(112 days)
Not Found
No
The document describes a standard I.V. fluid administration set with mechanical components for flow regulation and filtration. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies are focused on physical and biological properties, not computational performance.
No.
The device is an I.V. fluid administration set, which is used to deliver fluids, but it does not intrinsically provide therapy. It is a conduit for therapeutic agents.
No
Explanation: The device is an "I.V. Fluid Administration Set" used for the delivery of fluids, not for diagnosing conditions. Its description focuses on fluid pathway components, flow regulation, and sterility, with no mention of diagnostic functions.
No
The device description clearly outlines physical components like tubing, filters, spike, drip chamber, injection sites, and a flow regulator, indicating it is a hardware device. The performance studies also focus on physical properties and biological interactions, not software validation.
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 for "gravity fed I.V. therapy or with a pressure infuser, when an extended fluid path is required for administration." This describes a device used to deliver fluids into the body, not to test samples from the body.
- Device Description: The description details components like tubing, filters, spike, drip chamber, injection sites, and flow regulator. These are all typical components of an IV administration set, which is used for delivering fluids, not for diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is an IV administration set, which is a medical device used for delivering fluids intravenously.
N/A
Intended Use / Indications for Use
Indicated as a single use, sterile device for use in gravity fed I.V. therapy or with a pressure infuser, when an extended fluid path is required for administration.
Product codes
FPA
Device Description
Mobile I.V. Systems device, the Primary I.V. Fluid Administration Set consists of a tubing set with either a 0.2 um or a 1.2um GVS S.p.A filter, universal spike, all position drip chamber, two injection sites and a removable Easydrop flow regulator and is used as a fluid pathway for I.V. administration. Mobile I.V. will offer three models, which will allow the choice of 10drops/ml, 20 drops/ml, or 60 drops/ml. The Primary I.V. Fluid Administration Set was designed for Emergency Medical and Hospital settings and includes an all position drip chamber. The drip chamber allows the flow of liguid regardless of the position of the drip chamber.
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
Not Found
Intended User / Care Setting
Emergency Medical and Hospital settings
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Device Malfunction = Bench tests from ISO 8536-4, Infusion sets for single use, gravity feed
Section 6.2 Leak Testing
Section 6.3 Tensile Strength Testing
Section 6.8 Drip Chamber Fluid Delivery Testing
Section 6.10 Flow Rate Testing
Priming Volume Testing, per internal test method.
Adverse Tissue Reaction = Biocompatibility
Biocompatibility testing was performed on the predicate device by GVS. All materials of construction including solvents are the same as this predicate device.
ISO 10993-10, Sensitization, ISO 10993-11, Acute Systemic Injection, ISO 10993-3, Haemocompatibility; ISO 10993-5, Cytotoxicity MEM Elution; ISO 10993-10, Intracutaneous Injection
Infection = Sterilization
Sterility Testing: Validation will be done according to ISO 11137:2006, with a sterility assurance level of 10-6.
Sterile Packaging Testing: Validation will be done according to ISO 11607:2006, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Pyrogen Testing: Sets were validated according to USP 30:2007, Biological Tests and Assays, Bacterial Endotoxin Test and USP30:2007, Transfusion and Infusion Assemblies and Similar Medical Devices. The Kinetic Turbidimetric method was used.
Bacterial Retention Testing: Per industry recommendations, was performed on the predicate device, GVS Speedflow. The same filter is being used in the Mobile I.V. Systems Primary I.V. Fluid Administration Set.
The 0.2um was tested and found to remove greater than or equal to 99.9% of the challenged organism, Brevundimonas diminuta.
The 1.2 um was tested and found to remove >99.9% of the challenged organism, Candida Albicans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The 0.2um was tested and found to remove greater than or equal to 99.9% of the challenged organism, Brevundimonas diminuta.
The 1.2 um was tested and found to remove >99.9% of the challenged organism, Candida Albicans.
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.
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.
Not Found
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).
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.
0
K08ø695
MOBILE I.V. SYSTEMS, LLC
23630 North 35th Dr. Glendale, AZ 85310 623-434-3136 Fax: 623-434-3204
3. 510(k) Summary
JUL -1 2008
Updated Summary Prepared: 9 May 2008 Common Name: Primary IV Fluid Administration Set Classification Name: Intravascular Administration Sets Product Code: FPA Panel: General Hospital and Personal Use Device Classification: II
Substantially Equivalent to: The GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator, K061115.
