(86 days)
Not Found
No
The document describes a syringe pre-filled with Heparin Lock Flush Solution and its sterilization method. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a Heparin Lock Flush Solution intended to maintain the patency of vascular access devices. While essential for medical procedures, maintaining patency prevents issues rather than directly treating a disease or condition, which is characteristic of a therapeutic device. It helps to keep a channel open, not to introduce a treatment.
No
This device is a Heparin Lock Flush Solution, intended to maintain the patency of vascular access devices. Its function is to prevent blockages, not to diagnose a medical condition.
No
The device description explicitly states it is a syringe filled with a solution, which are physical components, 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 "maintaining the patency of vascular access devices (VAD's)". This is a therapeutic or maintenance function performed directly on a patient's vascular access device, not a diagnostic test performed on a sample taken from the body.
- Device Description: The device is a pre-filled syringe containing Heparin Lock Flush Solution. This is a drug delivery or device maintenance product, not a diagnostic reagent or instrument used to analyze a sample.
- No Mention of Diagnostic Testing: The description focuses on the physical characteristics of the syringe and the solution, sterilization, and equivalence to predicate devices used for flushing. There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)
10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter .
Product codes (comma separated list FDA assigned to the subject device)
NZW
Device Description
The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.
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)
Design Verification tests were performed based on the risk analysis performed and results of these tests demonstrate that the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe performed in an equivalent manner to the predicate devices 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
510(K) Summary of Safety and Effectiveness
Submitted By: 1.
John Roberts Regulatory Affairs Specialist
JUN 10 2009
BD Medical Surgical 1 Becton Drive Franklin Lakes, NJ 07417
Tel: 201 847 5473 201 847 5307 Fax:
2. Device Name:
Trade Name: Heparin Lock Flush Solution, USP -BD PosiFlushTM Heparin Lock Flush Syringe
Heparin Lock Flush Syringe Common Name:
Classification Name: Heparin, Vascular Access Flush
3. Predicate Device:
| Trade Name: | BD Pre-Filled Heparin Lock Flush in 0.9% Sodium Chloride Injection, USP syringe |
|---|---|
| Manufacturer: | Becton, Dickinson and Company |
| 510(k) Number: | K011967 |
| Trade Name: | 0.9% Sodium Chloride Injection, USP – BD Pre-Filled Flush Syringe |
| Manufacturer: | Becton, Dickinson and Company |
| 510(k) Number: | K003553 |
| Trade Name: | Monoject Prefill Heparin Lock Flush Syringe |
| Manufacturer: | Tyco Healthcare |
| 510(k) Number: | K013556 |
Device Description: 4.
The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.
000031
1
Intended Use: ડાં
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)
10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter .
Technological Characteristics: 6.
The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave.
The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.
7. Performance:
Design Verification tests were performed based on the risk analysis performed and results of these tests demonstrate that the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended.
000032
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. John Roberts Regulatory Affairs Specialist Becton Dickinson and Company BD Medical Surgical -1 Becton Drive MC237 Franklin Lakes, New Jersey 07417
JUN 1 0 2009
Re: K090680
Trade/Device Name: Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe
Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: NZW Dated: May 12, 2009 Received: May 13, 2009
Dear Mr. Roberts:
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 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. Roberts
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anthony V. Winter for
Susan Runner, D.D.S., M.A.
Acting 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): K090680
Device Name:
Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe
Indications for Use:
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)
10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
000030
510(k) Number: