(28 days)
Not Found
No
The document describes a standard infusion set and its components, with no mention of AI or ML capabilities. The performance studies focus on biocompatibility, sterility, and physical characteristics.
No
Explanation: This device is for delivering fluids into a patient's vascular system, which is a supportive function rather than directly treating a disease or condition.
No
The device is an infusion set intended for fluid delivery into a patient's vascular system, not for diagnosing medical conditions.
No
The device description clearly states it is an infusion set, which is a physical medical device used for fluid delivery. It mentions components like access ports and configurations, indicating hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of fluids (including blood and blood products) into a patient's vascular system. This is a therapeutic or supportive function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description focuses on the physical components and function of an infusion set for delivering fluids. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD-related terms: The text does not contain any terms typically associated with IVDs, such as "specimen," "assay," "analyte," "diagnosis," "monitoring," or "screening."
The device described is a medical device used for administering fluids directly to a patient, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
LIFESHIELD™ VISION™ Infusion 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.
Product codes (comma separated list FDA assigned to the subject device)
80-FPA
Device Description
The LIFESHIELD™ VISION™ infusion sets, are intended for use as gravity sets or with dedicated Hospira Infusion Pumps. These devices are obtainable in custom lengths and component options according to facility needs and physician preference, Hospira infusion sets are disposable devices for single patient use, which incorporate various set configurations and components. The components include Pre-pierced access ports (Pre-pierced Male Adapter Plug, Pre-pierced Y-site, and Pre-pierced T-connector) which are the subject of this submission, may be shared across Hospira set families may be used with sets for
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)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE*:
Biocompatibility tests (Cytotoxicity, Sensitization, Irritation / Intracutaneous Reactivity, Systemic Toxicity (Acute), Hemocompatibility) passed various ISO 10993 standards.
SAL 10-6 (Sterility) passed ISO 11137-2:2006.
Dimensional conformance and Connection compatibility passed ISO 594-2 1998.
Summary discussion of Bench Performance Data:
The LIFESHIELD™ VISION™ Infusion sets with Pre-pierced reseal access ports have passed all specified test requirements. The validation and verification testing have confirmed these devices meet user needs and design inputs for an infusion set. Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the "Performance Test Summary-New Devices" table above. These include sterility, biocompatibility, particulate, leakage, tensile strength, and filter characteristics.
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.
K941214 LIFESHIELD™ Extension Set, K052722 LIFESHIELD™ Latex Free Microbore Extension Set, K101677 Hospira Infusion Blood Sets
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
LIFESHIELD™ VISION™ Pre-Pierced Reseal Modification Special 510(k) Date: December 14, 2011
JAN 1 2 2012
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Section 6: 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of
21 CFR 807.92. LIFESHIELD" VISION" Infusion sets with Pre-pierced Reseal modi
| Submitter Information | ||
|---|---|---|
| Name | Hospira, Incorporated | |
| Address | D-393, Bldg. H2 | |
| 275 North Field Drive | ||
| Lake Forest, IL. 60046 | ||
| Phone number | (224) 212-5316 | |
| Fax number | 224-212-5401 | |
| Establishment | ||
| Registration Number | Owner/Operator #9063339 | |
| Name of contact person | Karen Keener | |
| Date prepared | December 14, 2011 | |
| Name of device | ||
| Trade or proprietary | ||
| name | LIFESHIELD™ VISION™ Infusion sets with Pre-pierced Reseal Access Port | |
| Common or usual name | Fluid Delivery Tubing | |
| Classification name | Infusion Sets | |
| Classification panel | Class II | |
| Regulation | 21-CFR Part 880.5440 | |
| Product Code(s) | 80-FPA | |
| Legally marketed device(s) to | ||
| which equivalence is claimed | K941214 LIFESHIELD™ Extension Set | |
| K052722 LIFESHIELD™ Latex Free Microbore Extension Set | ||
