(128 days)
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.
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.
The Hospira Blood Sets are being compared to a predicate device, the Hospira Infusion Blood Sets (K101677), due to a modification to the Secure Lock Male Luer and a change in the male luer adapter material. The study aims to demonstrate substantial equivalence to the predicate device.
The document provides information on non-clinical and performance testing to ensure the modified device meets the required standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate) | Reported Device Performance (Hospira Blood Sets) |
|---|---|
| Materials of Construction meet ISO 10993 applicable requirements | New data generated showing all materials (including alternate acrylic male luer adapter) meet ISO 10993 applicable requirements. |
| Material Biocompatibility: | Material Biocompatibility: |
| Cytotoxicity (ISO 10993-5) | Meets Cytotoxicity (ISO 10993-5) |
| Sensitization (ISO 10993-10) | Meets Sensitization (ISO 10993-10) |
| Intracutaneous Reactivity (ISO 10993-10) | Meets Intracutaneous Reactivity (ISO 10993-10) |
| Systemic Toxicity (ISO 10993-11) | Meets Systemic Toxicity (ISO 10993-11) |
| Subacute Toxicity (ISO 10993-11) | Meets Subacute Toxicity (ISO 10993-11) |
| Subchronic Toxicity (ISO 10993-11) | Meets Subchronic Toxicity (ISO 10993-11) |
| Pyrogenicity (ISO 10993-11) | Meets Pyrogenicity (ISO 10993-11) |
| Hemocompatibility (ISO 10993-4) | Meets Hemocompatibility (ISO 10993-4) |
| Device Performance (per ISO 1135-4, ISO 594-1, ISO 594-2): | Device Performance (per ISO 1135-4, ISO 594-1, ISO 594-2): |
| Product Sterility Assurance Level 10-6 | Product Sterility Assurance Level 10-6 |
| Particulate Contamination (ISO 1135-4:2012) | Meets Particulate Contamination |
| Leakage (ISO 1135-4:2012) | Meets Leakage |
| Tensile Strength (ISO 1135-4:2012) | Meets Tensile Strength |
| Closure-piercing pin (ISO 1135-4:2012) | Meets Closure-piercing pin requirements |
| Tubing (ISO 1135-4:2012) | Meets Tubing requirements |
| Blood Filter (ISO 1135-4:2012) | Meets Blood Filter requirements |
| Drip chamber and drip tube (ISO 1135-4:2012) | Meets Drip chamber and drip tube requirements |
| Flow Regulator (ISO 1135-4:2012) | Meets Flow Regulator requirements |
| Flow Rate (ISO 1135-4:2012) | Meets Flow Rate requirements |
| Injection Site (ISO 1135-4:2012) | Meets Injection Site requirements |
| Male Conical Fitting (ISO 1135-4:2012) | Meets Male Conical Fitting requirements |
| Protective Caps (ISO 1135-4:2012) | Meets Protective Caps requirements |
| Gauging (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Gauging requirements |
| Liquid Leakage (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Liquid Leakage requirements |
| Air Leakage (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Air Leakage requirements |
| Separation Force (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Separation Force requirements |
| Stress Cracking (ISO 594 Part 1:1986 and ISO 594 Part 2:1998) | Meets Stress Cracking requirements |
| Unscrewing Torque (ISO 594 Part 2:1998) | Meets Unscrewing Torque requirements |
| Ease of Assembly (ISO 594 Part 2:1998) | Meets Ease of Assembly requirements |
| Resistance to Overriding (ISO 594 Part 2:1998) | Meets Resistance to Overriding requirements |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each test in the non-clinical and performance evaluations. It states that "New data has been generated" for these tests. The provenance of the data (country of origin, retrospective/prospective) is not mentioned.
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 is a medical device for fluid delivery, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, this information is not applicable and not provided in the document. The "ground truth" for this device is based on objective measurements and adherence to international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to the type of device and testing described. Adjudication methods are typically used in studies involving subjective interpretation (e.g., by experts in medical imaging). The tests mentioned here are objective chemical, physical, and functional performance tests.
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
No, an MRMC comparative effectiveness study was not done. This is a traditional medical device (blood sets) and not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm or AI device. The performance is of the physical device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for the Hospira Blood Sets is defined by the objective pass/fail criteria established by recognized international standards (ISO 10993 for biocompatibility and ISO 1135-4, ISO 594-1, ISO 594-2 for performance). The results of these tests, demonstrating compliance with these standards, constitute the "ground truth" for the device's acceptable performance.
8. The sample size for the training set
This is not an AI or machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
Not applicable, as it is not an AI/ML device.
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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.
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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 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
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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)
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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:
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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. H3375 North Field DriveLake Forest, IL. 60046 |
| Phone number | (224) 212-6087 |
| Fax number | (224) 212-5401 |
| Establishment RegistrationNumber | 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) towhich 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, buretteassembly / blood pump assembly / or blood cylinder assembly, and injection siteassembly. 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 apatient'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 toblood 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:1. 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. | ||||||||||||||
| ComponentMale 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. |
|---|---|---|
| CytotoxicityISO 10993-5 | CytotoxicityISO 10993-5 | |
| SensitizationISO 10993-10 | SensitizationISO 10993-10 | |
| Intracutaneous ReactivityISO 10993-10 | Intracutaneous ReactivityISO 10993-10 | |
| Systemic ToxicityISO 10993-11 | Systemic ToxicityISO 10993-11 | |
| Subacute ToxicityISO 10993-11 | Subacute ToxicityISO 10993-11 | |
| Subchronic ToxicityISO 10993-11 | Subchronic ToxicityISO 10993-11 | |
| PyrogenicityISO 10993-11 | PyrogenicityISO 10993-11 | |
| HemocompatibilityISO 10993-4 | HemocompatibilityISO 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 toensure the device performs as intendedin accordance with applicablestandards. All testing is acceptable. | New performance data has been generatedto ensure the device performs as intended inaccordance with ISO 594-1, ISO 594-2, ISO1135-4. All testing is acceptable. |
|---|---|---|
| The product Sterility Assurance Levelis 10-6. | The product Sterility Assurance Levelis 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.
§ 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.