(123 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterility of a prefilled saline syringe, with no mention of AI or ML.
No.
The device is described as being used for "flushing of indwelling vascular access devices," which is a maintenance task and not a therapeutic intervention to treat a disease or condition.
No
The device is a prefilled syringe containing sodium chloride for flushing vascular access devices, not for diagnosing medical conditions. Its sole intended use is flushing, and no diagnostic capabilities are mentioned.
No
The device description clearly states it is a prefilled syringe with sodium chloride injection, 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 "only for the flushing of indwelling vascular access devices." This is a therapeutic or procedural use, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a prefilled syringe containing saline solution. This is a medical device used for flushing, not for analyzing biological samples.
- No mention of diagnostic testing: The document does not describe any process of analyzing biological samples or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for a therapeutic or procedural purpose, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Product codes
NGT
Device Description
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SF Syringe is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is sterilized via moist heat and provided externally sterile for use on a sterile field.
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)
Performance Testing conducted to support substantial equivalence.
Functional Testing:
- Container Closure Integrity: No dye in solution; No leakage in the luer well or tip threads; No leakage past the stopper ribs; No dye between stopper ribs. Subject device is identical to predicate.
- Break Loose Force: No leakage beyond stopper ribs. Subject device is identical to predicate.
- Break Out Force: Acceptable forces required to remove plunger rod. Subject device is identical to predicate.
- Sustaining Force: Consistent plunger rod forces. Subject device is identical to predicate.
- Pump Force: 10ml/hr - 20N; 1ml/hr - 13N; 0.1ml/hr - 9N. Subject device is identical to predicate.
- Dead Space / Expelled Volume: Equivalent to labeled volume on barrel. Subject device is identical to predicate.
- Syringe Induced Reflux: 0 average reflux when connected to a 4 Fr catheter. Subject device is identical to predicate.
- Package Integrity: Per ISO 11607. Subject device is equivalent to predicate.
- Package Stability: Per ISO 11607. Subject device is equivalent to predicate.
Sodium Chloride Injection, USP Testing:
- Baxterial Endotoxin: Per USP . Subject device is identical to predicate.
- Particulate Matter: Per USP . Subject device is identical to predicate.
- Assay of NaCl: Per USP . Subject device is identical to predicate.
- Heavy Metals: Per USP . Subject device is identical to predicate.
- Iron: Per USP . Subject device is identical to predicate.
- UV/vis: Per USP . Subject device is identical to predicate.
- pH: Per USP . Subject device is identical to predicate.
Biocompatibility Testing:
- Cytotoxicity: Per ISO10993-5:1999, Non-Toxic. Subject device is identical to predicate.
- Hemolysis: Per ISO10993-4:2002/A:2006, Non-Toxic. Subject device is identical to predicate.
- Acute Systemic Toxicity: Per ISO10993-11:2006, Non-Toxic. Subject device is identical to predicate.
- Intracutaneous Reactivity: Per ISO10993-10:2002/A1:2006, Non-Irritant. Subject device is identical to predicate.
- Sensitization: Per ISO10993-10:2002/A1:2006, Non-Sensitizer. Subject device is identical to predicate.
- Bacterial Mutagenicity: Per ISO10993-3, Non-Mutagenic. Subject device is identical to predicate.
- In Vitro Mouse Lymphoma: Per ISO10993-3, Non-Mutagenic. Subject device is identical to predicate.
- Mouse Embryo Assay: Per ISO10993-3, Non-Mutagenic. Subject device is identical to predicate.
- Occular Irritation: Per ISO10993-10:2002/A1:2006, Non-Irritant. Subject device is identical to predicate.
- Rabbit Pyrogen: Per ISO10993-11:2006, Non-Pyrogenic. Subject device is identical to predicate.
- Subchronic Intracutaneous Toxicity: Per ISO10993-11:2006, Non-Toxic. Subject device is identical to predicate.
- Chemical Extractables Analysis: LC/DAD/MS & GC/MS, No significant extractables. Subject device is identical to predicate.
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.
