(169 days)
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
The BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needle-shielding mechanism.
The design of the Nexiva IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port.
The provided document is a 510(k) premarket notification for the BD Nexiva™ Closed IV Catheter System, seeking substantial equivalence to predicate devices. It describes the device's intended use and technological characteristics but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data analysis, comparative effectiveness, or standalone performance metrics typically associated with AI/algorithm review.
Therefore, I cannot provide the requested information in the format of acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.
The document primarily focuses on:
- Description of the Device: BD Nexiva™ Closed IV Catheter System, its components, and its closed system features for blood exposure prevention.
- Intended Use: Short-term intravascular use for blood sampling, pressure monitoring, or fluid administration, with needle-shielding and luer access port for preventing needlestick injuries and blood exposure. It also notes suitability for power injectors.
- Technological Characteristics Comparison: Highlighting similarities to predicate devices (BD Saf-T-Intima™ IV Catheter and B. Braun Introcan® Safety™ IV Catheter) in materials, design features, and use with power injectors.
- Nonclinical Tests: Stating that the device materials were tested per ANSI/AAMI/ISO 10993-1 (1997) and a simulated use study compared Nexiva and Introcan catheters.
- Conclusion: The sponsor concluded substantial equivalence based on these nonclinical tests.
- FDA Communication: The FDA's letter confirming substantial equivalence to legally marketed predicate devices.
Missing Information:
The document is a regulatory submission for a medical device (intravascular catheter), not an AI/algorithm-based diagnostic or assistive system. As such, concepts like "acceptance criteria" and "device performance" in the context of sensitivity, specificity, accuracy, or other statistical measures, along with details on ground truth, expert adjudication, or MRMC studies for AI, are not applicable or reported here. The "study" mentioned is a "simulated use study" and materials testing, which are part of establishing substantial equivalence for physical medical devices rather than evaluating performance against specific diagnostic or prognostic metrics.
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BD Medical Systems 9450 South State Street Sandy ! '1ah 84070 tel 361.565.2300 fax: 801 565.2740 www.bd.com
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32843
PREMARKET NOTIFICATION
| Submitter: | Becton DickinsonInfusion Therapy Systems Inc. |
|---|---|
| Address: | 9450 South State StreetSandy, UT 84070 |
| Contact Person: | Leslie WoodManager, Regulatory Affairs |
| Telephone Number: | (801) 565-2504 |
| FAX Number: | (801) 565-2749 |
| Date Summary Prepared: | August 26, 2003 |
| Trade Name: | BD Nexiva™ Closed IV Catheter System |
| Common Name: | Intravascular Catheter |
| Classification Name: | Intravascular Catheter |
| Predicate Devices: | BD Saf-T-Intima™ IV CatheterB. Braun Introcan® Safety™ IV Catheter |
Description of the BD Nexiva™ Closed IV Catheter System:
The BD Nexiva Closed IV Catheter System consists of an over-the-needle, peripheral intravascular catheter made from Vialon™ polyurethane, integrated extension tubing with a Y adapter and clamp, BD Q-Syte™ luer access port, and a passive needle-shielding mechanism.
The design of the Nexiva IV catheter can be described as a closed system since it protects clinicians from blood exposure during the catheter insertion procedure. Since the needle is withdrawn through a septum that seals after the needle has been removed and both ports of the Y adapter are closed, blood is contained within the Nexiva device during catheter insertion. The pressure exerted on the needle as it passes through the septum wipes blood from the needle, further reducing potential blood exposure. The slide clamp on the integrated
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extension tubing is provided to eliminate blood exposure when the vent plug is replaced with an infusion set connection or a BD Q-Syte luer access port.
Intended Use:
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Technological Characteristics Comparison:
The Nexiva catheter is similar to the Saf-T-Intima catheter in that both have Vialon polyurethane catheters, notched needles, integrated extension tubing with Y adapters, removable access ports, and a closed system.
The Nexiva catheter is similar to the Introcan Safety catheter in that a variation in the needle circumference 'traps' the needle tip within a shield and both can be used with power injectors with a maximum pressure setting of 300 psi.
Nonclinical Tests Support Substantial Equivalence:
The Nexiva catheter is composed of materials that have been tested in accordance with ANSI/AAMI/ISO 10993-1 (1997).
The Nexiva and Introcan catheters were compared in a simulated use study.
Conclusions from Nonclinical Tests:
The Nexiva IV catheter is substantially equivalent to the Introcan device.
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 an emblem featuring a stylized eagle with three stripes extending from its wing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 2004
Ms. Leslie Wood Manager, Regulatory Affairs Becton Dickinson Infusion Therapy Systems, Incorporated 9450 South State Street Sandy, Utah 84070
Re: K032843
Trade/Device Name: BD Nexiva Closed IV Catheter System Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: December 10, 2003 Received: December 11, 2003
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 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.
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Page 2 - Ms. Wood
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 (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), 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 vours.
Chiu Lin, Ph. D.
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
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K 032843
INDICATIONS FOR USE
Device Proprietary Name:
BD Nexiva™ Closed IV Catheter System
Device Classification Name:
Intravascular Catheter (80 FOZ)
Indications for Use:
The Nexiva™ intravascular catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravascularly. The needle-shielding feature and luer access port aid in the prevention of needlestick injuries. Blood is contained within the device during the catheter insertion process aiding in the prevention of blood exposure. This catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The 18-24 gauge Nexiva catheters are suitable for use with power injectors rated for a maximum of 300 psi when the luer access port(s) is removed and a direct connection is made.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: __ X
OR
Coline Mr. Burdais
Over-The-Counter Use:
v. General Hospital,
510(k) Indications 9/3/03
510(k) Number: K032843
§ 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).