(57 days)
Not Found
No
The summary describes a manual blood pump and infusion set with material and dimensional changes, with no mention of AI or ML.
Yes
The device is described as an "infusion set" intended for "delivery of fluids...from a container to a patient's vascular system," which directly facilitates a medical treatment or procedure.
No
Explanation: The device is an infusion set intended for delivering fluids to a patient's vascular system, not for diagnosing medical conditions.
No
The device description clearly states it consists of physical components like tubing, a blood pump, and valves, indicating it is a hardware device.
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 in vivo (within the body) for therapeutic or supportive purposes, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details components like tubing, a blood pump, and valves, all consistent with a device for delivering fluids into the bloodstream.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
Therefore, this device falls under the category of a general medical device used for fluid delivery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Hospira 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.
Product codes
FPA
Device Description
The Hospira PVC Infusion Blood Sets with/without the Manual blood pump consists of Non-DEHP PVC tubing and components previously cleared in Hospira 510k's. The change addressed in this submission, is the material used to construct the cylindrical blood pump. The modified design incorporates a ball check valve previously used in the bulb style manual blood pump. Other changes include minor dimensional and geometric changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Test Summary-New Device
- Characteristic: Biocompatibility; Standard/Test Method: ISO 10993-5: 2009; Standard/Test Title: Cytotoxicity; Device Performance: Pass
- Characteristic: Biocompatibility; Standard/Test Method: ISO 10993-10: 2002; Standard/Test Title: Sensitization; Device Performance: Pass
- Characteristic: Biocompatibility; Standard/Test Method: ISO 10993-10: 2002; Standard/Test Title: Irritation / Intracutaneous Reactivity; Device Performance: Pass
- Characteristic: Biocompatibility; Standard/Test Method: ISO 10993-11:2006; Standard/Test Title: Systemic Toxicity (Acute); Device Performance: Pass
- Characteristic: Biocompatibility; Standard/Test Method: ISO 10993-4:2002; Standard/Test Title: Hemocompatibility; Device Performance: Pass
- Characteristic: SAL 10-6; Standard/Test Method: ISO 11137-2:2006; Standard/Test Title: Sterility; Device Performance: Pass
- Characteristic: Packaging; Standard/Test Method: ISO 1135-4:2004; Standard/Test Title: Transfusion Equipment for Medical Use; Device Performance: Pass
- Characteristic: Particulate; Not Found; Not Found; Not Found
- Characteristic: Bond Strength; Not Found; Not Found; Not Found
- Characteristic: Piercing function; Not Found; Not Found; Not Found
- Characteristic: Flow characteristics; Not Found; Not Found; Not Found
- Characteristic: Specific Required Physical Characteristics; Not Found; Not Found; Not Found
- Characteristic: Gravity Set Characteristics; Standard/Test Method: 8536-4:2004; Standard/Test Title: Infusion Equipment for Medical Use; Part 4.; Device Performance: Pass
- Characteristic: Dimensional Conformance and Connection compatibility; Standard/Test Method: ISO 594-2; Standard/Test Title: Conical Fittings with a 6% (Luer) Taper for syringes, needles, and certain other equipment; Device Performance: Pass
Summary Discussion of Bench Performance Data
The Hospira Blood administration sets with 200-micron filter and Non-DEHP PVC manual blood pump passed all specified test requirements. The validation and verification testing confirmed product meets user needs and design inputs for an administration set containing a manual blood pump. Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the 'Performance test summary" above. These standards address sterility, biocompatibility, particulate, leakage, tensile strength, filter characteristics, drip tube performance, flow control, and simulated actual conditions of use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Hospira Infusion Blood Sets K101677
510(k) SUMMARY
- B
A summary of 510(k) safety and effectiveness information in accordation with the requirements of 21 CFR 807.92.
