(46 days)
Not Found
No
The device description and intended use clearly describe a manual flow control device with head height compensation, and there is no mention of AI or ML in the provided text.
No
The device is used to control the infusion rate of IV fluids and is not directly involved in treating or diagnosing a condition.
No
The device is an I.V. set designed to control the infusion rate of fluids, not to diagnose a medical condition.
No
The device description clearly lists physical components like tubing, piercing pins, valves, and adapters, 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 to control the infusion rate of I.V. fluids into a patient's vascular system. This is a direct interaction with the patient's body for therapeutic purposes (delivering fluids), not for examining specimens from the body to obtain diagnostic information.
- Device Description: The components described are typical for an intravenous infusion set, designed for fluid delivery and control within the patient's circulatory system.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for the delivery of fluids into the body.
N/A
Intended Use / Indications for Use
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
Product codes
FPA, FPK
Device Description
The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dial-A-Flo®, K030467
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.
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K0632399
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510(k) SUMMARY
| 1. | Submitted by: | Hospira, Inc.
D-389, Bldg. H2
275 N. Field Drive
Lake Forest, IL 60045
Attn: Diane Rennpferd | Phone: (224) 212-5452
Fax: (224) 212-5401 |
|----|-----------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 2. | Date Prepared: | October 25, 2006 | |
| 3. | Name/Classification
of Device: | Fluid Delivery Tubing
Class II, 80-FPK, 21 CFR 880.5440 | |
| 4. | Trade Name of | LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets | |
5. Predicate Devices:
Proposed Device:
| Device Name | 510(k) Number |
|---|---|
| Dial-A-Flo® | PE |
| GraviTech™ Flow Controller | |
| Primary Set / GraviTech™ flow | |
| Controller Extension Set | K030467 (IV |
| Medical Inc.) |
6. Proposed Device Description:
The LifeShield® Latex-Free GraviTech™ Flow Controller !.V. Set will consist of variations of the following components: non-DEHP plasticized polyvinyl tubing, piercing pins, fluid shut off devices, integral CLAVE® ports or prepierced injection sites, backcheck valves, semi-rigid adapters, male adapter and air filter assembly. The GraviTech™ device provides a manual flow control with head height compensation to the LifeShield® product line.
7. Statement of Intended Use:
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
8. Summary of Technological Characteristics of New Device Compared to Predicate Devices:
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set as described in this submission is substantially equivalent to the predicate LifeShield® Latex-Free Requiator I.V. Dial-A-Flo® set family with respect to the following characteristics:
Similarities:
- · Intended for the delivery of fluids from a container to a patient's vascular system.
- · Provided with a sterile and non-pyrogenic fluid-path
- · Intended for one-time use
- · Technology and operating principles
- Method of sterilization
- · Similar materials of construction
- · Provides manual flow control
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K0632399
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Differences:
- · The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets will have head height compensation
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Set will meet the functional The Enooming "Leaver Pros described in the product labeling, and is as safe and effective in terms of substantial equivalence as the predicates LifeShield® Latex-Free Regulator I.V. terms of Jubotantial oquralenoo coh™ Flow Controller Primary Set / GraviTech™ flow Controller Extension Set (cleared under K030467 to IV Medical Inc.)
The claim for substantial equivalence is supported by the information provided in the 510(k) submission.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, to the right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Diane Rennpferd Senior Associate, Global Regulatory Affairs Devices Hospira, Incorporated 275 North Field Drive Department 389, Building H2 Lake Forest, Illinois 60045
DEC 1 1 2006
Re: K063239
Trade/Device Name: LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA, FPK Dated: October 25, 2006 Received: October 26, 2006
Dear Ms. Rennpferd:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting vour 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.
3
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. or the ret of with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (27 et read 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you dents of the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known)
063239
LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets Device Name:
Indications for Use:
The LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets are intended for use in controlling the infusion rate of I.V. fluids from a container to a patient's vascular system. The indications for use of the LifeShield® Latex-Free GraviTech™ Flow Controller I.V. Sets include intravenous infusion where a manual flow control is desired.
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)
Sraell for m21
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Seniology, General Hospit ... Dartel Devices
Image /page/4/Picture/14 description: The image shows a handwritten string of characters. The characters appear to be a combination of numbers and letters. The string reads 'K063259'. The handwriting is somewhat stylized, with some characters being more distinct than others.