(63 days)
Hospira Administration Sets are intended for the delivery of fluids from a container to a patient's vascular system. Hospira Administration sets are configured to ensure the intended use of the device is met. The sets are disposable devices for single patient use. Hospira Administration sets are intended for the delivery of fluids, including blood and blood products where indicated, from a container to a patient's vascular system.
The subject of this Special 510(k): Device Modification is the addition of an alternate luer activated needleless valve to existing Hospira Administration sets cleared under the identified predicate 510(k)s. Hospira Administration Sets are comprised of components in various combinations of the following: male luer adapter with cap, female luer with cap, piercing pin connector, tubing, flow control device, filter, in-line adapter, injection site assembly, luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, and blood chamber.
This document describes the 510(k) premarket notification for Hospira Administration Sets, specifically addressing the addition of an alternate luer-activated needleless valve, the Nuitiv™ Connector, to existing administration sets. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from recognized international standards for medical devices, particularly those for intravascular administration sets and luer connectors. The reported performance demonstrates compliance with these standards.
| Characteristic / Test | Acceptance Criteria (Implicitly from Standards) | Reported Device Performance (Nuitiv™ Connector) |
|---|---|---|
| Biocompatibility | Meets applicable material test requirements for ISO 10993 | Meets applicable material test requirements for ISO 10993, specifically: - ISO 10993-4 Hemocompatibility - ISO 10993-5 Cytotoxicity - ISO 10993-10 Sensitization - ISO 10993-11 Intracutaneous Irritation - Systemic Toxicity - Subacute Toxicity - Subchronic Toxicity - Pyrogenicity |
| Luer Connector Performance | Complies with ISO 594-1 and ISO 594-2 for conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment. | Complies with ISO 594-1 and ISO 594-2, specifically: - Section 4.1.1 Gauging (luer dimensions) - Section 4.2.1 Liquid Leakage - Section 4.2.2 Air Leakage - Section 4.3 Separation Force - Section 4.4 Unscrewing Torque - Section 4.5 Ease of Assembly - Section 4.6 Resistance to Overriding - Section 4.7 Stress Cracking |
| Administration Set Performance (general) | Complies with ISO 8536-4 and ISO 1135-4 for infusion equipment. | Complies with ISO 8536-4 and ISO 1135-4, specifically: - Section 6.1 Particulate Matter - Section 6.2 Air Leakage (for ISO 8536-4) - Section 6.3 Tensile Strength (for ISO 8536-4) - Section 5.1 Particulate Matter (for ISO 1135-4) - Section 5.2 Air Leakage (for ISO 1135-4) - Section 5.3 Tensile Strength (for ISO 1135-4) |
| Administration Set Performance (with pressure infusion equipment) | Complies with ISO 8536-8 for infusion equipment for use with pressure infusion equipment. | Complies with ISO 8536-8, specifically: - Section A.3.2 Air Leakage - Section A.3.3 Air Leakage - Section A.3.4 Liquid Leakage |
| Sterility Assurance Level (SAL) | 10^-6 | 10^-6 |
| Functional Claims & Intended Use | Meets functional claims and intended use as described in product labeling. | Meets functional claims and intended use as described in the product labeling. |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes (number of units tested) for each individual non-clinical performance bench test. It uses the phrase "All testing is acceptable," implying that sufficient units were tested to demonstrate compliance with the specified standards.
The data provenance is from non-clinical bench testing conducted to evaluate the performance and material characteristics of the Nuitiv™ Connector and the administration sets incorporating it. This is prospective testing specifically performed for this 510(k) submission. The country of origin of the data is not explicitly stated, but it is implied to be internal testing by Hospira, Inc., a U.S.-based company.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of submission (device modification for administration sets) does not involve expert-established ground truth in the way a diagnostic AI product would. The "ground truth" for these tests are the established international standards (ISO standards) themselves and the objective, measurable criteria they define. No human experts are used to establish "ground truth" for these mechanical and material tests; the tests evaluate direct physical properties and biological responses against predefined limits.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human interpretation or subjective assessment that would require an adjudication method like 2+1 or 3+1. The tests yield objective, quantitative results (e.g., force measurements, leak rates, chemical analyses) that are compared against predefined pass/fail criteria from the standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is typically relevant for medical imaging AI devices where human readers interpret medical images with and without AI assistance. This submission is for a physical medical device (administration sets) and a component change, not an AI or diagnostic imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, the "standalone" performance was evaluated. The performance bench tests described for the Nuitiv™ Connector are a standalone assessment of its properties and function without human interaction beyond its intended use. However, this is not an "algorithm-only" standalone performance as typically discussed in AI/software medical device contexts. It is a standalone evaluation of the physical device component.
