The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.

Device Description

The OnSite-IV™ device is a sterile, single use device that, through the use of an integrated vial spike, facilitates creation of a sterile fluid path to transfer liquid from the syringe body to a standard pharmaceutical vial with a 20 mm cap containing a drug, in order to mix or reconstitute the drug and aspirate and transfer the prepared drug back into the syringe body for delivery into an IV bag or elastomeric pump. The device is intended to be used by health care professionals (HCPs) such as physicians, nurses and pharmacists in a clinical setting.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (OnSite-IV™), not an AI/ML device. As such, the information typically requested regarding acceptance criteria and studies for AI/ML performance (like sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information) is not applicable here.

This document describes the equivalence of a physical medical device (Intravascular Administration Set) to existing predicate devices based on its design features, intended use, and non-clinical performance testing.

Here's a summary of the non-clinical testing performed and the general acceptance criteria inferred, as best as can be derived from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria values for each test, but rather confirms that the device "operates as specified" and "functions as intended." The "reported device performance" is a confirmation of passing these tests.

Acceptance Criteria Category	Specific Test (Standard)	Reported Device Performance
Sterility	Sterilization Validation (ANSI/AAMI/ISO 11137-2:2013)	Achieves 10^-6 sterility assurance level (SAL)
Biocompatibility	Cytotoxicity (ISO 10993-5)	Passed
	Maximization Sensitization (ISO 10993-10)	Passed
	Intracutaneous Reactivity Irritation (ISO 10993-10)	Passed
	Acute Systemic Toxicity (ISO 10993-11)	Passed
	Hemolysis, Extract Method (ASTM F 756)	Passed
	Hemolysis, Direct Method (ASTM F 756)	Passed
	Materials Mediated Pyrogen Test (ISO 10993-11, USP <151>)	Passed
Physical Performance (ISO 7886-1:1993 for syringes)	Limits for Acidity or Alkalinity	Passed
	Limits for Extractable Metals	Passed
	Tolerance on Graduated Capacity	Passed
	Dead Space	Passed
	Liquid Leakage at Syringe Piston under Compression	Passed
	Air Leakage at Syringe Piston under Compression	Passed
	Air Leakage past Syringe Piston during Aspiration	Passed
	Fiducial Line	Passed
	Fit of Piston in Barrel	Passed
Additional Performance Testing	Luer Connection Performance (ISO 594-1, ISO 594-2)	Passed
	Particulate Matter (USP <788>)	Passed
	Performance of the Bacterial Retentive Filter (ASTM F2101)	Passed
Internal Requirements (after sterilization, transport, aging)	Visual Inspection	All features verified to operate as specified (passed)
	Device Retained Volume After Use	All features verified to operate as specified (passed)
	Drug Mixing	All features verified to operate as specified (passed)
	Force to Operate Valve	All features verified to operate as specified (passed)
	Graduated Marking Durability	All features verified to operate as specified (passed)

2. Sample size used for the test set and the data provenance
Not applicable as this is a physical device, not an AI/ML system evaluated on a dataset. The testing refers to physical samples of the device. The document does not specify the number of devices or components tested for each non-clinical performance test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert review are concepts for diagnostic performance evaluation of AI/ML systems. This document describes physical and biological performance tests.

4. Adjudication method for the test set
Not applicable. Adjudication methods are relevant for human interpretation disagreement in diagnostic performance studies.

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 is not an AI/ML device, and no human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device's performance is adherence to established international standards (ISO, ASTM, USP) and internal specifications for physical and biological properties.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established
Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 6, 2016

PharmaC, LLC % Sigi Caron Medtech Consultants. Inc. 20370 Skyhawk Lane Topanga, California 90290

Re: K161800

Trade/Device Name: OnSite-IVTM Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: November 7, 2016 Received: November 8, 2016

Dear Sigi Caron:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161800

Device Name OnSite-IVTM

Indications for Use (Describe)

The OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY - K161800

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

DATE PREPARED	December 6, 2016
APPLICANT	PharmaC, LLC.6655 North Vista LaneJackson, WY 83001Tel: (307) 690-3648
OFFICIAL CORRESPONDENT	Sigi CaronVice President, Regulatory and Clinical Affairs, PharmaC,LLC.Principal, MedTech Consultants, Inc.20370 Skyhawk LaneTopanga, CA 90290sigi@medtechconsultants.comTel: (310) 455-3473Fax: (888) 295-1535
TRADE NAME	OnSite-IVTM
COMMON NAME	Vial Adapter / Reconstitution Device
DEVICE CLASSIFICATION	Regulation Number - 21 CFR §880.5440Regulation Name - Intravascular administration setProduct Code LHI, Class-II
PREDICATE DEVICE	E-Z-Link - K133097IV Fluid Transfer Pin - K925401

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE:

The OnSite-IV™ is a single use sterile device indicated for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.

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SUBSTANTIALLY EQUIVALENT TO:

The OnSite-IV™ device is substantially equivalent in intended use and technological features to the E-Z Link device (K133097) and the IV Fluid Transfer Pin (K925401).

