(86 days)
Not Found
Not Found
No
The summary describes a standard IV filter for parenteral nutrition and contains no mention of AI, ML, image processing, or performance studies typically associated with AI/ML devices.
No
The device is an IV filter used with parenteral nutrition admixtures, which prevents hazards like precipitation but does not directly treat a disease or condition.
No.
The device is an IV filter used for infusing parenteral nutrition admixtures, which is a treatment modality rather than a diagnostic tool. Its function is to filter solutions, not to identify or characterize a disease or condition.
No
The 510(k) summary describes an IV filter, which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "IV filter" used for "infusing either central or peripheral parenteral nutrition admixtures." This describes a device used in vivo (within the body) for administering substances, not a device used in vitro (outside the body) for examining specimens from the body.
- Device Description: While the description is "Not Found," the intended use is the primary indicator of whether a device is an IVD.
- Other Sections: The absence of information related to image processing, AI/ML, input imaging modality, anatomical site, patient age range, intended user/care setting, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are typically relevant for devices that analyze biological samples or medical images.
- Predicate Devices: The predicate devices listed are "Administration Set with an 0.22um filter" and "Administration Set with 1.2 um IV-3." These are also devices used for administering fluids intravenously, not for in vitro diagnostic testing.
In summary, the function of this device is to filter fluids being administered intravenously, which is an in vivo application, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.
Product codes
Not Found
Device Description
Not Found
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)
Not Found
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.
The Arbor Medical AutoPrime™ I.V. is as safe and effective as the 3M Health Care AVITM Administration Set with an 0.22um filter and the Block Medical Verifuse® Administration Set with 1.2 um IV-3.
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
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
Image /page/0/Picture/0 description: The image shows a sequence of handwritten digits. The digits are 5, 9, 6, 4, 2, 8, and 3. The digits are written in black ink on a white background and are connected to each other.
510(k) Sumn
Appendix B
Arbor Medical Arbor Technologies, Inc. 401 West Morgan Road Ann Arbor, MI 48108-9109 Phone: (313) 665-3300 Fax:
Date prepared: September 16, 1996
JAN 2 2 1997
Trade name: AutoPrimeTM
Contact person: Dawn I. Moore
Common name: I.V. Filter and set
Classification name: Infusion line filter and administration set (21 CFR 880.5440)
The Arbor Medical AutoPrime™ I.V. is as safe and effective as the 3M Health Care AVITM Administration Set with an 0.22um filter and the Block Medical
Verifuse® Administration Set with 1.2 um IV-3. All filters are intended to filter intravenous solutions.
Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.
Technological Characteristics:
-
The 0.22um filters both make a claim of passing a bacterial challenge of 107 with Pseudomonas.diminuta. referred to as a HIMA challenge. Materials of construction are the same. both filters are made with 0.22um polyethersulfone main membranes, vent filters made with .02um PTFE and housings made from modified acrylic. Bench test data is not required due to there being no technological differences that raise issues of safety or efficacy.
-
The 1.2um filters both make a claim of retaining Candida Albicans. Materials of construction are the same, both filters are made with 1.2um polyethersulfone main membranes. vent filters made with .02um PTFE and housings made from blue modified acrylic. Bench test data is not required due to there being no technological differences that raise issues of safety or efficacy.