7. The Type of Ground Truth Used
The ground truth used for this study is based on:
- Established International Standards: Specifically, various ISO standards for medical devices, infusion equipment, and luer connectors (e.g., ISO 10993, ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-8, ISO 1135-4).
- Objective Engineering and Material Science Principles: The tests evaluate measurable physical properties and material characteristics against predefined limits identified in these standards.
It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for diagnostic or therapeutic efficacy studies.
8. The Sample Size for the Training Set
Not applicable. This is a submission for a physical medical device. There is no concept of a "training set" or "machine learning model" involved. The testing focuses on the performance of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device submission of this type.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2016
Hospira, Inc. Mr. David Blonski Director Regulatory Affairs 375 Field Drive D-393, Building H3 Lake Forest, Illinois 60045
Re: K160870
Trade/Device Name: Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Burette Sets, and Hospira Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 2, 2016 Received: May 3, 2016
Dear Mr. 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.
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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 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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang-S
for 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
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Indications for Use
510(k) Number (if known) K160870
Device Name
Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, Hospira Blood Sets
Indications for Use (Describe)
Hospira Primary sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Hospira Burette sets are indicated for the delivery of fluids 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 patients vascular system.
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 consists of the word "Hospira" in a sans-serif font, with a stylized graphic above it. The graphic features three curved lines that resemble an abstract representation of a medical symbol or a stylized wave pattern. The logo is presented in grayscale.
510(k) Summary-K160870
A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for Hospira Administration Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60045 |
| Phone number | 24-212-5010 |
| Mobile number | 224-515-6807 |
| Fax number | (224) 212-5401 |
| Establishment RegistrationNumber | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | May 24, 2016 |
| Name of device | |
| Trade or proprietary name | Hospira Administration Sets: Hospira Primary Sets, Hospira Extension Sets, HospiraBurette Sets, Hospira 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) towhich equivalence is claimed | Hospira Primary Sets - K142367Hospira Primary Sets - K143015Hospira Extension Sets - K142433Hospira Extension Sets - K142974Hospira Burette Sets - K142622Hospira Blood Sets - K143087 |
| Reason for 510(k) submission | Device modification adding an alternate luer activated needleless valve. |
| Device description | The subject of this Special 510(k): Device Modification is the addition of an alternateluer activated needleless valve to existing Hospira Administration sets cleared underthe identified predicate 510(k)s.Hospira Administration Sets are comprised of components in various combinations ofthe following: male luer adapter with cap, female luer with cap, piercing pinconnector, tubing, flow control device, filter, in-line adapter, injection site assembly,luer activated needleless valve Nuitiv™ Connector, check valve, burette chamber, andblood chamber. |
| Intended Use of Device | Hospira Administration Sets are intended for the delivery of fluids from a container toa patient's vascular system. Hospira Administration sets are configured to ensure theintended use of the device is met. The sets are disposable devices for single patientuse.Hospira Administration sets are intended for the delivery of fluids, including bloodand blood products where indicated, 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 simple, sans-serif font, with the "H" capitalized and the rest of the letters in lowercase. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized arch or a representation of connectivity.
