(656 days)
No
The device description and intended use are for prefilled saline syringes, which are a simple medical device and do not involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
The device is indicated for flushing and maintaining the patency of intravascular catheters, which are maintenance and preventative actions, not therapeutic treatment of a disease or condition.
No
Explanation: The device is described as prefilled syringes with saline solution for flushing and maintaining patency of intravascular catheters, not for diagnosing medical conditions.
No
The device description clearly states it is a prefilled syringe with a saline solution, which are physical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters." This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The description reinforces the intended use and mentions the contents (sterile 0.9% saline solution) and the purpose (flushing and maintaining patency). There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a medical device used for a procedural purpose related to maintaining the function of intravascular catheters.
N/A
Intended Use / Indications for Use
The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.
Product codes
FMF, FOZ
Device Description
B. Braun Medical. Inc. intends to introduce into interstate commerce the Braun Prefilled Syringes. The syringes are aseptically filled with sterile 0.9% saline solutions intended solely for use in flushing intravascular catheters and maintain the patency of indwelling intravascular catheters. The syringes and solutions are not intended for use as anticoagulant therapy. The aseptic filling of these syringes with these solutions does not alter the intended use of the svringes or the solutions. The svringes have been cleared for marketing under K760392. The solutions meet the specifications of the applicable USP monograph for sodium chloride.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
DEC 1 6 1998
510(k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem. PA 18018 (610)691-5400
August 31, 1998
CONTACT: Mark S. Alsberge, Regulatory Affairs Director
PRODUCT NAME: Braun Prefilled Syringes
Prefilled Intravascular Catheter TRADE NAME: Flush Syringes
CLASSIFICATION NAME:
Class: Il Panel: 80 General Hospital Devices Procode: FMF Piston Syringe
These devices have also been reviewed by the FDA as Accessory items to:
Class: II Panel: 80 General Hospital Devices Procode: FOZ Intravascular Catheters
DEVICE DESCRIPTION:
B. Braun Medical. Inc. intends to introduce into interstate commerce the Braun Prefilled Syringes. The syringes are aseptically filled with sterile 0.9% saline solutions intended solely for use in flushing intravascular catheters and maintain the patency of indwelling intravascular catheters. The syringes and solutions are not intended for use as anticoagulant therapy. The aseptic filling of these syringes with these solutions does not alter the intended use of the svringes or the solutions. The svringes have been cleared for marketing under K760392. The solutions meet the specifications of the applicable USP monograph for sodium chloride.
1
MATERIALS:
The materials use to manufacture the syringes, as well as, the solutions used to fill the syringes have previously been reviewed by the FDA and determined to be suitable for the intended use of this product. The processes used to aseptically fill these syringes do not alter the properties or intended use of these materials.
| 510(k) number | Name | Applicant |
|---|---|---|
| K760392 | Syringes | B. Braun Instruments, Inc. |
| K952645 | Vital Signs Saline | |
| Vascular Access Flush | ||
| Device | Vital Signs, Inc. | |
| Unknown | SolopakTM | |
| 0.9% Sodium Chloride | Solopak Medical Products, | |
| Inc. |
SUBSTANTIAL EQUIVALENCE TO:
SUBSTANTIAL EQUIVALENCE:
B.Braun has marketed the syringes used in this device since their clearance by the FDA in 1976 (K760392). The solutions used in this device have also been cleared for their intended use by FDA review. The solutions meet the specifications of the applicable USP monograph for 0.9% sodium chloride USP. The processes used to aseptically fill these syringes do not alter the properties or intended use of these materials. The intended use, design, and labeling (warnings and claims) are substantially equivalent to the above listed devices. There are no new issues regarding safety and effectiveness raised by B. Braun Medical, Inc.'s intent to introduce into interstate commerce the Braun Prefilled Syringes.
2
1 The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from a FDA -requlatory point of view under the Federal Food. Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
SAFETY AND EFFECTIVENESS:
The aseptic filling of these syringes with the solution does not alter the intended use of the svringe or the solution. The manufacturing processes and controls adhere to currently accepted quidelines and standards of practice.
Currently marketed prefilled syringes incorporate similar features and are available from a number of manufacturers for the same intended use. A review of the current literature and MDRs indicate that there are no additional risks or concerns associated with the use of prefilled syringes solely for use in flushing intravascular catheters or in preventing blood clots in these catheters.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an abstract symbol that resembles a human figure or a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1998
Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue 18018-0027 Bethlehem, Pennsylvania
Re : K970736 Trade Name: Braun Prefilled Syringes Requlatory Class: II Product Code: FOZ September 11, 1998 Dated: September 21, 1998 Received:
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ರ್ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
4
Page 2 - Mr. Alsberge
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timoty A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SIO(k) Number (if known): K9707 36
Normal Saline Prefilled Syringes Device Name:
Indications For Use:
The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.
The following table lists the available fill volumes and syringe sizes. .
| DESCRIPTION | Fill
Vol | ml | Syr
Size | ml | CAPS
Product# | WSN# |
|-------------------------|-------------|----|-------------|----|------------------|--------------|
| 0.9% Sodium Chloride PF | 1 | ml | 3 | ml | 000-NS-0103 | 8193-9101-11 |
| | 2 | ml | 3 | ml | 000-NS-0203 | 8193-9101-12 |
| | 3 | ml | 6 | ml | 000-NS-0306 | 8193-9101-23 |
| | 3 | ml | 12 | ml | 000-NS-0312 | 8193-9101-33 |
| | 5 | ml | 6 | ml | 000-NS-0508 | 8193-9101-24 |
| | 5 | ml | 12 | ml | 000-NS-0512 | 8193-9101-34 |
| | 10 | ml | 12 | ml | 000-NS-1012 | 8193-9101-35 |
CAPS FLUSH SYRINGE PRODUCT LISTING TABLE
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Cusack
(Division Sign-Off) Division of Dental, Infor and General Hospit 510(k) Number
Prescription Use_X (Pcr 21 CFR 801.109) .. OR
Over-The-Counter Use
(Optional Formal 1-2-90)