VERSARATE FLOW RATE CONTROLER

K123729 · Emed Technologies Corporation · FPA · Dec 21, 2012 · General Hospital

Device Facts

• Record ID: K123729
• Device Name: VERSARATE FLOW RATE CONTROLER
• Applicant: Emed Technologies Corporation
• Product Code: FPA · General Hospital
• Decision Date: Dec 21, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

Device Story

VersaRate™ Flow Rate Controller is a disposable, manual IV flow control device. It connects to standard administration sets and fluid sources via luer lock connectors. Operation involves user rotation of a flow dial to adjust the internal fluid path dimensions, thereby regulating the fluid flow rate (5–230 mL/hr). Used in clinical settings to manage fluid delivery; provides precise, controlled infusion. Benefits include extended duration of use (up to 72 hours) and high pressure tolerance (up to 25 psi) compared to predicate. Healthcare providers manually set the rate; output is the physical regulation of fluid flow to the patient.

Clinical Evidence

Bench testing only. Testing compared flow rate control (5–230 mL/hr), residual volume (<0.25 mL), duration of use (72 hours), and pressure tolerance (25 psi) against the predicate. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemocompatibility) and ASTM 756, with all tests passing.

Technological Characteristics

Materials: PVC (Luer, Tubing), Polycarbonate and styrene-ethylene-butylene (Regulator). Principle: Manual mechanical flow restriction via dial-adjusted fluid path dimensions. Form factor: 16 cm length. Connectivity: None (standalone). Sterilization: Ethylene Oxide. Shelf life: 4 years.

Indications for Use

Indicated for patients requiring intravascular infusion of fluids in a precise manner for a duration not exceeding 72 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Baxter Extension Set w/Flow Regulator (K890489)

Submission Summary (Full Text)

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Section 5. 510(k) Summary

K123729 K Number

Submission Date:

11/6/12

Class II

General Information

Classification

Trade Name

VersaRate™ Flow Rate Controller

Common Name:

I.V. Flow Controller

Classification Name and Reference:

Intravascular Administration Set

21 CFR §880.5440

Submitter

Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 916.932.0071 x114 Tel: [phone] Fax:

#### Intended Use

The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

#### Predicate Device(s)

Baxter Extension Set w/Flow Regulator (K890489)

#### Device Description

The EMED VersaRate™ Flow Rate Controller is a disposable device allowing users to adjust the flow rate of fluids. The EMED VersaRate™ Flow Rate Controller can be connected to commercially available administration sets and fluid sources utilizing standard luer lock connectors.

#### Materials and Characteristics

The EMED VersaRate™ Flow Rate Controller is equivalent in performance, physical properties, using similar materials, and having the same indications for use as the

# DEC 2 1 2012

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predicate device. Therefore no new issues of safety or effectiveness are introduced by the minimal differences in design.

Table 5-1 below provides a comparison of technological and other characteristics of the EMED VersaRate™ Flow Rate Controller and the predicate.

| | EMED VersaRate™<br>Flow Rate Controller | Baxter Extension Set<br>w/Flow Regulator |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The VersaRate™ Flow<br>Rate Controller is<br>intended for use in the<br>intravascular infusion of<br>fluids to be delivered to<br>the patient in a precise<br>manner for no longer than<br>72 hours. | The Extension set with<br>Flow Regulator is<br>intended for use in the<br>administration of<br>intravenous fluids to be<br>delivered to the patient in<br>a precise manner over a<br>specified period of time. |
| Flow Control<br>Material/Components | Biocompatible, non-toxic<br>materials widely used in<br>medical products, such as:<br>Luer: PVC<br>Tubing: PVC<br>Regulator: Polycarbonate<br>and styrene-ethylene-<br>butylene | Biocompatible, non-toxic<br>materials widely used in<br>medical products. |
| Method of<br>Sterilization | Ethylene Oxide | Radiation |
| Principle of Flow Rate<br>Control | The fluid path of the<br>VersaRate™ Flow Rate<br>Controller is regulated by<br>rotating the flow dial to<br>alter dimensions of the<br>internal fluid path, thereby<br>altering the flow rate. | Fluid flow is regulated by<br>rotating the diaphragm<br>holder to create a<br>restrictive path of varying<br>depth thereby altering the<br>rate of fluid<br>administration. |
| Length | 16 cm | 46 cm |

Table 5-1

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# Performance

Table 5-2 below summarizes testing results performed to establish conformance of the VersaRate™ Flow Rate Controller to internal product specifications and requirements, as well as equivalence to the predicate device.

