(24 days)
The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's).
The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications. The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10-6 as the Predicate Device.
The provided text describes a 510(k) premarket notification for a modified medical device, the 0.9% Sodium Chloride Injection, USP-BD Posiflush SF Flush Syringe. The modification is primarily a change in the individual package wrap to allow for sterilization and maintain sterility of the device's exterior for sterile field applications. The core device (syringe and its contents) remains unchanged from its predicate.
Based on the information provided, the following points can be extracted or inferred regarding the device's acceptance criteria and the study that proves it:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalence to Predicate Device: Must perform in an equivalent manner to the predicate device in terms of safety and effectiveness. | "Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." |
| Sterility Assurance Level (SAL): Maintain SAL of 10-6. | The modified device "has the same intended use and SAL of 10-6 as the Predicate Device." |
| Purpose: Intended for use in maintaining patency of vascular access devices (VAD's). | The modified device "is intended for use in maintaining patency of vascular access devices (VAD's)." |
| Sterile Field Application: Capable of being sterilized and maintaining sterility of the exterior for sterile field applications. | The modification was made by "changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications." |
| Material Equivalence: Manufactured of the same materials as the predicate device. | The modified device "is manufactured of the same materials... as the Predicate Device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a sample size for a test set in the traditional sense of a clinical trial. The evaluation primarily relied on "Design Verification tests" based on a "risk analysis." These tests would likely involve laboratory or engineering testing of the package and device properties, rather than human subject testing with a specific "test set" sample size. The data provenance is not specified, but it would be from internal Becton Dickinson testing (likely in the US, given the submission to the FDA). The study is retrospective in the sense that it evaluates a modified device against an already existing predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Given the nature of the device modification (packaging for sterile field use), "ground truth" would be established through engineering and sterility testing protocols rather than clinical expert consensus on diagnostic or outcomes data.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of an expert panel or adjudication for the design verification tests.
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
No MRMC comparative effectiveness study was done. This type of study is not relevant for this device, which is a saline flush syringe, not a diagnostic imaging or AI-assisted device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No standalone algorithm-only performance study was done. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance claims would be based on:
- Engineering specifications and test standards: For material properties, sterile barrier integrity, and mechanical function of the syringe.
- Microbiological testing: To confirm the sterility assurance level (SAL) of 10-6 and the ability of the new packaging to maintain sterility.
- Risk analysis: Used to identify potential failure modes and determine the necessary verification tests.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that would require a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study:
The study conducted to prove the device meets acceptance criteria was a Design Verification process. This process involved performing various tests based on a risk analysis. The core objective was to demonstrate that the modified device (with new packaging allowing for sterile field use) performed equivalently to the predicate device in terms of safety and effectiveness, manufactured from the same materials, met the same intended use, and maintained the same sterility assurance level (SAL of 10-6). The specific tests and their outcomes are not detailed, but the submission claims that the results "demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." This type of study is typical for minor modifications to already approved medical devices where the changes do not impact the fundamental design or performance of the active components.
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AUG 2 6 2004
510K SUMMARY OF SAFETY AND EFFECTIVENESS
1. Submitted By:
Peter Zurlo Manager. Regulatory Affairs
B D Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417-1883
Phone: 201-847-6447 201-847-4855 Fax:
2. Device Name:
Trade Name: 0.9% Sodium Chloride Injection, USP-BD Posiflush SF Flush Syringe
Common Name: Saline Flush Syringe
Classification Name: Device, Flush, Vascular Access
3. Predicate Device:
0.9% Sodium Chloride Injection, USP-BD Posiflush SP Prc-filled Flush Syringe
Manufactured by: Becton Dickinson and Company
4. Device Description:
The Predicate Device, the 0.9% Sodium Chloride Injection, USP- BD Posiflush SP Pre-Filled Flush Syringe (510(k) Number: K003553) is a single use disposable Hypodermic syringe filled with 0.9% Sodium Chloride Injection, USP and is intended for use in maintaining patency of vascular access devices (VAD's). The Predicate Device is only fluid path sterile to SAL of 10-
The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications.
The Modified Device is manufactured of the same materials, has the same intended use and SAL of 106 as the Predicate Device.
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న్. Intended Use:
Same intended use as the Predicate Device.
The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes is intended for use in maintaining patency of vascular access devices (VAD's).
Technological Characteristics:
The Modified Device, the subject of this 510(k), the 0.9% Sodium Chloride Injection, USP BD Posiflush SF Pre-Filled Flush Syringe was modified by changing the current individual package wrap to a package that is capable of being sterilized and will maintain sterility of the exterior of the device. This will allow the device to be used on sterile field applications.
The Modified Device is manufactured of the same materials, has the same intended use and SAL of 10t as the Predicate Device.
6. Performance:
Design Verification tests were performed based on the risk analysis performed and the results of these tests demonstrate that the BD Posiflush SF Flush Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.
The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E, under which a device can be marketed without pre-approval or classification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construcd as an admission against interest under the US patent Laws or their application by the courts.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 6 2004
Becton Dickinson C/O Mr. Peter Zurlo Manager, Regulatory Affairs BD Medical Surgical 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K042061
Trade/Device Name: 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringe Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NGT Dated: July 29, 2004 Received: August 2, 2004
Dear Mr. Zurlo:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Zurlo
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known) | K042061 |
|---|---|
| Device Name | 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringe |
| Indications for Use | The 0.9% Sodium Chloride Injection, USP, BD Posiflush SF Flush Syringes are intended for use in maintaining patency of vascular access devices (VAD's). |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801. 109)
Kei Muler
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number
00020
§ 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).