(87 days)
Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
The Hospira Extension Sets with Secure Lock are intended for use as gravity sets. Hospira Extension sets are comprised of various components including the following: male luer adapter with cap, tubing, female luer adapter, flow control device, in-line adapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets are configured to ensure the intended use of the device is met. Hospira Externsion 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Hospira Extension Sets, formatted to answer your specific questions.
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical effectiveness study of a new AI-powered medical device. Therefore, many of your questions regarding AI-specific studies, such as effect size of human readers with AI, training set details, and specific expert qualifications for ground truth in AI, are not applicable to this document. This device is a physical medical device (intravascular administration set), not an AI/software device.
Acceptance Criteria and Device Performance for Hospira Extension Sets
This document describes a 510(k) submission for Hospira Extension Sets, a physical medical device. The "acceptance criteria" here refer to performance standards and substantial equivalence claims, not diagnostic performance of an AI model.
The study presented focuses on demonstrating that the revised Hospira Extension Sets (with modifications to the Secure Lock Male Luer) perform comparably to previously cleared predicate devices and meet relevant performance standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance |
|---|---|---|
| Functional Claims / Intended Use | "meet the functional claims and intended use as described in the product labeling" | The device "meets the functional claims and intended use as described in the product labeling." |
| Material Equivalence | Materials of construction for the proposed device are the same as predicate (with specified exceptions). | Male luer adapter material changing to an alternate acrylic material. |
| Design Equivalence | Design remains the same as predicate (with specified exceptions). | Minor dimensional modifications to the male luer adapter to enhance connection with female luers. |
| Performance Testing | Device performs as intended in accordance with applicable standards. | New performance data generated to ensure device performs as intended in accordance with: - ISO 594-1 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements) - ISO 594-2 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings) - ISO 8536-4 (Infusion equipment for medical use — Part 4: Infusion sets for single use, gravity feed) - ISO 8536-10 (Infusion equipment for medical use — Part 10: Accessories for fluid lines for single use with pressure infusion equipment) "All testing is acceptable." |
| Sterility Assurance Level (SAL) | SAL of 10⁻⁶ | Product Sterility Assurance Level is 10⁻⁶. |
| Substantial Equivalence | Device is substantially equivalent to predicate devices. | The device is declared "substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683 and Hospira Infusion Blood Sets cleared under K101677." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in this summary. The summary refers to "performance testing" and "new performance data" under various ISO standards, which would imply defined sample sizes for physical testing, but these specifics are not provided in the publicly available 510(k) summary.
- Data Provenance: Not explicitly stated. Given the nature of a 510(k) for a manufacturing change to an existing device, it's highly likely this "new performance data" would come from laboratory testing conducted by or for Hospira. There is no indication of retrospective or prospective clinical data in the traditional sense for this type of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This device is a physical, non-diagnostic medical device. The "ground truth" here is adherence to engineering standards and functional performance, not human expert interpretation of medical images or data.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies (e.g., radiology reads). This document describes the testing of a physical medical device against engineering standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. An MRMC study is not applicable to this physical medical device. This type of study is specifically designed for assessing the diagnostic performance of software or imaging systems, often with and without AI assistance to human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- No. This question applies to AI algorithms. The Hospira Extension Set is a physical medical device with no AI component. The performance discussed is the standalone performance of the physical device according to engineering and functional standards.
7. The Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on adherence to international engineering standards (ISO 594-1, ISO 594-2, ISO 8536-4, ISO 8536-10) and the functional claims outlined in the product labeling. This is determined through physical and mechanical testing, not by expert consensus on clinical findings or pathological outcomes.
8. The Sample Size for the Training Set
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no AI component, there is no training set or ground truth established for it.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9.2015
Hospira, Incorporated Mr. David Blonski Director Regulatory Affairs 375 N. Field Drive Lake Forest, IL 60046
Re: K142974
Trade/Device Name: Hospira Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: October 10, 2014 Received: October 14, 2014
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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Page 2 - Mr. Blonski
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,
Susan Russo, DDS, MA
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
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Indications for Use Statement
K142974 510(k) Number:
Device Name: Hospira Extension Set
Indications for Use: Hospira Extension sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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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 appears to be three curved lines that converge at the top, creating a sense of movement or flow.
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 Extension Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3375 North Field DriveLake Forest, IL. 60046 |
| Phone number | (224) 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 | Oct. 10, 2014 |
| Name of device | |
| Trade or proprietary name | Extension 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 | LifeShield Vision Infusion Sets – K113683Hospira 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 Extension Sets with Secure Lock are intended for use as gravity sets.Hospira Extension sets are comprised of various components including the following:male luer adapter with cap, tubing, female luer adapter,flow control device, in-lineadapter, injection site assembly, stopcock and Dial-A-Flo. Extension sets areconfigured to ensure the intended use of the device is met. Hospira Externsion sets areintended for the delivery of fluids from a container to a patient's vascular system. Thesets are disposable devices for single patient use. |
| Intended Use of Device | Hospira Extension set is intended for the delivery of fluids from a container to apatient'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 gray, sans-serif font. Above the name is an abstract graphic consisting of three curved lines that converge at the top, resembling a stylized, modern design element.
| Summary of the technological characteristics of the device compared to the predicate device | ||
|---|---|---|
| Characteristic | Predicate | Proposed Device |
| Indications for Use | Hospira Extension Set is intended forthe delivery of fluids from a containerto a patient's vascular system. | Hospira Extension Set is indicated for thedelivery of fluids from a container to apatient's vascular system. |
| Design and Materials ofConstruction | The materials of construction for theproposed device are exactly the same asthe materials for the predicate product | The design and materials of constructionremain the same as the predicate productwith the following exceptions:1. The male luer adapter material ischanging to an alternate acrylic material.2. Minor dimensional modifications arebeing made to the male luer adapter toenhance connection with female luers. |
| Summary of non-clinical tests fordetermination of substantialequivalence | ||
| 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, ISO8536-4 and ISO 8536-10. All testing isacceptable. |
| The product Sterility Assurance Levelis $10^{-6}$ . | The product Sterility Assurance Levelis $10^{-6}$ . |
Conclusion
Hospira Extension Sets meet the functional claims and intended use as described in the product labeling. The safety and effectiveness are substantially equivalent to the LifeShield Vision Infusion Sets cleared under K113683 and Hospira 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.