(169 days)
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No
The document describes a simple fluid delivery device (extension set) with no mention of AI/ML technology or any features that would require such technology.
No
The device is described as an extension set for LV therapy that extends the fluid path for fluid or drug administration, acting as a tubing extension rather than directly treating a condition.
No
The device is described as an extension set for IV therapy, used for fluid or drug administration, and does not mention any function related to diagnosing medical conditions.
No
The device description clearly states it consists of physical components like fluid delivery tubing, luer connectors, and clamps, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "LV. therapy when extended fluid path is required for fluid or drug administration." This describes a device used in vivo (within the body) for delivering fluids or drugs to a patient.
- Device Description: The description details components like tubing, luer connectors, and clamps, all consistent with devices used for intravenous fluid administration.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a patient's health. IVDs are typically used for testing blood, urine, tissue, etc.
Therefore, this device is a medical device used for fluid administration, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The extension sets are intended for use in I.V. therapy when extended fluid path is required in the administration of I.V. solutions or drugs. Benlan Inc. does not cause or promote new intended uses for these devices.
These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.
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.
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Attachment 1
510(k) Summary of Safety and Effectiveness
Med-Rx® Extension Sets
Submitter Information:
Bill C.K. Lim Manager of Regulatory Affairs Benlan Inc. 2760 Brighton Road Oakville, Ontario L6H 5T4 Canada
905 829-5004 Phone Fax 905 829-5006
Date 510(k) Summary Prepared: March 3, 1999
Name/Classification of the Device:
| Classification Name: | Intravascular Administration Set |
|---|---|
| Common Name: | I.V. Extension Sets |
| Propriety Name: | Med-Rx® Extension Set |
| Classification/Panel | Class II in CFR 880.5440, |
| Intravascular Administration Set | |
| Panel: General Hospital (GH) |
Identification of the Legally Marketed Device to which the Submitter Claims Equivalence:
The Med-Rx® Extension sets are substantially identical in materials, packaging, sterilization, and intended use to Medex Extension Sets, MX454-FL, MX448-L36 and 536040 manufactured by Medex Inc.
Description of the Subject Device:
The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore.
1
The extension sets may include pinch or slide clamps.
Intended Use of the Subject Device:
The extension sets are intended for use in I.V. therapy when extended fluid path is required in the administration of I.V. solutions or drugs. Benlan Inc. does not cause or promote new intended uses for these devices.
Technological Characteristics of the Subject Device:
There are no differences in the characteristics of the subject device and the predicate(s).
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 25 1999
Mr. Bill C.K. Lim Manager, Regulatory Affairs Benlan, Incorporated 2760 Brighton Road Oakville, Ontario CANADA L6H 5T4
K990777 Re :
Med-Rx® Extension Set Trade Name: Regulatory Class: II Product Code: FPA June 18, 1999 Dated: Received: June 22, 1999
Dear Mr. Lim
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 Regulations, Title 21, Parts 800 to 895. A 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
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Page 2 - Mr. Lim
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 debtired in your and equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 yitro 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 obcarned from one (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
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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Med-Rx® Extension Sets Attachment 3
510(k) Number (if known) _
Device Name: Med-Rx® Extension Sets
Indications for Use:
These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.
(Please Do Not Write Below This Line / Continue on Another Page if Needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peterson Cusack
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number 494077
Prescription Use (per 21 CFR 801.109)
。 こ
OR
Over the Counter Use _
(Optional Format 1-2-96)