(363 days)
No
The summary describes a physical catheter and its intended use, with no mention of software, algorithms, or AI/ML terms.
No.
The device is a catheter used for venous access or intravenous therapy, which supports therapeutic interventions but is not a therapeutic device itself.
No
The device is a peripherally inserted catheter used for venous access or intravenous therapy, which are treatment modalities, not diagnostic ones.
No
The device description clearly states it is a peripherally inserted catheter, 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 is "Peripherally inserted catheter for venous access or intravenous therapy." This describes a device used in vivo (within the body) for delivering substances or accessing the bloodstream.
- Device Description: The description reinforces this by detailing a catheter inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease. IVDs typically involve analyzing samples like blood, urine, or tissue.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla.
Product codes
FOZ
Device Description
Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations, as sterile individual units or in trays along with the components used for insertion.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
V-Cath® ML, L-CATH® Mid Line (K924968)
Reference Device(s)
Centermark (K920828)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).
0
・・ - 4 に、
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION FOR MIDMARK™ MIDLINE CATHETER
100 - 4 1996
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- Classification Name: Catheter, Intravascular 80FOZ Common Name: Peripherally Inserted Catheter Proprietary Name: MIDMARK™ Midline Catheter
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- Establishment Registration Number: 2938241
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- Establishment Name/Address: Menlo Care, Inc. 1350 Willow Rd., Suite 101 Menlo Park, CA 94025
- র্ব . Classification: Class II
- ട്. Substantially Equivalent Devices: V-Cath® ML, L-CATH® Mid Line (K924968)
- ર. Description and Device Eunction: Peripherally inserted catheter for venous access or intravenous therapy. Method of insertion is through an introducer. The optimal catheter tip location is below the shoulder at the level of the axilla. The products will be available in single and dual lumen configurations, as sterile individual units or in trays along with the components used for insertion.
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- Component Specifications: All Midmark components and materials are identical to that of Centermark (K920828).
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- Performance Standards: No performance standards have been established by the FDA.
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- Packaging and Sterilization: These devices will be packaged in peelable polymer pouches and sterilized by exposure to high energy electron radiation. Insertion trays will be sterilized by exposure to ethylene oxide.
Non-pyrogenicity will be established for each production lot by the LAL procedure.