SELEC-3 I.V.ADMINISTRATION SET

K142097 · Biomedix, Inc. · FPA · Aug 29, 2014 · General Hospital

Device Facts

• Record ID: K142097
• Device Name: SELEC-3 I.V.ADMINISTRATION SET
• Applicant: Biomedix, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 29, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.

Device Story

Single-use, sterile IV administration set; provides fluid pathway to vascular system. Features selectable drop chamber (10, 15, or 60 drops/cc) and Y-sites for medication administration. Used by nurses and paramedics in pre-hospital, emergency room, and field settings. Device facilitates controlled fluid delivery to patients; manual operation by clinician.

Clinical Evidence

Bench testing only. Testing included flow rate verification, leakage, microbial ingress, and pull force testing. Biocompatibility assessed per ISO 10993-1:2009. Sterility validated per ANSI/AAMI/ISO 11137-2:2012.

Technological Characteristics

Constructed of biocompatible plastics. Features selectable drop chamber (10, 15, 60 drops/cc) and Y-sites. Gamma sterilized per ANSI/AAMI/ISO 11137-2:2012. Externally communicating, indirect blood path, prolonged duration device.

Indications for Use

Indicated for delivery of fluids and soluble drugs into the vascular system. Targeted for use by nurses and paramedics in pre-hospital, emergency room, and field settings.

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

• SELEC-3 I.V Administration Set (K925645)

Submission Summary (Full Text)

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

August 29, 2014

Biomedix, Inc. Ms. Myra J. Bender President 3895 West Vernal Pike Bloomington, IN 47404

Re: K142097

Trade/Device Name: Biomedix SELEC-3 I.V. Administration Set Regulation Number: 21 CFR 888.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 31, 2014 Received: August 1, 2014

Dear Ms. Bender:

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.

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

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

# Erin | Keith -S

Erin I. Keith, M.S. 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)

K142097

Device Name

Biomedix SELEC-3 I.V. Administration Set

#### Indications for Use (Describe)

The SELEC-3 I.V. Administration Set is used to provide a pathway to deliver fluid into the vascular system. This product is targeted for use by nurses and paramedics in pre-hospital, emergency room and field settings.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for BIOMEDIX, Inc. The text is in a bold, sans-serif font with horizontal lines running through each letter. The word "BIOMEDIX" is stacked on top of the word "quality medical products".

# quality medical products

# SPECIAL 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92

| Submitter/Contact Information | |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | Biomedix, Inc. |
| Address | 3895 West Vernal Pike<br>Bloomington, IN 47404 |
| Phone number | [phone] |
| Fax number | [phone] |
| Establishment Registration<br>Number | 1833470 |
| Name of contact person | Myra J. Bender |
| Date prepared | July 31, 2014 |
| Name of device | |
| Trade or proprietary<br>name | Biomedix SELEC-3 I.V. Administration Set |
| Common or usual name | Intravascular Administration Set |
| Classification name / Regulation<br>number | Set, Administration, Intravascular (21 CFR § 888.5440) |
| Classification panel | General Hospital |
| Product Code(s) | FPA |
| Legally marketed device(s) to<br>which equivalence is claimed | SELEC-3 I.V Administration Set (K925645)<br>Biomedix, Inc. |
| Reason for 510(k) submission | Device modification |
| Device description | The Biomedix SELEC-3 I.V. Administration Set is a single-<br>use, sterile device used for the administration of solutions<br>and fully soluble drugs into the vascular system of a patient. |
| Indications for use | The SELEC-3 I.V. Administration Set is used to provide a<br>pathway to deliver fluid into the body via the vascular<br>system. This product is targeted for use by nurses and<br>paramedics in pre-hospital, emergency room and field<br>settings. |

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# Summary of Technological Characteristics

The SELEC-3 I.V. Administration Set is constructed of biocompatible plastics. It incorporates a Selectable Drop Chamber that allows the user to choose between a flow rate of 10, 15, or 60 drops/cc at any time. Also included are Y-sites that allow the user to add medication. The intended use, basic design, and function are identical to the predicate device.

## Testing Summary

The SELEC-3 I.V. Administration Set has met Biomedix testing and acceptance criteria related to flow rate verification, leakage, microbial ingress, and pull force testing.

## Biocompatibility

Biocompatibility has been assessed in accordance with ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing. The SELEC-3 I.V. Administration Set has been categorized as an externally communicating device, indirect blood path, prolonged duration. Based on testing applicable to this categorization, biocompatibility has been demonstrated.

## Sterility

SELEC-3 I.V. Administration Sets are provided as sterile, single use devices that are individually packaged. The device is gamma sterilized through a validated process with the dose set in conformance with ANSI/AAMI/ISO 11137-2: 2012, "Sterilization of health care products-Radiation- Part 2: Establishing the Sterilization Dose," Method-VDmax25.

### Bacterial Endotoxins

The SELEC-3 I.V. Administration Set is monitored for bacterial endotoxins.

### Conclusion

The SELEC-3 I.V. Administration Set met all established acceptance criteria for design verification testing. Testing demonstrated that the device is safe and effective when used as intended.