(196 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical safety features and standard biocompatibility/sterility testing, with no mention of AI/ML terms or functionalities.
No
The device is described as an IV catheter safety system designed to reduce needle stick injuries, not to treat or diagnose a medical condition.
No
The device description indicates it is a "needle safety feature for an IV catheter" designed to "reduce needle stick injuries." Its performance studies focus on safety and effectiveness, rather than diagnosing conditions.
No
The device description explicitly states it is a "needle safety feature for an IV catheter" and is "being provided on a variety of IV catheters," indicating it is a physical component integrated with hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: This section is "Not Found," which is a key indicator for IVDs. IVDs have specific intended uses related to diagnosing diseases or conditions using samples from the human body.
- Device Description: The description clearly states it's a "needle safety feature for an IV catheter" designed to "reduce needle stick injuries." This is a mechanical safety feature for a medical device used for administering fluids or medications, not for diagnostic testing.
- No mention of biological samples: There is no mention of the device being used with blood, urine, tissue, or any other biological sample, which is fundamental to IVDs.
- No mention of diagnostic purpose: The purpose described is safety and delivery of substances, not diagnosis.
The information provided strongly suggests this is a medical device used in patient care, specifically related to IV access, and not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Not Found
Product codes
Not Found
Device Description
The PROTECTIV 2000 IV Catheter Safety System is a needle safety feature for an IV catheter. The IV catheter portion of the system is the same product that is currently marketed by JJMI. The PROTECTIV 2000 IV Catheter Safety System is designed to reduce needle stick injuries. The PROTECTIV 2000 IV Catheter Safety System is being provided on a variety of IV catheters.
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
The Safety system has passed all tests for safety and effectiveness (i.e. biocompatability, sterility and system performance). The testing and conclusions are summarized below;
Test: Cannula Security Force to Advance/Lock IVC Safety Mechanism Efficacy Tip Protector/Primary Member Security Cannula Orientation FIPG Efficacy Biocompatability Per ISO 10993 Simulated Clinicals Sterilization
Conclusion: Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed Passed Passed
Key Metrics
Not Found
Predicate Device(s)
PROTECTIV IV Catheter Safety System and the PROTECTIV Plus IV Catheter Safety System
Reference Device(s)
Not Found
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
K 942226
510(k) Summary of Safety and Effectiveness
PROTECTIV* 2000 IV CATHETER SAFETY SYSTEM
Company Name & Address:
Johnson & Johnson Medical Incorporated 2500 East Arbrook Boulevard Arlington, Texas 76004-3130
Identification of the Legally Marketed Device:
PROTECTIV IV Catheter Safety System and the PROTECTIV Plus IV Catheter Safety System
Description of the Device:
The PROTECTIV 2000 IV Catheter Safety System is a needle safety feature for an IV catheter. The IV catheter portion of the system is the same product that is currently marketed by JJMI. The PROTECTIV 2000 IV Catheter Safety System is designed to reduce needle stick injuries. The PROTECTIV 2000 IV Catheter Safety System is being provided on a variety of IV catheters.
Comparison Information
| FEATURE | PROTECTIV I.V.
AND
PROTECTIV PLUS | PROTECTIV 2000 |
|-------------------------------------|-----------------------------------------|-----------------------|
| Flash back visualization | Close to catheter hub | Close to catheter hub |
| Locking as part of threading action | yes | yes |
| Tactile feel of locking | yes | yes |
| Audible click upon locking | yes, single click | yes, single click |
| Prevents needle sticks | yes | yes |
| Irreversible safety mechanism | yes | yes |
| Covered needle tip | yes | yes |
| Gasket wipes blood from cannula | yes | yes |
| One finger push to activate | yes | yes |
| Grips for secure handling | yes | yes |
| EtO sterilized | yes | yes |
| Single sterile wrapped | yes | yes |
| Designed to prevent needle sticks | yes | yes |
| Preloaded | yes | yes |
Trademark
1
Discussion of Tests/Studies with Conclusions:
The Safety system has passed all tests for safety and effectiveness (i.e. biocompatability, sterility and system performance). The testing and conclusions are summarized below;
Test
Conclusion
Cannula Security Force to Advance/Lock IVC Safety Mechanism Efficacy Tip Protector/Primary Member Security Cannula Orientation FIPG Efficacy Biocompatability Per ISO 10993 Simulated Clinicals Sterilization
Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed the minimum requirement Passed Passed Passed