(212 days)
Not Found
No
The device description and intended use are for a pre-filled syringe containing Heparin Lock Flush Solution, a standard medical product for maintaining vascular access device patency. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The device's intended use is to maintain the patency of vascular access devices, which is a maintenance function rather than a direct therapeutic action to treat a disease or condition. The Heparin contained is for flushing to prevent clotting in the VAD, not to treat a pre-existing medical condition of a patient.
No
Explanation: The device is a Heparin Lock Flush Solution syringe intended for maintaining the patency of vascular access devices (VADs), which is a therapeutic and maintenance function, not a diagnostic one.
No
The device description clearly indicates it is a physical syringe containing a solution, not a software product.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "maintaining patency of vascular access devices (VAD'S)". This describes a direct therapeutic or maintenance action within the body (or on a device connected to the body), not a 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 substance administered to the patient (or into a device connected to the patient) to prevent clotting.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing a biological sample (blood, urine, tissue, etc.) to provide diagnostic information.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S).
Product codes
NGT
Device Description
Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe. Product sizes/reorder numbers include various concentrations of Heparin (10u/mL and 100u/mL) in different fill volumes (2mL, 3mL, 5mL, 6mL) within 3mL, 5mL, or 10mL syringes. Some configurations also include a blunt plastic cannula or are part of a SASH Kit (Saline, Administer, Saline, Heparin) with 0.9% Sodium Chloride Syringes. The device contains a sterile flush solution (0.9% Sodium Chloride Injection, USP and Heparin Sodium 10 and 100U/mL solution), has sterile solution contents and fluid path, is aseptically filled, features a three-piece piston design, and has a barrel molded from polypropylene.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
1 Becton Drive Franklin Lakes, New Jersey 07417 tel: 201.847.6800 www.bd.com
K04967
JAN 2 3 2002
Image /page/0/Picture/3 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a stylized sun-like symbol on the left and the letters "BD" on the right. The sun-like symbol has a circle with rays emanating from the top and a stylized figure at the bottom. The letters "BD" are in a bold, sans-serif font.
Indispensable to human health
Summary of Safety and Effectiveness for the Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe
1 BD Contact person:
Gregory W. Morgan Head of Regulatory BD Medical Surgical - Mail Code 226 1 Becton Drive Franklin Lakes, NJ 07417-1880 Phone (201) 847-4344 (201) 847-4855 Fax
- 2 Device Name: Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe
- 3 Predicate Device(s):
- 4 Product Description / Function:
Product sizes/reorder numbers: The following sizes/reorder numbers of the Heparin Lock Flush Solution, USP syringes to be offered are:
| BD | |
|---|---|
| Cat. # | Description |
| 306509 | Heparin, 10u/mL, 6mL Fill In 10mL Syringe |
| 306510 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe |
| 306511 | Heparin, 10u/mL, 5mL Fill In 5mL Syringe |
| 306521 | Heparin, 10u/mL, 3mL Fill In 10mL Syringe |
| 306512 | Heparin, 10u/mL, 3mL Fill In 3mL Syringe |
| 306527 | Heparin, 10u/mL, 2mL Fill In 3mL Syringe |
| 306513 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe |
| 306514 | Heparin, 100u/mL, 3mL Fill In 10mL Syringe |
1
| BD
| Cat. # | Description |
|---|---|
| 306515 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe |
| 306516 | Heparin, 100u/mL, 3mL Fill In 5mL Syringe |
| 306517 | Heparin, 100u/mL, 3mL Fill In 3mL Syringe |
| 306528 | Heparin, 100u/mL, 2mL Fill In 3mL Syringe |
| 306525 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306531 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306529 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe With Blunt Plastic Cannula |
| 306537 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock |
| Flush Syringe), 5mL Fill In 10mL Syringe - 100u/mL Heparin | |
| 306538 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 10u/mL Heparin Lock |
| Flush Syringe), 3mL Fill In 3mL Syringe - 10u/mL Heparin | |
| 306539 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock |
| Flush Syringe), 3mL Fill In 5mL Syringe - 100u/mL Heparin |
Intended Uses: Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S).
-
5 Equivalence determination:
The elements of comparison between the Heparin Lock Flush Solution. USP syringes with the BD Preefil™ Normal Saline Flush syringe, the Baxter Heparin Lock Flush syringe and Vital Signs Heparin Lock Flush Device predicate devices are as follows: -
The Heparin Lock Flush Solution, USP syringe contains sterile flush (0.9% ● Sodium Chloride Injection, USP and Heparin Sodium 10 and 100U/mL solution as does the predicate devices).
-
The Heparin Lock Flush Solution, USP syringe has a sterile solution contents . and fluid path as do the predicate devices.
-
The Heparin Lock Flush Solution, USP syringe is aseptically filled as the . predicate device, BD Preefil TM.
-
The Heparin Lock Flush Solution, USP syringe is a three-piece piston design . as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe.
-
. The Heparin Lock Flush Solution, USP syringe barrel is molded from polypropylene as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe.
-
. The Heparin Lock Flush Solution, USP syringe has a similar package unit design as the predicate device, BD Preefil ™.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three stylized human figures.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 3 2002
Mr. Gregory W. Morgan BD Medical Surgical BD Medical Injections Systems 1 Becton Drive, MC 226 Franklin Lakes, New Jersey 07417
Re: K011967
Trade/Device Name: BD Pre-Filled Heparin Lock Flush Syringe Regulation Number: 880.5200 Regulation Name: Heparin Lock Flush Syringe Regulatory Class: II Product Code: NGT Dated: November 7, 2001 Received: November 8, 2001
Dear Mr. Morgan:
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.
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.
3
Page 2 - Mr. Morgan
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/adrh/dsma/dsmamain.html
Sincerely yours,
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining
patency of vascular access devices (VAD'S).
Patricie Cucenate
Division Sign. Oto
sion Sign-Off) sion of Dental, Infection Corn Fral Hospital T