| Summary of the technological characteristics of the device compared to the predicate device | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | Predicates | Proposed Device | |||||
| K142367 | K143015 | K142433 | K142974 | K142622 | K143087 | K160870 | |
| Indications for Use | Indications for Use:Hospira Primary sets areindicated for the deliveryof fluids from a containerto a patient's vascularsystem. | Indications for Use:HospiraPrimarysets areindicatedfor thedeliveryof fluidsfrom acontainerto apatient'svascularsystem. | Indications for Use:HospiraExtensionsets areindicatedfor thedeliveryof fluidsfrom acontainerto apatient'svascularsystem. | Indications for Use:HospiraExtensionsets areindicatedfor thedeliveryof fluidsfrom acontainerto apatient'svascularsystem. | Indications for Use:HospiraBurettesets areindicatedfor thedeliveryof fluidsfrom acontainerto apatient'svascularsystem. | Indications for Use:HospiraBlood setsareindicatedfor thedeliveryof fluidsincludingbut notlimited toblood andbloodproductsfrom acontainerto apatient'svascularsystem. | Indications for Use: Hospira Primary sets areindicated for the delivery of fluids from acontainer to a patient's vascular system.Indications for Use: Hospira Extension sets areindicated for the delivery of fluids from acontainer to a patient's vascular system.Indications for Use: Hospira Burette sets areindicated for the delivery of fluids from acontainer to a patient's vascular system.Indications for Use: Hospira Blood sets areindicated for the delivery of fluids including butnot limited to blood and blood products from acontainer to a patient's vascular system. |
| Design andMaterials ofConstruction | The predicate component,the CLAVETM Connectoris a luer activatedneedleless valve clearedunder predicate 510(k)K142367The CLAVETMConnector consists of thefollowing materials:Body: PBT - GE Valox215 or Valox315Spike: MABS - Terlux2812TR orPolycarbonate –Bayer MakrolonRX 2530-451118Plug: Silicone –Wacker ElastosilLR 3003/70Lubricant: Silicone,Dow, FS- | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | The proposed alternate component, the NuitivTMConnector is a luer activated needleless valve.The NuitivTM Connector consists of thefollowing materals:Body: Polycarbonate, MakrolonRX1805Tritan MX731 copolyesterSpike:Plug: Silicone - Wacker ElastosilLR3066/55 (gland)Lubricant: Silicone - Med400, nusil |
| Summary of the technological characteristics of the device compared to the predicate device | |||||||
| Characteristic | K142367 | K143015 | K142433 | K142974 | K142622 | K143087 | Proposed DeviceK160870 |
| Summary of non-clinical tests for determination of substantial equivalence | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:All materials of construction for the predicate component CLAVETM Connector meet the applicable material test requirements for ISO 10993 as demonstrated in the predicate 510(k). | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | Based on the design control activities, risk assessment and verification/validation testing for the subject device modifications the following performance bench tests were performed on the subject devices:All materials of construction for the proposed component NuitivTM Connector meet the applicable material test requirements for ISO 10993 as follows:ISO Standard Biological Effect10993-4 Hemocompatibility10993-5 Cytotoxicity10993-10 Sensitization10993-11 Intracutaneous IrritationSystemic ToxicitySubacute ToxicitySubchronic ToxicityPyrogenicity |
| Summary of Performance Testing | Performance testing for predicate component CLAVETM Connector was conducted as indicated in the predicate 510(k) to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.The product Sterility Assurance Level is for Hospira Administration sets is 10-6. | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | Same asK142367 | Performance data has been generated for the proposed NuitivTM Connector in accordance with:ISO 594-1 Section 4.1.1 GaugingISO 594-2 Section 4.2.1 Liquid LeakageSection 4.2.2 Air LeakageSection 4.3 Separation ForceSection 4.4 Unscrewing TorqueSection 4.5 Ease of AssemblySection 4.6 Resistance to OverridingSection 4.7 Stress CrackingISO 8536-4 Section 6.1 Particulate MatterSection 6.2 Air LeakageSection 6.3 Tensile StrengthISO 8536-8 Section A.3.2 Air LeakageSection A.3.3 Air LeakageSection A.3.4 Liquid LeakageISO 1135-4 Section 5.1 Particulate MatterSection 5.2 Air LeakageSection 5.3 Tensile StrengthAll testing is acceptable.The product Sterility Assurance Level is 10-6. |
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Image /page/5/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 appears to be three curved lines that converge at the top, creating an abstract shape. The logo is presented in grayscale.
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Image /page/6/Picture/1 description: The image shows the Hospira logo. The logo consists of the word "Hospira" in a gray, sans-serif font. Above the word is an abstract graphic of three curved lines that converge at the bottom and spread out at the top, resembling an arch or a stylized representation of movement. The lines are also gray, matching the color of the text.
Conclusion
The proposed alternate component Nuitiv™ Connector in the subject devices meets the functional claims and intended use as described in the product labeling. The proposed component Nuitiv™ Connector in the subject devices is substantially equivalent to the predicate device component CLAVE™ Connector.
§ 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.