DERMATECH IV HOLDER

K060488 · Dermatech Medical, Inc. · FPA · Jun 8, 2006 · General Hospital

Device Facts

• Record ID: K060488
• Device Name: DERMATECH IV HOLDER
• Applicant: Dermatech Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

DermaTech IV Holder is a device intended to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a patient's artery or vein.

Device Story

DermaTech Sterile IV Holder is a sterile, tape-less anchoring system for IV administration. Device consists of non-pyrogenic PVC tubing with ABS male and female luer locks, two low-density polyethylene clam shell tubing holders, and a polypropylene hybrid stretch bonded laminate Velcro strap. After needle or catheter insertion into an artery or vein, the device is attached to secure the line for fluid administration. Used in clinical settings to maintain IV access. Benefits include secure, tape-less anchoring of IV lines.

Clinical Evidence

Bench testing only. Comparison of flow rate, backpressure leakage, and vacuum leakage between the subject device and predicate devices demonstrated substantial equivalence.

Technological Characteristics

Materials: Non-pyrogenic PVC tubing, ABS male/female luer locks, low-density polyethylene clam shell tubing holders, polypropylene hybrid stretch bonded laminate Velcro strap. Connectivity: Standard male/female Luer locks. Form factor: Tape-less anchoring system for IV administration sets.

Indications for Use

Indicated for use as an intravascular administration set to administer fluids through a catheter or needle inserted into a patient's artery or vein.

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

• BD Posiflow Positive Displacement Device
• Vital Care IV Administration Set
• Nexus TKO Needleless Access Device

Submission Summary (Full Text)

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K06 0488

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JUN - 8 2006

1000

DermaTech Medical 1971 S. Estes St. Lakewood, Colorado 80227 Tel: [phone] Fax: [phone]

# Premarket Notification [510(k)] Summary

| Submitter: | DermaTech Medical |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Address: | 1971 S. Estes St.<br>Lakewood, Colorado 80227 |
| Contact Person: | Glenn Thibault (Consultant) |
| Address: | 102 Heritage Ave<br>Castle Rock, Colorado 80104 |
| Telephone Number: | 303.596.1108 |
| FAX Number: | 303.320.4664 |
| Date Prepared: | February 20, 2006 |
| Trade Name: | DermaTech Medical Sterile IV Holder |
| Common Name: | DermaTech Medical Sterile IV Holder |
| Classification Name: | IV Administration Set |
| Predicate Devices: | BD Posiflow Positive Displacement Device<br>Vital Care IV Administration Set<br>Nexus TKO Needleless Access Device |

#### Description:

The DermaTech Sterile IV Holder is a sterile tape-less anchoring system comprising of Non-pyrogenic, PVC tubing with ABS male and female luer locks at each end, two Low Density Polyethylene Clam Shell tubing holders with a Polypropylene Hybrid Stretch Bonded Laminate Velcro strap. Once a needle or catheter is inserted into the artery or vein the DermaTech Sterile IV Holder is attached and provides a app-lecs a securing method to administer IV fluids.

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Image /page/1/Picture/1 description: The image shows the logo for DermaTech Medical. The text "DermaTech" is in a stylized font at the top of the image. Below that is a black graphic, and below that is the word "Medical" in a simple font.

### Intended Use:

DermaTech IV Holder is a device intended to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a patient's artery or vein.

## Technological Characteristics Comparison:

All Materials are similar to the predicate devices; the product is used for IV administration in a tapeless manner. The Set is connected utilizing common male and female Luer Locks.

## Non-clinical Tests Support Substantial Equivalence:

The current devices where compared for flow rate, backpressure leakage, and vacuum Leakage to the DermaTech IV Holder.

### Conclusions from Non-clinical Tests:

The comparison test verifies the predicate devices and the DermaTech IV Holder are substantially Equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

DermaTech Medical, Incorporated C/O Mr. Glenn Thibault Consultant G & N Consulting 102 Heritage Avenue Castle Rock, Colorado 80104

Re: K060488

Trade/Device Name: DermaTech IV Holder Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, KMK Dated: April 21, 2006 Received: April 21, 2006

Dear Mr. Thibault:

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. Thibault

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,

Syndie H. Michael Omd.

Chíu 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): K060488

#### Device Name: DermaTech IV Holder

Indications For Use: The DermaTech IV Holder is intended as an intravascular administration set to administer fluids through a catheter or needle inserted into a patients artery or vein.

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)

Ciptura V. nuth

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

000x) Number:_K46q488

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