| Submitter Information [21 CFR 807.929(a)(1)] | |
|---|---|
| Name | Hospira Incorporated |
| Address | D-389, Bldg H2, 375 N. Field Drive, Lake Forest, Illinois 60045 |
| Phone number | 224-212-5316 |
| Fax number | 224-212-5401 |
| Establishment Registration | |
| Number | 9063339 |
| Name of contact person | Karen Keener |
| Date prepared | July 20, 2010 |
| Name of the device [21 CFR 807.92(a)(2)] | |
| Trade or proprietary name | Hospira PVC Infusion Blood Set |
| Common or usual name | Fluid delivery tubing |
| Classification name | Sets, Administration, Intravascular |
| Classification panel | General Hospital |
| Regulation | 880.5440 |
| Product Code(s) | FPA |
| Legally marketed device(s) | |
| to which equivalence is | |
| claimed [21 CFR | |
| 807.92(a)(3)] | Hospira Infusion Blood sets utilize components from various Hospira |
| Infusion set families; including but not limited to: | |
| Lifeshield Latex-Free Veniloop Connector with Prepierced Injection | |
| Site, Non-DEHP (K063239) | |
| Lifeshield Latex-Free Plum Non-Vented Blood set (K030002) | |
| HEMA Y-Type Transfusion Blood Filter Pump Set 100 Inch-SL with | |
| Prepierced Reseals (Latex-Free) (K780880) | |
| Reason for 510(k) | |
| submission | To offer a non-DEHP PVC alternative Infusion set with a manual |
| blood pump. | |
| Device description | |
| [21 CFR 807.92(a)(4)] | The Hospira PVC Infusion Blood Sets with/without the Manual blood |
| pump consists of Non-DEHP PVC tubing and components previously | |
| cleared in Hospira 510k's. The change addressed in this submission, | |
| is the material used to construct the cylindrical blood pump. The | |
| modified design incorporates a ball check valve previously used in | |
| the bulb style manual blood pump. Other changes include minor | |
| dimensional and geometric changes. | |
| Intended use of the device | |
| [21 CFR 807.92(a)(5)] | Hospira 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. |
1
Hospira Infusion Blood Sets K101677
Attachment 2
| Performance Data [21 CFR 807.92(b)] | |||
|---|---|---|---|
| Summary of non-clinical tests conducted for determination of substantial equivalence | |||
| [21 CFR 807.92(b)(1)] | |||
| Performance Test Summary-New Device | |||
| Characteristic | Standard/Test Method | Standard / Test Title | Device Performance |
| Biocompatibility | ISO 10993-5: 2009 | Cytotoxicity | Pass |
| Biocompatibility | ISO 10993-10: 2002 | Sensitization | Pass |
| Biocompatibility | ISO 10993-10: 2002 | Irritation / | |
| Intracutaneous | |||
| Reactivity | Pass | ||
| Biocompatibility | ISO 10993-11:2006 | Systemic Toxicity | |
| (Acute) | Pass | ||
| Biocompatibility | ISO 10993-4:2002 | Hemocompatibility | Pass |
| SAL 10-6 | ISO 11137-2:2006 | Sterility | Pass |
| Packaging | ISO 1135-4:2004 | Transfusion | |
| Equipment for | |||
| Medical Use | Pass | ||
| Particulate | |||
| Bond Strength | |||
| Piercing function | |||
| Flow characteristics | |||
| Specific Required | |||
| Physical Characteristics | |||
| Gravity Set | |||
| Characteristics | 8536-4:2004 | Infusion | |
| Equipment for | |||
| Medical Use; Part |
-
| Pass |
| Dimensional
Conformance
and
Connection compatibility | ISO 594-2 | Conical Fittings
with a 6% (Luer)
Taper for syringes,
needles, and
certain other
equipment | Pass |
Summary Discussion of Bench Performance Data
The Hospira Blood administration sets with 200-micron filter and Non-DEHP PVC manual blood pump passed all specified test requirements.
The validation and verification testing confirmed product meets user needs and design inputs for an administration set containing a manual blood pump.
Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the 'Performance test summary" above. These standards address sterility, biocompatibility, particulate, leakage, tensile strength, filter characteristics, drip tube performance, flow control, and simulated actual conditions of use.
2
K101677
Hospira Infusion Blood Sets K101677
Attachment 2
Summary of clinical tests conducted for determination of substantial equivalence or of clinical information
[21 CFR 807.92(b)(2)]
Not required. Bench testing can adequately address the safety and efficacy of this product.
Statement of Safety and Efficacy
[21 CFR 807.92]
The Hospira Infusion Blood Sets with/without Manual Blood Pump meet the functional claims, and intended use as described in the product labeling.
The safety and effectiveness are equivalent to the predicate Hospira Administration Blood Sets with Manual Blood Pump. The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993=0002
Ms. Karen Keener Global Regulatory Associate Hospira, Incorporated 375 North Field Drive Lake Forest, Illinois 60045
Re: K101677
Trade/Device Name: Hospira Infusion Blood Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 29, 2010 Received: July 30, 2010
AUG11 2010
Dear Ms. Keener:
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.
4
Page 2- Ms. Keener
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Susan Dunne
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology; General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 5:
510(k) Number (if known) K IO| 6 7 7
Device Name: Hospira Infusion Blood Sets
Indications for Use: Hospira Administration sets are intended for the delivery of fluids including but not limited to blood and blood products from a container into a patients vascular system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over –The- Counter Use {Part 21 CFR *)& Subpart C)
(Please do not write below this line – continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K101677
Section 5: Indications for use Page 1 of 1