TECHNICAL CHARACTERISTICS:

The design and handling characteristics of the OnSite-IV are based on a standard injection syringe. The OnSite-IV consists of three main components: Syringe Barrel, Stopper, and Plunger with integrated vial spike (IV Fluid Transfer Pin - K925401). The Syringe Barrel has an elliptical shape with a Luer lock connector and is printed with graduation markers to indicate volume. The Syringe Barrel also has an arrow marker to indicate rotational position. The Stopper is an elastomeric sealing material that has an elliptical shape to prevent rotation within the Syringe Barrel. Rotation of the Stopper is prevented to allow the stopper to act as a valve. The Stopper has a fluid pathway and features that create a valve at the interface between the Plunger and Stopper. The Plunger has an internal fluid pathway along its length and an arrow marker to indicate rotational position. The integrated vial spike on the Plunger utilizes a bacterial retentive air-venting filter.

The OnSite-IV™ device shares the same design features as the predicate devices and does not introduce any new technological characteristics. The indications for use are similar. Both are intended for use to mix drugs in a standard pharmaceutical vial and to transfer the prepared drug back into the syringe. The OnSite-IV™ is used to transfer prepared drug into an IV bag or an elastomeric pump. This additional capability does not impact the performance of the OnSite-IVTM. The following table compares the feature of the proposed device and its predicates.

ELEMENT	ONSITE-IV™	E-Z-LINKK133097	IV FLUIDTRANSFER PINK925401
Indications for Use	The OnSite-IV™ is asterile, single usedevice indicated forthe preparation and /or transfer of drugsfrom a standardpharmaceutical vialinto an elastomericpump or IV bag.	Single use, steriledevice forpreparation or drugsin a standard vialusing liquid from astandard luersyringe to transferthe prepared drugback into thesyringe for delivery.	Vented withsecurity clip forpreparing anddispensingdiluent fromstandard 20 mmrubber-stoppered vials
Design Features
Has vial adapter / vialaccess component	yes	yes	yes
Has a syringe component	yes	yes	No syringecomponent
ELEMENT	ONSITE-IVTM	E-Z-LINKK133097	IV FLUIDTRANSFER PINK925401
Syringe and vial adapterintegrated into onecomponent	yes	No, 2 componentsystem	No. Only vialadapter
Needleless access to vial	yes	No, contains plasticand stainless steelcannulas	yes
Sterile, biocompatiblefluid path	yes	yes	yes
Assembled from plasticinjection moldedcomponents	yes	yes	yes
Single use, sterile	yes	yes	yes
Principles of Operation
Manually operated	yes	yes	yes
• mechanicallyconnected to a drugvial	yes	yes	yes
• transfers liquidmanually using asyringe plunger rod	yes	yes	No. Notsupplied withsyringe
• mixing / drugreconstitutionachieved throughmanual agitation ofthe vial whileconnected to device	yes	yes	yes
• mixed drug ismanually aspiratedback into the syringebarrel using thesyringe plunger rod	yes	yes	No. Notsupplied withsyringe

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SUMMARY OF NONCLINICAL TESTING:

Design verification & validation testing was conducted per FDA recognized standards and additional device specific performance requirements. Testing per ISO 7886-1:1993 - Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use included:

Limits for Acidity or Alkalinity ●
. Limits for Extractable Metals
Tolerance on Graduated Capacity ●

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Dead Space ●
Liquid Leakage at Syringe Piston under Compression
Air Leakage at Syringe Piston under Compression ●
Air Leakage past Syringe Piston during Aspiration
Fiducial Line
. Fit of Piston in Barrel

Sterilization of the device was validated in accordance with the VDmax 25 method described by ANSI/AAMI/ISO 11137-2:2013 to establish a 106 sterility assurance level (SAL).

Biocompatibility testing was conducted based on the nature and duration of contact, the construction of the device, and both the ISO 10993-1 recommendations and the FDA Guidance for Use of ISO10993-1:

Cytotoxicity Study using the ISO Elution Method (ISO 10993-5) ●
Maximization Sensitization (ISO 10993-10)
Intracutaneous Reactivity Irritation Test in Rabbits (ISO 10993 Part 10)
Acute Systemic Toxicity Test in Mice (ISO 10993-11)
Hemolysis, Extract Method (ASTM F 756)
Hemolysis, Direct Method (ASTM F 756)
Materials Mediated Pyrogen Test in Rabbits (ISO 10993-11, USP <151>)

Additional performance testing of the device included:

Luer Connection Performance (ISO 594-1, ISO 594-2) ●
Particulate Matter (USP <788>)
. Performance of the Bacterial Retentive Filter (ASTM F2101)

Further performance-based testing to internal requirements was also conducted after sterilization, simulated transportation conditioning and accelerated aging:

Visual Inspection ●
Device Retained Volume After Use
Drug Mixing
Force to Operate Valve ●
Graduated Marking Durability

All features provided for the OnSite-IV™ have been verified to operate as specified. Testing confirms that the OnSite-IV™ can be used according to its intended use and in an equivalent manner to the predicate devices.

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CONCLUSIONS - BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

The OnSite-IV™ is substantially equivalent to the listed predicate devices (E-Z Link device, K133097 and IV Fluid Transfer Pin - K925401) with respect to its indications for use (intended use) and technical characteristics. The differences between the E-Z Link and the OnSite-IV™ are that the E-Z link uses plastic and stainless steel cannulas to access the drug vial, and the syringe and adapter are provided as separate components. The OnSite-IV™, on the other hand, utilizes an integrated universal vial spike adapter (one integrated device, not two components). Testing per FDA recognized consensus standards, other standards and device specific bench testing demonstrate that the OnSite-IV™ functions as intended in the specific use conditions. The information and data provided in this 510(k) submission identifies that the subject device is substantially equivalent to the predicate devices.

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.