| K101677 Hospira Infusion Blood Sets | 10/03/1994 | |
| 11/02/2005 | ||
| 08/11/2010 | ||
| The changes addressed in this submission include: | ||
| Material change of the pre-pierced housing access port from an acrylic multipolymer to polycarbonate Addition of a Septum Holder using a medical grade material Minor Dimensional change to the pre-pierced access ports Use of BD plastic blunt cannula for port access | ||
| Device description | The LIFESHIELD™ VISION™ infusion sets, are intended for use as gravity sets or | |
| with dedicated Hospira Infusion Pumps. These devices are obtainable in custom | ||
| lengths and component options according to facility needs and physician | ||
| preference, Hospira infusion sets are disposable devices for single patient use, | ||
| which incorporate various set configurations and components. | ||
| The components include Pre-pierced access ports (Pre-pierced Male Adapter Plug, | ||
| Pre-pierced Y-site, and Pre-pierced T-connector) which are the subject of this | ||
| submission, may be shared across Hospira set families may be used with sets for |
1
| Section 6: | 510(k) SUMMARY | |
|---|---|---|
| Intended use of the device | Infusion sets are intended for the delivery of fluids including but not limited to | |
| blood and blood products from a container into a patient's vascular system. gravity or other pump platforms. | ||
| Summary of the technological characteristics of the device compared to the predicate device | ||
| Characteristic | Proposed Device | Predicate |
| Intended Use | Same | Same |
| Set Functionality | Same | Same |
| Visual characteristics | Colorless polycarbonate of similar size | Green Acrylic Multipolymer |
| white septum holder | Does not contain septum holder. | |
| Bonding processes | Same | Same |
| Biocompatibility | Same | Same |
| Principle of Operation | Same | Same |
| Port Access | Plastic Blunt Cannula and needles | |
| ≤18guage | Metal Cannula and needles | |
| PERFORMANCE DATA | ||
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE* | ||
| 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: 2010 | Sensitization |
| Pass | ||
| Biocompatibility | ISO 10993-10: 2010 | Irritation / Intracutaneous |
| Reactivity | ||
| Pass | ||
| Biocompatibility | ISO 10993-11:2006 | Systemic Toxicity (Acute) |
| Pass | ||
| Biocompatibility | ISO 10993-4:2006 | Hemocompatibility |
| Pass | ||
| SAL 10-6 | ISO 11137-2:2006 | Sterility |
| Pass | ||
| Dimensional conformance | ||
| and | ||
| Connection compatibility | ISO 594-2 1998 | Conical fittings with a 6% |
| (LUER) taper for syringes, | ||
| needles and certain other | ||
| equipment | ||
| Pass |
Summary discussion of Bench Performance Data
The LIFESHIELD" VISION" Infusion sets with Pre-pierced reseal access ports have passed all specified test requirements.
The validation and verification testing have confirmed these devices meet user needs and design inputs for an infusion set.
Testing also confirmed physical attributes and device performance meet requirements of the standards listed in the "Performance Test Summary-New Devices" table above. These starility, biocompatibility, particulate, leakage, tensile strength, and filter characteristics.
2
Section 6: 510(k) SUMMARY
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
Statement of Safety and Efficacy:
The LIFESHIELD" VISION" Infusion sets with pre-pierced reseal access port meet the functional claims, and intended use as described in the product labeling. The safety and effectiveness, are substantially equivalent to the predicate Hospira Infusion sets cleared in K941214 LIFESHIELD " Extension Set, K052722 LIFESHIELD" Latex Free Microbore Extension Set and K101677 Hospira Infusion Blood Sets.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its wing and body. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JAN 1 2 2012
Ms. Karen Keener Senior Specialist Hospira, Incorporated 375 N. Field Drive Lake Forest, Illinois 60045
Re: K113683
Trade/Device Name: LIFESHIELD™ VISION™ Infusion sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 14, 2011 Received: December 15, 2011
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,
Anthony D. Watson
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: Indications for Use
510(k) Number (unknown at this time) & 113683
Device Name: LIFESHIELD™ VISION™ Infusion sets
Indications for Use:
LIFESHIELD™ VISION™ Infusion 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 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Khd C. A
(Division Sign-Off) 1/9/12
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113683