(187 days)
K# unknown, K# unknown, K# unknown
Not Found
No
The summary describes a mechanical device for accessing venous ports and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as an access tool (allows transcutaneous cannulation of venous access ports) rather than a device intended to treat a pathological condition or alleviate symptoms.
No
The device description indicates it is used for "transcutaneous cannulation of subdermally implanted venous access ports," which is a procedure for administering or withdrawing substances, not for diagnosing a condition.
No
The device description explicitly lists physical components such as a flexible catheter, hub, septum, tubing, and stylet, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "transcutaneous cannulation of subdermally implanted venous access ports." This describes a procedure performed on a patient's body to access a medical device.
- Device Description: The description details components like a catheter, hub, septum, tubing, and stylet. These are all components of a device used for accessing the bloodstream or delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing samples outside the body. The FlexNeedle™ is designed for accessing a port within the body.
N/A
Intended Use / Indications for Use
The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The FlexNeedle™ is composed of a flexible catheter; a hub with elastomeric septum and side port; sideleg tubing with luer infusion fitting, cap, and pinch clamp; and an insertion stylet.
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.
K# unknown, K# unknown, K# unknown
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
K 961049
10. 510(k) SUMMARY
- (1) Lighthouse Medical, Inc. 100 Beaver St. Waltham, MA 02154
Contact Person: Jenna Andelman Date Summary Prepared: March 12, 1996
| (2) | Trade or Proprietary Name: | FlexNeedle™ |
|---|---|---|
| Common Name: | Intravascular administration set | |
| Classified Name: | Intravascular administration set |
- (3) Luther Medical Products L-CATH for Ports (K# unknown) Predicates: Medex SureCath Port Access Catheter (K# unknown) SIMS Deltec Gripper (K# unknown).
- (4) Description of Device:
The FlexNeedle™ is composed of a flexible catheter; a hub with elastomeric septum and side port; sideleg tubing with luer infusion fitting, cap, and pinch clamp; and an insertion stylet.
-
(5) Intended Use:
The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports. -
The FlexNeedle™ has the same technological characteristics as the above (6) predicate devices in that it is a hollow tube with a luer fitting intended to remain in a subcutaneous access port in order to provide access to the bloodstream.