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.

Indicated as a single use, sterile device for use in I.V. therapy when an extended fluid path is required for administration.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for an I.V. Administration Set, focusing on its substantial equivalence to a predicate device. It details various bench tests and biocompatibility assessments but does NOT describe an AI-powered device or associated performance studies involving AI. Therefore, I cannot provide details on AI acceptance criteria, specific AI performance metrics, or multi-reader multi-case studies.

However, I can extract the acceptance criteria and the studies that prove the I.V. Administration Set meets these criteria based on the information provided, treating the entire product as the "device" in this context.

Here's an analysis of the provided information, framed to answer the questions about acceptance criteria and study descriptions for the physical medical device:

Acceptance Criteria and Study for MOBILE I.V. SYSTEMS, LLC Primary I.V. Fluid Administration Set

The device in question is a physical medical device, an "I.V. Administration Set," and not an AI-powered diagnostic tool. Therefore, the "acceptance criteria" relate to its functional performance, safety, and substantial equivalence to a predicate device, as demonstrated through bench testing, biocompatibility testing, and sterilization validation.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance / Study Finding
Device Malfunction	Bench Testing (ISO 8536-4, Infusion sets for single use, gravity feed):	Performed and validated. The submission states that these tests were performed to validate critical parameters and reduce risk, implying successful completion. The device is found substantially equivalent based on these results.
	- 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	Performed per internal test method. Implied successful, as part of the overall substantial equivalence claim.
Adverse Tissue Reaction	Biocompatibility Testing (ISO 10993 series):	Testing performed on the predicate device by GVS. All materials of construction for the Mobile I.V. Systems device are stated to be the same as the predicate device. Therefore, the predicate's successful biocompatibility results are applied. - 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 (Note: 10993-10 appears twice for different tests; this is as listed in the document for Sensitization and Intracutaneous Injection)
Infection	Sterility Testing (ISO 11137:2006)	Validation will be done according to ISO 11137:2006, with a sterility assurance level of 10-6. (Note: "Will be done" implies this was a commitment for future validation but accepted for 510(k) submission based on the protocol).
	Sterile Packaging Testing (ISO 11607:2006)	Validation will be done according to ISO 11607:2006. (Same note as above).
	Pyrogen Testing (USP 30:2007, <85> and <161>)	Sets were validated using the Kinetic Turbidimetric method. Implied successful.
	Bacterial Retention Testing (on predicate device, GVS Speedflow)	Performed on the predicate device (same filter used). - 0.2 um filter: removed ≥99.9% of Brevundimonas diminuta. - 1.2 um filter: removed >99.9% of Candida Albicans. (These results were accepted due to the use of the same filter).
Improper Use	Labeling	Mitigation measure is proper labeling. While no "performance" result is given, the implication is that the labeling will be compliant and adequate to mitigate this risk. This is typically reviewed by the FDA as part of the submission process and confirmed by the approval letter.
Overall Equivalence	Substantial Equivalence to Predicate Device (GVS Speedflow I.V. Administration Set with Easydrop Flow Regulator, K061115). The new device has the same materials, solvents, intended use, and similar design elements (e.g., all-position drip chamber).	The FDA determined the device is substantially equivalent to the predicate device, allowing it to be marketed. The summary states that "The materials and solvents... are the same as, 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. Sample Size Used for the Test Set and the Data Provenance

The document does not specify exact sample sizes (e.g., number of sets tested) for each bench test conducted. It only mentions what tests were performed.

Test Set: Not explicitly stated as a number of devices, but rather specific tests according to ISO standards.
Data Provenance: The tests are standard bench tests, not clinical data from patients. They are performed in a laboratory setting. Biocompatibility and Bacterial Retention data were derived from testing performed on the predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. This is a physical device, and its "ground truth" is established through engineering and scientific bench testing against established international standards (ISO, USP) for physical and chemical properties, sterilization, and biocompatibility. There are no "experts" establishing a "ground truth" in the way radiologists establish ground truth for diagnostic images. The test results themselves, when compliant with the specified standards, serve as the "ground truth" for the device's performance.

4. Adjudication Method for the Test Set

Not applicable. This concept ("2+1", "3+1") is typically relevant for expert consensus in clinical data labeling or interpretation, especially with AI. For a physical device, compliance is determined by meeting objective quantitative or qualitative criteria within the specified test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This device is an I.V. administration set, not an AI diagnostic tool that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety is based on:

Compliance with International Standards: ISO 8536-4 (Infusion sets), ISO 10993 (Biocompatibility), ISO 11137 (Sterilization), ISO 11607 (Packaging), and USP 30 (Pyrogen).
Predicate Device Data: Biocompatibility and bacterial retention were established by tests performed on the predicate device, given the identical materials and components.
Internal Test Methods: For priming volume testing.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this physical device.

Summary

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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

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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, <85> Biological Tests and Assays, Bacterial Endotoxin Test and USP30:2007, <161> 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.

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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.

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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

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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

Regulation Number and Section

§ 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.