INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...

K112073 · Rx Devices, LLC · FPA · Apr 11, 2012 · General Hospital

Device Facts

• Record ID: K112073
• Device Name: INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
• Applicant: Rx Devices, LLC
• Product Code: FPA · General Hospital
• Decision Date: Apr 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.

Device Story

InfuSite Needleless Access Device is a closed-system, needleless catheter accessory. Device features polycarbonate male/female luer housing with swabable silicone membrane. Membrane opens automatically upon connection with male luer and closes upon disconnection. Used for blood sampling, intermittent injection, or continuous infusion of fluids/medications. Operated by clinicians in clinical settings. Device requires disinfection before and after use. No metallic components. Provides secure, luer-compatible access point for intravascular administration sets.

Clinical Evidence

Bench testing only. Biocompatibility data confirms materials are non-irritant and non-toxic. Performance testing demonstrates substantial equivalence to predicate devices.

Technological Characteristics

Polycarbonate male/female luer housing; swabable silicone membrane. Closed-system design. No metallic components. Designed per ISO and FDA design control guidelines.

Indications for Use

Indicated for patients requiring blood sampling, intermittent injection, or continuous infusion of fluids or medications via luer-compatible intravascular access systems.

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

• Smartsite (K960280)
• Swabsite (K002689)

Submission Summary (Full Text)

{0}------------------------------------------------

# K112073

APR 1 1 2012

## PREMARKET NOTIFICATION 510(k) SUMMARY (As Required By 21 CFR 807.93)

Date of Preparation: July 6, 2011

Applicant:

Rx Devices LLC 2030 Oakes Blvd. Naples, FL 34119

Contact Individual: Charles Hokanson, CEO (610 715-3263) [e-mail]

Trade Name: InfuSite Needleless Access Device

Common Name: Needleless Access Device

Regulation Number: 880.5440

FPA Product Code:

Classification Name: Set, Administration, Intravascular

Classification: Class II

Predicate Device Name: Smartsite K960280, Swabsite K002689

### Device Description:

The InfuSite Needleless Access Device is a closed system needleless multi-purpose catheter accessory, permitting blood sampling, intermittent injection or continuous infusion of fluids or medications. Connection is exclusively with the Luer systems. The InfuSite Needleless Access Device has a polycarbonate male/female luer housing with a swabable silicone membrane, which opens automatically upon connection with a male luer and closes automatically when the male luer is disconnected. Disinfection must be carried out before and after use. The InfuSite contains no metallic components.

{1}------------------------------------------------

#### Intended Use:

The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.

#### Technology Characteristics:

The InfuSite Needleless Access Device is substantially equivalent to the predicate devices. No new materials or new issues of safety and efficacy have been introduced with this device.

#### Summary of Design Control Activities:

The Infusite was designed and developed in accordance ISO and FDA design control guidelines. Biocompatibility data demonstrates that the materials used are non-irritant and non-toxic. Performance testing demonstrates that the device is substantially equivalent to the predicate devices (SmartSite, K960280, Swabsite K002689). Risk Assessment was conducted in compliance with ISO 14971.

#### Conclusion:

The indications for use are identical to the predicate devices. The materials and technology of the InfuSite Needleless Access Device are equivalent to the predicate devices and no new issues of safety and efficacy have been introduced with this device. Biocompatibility testing, performance testing and risk assessment demonstrate that the InfuSite Needleless Access Device is substantially equivalent to the predicate devices, and safe and effective, when used in accordance with the supplied instructions for use.

{2}------------------------------------------------

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

Mr. Charles Hokanson CEO Rx Devices LLC 2030 Oakes Blvd. Naples, Florida 34119

ARR. 1 1 2012

Re: K112073

Trade/Device Name: InfuSite Needleless Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 12, 2012 Received: March 14, 2012

Dear Mr. Hokanson:

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.

{3}------------------------------------------------

#### Page 2 - Mr. Hokanson

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. D. Awuta

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation

Center for Devices and Radiological Health

#### Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known):

InfuSite Needleless Access Device Device Name:

Indications For Use:

The InfuSite Needleless Access Device is a closed system needleless accessory, which permits blood sampling, intermittent injection or infusion of fluids or medications when connected exclusively to luer systems.

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) | |
|--------------------------------------------------------|---------|
| (Division Sign-Off) | 4/12/12 |

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K112073