## Table 5-2

| | VersaRate™ Flow Rate<br>Controller | Baxter Extension Set<br>w/Flow Regulator |
|----------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Flow Rate Control<br>Range | 5 – 230 mL/hr at 80 cm<br>head height | 5 – 250 mL/hr |
| Residual Volume of<br>Set | < 0.25 ml | 2.9 mL |
| Duration of Use | Performance remains<br>within tolerance up to 72<br>hrs. | Performance remains<br>within tolerance up to 24<br>hrs. |
| Pressure | Up to 25 psi | Up to 3 psi |

The outcomes of these tests further indicate that the VersaRate™ Flow Rate Controller is substantially equivalent to the predicate in performance, effectiveness, and safety.

.

。

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### Biocompatibility

In accordance with ISO 10993, studies were performed including cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility. Table 5-3 presents a summary of testing and results indicating compliance with biocompatibility standards.

| Table 5-3 | |
|-----------|--|
|-----------|--|

| Test Performed | Standard | Test Name | Test<br>Result | Other Name |
|------------------|--------------|----------------------------|----------------|-----------------------------------------------|
| Biocompatibility | ISO 10993-5 | Cytotoxicity | Pass | Neutral Red<br>Uptake |
| Biocompatibility | ISO 10993-10 | Sensitization | Pass | Kligman<br>Maximization |
| Biocompatibility | ISO 10993-10 | Irritation | Pass | Intracutaneous<br>Injection |
| Biocompatibility | ISO 10993-11 | Acute systemic<br>toxicity | Pass | Systemic Injection |
| Biocompatibility | ISO 10993-11 | Pyrogenecity | Pass | Rabbit Pyrogen |
| Biocompatibility | ISO 10993-4 | Hemocompatibility | Pass | Unactivated Partial<br>Thromboplastin<br>Time |
| Biocompatibility | ASTM 756 | Hemocompatibility | Pass | Hemolysis<br>(complete) |

#### Sterility, Shelf-life, and Packaging

The VersaRate™ Flow Rate Controller will be sterilized to a sterility assurance level (SAL) of 10 of 10 and with a shelf life of 4 years.

#### Summary of Substantial Equivalence

The EMED Technologies Corporation VersaRate™ Flow Rate Controller is substantially equivalent to the commercially available predicate device in terms of function, safety, performance, intended use, technology/principles and mechanical properties. Differences between the EMED VersaRate™ Flow Rate Controller and the predicate do not raise any new issues of safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the text "Public Health Service" in a bold, serif font. The text is stacked vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background.

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

### December 21, 2012

EMED Technologies Corporation C/O Mr. Morten S. Christensen Staff Engineer Underwriters Laboratories, Incorporated 455 East Trimble Road SAN JOSE CA 95131-1230

Re: K123729

Trade/Device Name: VersaRate™ Flow Rate Controller Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA . Dated: November 29, 2012 Received: December 5, 2012

#### Dear Mr. Christensen:

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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#### Page 2 - Mr. Christensen

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony Lo m

Anthony D. Watson, B.S., M.S., M.B.A. 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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# Section 4. Indications for Use Statement

510(k) Number (if known):

Device Name:

Indications for Use:

# [TBD] K123729

VersaRate™ Flow Rate Controller

The VersaRate™ Flow Rate Controller is intended for use in the intravascular infusion of fluids to be delivered to the patient in a precise manner for no longer than 72 hours.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRI

12/19/12

Division Sign-Off) (Division Sign-con)
Division of Anesthesiology, General Hospital Division Control, Dental Devices

:10(k) Number: K123729

Section 4, Page 1