(29 days)
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Not Found
No
The summary describes a physical medical device (a needleless access connector) and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is an accessory for needleless access and fluid delivery, not a device that itself provides therapy.
No
Explanation: The device is described as an "accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system." This description clearly indicates a therapeutic or interventional function, not a diagnostic one.
No
The device is described as a "Needleless Access Connector," which is a physical hardware component used in intravenous therapy. The description focuses on its function as a sterile injection site for fluid delivery, not on software processing or analysis.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an accessory to an intravascular catheter used for delivering fluids to a patient's vascular system. This involves direct interaction with the patient's body for therapeutic or diagnostic purposes in vivo.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The NAC™ PLUS Needleless Access Connector is a medical device used for administering substances directly into a patient's bloodstream, which is an in vivo application, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.
Product codes
FPA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tim Truitt Manager, Research & Development Medegen Medical Manufacturing Services 930 Wanamaker Avenue Ontario, California 91761-8151
2004 JUN 4
Re: K041179 Trade/Device Name: The NAC™ PLUS Needleless Access Connector Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 5, 2004 Received: May 6, 2004
Dear Mr. Truitt:
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 mendments, 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 (1111), it noy of 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.
1
Page 2 -Mr. Truitt
Please be advised that FDA's issuanee of a substantial equivalence determination does not Freast that FDA has made a determination that your device complies with other requirements hicall that 127 mis made a eversiand regulations administered by other Federal agencies. of the Act of ally I edetal status and sequirements, including, but not limited to: registration You must comply with an the Het 5 requirements (21 CFR Part 801); good manufacturing practice alla listing (21 CF RT rat 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality brovisions (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) This tetter will anon 700 be 500 finding of substantial equivalence of your device to a premaired noutheation - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you desire specific at 100 to pliance 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 may overn band 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 yours,
Kein Muly
ton ch
for 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
2
Section 3
510(k) Number: __ IBD_K 041179
Device Name: The NAC™ PLUS Needleless Access Connector
Indications for Use:
The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
Ticle Hubbard for ADW
vision Sign-Off)
ision of Anesthesiology, General Hospital, Division of Antol. Dental Devices
510(k) Number:
OR
Section 3 - 1