(14 days)
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No
The summary describes a simple mechanical connector for fluid delivery and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is an accessory for fluid delivery to a patient's vascular system, not for treating a disease or condition itself.
No
Explanation: The MaxPlus Tru-Swab Positive Displacement Connector is described as an accessory for fluid delivery to a patient's vascular system, not for diagnosing a condition.
No
The device is described as a "Positive Displacement Connector," which is a physical accessory to an intravascular administration set. The description focuses on its function as a sterile injection site for fluid delivery, indicating a hardware component.
Based on the provided information, the MaxPlus Tru-Swab Positive Displacement Connector 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 for delivering fluids to a patient's vascular system. This is a device used in vivo (within the body) for direct patient treatment.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. They are used outside the body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, diagnostic testing, or any function related to determining a medical condition based on laboratory results.
Therefore, the MaxPlus Tru-Swab Positive Displacement Connector falls under the category of a medical device used for patient treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used 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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 - 2005
Medegen Medical Manufacturing System c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K051939
Trade/Device Name: Maxplus Tru-Swab Positive Displacement Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: July 14, 2005 Received: July 18, 2005
Dear Mr. Job:
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.
1
Page 2 - Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be actives that I Dri bristian that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacar statutes and securements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, laoomig (DF OF RT 820); and if applicable, the electronic form in the quarty by sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only to begin marketing your device as described in your Section 510(k) I his icher will anow you to begin mains of substantial equivalence of your device to a legally prematicated predicated on " 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 If you desire specific acrioliance at (240) 276-0115. 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 other general 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/industry/support/index.html.
Sincerely yours,
Clu L
Sida Liu, 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
2
45/939 510(k) Number (if known):
Device Name: MaxPlus™ Tru-Swab™ Positive Displacement Connector.
Indications for Use:
The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used 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)
signature
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
(Per 21 CFR 801.109)
15431939 510(k) Number:_ Prescription Use
OR
Over-The-Counter Use
(Optional Format 1-2-96)