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
§ 880.5200 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
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an emblem that resembles an abstract caduceus, with three stylized human profiles forming the staff and a serpent-like shape winding around them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 4, 2016
Becton, Dickinson and Company John Blewitt Regulatory Affairs Manager 1 Becton Drive Franklin Lakes, NJ 07417
Re: K153481
Trade/Device Name: 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: March 4, 2016 Received: March 7, 2016
Dear Mr. Blewitt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe
Indications for Use (Describe)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitted By: | John Blewitt
Regulatory Affairs Manager
Becton, Dickinson and Company
Medication and Procedural Solutions
1 Becton Drive
Franklin Lakes, NJ 07417
Phone: (201)847-5473; Fax: (201)847-5307 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | April 1, 2016 |
| Trade Name: | 0.9% Sodium Chloride Injection, USP, BD PosiFlushTM SF Syringe |
| Common Name: | 0.9% Sodium Chloride Injection Flush Syringe |
| Classification Name: | Saline, Vascular Access Flush |
| Classification
Regulation | 21 CFR §880.5200 |
| Class | Class II |
| Product Code: | NGT |
| Predicate Device: | K121050
0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP and SF Syringe |
Device Description
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SF Syringe is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is sterilized via moist heat and provided externally sterile for use on a sterile field.
Intended Use
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.
Comparison of Technological Characteristics
The subject 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is equivalent to that of the predicate 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe in intended use, materials and performance characteristics. The subject device 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe, includes a change from Tyvek to new primary packaging materials consisting of medical grade paper and multi-layer film. Based on results of performance testing conducted, the subject device is substantially equivalent to the predicate device.
4
Performance
Performance Testing conducted to support substantial equivalence
| Performance
| Characteristic | Predicate Device | Subject Device |
|---|---|---|
| K121050: 0.9% Sodium Chloride | ||
| Injection, USP, BD PosiFlush™ SF | ||
| Syringe | 0.9% Sodium Chloride Injection, | |
| USP, BD PosiFlush™ SF Syringe | ||
| Functional Testing | ||
| Container Closure Integrity | No dye in solution; | |
| No leakage in the luer well or tip | ||
| threads; | ||
| No leakage past the stopper ribs; | ||
| No dye between stopper ribs | Identical to predicate | |
| Break Loose Force | No leakage beyond stopper ribs | Identical to predicate |
| Break Out Force | Acceptable forces required to | |
| remove plunger rod | Identical to predicate | |
| Sustaining Force | Consistent plunger rod forces | Identical to predicate |
| Pump Force | 10ml/hr - 20N | |
| 1ml/hr - 13N | ||
| 0.1ml/hr - 9N | Identical to predicate | |
| Dead Space / Expelled | ||
| Volume | Equivalent to labeled volume on | |
| barrel | Identical to predicate | |
| Syringe Induced Reflux | 0 average reflux when connected | |
| to a 4 Fr catheter | Identical to predicate | |
| Package Integrity | Per ISO 11607 | Equivalent to predicate |
| Package Stability | Per ISO 11607 | Equivalent to predicate |
| Sodium Chloride Injection, USP Testing | ||
| Baxterial Endotoxin | Per USP | Identical to predicate |
| Particulate Matter | Per USP | Identical to predicate |
| Assay of NaCl | Per USP | Identical to predicate |
| Heavy Metals | Per USP | Identical to predicate |
| Iron | Per USP | Identical to predicate |
| UV/vis | Per USP | Identical to predicate |
| pH | Per USP | Identical to predicate |
| Biocompatibility Testing | ||
| Cytotoxicity | Per ISO10993-5:1999, Non-Toxic | Identical to predicate |
| Hemolysis | Per ISO10993-4:2002/A:2006, Non- | |
| Toxic | Identical to predicate | |
| Acute Systemic Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Intracutaneous Reactivity | Per ISO10993-10:2002/A1:2006, | |
| Non-Irritant | Identical to predicate | |
| Sensitization | Per ISO10993-10:2002/A1:2006, | |
| Non-Sensitizer | Identical to predicate | |
| Bacterial Mutagenicity | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| In Vitro Mouse | ||
| Lymphoma | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Mouse Embryo Assay | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Occular Irritation | Per ISO10993-10:2002/A1:2006 | Identical to predicate |
| Non-Irritant, | ||
| Rabbit Pyrogen | Per ISO10993-11:2006, Non- | |
| Pyrogenic | Identical to predicate | |
| Subchronic | ||
| Intracutaneous Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Chemical Extractables | ||
| Analysis | LC/DAD/MS & GC/MS, No | |
| significant extractables | Identical to predicate |
5
Clinical Testing
Clinical testing was not required for this submission.
Substantial Equivalence Statement
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are substantially equivalent in intended use, principles of operation and technology, design and materials, and performance to the predicate devices.
Conclusion
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes have been validated to meet the established performance criteria. The results of the analysis and verification studies demonstrate that the 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF syringes are substantially equivalent to the predicate devices.