(123 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe:
This document is a 510(k) summary for a medical device that claims substantial equivalence to a predicate device, rather than a study proving the device meets novel acceptance criteria through a comparison against a primary ground truth. It focuses on demonstrating that the subject device (with new packaging) performs identically to the predicate device, which has already been deemed safe and effective.
Therefore, many of the typical questions asked for an AI/diagnostic study (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission. This is a submission for a modification to an existing device (packaging change), where the primary goal is to show that the modified device maintains the performance characteristics of the original device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device (K121050). The reported device performance for the subject device is consistently "Identical to predicate" or "Equivalent to predicate".
| Performance Characteristic | Acceptance Criteria (Predicate Device K121050) | Reported Device Performance (Subject Device) |
|---|---|---|
| Functional Testing | ||
| Container Closure Integrity | No dye in solution; No leakage in luer well or tip threads; No leakage past 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 | Identical to predicate |
| Pump Force (1ml/hr) | 13N | Identical to predicate |
| Pump Force (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 | ||
| Bacterial Endotoxin | Per USP <85> | Identical to predicate |
| Particulate Matter | Per USP <788> | Identical to predicate |
| Assay of NaCl | Per USP <11> | Identical to predicate |
| Heavy Metals | Per USP <231> | Identical to predicate |
| Iron | Per USP <241> | Identical to predicate |
| UV/vis | Per USP <851> | Identical to predicate |
| pH | Per USP <791> | 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, Non-Irritant | Identical to predicate |
| 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 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states that "Performance Testing conducted to support substantial equivalence." It details the types of tests performed (Functional, Chemical, Biocompatibility) but does not specify the sample sizes for these tests or the data provenance. These tests would typically be laboratory-based rather than involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment. The performance criteria are objective measurements as per recognized standards (e.g., USP, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The tests performed are objective, quantitative or qualitative measurements against established specifications/standards, not subjective assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This device is a pre-filled saline syringe, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a manual medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or acceptance criteria for this medical device are based on:
- Established standards and regulations: e.g., USP (United States Pharmacopeia) for chemical properties and bacterial endotoxin, ISO (International Organization for Standardization) for biocompatibility and package integrity.
- Performance of the predicate device: The subject device is designed to perform "Identical to predicate" or "Equivalent to predicate" in all tested characteristics. The predicate device's performance already demonstrates its safety and effectiveness.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As above, no training set is relevant for this type of device.
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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
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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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510(k) Summary
| Submitted By: | John BlewittRegulatory Affairs ManagerBecton, Dickinson and CompanyMedication and Procedural Solutions1 Becton DriveFranklin Lakes, NJ 07417Phone: (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 |
| ClassificationRegulation | 21 CFR §880.5200 |
| Class | Class II |
| Product Code: | NGT |
| Predicate Device: | K1210500.9% 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.
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Performance
Performance Testing conducted to support substantial equivalence
| PerformanceCharacteristic | Predicate Device | Subject Device |
|---|---|---|
| K121050: 0.9% Sodium ChlorideInjection, USP, BD PosiFlush™ SFSyringe | 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 tipthreads;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 toremove plunger rod | Identical to predicate |
| Sustaining Force | Consistent plunger rod forces | Identical to predicate |
| Pump Force | 10ml/hr - 20N1ml/hr - 13N0.1ml/hr - 9N | Identical to predicate |
| Dead Space / ExpelledVolume | Equivalent to labeled volume onbarrel | Identical to predicate |
| Syringe Induced Reflux | 0 average reflux when connectedto 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 <85> | Identical to predicate |
| Particulate Matter | Per USP <788> | Identical to predicate |
| Assay of NaCl | Per USP <11> | Identical to predicate |
| Heavy Metals | Per USP <231> | Identical to predicate |
| Iron | Per USP <241> | Identical to predicate |
| UV/vis | Per USP <851> | Identical to predicate |
| pH | Per USP <791> | 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 MouseLymphoma | 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 |
| SubchronicIntracutaneous Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Chemical ExtractablesAnalysis | LC/DAD/MS & GC/MS, Nosignificant extractables | Identical to predicate |
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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.
§ 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).