||
| equivalence | All materials of construction for Hospira | |
| Sapphire Sets meet the applicable material | ||
| test requirements for ISO 10993 as | ||
| demonstrated in the predicate 510(k)s. | All materials of construction for Hospira | |
| Sapphire Sets remain the same as the | ||
| predicate product. Additional data has been | ||
| generated demonstrating that Hospira | ||
| Sapphire sets, which are comprised of a | ||
| combination of Hospira IV set components | ||
| with the Sapphire Cassette, meet the | ||
| applicable material test requirements for | ||
| ISO 10993 as follows: | ||
| ISO Standard Biological Effect | ||
| 10993-4 Hemocompatibility | ||
| 10993-5 Cytotoxicity | ||
| 10993-10 Sensitization | ||
| 10993-11 Intracutaneous Irritation | ||
| Systemic Toxicity | ||
| Subacute Toxicity | ||
| Pyrogenicity | ||
| Performance testing for all Hospira Sapphire | ||
| set components, with the exception of the | ||
| Sapphire Cassette, was conducted as | ||
| indicated in the predicate 510(k)s to ensure | ||
| the device performs as intended in | ||
| accordance with applicable standards. All | ||
| testing is acceptable. |
Performance testing for the Q Core Medical
Ltd. Sapphire Cassette , was conducted as
indicated in the predicate 510(k) to ensure
the cassette performs with the Sapphire
Pump as intended in accordance with
applicable standards.
All testing is acceptable. | New performance data has been generated
to ensure the Hospira Sapphire Sets, a
combination of Hospira IV set components
with the Sapphire Cassette, perform as
intended in accordance with:
ISO 8536-4, 6.1 Particulate Contamination
ISO 8536-4, 6.2 Leakage
ISO 8536-4, 6.3 Tensile Strength
ISO 1135-4, 5.3 Tensile Strength
Additionally, flow rate accuracy testing
using the proposed Hospira Sapphire Sets
and the Sapphire Infusion System has been
conducted.
All testing is acceptable.
The product Sterility Assurance Level |
| | The product Sterility Assurance Level is 10-6 | is 10-6 |
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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic consisting of three curved lines that converge at the bottom and spread out at the top, resembling stylized blades of grass or a stylized flower. The logo is presented in grayscale.
Conclusion
Hospira Sapphire Sets meet the functional claims and intended use as described in the product labeling. Hospira Sapphire Sets are substantially equivalent to the predicate device.