(121 days)
Not Found
No
The device description and performance studies focus on the physical components and fluid delivery function of a gravity infusion set, with no mention of AI or ML technologies.
No
The device is used for the delivery of fluids to a patient's vascular system, which is a supportive rather than a therapeutic function. It does not actively treat or cure a disease.
No
Explanation: The device is described as being for "delivery of fluids... to a patient's vascular system." This is a therapeutic function, not a diagnostic one. Diagnostic devices are used to identify a condition, disease, or its nature.
No
The device description explicitly lists physical components such as tubing, flow control device, piercing pin assembly, and burette assembly, indicating it is a hardware device for fluid delivery.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "delivery of fluids including but not limited to blood products from a container to a patient's vascular system." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose or monitor a condition.
- Device Description: The description details components like tubing, flow control, and a piercing pin assembly, all consistent with an infusion set for delivering fluids. There is no mention of components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering fluids to the patient.
N/A
Intended Use / Indications for Use
Hospira Burette sets are indicated for the delivery of fluids including but not limited to blood products from a container to a patient's vascular system.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Hospira Burette Sets with Secure Lock are intended for use as gravity sets.
Hospira Burette sets are comprised of various components including the following: male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette assembly and injection site assembly. Burette sets are configured to ensure the intended use of the device is met. Hospira Burette 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system
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 testing was conducted to ensure the device performs as intended in accordance with applicable standards. All testing is acceptable.
New performance data has been generated to ensure the device performs as intended in accordance with ISO 594-1, ISO 594-2, ISO 8536-4. All testing is acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The product Sterility Assurance Level is 10-6.
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.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 10, 2015
Hospira, Incorporated Mr. David Blonski Director Regulatory Affairs 375 N. Field Drive Lake Forest, IL 60046
Re: K142622
Trade/Device Name: Burette Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 18, 2014 Received: December 19, 2014
Dear Mr. Blonski:
This letter corrects our substantially equivalent letter of January 15, 2015.
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
1
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. 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/ResourcesforYou/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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142622
Device Name Hospira Burette Set
Indications for Use (Describe)
Hospira Burette 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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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 is composed of three curved lines that converge at the top, resembling a stylized representation of a plant or abstract design. The logo is presented in black and white.
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 Burette Sets.
| Submitter Information | |
|---|---|
| Name | Hospira, Incorporated |
| Address | D-393, Bldg. H3 |
| 375 North Field Drive | |
| Lake Forest, IL. 60046 | |
| Phone number | (224) 212-5010 |
| Fax number | (224) 212-5401 |
| Establishment Registration | |
| Number | 3005579246 (Owner/Operator #9063339) |
| Name of contact person | David Blonski, Director Regulatory Affairs |
| Date prepared | 09/19/2014 |
| Name of device | |
| Trade or proprietary name | Burette 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) to | |
| which equivalence is claimed | LifeShield Vision Infusion Sets - K113683 |
| Reason for 510(k) submission | The changes addressed in this submission include: |
| • Modification to Secure Lock Male Luer | |
| Device description | The Hospira Burette Sets with Secure Lock are intended for use as gravity sets. |
| Hospira Burette sets are comprised of various components including the following: | |
| male luer adapter with cap, tubing, flow control device, piercing pin assembly, burette | |
| assembly and injection site assembly. Burette sets are configured to ensure the | |
| intended use of the device is met. Hospira Burette 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. | |
| Intended Use of Device | Hospira Burette 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. |
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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 features three curved lines that converge at the top, resembling a stylized abstract shape. The logo is presented in grayscale.
| 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 Burette 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) | The design and materials of construction | |
| remain the same as the predicate product | ||
| with the following exceptions: |
- 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. |
| Summary of non-clinical tests for
determination of substantial
equivalence | All materials of construction for
Hospira Burette Sets meet the
applicable material test requirements
for ISO 10993 | New data has been generated demonstrating
that all materials of construction for Hospira
Burette Sets meet the applicable material
test requirements for ISO 10993. |
| Summary of Performance Testing | Performance testing was conducted to
ensure the device performs as intended
in accordance with applicable
standards. All testing is acceptable.
The product Sterility Assurance Level
is 10-6. | New performance data has been generated
to ensure the device performs as intended in
accordance with ISO 594-1, ISO 594-2, ISO
8536-4. All testing is acceptable.
The product Sterility Assurance Level
is 10-6. |
Conclusion
Hospira Burette 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.