SUREFLOW SAFETY INFUSION DEVICE

K051943 · Intrasafe Medical, LLC · FPA · Oct 4, 2005 · General Hospital

Device Facts

• Record ID: K051943
• Device Name: SUREFLOW SAFETY INFUSION DEVICE
• Applicant: Intrasafe Medical, LLC
• Product Code: FPA · General Hospital
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.

Device Story

SureFlow™ Safety Infusion Device is a sterile, single-use intravenous fluid administration set. It features 3 ports with swabable luers, integrated check valves, and pre-attached needleless injection ports connecting to a drip chamber, plus a 4th port for chamber flushing. Operated by healthcare practitioners in clinical settings, it facilitates simultaneous IV therapy via syringe, gravity, or infusion pump. The device functions as a safety mechanism by eliminating needles, thereby reducing accidental needlestick risks. It also aids in reducing nosocomial infections by maintaining a sterile, uninterrupted fluid path once needleless syringes are connected, avoiding the need to break the fluid path for repetitive access. The device is discarded after infusion completion.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing and biocompatibility testing.

Technological Characteristics

Needleless, sterile, single-use IV administration set. Constructed from conventional medical-grade, biocompatible materials. Features 3 ports with swabable luers, integrated check valves, and a 4th flushing port. Connects to a drip chamber. Mechanical fluid regulation.

Indications for Use

Indicated for use by healthcare practitioners to administer multiple simultaneous intravenous medications to patients via syringe, gravity, or infusion pump using needleless components.

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

• Multiport® Manifold Set with Swabable Valves (K040385)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| Submitted by: | Intrasafe Medical, LLC<br>13601 Preston Road, Suite #900W<br>Dallas, Texas 75240<br>[phone] Phone<br>[phone]FAX |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Shepard G. Bentley<br>Synergy Biomedical, LLC<br>28202 Cabot Road, Suite 300<br>Laguna Niguel, CA 92677<br>[phone] Phone<br>[phone] FAX<br>E:Mail [e-mail] |
| Date Prepared: | 16 July 2005 |
| Device Name: | SureFlow™ Safety Infusion Device |
| Trade Name: | SureFlow™ Safety Infusion Device |
| Common Name: | Intravascular Administration Set, Needleless |
| Classification Name: | Set, Administration, Intravascular |
| Device Class: | II (two) |
| Procode: | FPA |
| CFR Reference: | 880.5440 |
| Predicate Device: | Multiport® Manifold Set with Swabable Valves, Mode |
| Predicate 510(k) #: | K040385 |
| Device Description: | The SureFlow™ Safety Infusion Device is a needleless, sterile,<br>non-pyrogenic single use intravenous fluid administration set<br>which provides multiple access ports and regulates the<br>directional flow of fluids for simultaneous intravenous therapy.<br>It has 3 ports with swabable luers, integrated check valves, and<br>pre-attached needleless injection ports all connecting to a drip<br>chamber. A 4th port with a swabable luer and pre-attached<br>needleless injection port allows for flushing of the chambers.<br><br>It is manufactured with conventional medical grade,<br>biocompatible materials. It operates as a safety device by<br>eliminating the use of needles in the delivery of medications<br>via IV infusion, thus eliminating the opportunity for accidental<br>needlesticks.<br><br>In addition, the SureFlow™ aids in reducing nosocomial<br>infections by not requiring a break in the fluid path once the |

Synergy Biomedical

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needleless syringes are connected to the SureFlow™. The valves are swabbed prior to connection which provides an uninterrupted, sterile fluid path versus the current practice of repetitive access to the IV port with needles which are exposed to airborne contamination.

It is supplied sterile for single use only

The SureFlow™ Safety Infusion Device is a device intended to Intended Use: allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.

> It is manufactured with conventional medical grade, biocompatible materials. By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks, as well as, aiding in reducing nosocomial infections by not requiring a break in the fluid path once the needleless syringes are connected to the SureFlow™ .

When the infusion is complete, the device is discarded according to the appropriate disposal procedure for the health care provider.

Technological Comparison: A summary of the technological characteristics of this device compared to the predicate device can be seen in the Comparison Table in the Specifications Section. This device and the predicate have similar technological characteristics and are substantially equivalent.

Non-Clinical Data: The SureFlow™ Safety Infusion Device has been shown to be substantially equivalent to the predicate device by non-clinical performance data. The testing involved performance testing, and biocompatibility testing.

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Public Health Service

OCT 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Intrasafe Medical, LLC C/O Mr. Shepard G. Bentley Regulatory Consultant to Intrasafe Medical, LLC. Synergy Biomedical, LLC. 28202 Cabot Road, Suite 300 Laguna Niguel, California 92677

Re: K051943

Trade/Device Name: SUREFLOW SAFETY INFUSION DEVICE Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: July 16, 2005 Received: July 18, 2005

Dear Mr. Bentley:

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 - Mr. Bentley

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Saytie y. Michael Oms.

Chiú 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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## Indications for Use

510(k) Number (if known): K051943

SureFlow™ Safety Infusion Device Device Name:

Indications for Use:

The SureFlow™ Safety Infusion Device is a device intended to allow a health care practitioner to administer multiple intravenous medications simultaneously to a patient's vascular system utilizing needleless components and an I.V. manifold via syringe, gravity or infusion pump.

By being needleless, it operates as a safety device which is designed to aid in reducing the possibility of accidental needle sticks.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Arter U, nate

(Division Sian-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: __

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