(128 days)
Not A Reference
No
The device description and performance studies focus on the physical components and fluid delivery function, with no mention of AI or ML.
No
The device is described as being for "delivery of fluids including but not limited to blood products from a container to a patient's vascular system," which is a delivery mechanism, not a therapeutic treatment itself.
No
This device is described as a blood set for delivering fluids and blood products to a patient's vascular system, not for diagnosing a medical condition.
No
The device description explicitly lists multiple physical components (male luer adapter, tubing, flow control device, etc.), indicating it is a hardware 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 clearly stated as "delivery of fluids including but not limited to blood products from a container to a patient's vascular system." This describes a device used for administering substances directly to a patient, which is a therapeutic or supportive function, not a diagnostic one.
- Device Description: The description details components like tubing, flow control devices, and piercing pins, all consistent with a device for fluid delivery into the body. There is no mention of components or functions related to analyzing samples in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting analytes, or providing information for diagnosis, monitoring, or screening.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Hospira Blood Sets with Secure Lock are intended for use as gravity sets. Hospira Blood sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly / blood pump assembly / or blood cylinder assembly, and injection site assembly. Blood sets are configured to ensure the intended use of the device is met. Hospira Blood sets are intended for the delivery of fluids from a container to a patient's vascular system. 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)
Performance testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.
New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, ISO 1135-4. All testing is acceptable.
The product Sterility Assurance Level is 10-6.
ISO 1135-4:2012
Particulate Contamination
Leakage
Tensile Strength
Closure-piercing pin
Tubing
Blood Filter
Drip chamber and drip tube
Flow Regulator
Flow Rate
Injection Site
Male Conical Fitting
Protective Caps
ISO 594 Part 1: 1986
Gauging
Liquid Leakage
Air Leakage
Separation Force
Stress Cracking
ISO 594 Part 2: 1998
Gauging
Leakage (liquid)
Leakage (air)
Separation Force
Unscrewing Torque
Ease of Assembly
Resistance to Overriding
Stress Cracking
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.
Not Found
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2015
Hospira, Inc. Charles Neitzel Senior Regulatory Affairs Associate D-0393 Bldg. H3 375 North Field Street Lake Forest, IL 60045
Re: K143087
Trade/Device Name: Hospira Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 29, 2015 Received: January 30, 2015
Dear Charles Neitzel:
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 (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.
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/Resourcesfor You/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 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 vours.
Erin | Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K143087
Device Name
Hospira Blood Sets
Indications for Use (Describe)
Hospira Blood sets are indicated for the delivery of fluids including but not limited to blood products 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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."
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Image /page/4/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic features three curved lines that converge at a point, creating an abstract, modern design. The logo is presented in grayscale.
Section 5 510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92 for Hospira Blood Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3 |
| 375 North Field Drive | |
| Lake Forest, IL. 60046 | |
| Phone number | (224) 212-6087 |
| Fax number | (224) 212-5401 |
| Establishment Registration | |
| Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | Charles Neitzel, Senior Regulatory Affairs Specialist |
| Date prepared | 10/24/2014 |
| Name of device | |
| Trade or proprietary name | Blood Sets |
| Common or usual name | I.V Administration Sets |
| Classification name | Intravascular Administration Set, 21 CFR 880.5440, Class II |
| Product Code(s) | FPA |
| Legally marketed device(s) to | |
| which equivalence is claimed | Hospira Infusion Blood Sets – K101677 |
| Reason for 510(k) submission | The changes addressed in this submission include: |
| • Modification to Secure Lock Male Luer | |
| Device description | The Hospira Blood Sets with Secure Lock are intended for use as gravity sets. |
| Hospira Blood sets are comprised of various components including the following: | |
| male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette | |
| assembly / blood pump assembly / or blood cylinder assembly, and injection site | |
| assembly. Blood sets are configured to ensure the intended use of the device is met. | |
| Hospira Blood sets are intended for the delivery of fluids from a container to a | |
| patient's vascular system. The sets are disposable devices for single patient use. | |
| Intended Use of Device | Hospira 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. |
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Image /page/5/Picture/1 description: The image shows the Hospira logo. The logo features the company name in a simple, sans-serif font, with the letters in gray. Above the name is an abstract graphic consisting of three curved lines that converge at the top, creating a sense of movement or flow. The lines are also in gray, complementing the text.
