(162 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No
This device is an accessory to an intravascular administration set, designed to facilitate fluid transfer, not to provide therapy itself.
No
This device is described as an accessory to an intravascular administration set that permits injection, gravity flow, or withdrawal of fluids. Its function is to manage fluid flow in a closed system, not to gather information about a patient's health status for diagnostic purposes.
No
The device description clearly describes a physical, mechanical valve (a "closed system that opens when a standard male luer taper is inserted and closes automatically"). There is no mention of software as the primary component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's an "accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids." This describes a device used for administering or withdrawing substances directly from the vascular system of a patient.
- Device Description: The description reinforces its function as a connector for fluid transfer within a closed system, activated by a standard luer taper.
- Anatomical Site: The anatomical site is the "vascular system," which is within the living body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for fluid management.
N/A
Intended Use / Indications for Use
The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter. An administration set may include the needle or catheter, tubing, flow regulator, drip chamber, infusion line filter, IV set stopcock, fluid delivery tubing, connectors between parts of the set, side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container.
Product codes
FPA
Device Description
The BD Saf-T PRN Luer Activated Valve is a closed system that opens when a standard male luer taper is inserted and closes automatically when the male luer taper is disconnected. The BD Saf-T PRN valve permits injection, gravity flow or withdrawal of fluids. It is compatible with standard luer slip and luer lock adapters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
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)
Nonclinical Tests Support Substantial Equivalence:
The following characteristics of the BD Saf-T PRN Luer Activated Valve and the Clave Connector C-1000 were shown to be substantially equivalent: actuation force, luer torque and pull forces, flow rate, back pressure, insertion force to access the device, leak testing, hemolysis, and microbial ingress.
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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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BD Medical Systems 9450 South State Street Sandy, Utah 84070 tel: 801.565.2300 fax: 801.565.2740 www.bd.com
Image /page/0/Picture/3 description: The image shows the BD logo, which consists of a stylized sun-like symbol with a human-like figure at the bottom left. To the right of the symbol are the letters 'BD' in a bold, sans-serif font. Below the letters, there is the text 'indispensable to human health' in a smaller, sans-serif font.
Premarket Notification [510(k)] Summary
| Submitter: | Becton Dickinson Infusion Therapy Systems Inc. |
|---|---|
| Address: | 9450 South State Street |
| Sandy, UT 84070 | |
| Contact Person: | Leslie Wood |
| Manager, Regulatory Affairs | |
| Telephone Number: | (801) 565-2504 |
| FAX Number: | (801) 565-2749 |
| Date Summary Prepared: | October 25, 2001 |
| Trade Name: | BD Saf-T PRN Luer Activated Valve |
| Common Name: | Luer Activated Valve |
| Classification Name: | Accessory to an Intravascular Administration Set |
| Predicate Device: | Clave® Connector C-1000 |
| ICU Medical Inc. | |
| K970855 |
Description of the BD Saf-T PRN Luer Activated Valve:
The BD Saf-T PRN Luer Activated Valve is a closed system that opens when a standard male luer taper is inserted and closes automatically when the male luer taper is disconnected. The BD Saf-T PRN valve permits injection, gravity flow or withdrawal of fluids. It is compatible with standard luer slip and luer lock adapters.
Intended Use of the BD Saf-T PRN Luer Activated Valve:
The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
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Technological Characteristics Comparison:
The BD Saf-T PRN Luer Activated Valve and the Clave Connector are both IV administration set accessories that provide needleless access. Both products are (1) activated by the insertion of a luer taper, (2) built with a polycarbonate body and silicone seal; (3) have the same indications for use, and (4) similar performance characteristics.
Nonclinical Tests Support Substantial Equivalence:
The following characteristics of the BD Saf-T PRN Luer Activated Valve and the Clave Connector C-1000 were shown to be substantially equivalent: actuation force, luer torque and pull forces, flow rate, back pressure, insertion force to access the device, leak testing, hemolysis, and microbial ingress.
Conclusions from Nonclinical Tests:
The BD Saf-T PRN Luer Activated Valve is substantially equivalent to the Clave® Connector C-1000 manufactured by ICU Medical.
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 premarket approval or reclassification. 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 construed as an admission against interest under the US Patent Laws or their application by the courts.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, with three abstract shapes that could represent people or snakes.
APR 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070
Re: K013621
Trade/Device Name: BD SAF-T PRN Access Site, Model 385100 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 27, 2002 Received: February 28, 2002
Dear Ms. Wood:
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 approvisions 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 (1 11 )) it 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.
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You must comply with all the Act's requirements, including, but not limited to: registration r od intilition (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and ilsung (21 et read on ) en alley systems (QS) regulation (21 CFR Part 820); and if requirences as bet relia 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 alle Free may of stance 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,
Tim A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Indications for Use:
21 CFR Part 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES General Hospital and Personal Use Therapeutic Devices Sec. 880.5440:
An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter. An administration set may include the needle or catheter, tubing, flow regulator, drip chamber, infusion line filter, IV set stopcock, fluid delivery tubing, connectors between parts of the set, side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container.
The BD Saf-T PRN Luer Activated Valve needleless connector is an accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
Patricio Cucenite
(Division Sign-Off) ( Tivision Sign of Dental, Infection Control, and General Hospital Devices 510(k) Number --
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