Description: Mobile I.V. Systems device, the Primary I.V. Fluid Administration Set consists of a tubing set with either a 0.2 um or a 1.2um GVS S.p.A filter, universal spike, all position drip chamber, two injection sites and a removable Easydrop flow regulator and is used as a fluid pathway for I.V. administration. Mobile I.V. will offer three models, which will allow the choice of 10drops/ml, 20 drops/ml, or 60 drops/ml. The Primary I.V. Fluid Administration Set was designed for Emergency Medical and Hospital settings and includes an all position drip chamber. The drip chamber allows the flow of liguid regardless of the position of the drip chamber.
Intended Use: Indicated as a single use, sterile device for use in gravity fed I.V. therapy or with a pressure infuser, when an extended fluid path is required for administration.
Risk Analysis Method- The FDA Guidance, Intravascular Administration Sets Premarket Notification Submissions [510(k)] was used for the Risk Analysis. The specific risks associated with this device were:
| Identified Risk | Mitigation Measure |
|---|---|
| Device Malfunction | Bench Testing |
| Adverse Tissue Reaction | Biocompatibility |
| Infection | Sterilization |
| Improper Use | Labeling |
Device Characteristics: In order to validate critical parameters of the product required to reduce risk, the following were performed:
Device Malfunction = Bench tests from ISO 8536-4, Infusion sets for single use, gravity feed
Section 6.2 Leak Testing Section 6.3 Tensile Strength Testing Section 6.8 Drip Chamber Fluid Delivery Testing Section 6.10 Flow Rate Testing
1
K$\phi$8$\phi$695 page 2 of 2
MOBILE I.V. SYSTEMS, LLC
23630 North 35th Dr. Glendale, AZ 85310 623-434-3136 Fax: 623-434-3204
5. 510(k) Summary - continued
Bench Testing - continued
Priming Volume Testing, per internal test method.
Adverse Tissue Reaction = Biocompatibility
Biocompatibility testing was performed on the predicate device by GVS. All materials of construction including solvents are the same as this predicate device.
ISO 10993-10, Sensitization, ISO 10993-11, Acute Systemic Injection, ISO 10993-3, Haemocompatibility; ISO 10993-5, Cytotoxicity MEM Elution; ISO 10993-10, Intracutaneous Injection
Infection = Sterilization
Sterility Testing: Validation will be done according to ISO 11137:2006, with a sterility assurance level of 10-6.
Sterile Packaging Testing: Validation will be done according to ISO 11607:2006, Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems.
Pyrogen Testing: Sets were validated according to USP 30:2007, Biological Tests and Assays, Bacterial Endotoxin Test and USP30:2007, Transfusion and Infusion Assemblies and Similar Medical Devices. The Kinetic Turbidimetric method was used.
Bacterial Retention Testing: Per industry recommendations, was performed on the predicate device, GVS Speedflow. The same filter is being used in the Mobile I.V. Systems Primary I.V. Fluid Administration Set.
The 0.2um was tested and found to remove ≥99.9% of the challenged organism, Brevundimonas diminuta.
The 1.2 um was tested and found to remove >99.9% of the challenged organism, Candida Albicans.
Summary: The materials and solvents of the Primary I.V. Fluid Administration Set are the Summal y . The materials since, GVS Speedflow I.V. Set w/Easydrop Regulatory. K# 061115. The intended use and test results show or will show that the Mobile I.V. Systems Primary I.V. Fluid Administration Set is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL -1 2008
Northwind Technologies, Corporation Mobile I.V. Systems, LLC C/O Ms. Dawn I. Moore Regulatory Consultant Dawn I. Moore 20171 Bowens Road Manchester, Michigan 48158
Re: K080695
Trade/Device Name: I.V. Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 23, 2008 Received: May 23, 2008
Dear Ms. Moore:
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.
3
Page 2 - Ms. Moore
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 (QS) 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 (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 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/industry/support/index.html.
Sincerely yours,
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
4
K080 695
Indications for Use Statement
510(k) Number:
K080695 (to be assigned)
Device Name:
I.V. Administration Sets
Indications for Use:
Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.
Prescription Use: V (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anthony D. Water
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: 上一次必必的 695