| Summary of the technological characteristics of the device compared to the predicate device | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Characteristic | Predicate | Proposed Device | ||||||||||||||
| Indications for Use | LifeShield Infusion Sets are intended for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system. | Hospira 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. | ||||||||||||||
| Design and Materials of Contruction | The design and materials of construction are as cleared under the predicte 510(k) |
Hospira Blood Sets are comprised of the following minimum components: | The design and materials of construction remain the same as the predicate product with the following exceptions:
- The male luer adapter material is changing to an alternate acrylic material. Minor dimensional modifications are being made to the male luer adapter to enhance connection with female luers. | | | | | | | | | | | | | | |
| | Component
Male Luer Adapter Male / Luer Adapter Acrylic Spin Collar Polycarbonate Hood / Cap Polypropylene Tubing PVC, Non-Pthalatae Flow Control Device High Density Polyethylene or ABS Piercing Pin Assembly ABS / Polyetylene / Acrylic / Nylon | | | | | | | | | | | | | | | |
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Hospira Blood Sets
Traditional 510(k)
Section 5: 510(k) Summary
Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" slightly larger than the other letters. Above the word, there is a stylized graphic element that resembles three curved lines or arcs, arranged in a way that suggests movement or a stylized representation of a plant. The logo is presented in grayscale.
| Summary of non-clinical tests for determination of substantial equivalence | All materials of construction for Hospira Blood Sets meet the applicable material test requirements for ISO 10993. | New data has been generated demonstrating that all materials of construction for Hospira Blood Sets meet the applicable material test requirements for ISO 10993. |
|---|---|---|
| Cytotoxicity | ||
| ISO 10993-5 | Cytotoxicity | |
| ISO 10993-5 | ||
| Sensitization | ||
| ISO 10993-10 | Sensitization | |
| ISO 10993-10 | ||
| Intracutaneous Reactivity | ||
| ISO 10993-10 | Intracutaneous Reactivity | |
| ISO 10993-10 | ||
| Systemic Toxicity | ||
| ISO 10993-11 | Systemic Toxicity | |
| ISO 10993-11 | ||
| Subacute Toxicity | ||
| ISO 10993-11 | Subacute Toxicity | |
| ISO 10993-11 | ||
| Subchronic Toxicity | ||
| ISO 10993-11 | Subchronic Toxicity | |
| ISO 10993-11 | ||
| Pyrogenicity | ||
| ISO 10993-11 | Pyrogenicity | |
| ISO 10993-11 | ||
| Hemocompatibility | ||
| ISO 10993-4 | Hemocompatibility | |
| ISO 10993-4 |
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Image /page/7/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a simple, sans-serif font, with the "H" slightly larger than the other letters. Above the word, there is a stylized graphic of three curved lines that converge at the top, resembling an abstract arch or a stylized representation of a medical device. The logo is presented in grayscale.
| Summary of Performance Testing | Performance testing was conducted to
ensure the device performs as intended
in accordance with applicable
standards. All testing is acceptable. | New performance data has been generated
to ensure the device performs as intended in
accordance with ISO 594-1, ISO 594-2, ISO
1135-4. All testing is acceptable. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The product Sterility Assurance Level
is 10-6. | The product Sterility Assurance Level
is 10-6 |
| | ISO 1135-4:2012 | ISO 1135-4:2012 |
| | Particulate Contamination | Particulate Contamination |
| | Leakage | Leakage |
| | Tensile Strength | Tensile Strength |
| | Closure-piercing pin | Closure-piercing pin |
| | Tubing | Tubing |
| | Blood Filter | Blood Filter |
| | Drip chamber and drip tube | Drip chamber and drip tube |
| | Flow Regulator | Flow Regulator |
| | Flow Rate | Flow Rate |
| | Injection Site | Injection Site |
| | Male Conical Fitting | Male Conical Fitting |
| | Protective Caps | Protective Caps |
| | ISO 594 Part 1: 1986 | ISO 594 Part 1:1986 |
| | Gauging | Gauging |
| | Liquid Leakage | Liquid Leakage |
| | Air Leakage | Air Leakage |
| | Separation Force | Separation Force |
| | Stress Cracking | Stress Cracking |
| | ISO 594 Part 2: 1998 | ISO 594 Part 2: 1998 |
| | Gauging | Gauging |
| | Leakage (liquid) | Leakage (liquid) |
| | Leakage (air) | Leakage (air) |
| | Separation Force | Separation Force |
| | Unscrewing Torque | Unscrewing Torque |
| | Ease of Assembly | Ease of Assembly |
| | Resistance to Overriding | Resistance to Overriding |
| | Stress Cracking | Stress Cracking |
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Image /page/8/Picture/1 description: The image shows the Hospira logo. The logo features the company name "Hospira" in a simple, sans-serif font, with the "H" slightly larger than the other letters. Above the name is an abstract graphic element consisting of several curved lines that converge at the top, resembling a stylized, modern design.
Conclusion
Hospira Blood Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the Infusion Blood Sets cleared under K101677.