FLOWEASE [SUBCUTANEOUS] INFUSION SET

K121092 · Baxter Healthcare Corp · FPA · Jun 29, 2012 · General Hospital

Device Facts

• Record ID: K121092
• Device Name: FLOWEASE [SUBCUTANEOUS] INFUSION SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jun 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Intended for the subcutaneous infusion of fluid medicines.

Device Story

FlowEase is a single-use, disposable subcutaneous infusion set. It consists of a female Luer lock connector, 24-inch non-DEHP PVC tubing, and a hub with wings. The hub secures a 24-gauge thin-wall AISI 304 stainless steel needle with a 90-degree bend. A UV-curable acrylated urethane adhesive secures the needle in the hub. The device includes an HDPE slide clamp for flow control and is supplied with an LDPE needle protector and ABS Luer lock cap. Available in 6 mm, 9 mm, and 12 mm needle lengths. Packaged with a dressing to secure the device to the patient. Gamma sterilized and non-pyrogenic. Used in clinical or home settings for fluid medicine delivery.

Clinical Evidence

Bench testing only. Device performance and safety verified through functional and biocompatibility testing in accordance with ISO 14971:2007 risk management requirements.

Technological Characteristics

Materials: AISI 304 stainless steel (needle), non-DEHP PVC (tubing/hub), copolyester (connector), HDPE (clamp), LDPE (protector), ABS (cap), UV-curable acrylated urethane (adhesive). Dimensions: 24-inch tubing, 24-gauge needle (6, 9, 12 mm lengths). Sterilization: Gamma. Connectivity: None (mechanical).

Indications for Use

Indicated for patients requiring subcutaneous infusion of fluid medicines.

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 SUB-Q-Set® Subcutaneous Infusion Set (K925362)
• RMS Subcutaneous Needle Set (K102512)
• Evans SubQ (K020530)

Submission Summary (Full Text)

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Page 1 of 3 Section 5. 510(k) Summary

Traditional 510(k) Premarket Notification FlowEase [Subcuraneous| Infusion Set

#### 5. 510(K) SUMMARY

# JUN 2 9 2012

#### DATE SUMMARY PREPARED: 05 February 2012

OWNER:

# CONTACT PERSON:

Baxter Healthcare Corporation One Baxter Way Westlake Village, CA 91362 Niedre M. Heckman, MS, MPH, RAC Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village. CA 91362 Telephone: [phone] Fax: [phone] Email: niedre_heckman @ baxter.com Trade Name:

DEVICE NAME:

FlowEase [Subcutaneous] Infusion Set IV Administration Set 21 CFR 880.5440, Set, Administration, Intravascular Class II FPA

### Table 5-1. Predicate Devices

Common Name:

Classification:

Product Code:

Class:

| Predicate<br>510(k) | Device Name | Company | Clearance<br>Date |
|---------------------|------------------------------------------------|-------------------------------|-------------------|
| K925362 | Baxter SUB-Q-Set® Subcutaneous Infusion<br>Set | Baxter Healthcare Corporation | 08/28/1993 |
| K102512 | RMS Subcutaneous Needle Set | Repro-Med Systems, Inc. | 05/20/2011 |
| K020530 | Evans SubQ | Evans Medical Inc. | 04/29/2002 |

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Traditional 510(k) Premarket Notification
FlowEase [Subcutaneous] Infusion Set

# 112409

Page 2 of 3 Section 5, 510(k) Summary

# DEVICE DESCRIPTION:

FlowEase [Subcutaneous] Infusion Set is a single use disposable device intended for the subcutaneous infusion of fluid medicines.

The FlowEase [Subcutaneous] Infusion Set consists of a copolyester blend Female ISO 594-2 Luer Lock Connector attached to a 24 inch length of non-DEHP PVC Tubing that is connected to a non-DEHP PVC Hub with wings. The Hub holds a 24-Gauge thin wall AISI 304 stainless steel Needle with a 90° bend at the distal end.

A medical grade UV-curable acrylated urethane Adhesive is placed on the outside bend of the needle to secure it within the Hub.

The FlowEase [Subcutaneous] Infusion Set also includes a HDPE Bantam Slide Clamp used to start and stop fluid flow. The needle is supplied covered with an LDPE Needle Protector, and the Female Luer Lock Connector is covered with an ABS Male ISO 594-2 Luer Lock Cap.

The FlowEase [Subcutaneous] Infusion Set will be marketed with a 24-Gauge thin wall needle that will be available in three needle lengths: 6 mm, 9 mm, and 12 mm. Each set will be packaged with a commercially available dressing, used to hold the device in place on the patient.

The FlowEase [Subcutaneous] Infusion Set is provided Gamma sterilized and non-pyrogenic. Each Set is packaged individually in a medical grade thermoformed copolyester tray with a Tyvek® lid, labeled according to needle size.

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K.121092

Traditional 510(k) Premarker Notification FlowEase (Subcutaneous) Infusion Set

#### Page 3 of 3 Section 5, 510(k) Summary

# STATEMENT OF INTENDED USE: TECHNOLOGICAL CHARACTERISTICS:

## ASSESSMENT OF NONCLINICAL DATA:

CONCLUSIONS:

Intended for the subcutaneous infusion of fluid medicines.

The FlowEase [Subcutancous] Infusion Set is substantially equivalent to the predicate devices with regard to technological characteristics, performance, and intended use.

Baxter Healthcare Corporation conducts risk analysis according to the requirements of ISO 14971:2007 Medical Devices-Application of Risk Management to Medical Devices.

Device performance and safety have been verified through functional and biocompatibility testing.

The FlowEase [Subcutaneous] Infusion Set is substantially equivalent to the predicate devices. Testing against established standards and guidelines for its intended use demonstrate that the proposed device is as safe and effective as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Niedre Heckman Manager, Regulatory Affairs Baxter Healthcare Corporation One Baxter Way Westlake Village, California 91362

JUN 2 9 2012

Re: K121092

Trade/Device Name: FlowEase Subcutaneous Infusion Set Regulation Number: 21 CFR 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 6, 2012 Received: April 10, 2012

Dear Ms. Heckman:

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 (sec 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- Ms. Heckman

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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm 15809.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/MedicalDcvices/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/McdicalDevices/Resourcesfor You/Industry/default.htm.

**Sincerely yours,**

for the benefit of

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

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KI2I\\$\\$92

Traditional SI0(k) Premarket Notification FlowEase (Subcutaneous) Infusion Set

Page I of I Section 4. Indications for Use

4. INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name:

FlowEase [Subcutaneous] Infusion Set

Indication(s) for Use:

Intended for the subcutaneous infusion of fluid medicines.

D Prescription Use: 21 CFR 801 Subpart D

AND/OR

Over-the-Counter Use: T 21 CFR 801 Subpan C

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Richard C Chapman 6/28/12

Page _ of

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

21092 510(k) Number: