(24 days)
Not Found
No
The 510(k) summary describes a pre-filled syringe for flushing vascular access devices, with a modification to the packaging for sterile field use. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML. The performance studies focus on equivalence to the predicate device based on design verification tests, not on algorithmic performance metrics.
No
The device is described as a flush syringe used to maintain patency of vascular access devices, which is a maintenance function, not a therapeutic treatment.
No
Explanation: The device is a pre-filled saline syringe intended for maintaining the patency of vascular access devices, not for diagnosing medical conditions.
No
The device description clearly states it is a pre-filled syringe containing 0.9% Sodium Chloride Injection, USP, which is a physical medical device (a syringe with a liquid). The modification is to the packaging for sterile field use.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "maintaining patency of vascular access devices (VAD's)". This is a direct interaction with a patient's vascular system, not the examination of specimens derived from the human body.
- Device Description: The description focuses on the physical characteristics of the syringe and its packaging for sterile field use. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. There is no mention of detecting diseases, conditions, or states of health through in vitro examination.
Therefore, this device falls under the category of a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
Product codes (comma separated list FDA assigned to the subject device)
NGT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular access devices (VAD's)
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)
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.
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
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.
1
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.
2
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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.
3
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
4
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