(62 days)
No
The 510(k) summary describes a physical medical device (catheter) and its mechanical and performance characteristics. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is a catheter used for administering fluids and sampling blood, not for treating a disease or condition as a therapeutic device would.
No
The device is a catheter for administering fluids or sampling blood, not for diagnosing medical conditions. Its function is to provide vascular access, not to interpret or analyze physiological data for diagnostic purposes.
No
The device description clearly outlines a physical catheter with an introducer needle and safety mechanism, indicating it is a hardware medical 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 "sample blood or administer fluids intravenously" and provide "peripheral vascular access and administration of fluids, medications and nutritional therapy." This describes a device used in vivo (within the body) for direct patient care, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter inserted into the vascular system, which is consistent with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Mini-Midline™ Extended Dwell Safety Catheter is a medical device used for direct patient treatment and access, not an IVD.
N/A
Intended Use / Indications for Use
The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (
§ 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
K130≤18
Section 6
510(k) Summary of Safety and Effectiveness
6. 510(k) Summary of safety and effectiveness
APR 3 0 2013
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | Luther NeedleSafe Products, Inc. |
|---|---|
| DATE PREPARED: | February 21, 2013 |
| CONTACT PERSON: | Rebecca K Pine |
| Luther NeedleSafe Products, Inc. | |
| 7 Rimani Drive | |
| Mission Viejo, CA 92692 | |
| Phone: (760) 809.5178 | |
| TRADE NAME: | Mini-Midline™ Extended Dwell Safety Catheter |
| COMMON NAME: | Intravascular Catheter |
| CLASSIFICATION | |
| NAME: | Catheter, Intravascular, Therapeutic, Short-Term, less than 30 |
| days | |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 880.5200 |
| PRODUCT CODE | FOZ |
| PREDICATE DEVICES: | PowerGlide Midline Catheter (K121073) |
| Rapid Intravascular Start System (K112347) | |
| BD Incyte Autoguard IV Catheter (K110443) |
Substantially Equivalent To:
The Mini-Midline Extended Dwell Safety Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the PowerGlide Midline Catheter, Rapid Intravascular Start System and the BD Insyte Autoguard IV Catheter.
Description of the Device Subject to Premarket Notification:
The Mini-Midline Extended Dwell Safety Catheter is a sterile, single use device designed to provide access to the patient's vascular system. The device provides peripheral vascular access and administration of fluids, medications and nutritional therapy as prescribed. The device consists of an introducer needle, passive safety mechanism and single lumen catheter. The Mini-Midline Extended Dwell Safety Catheter is 20 gauge.
Luther NeedleSafe Products, Inc. Mini-Midline™ Extended Dwell Safety Catheter
Page 11 of 58 Premarket Notification
1
Indication for Use:
The Mini-Midline™ Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (