CLICK-ON

K040633 · Unomedical A/S · FPA · Apr 1, 2004 · General Hospital

Device Facts

• Record ID: K040633
• Device Name: CLICK-ON
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Apr 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Unomedical Comfort™ Subcutaneous Infusion Sets with Indwelling Catheters continue to be intended for the infusion and/or injection of fluids into the body below the surface of the skin.

Device Story

The Click-on Infusion Set Cover is a cosmetic accessory for Unomedical Comfort Subcutaneous Infusion Sets. The device functions as a protective or aesthetic cover for the infusion set, which is used to deliver fluids subcutaneously. It does not alter the fundamental technological characteristics or the intended use of the underlying infusion set. The device is intended for use by patients or clinicians in clinical or home settings where subcutaneous infusion is required.

Clinical Evidence

Bench testing only. Physical testing confirmed the covers met their specifications.

Technological Characteristics

Cosmetic accessory for subcutaneous infusion sets. No change to technological characteristics of the predicate device. Physical specifications verified via bench testing.

Indications for Use

Indicated for the infusion and/or injection of fluids into the body below the surface of the skin.

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

• Comfort Subcutaneous Infusion sets (K040633)

Submission Summary (Full Text)

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## APR - 1 2004

8.0 510(K) SUMMARY Date Prepared: February 26, 2004

- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark

| 8.2 | | Trade/Proprietary Name: Click-On Infusion Set Cover |
|-----|----------------------|--------------------------------------------------------|
| 8.3 | Common/Usual Name: | Infusion Set Cover |
| 8.4 | Classification Name: | Intravascular Administration<br>Set Accessory |

#### 8.5 Substantial Equivalence

The additional Click-on Covers Marketed with the Comfort Subcutaneous Infusion sets are substantially equivalent to the currently marketed Comfort Subcutaneous Infusion sets.

#### Intended Use 8 6

The Intended Use for the device has not changed. The Unomedical Comfort™ Subcutaneous Infusion Sets with Indwelling Catheters continue to be intended for the infusion and/or injection of fluids into the body below the surface of the skin. The addition of the Click-on Infusion set cover is only cosmetic.

#### Technological Characteristics 8.7

This modification does not change the technological characteristics of the current product.

#### Performance Data 8.8

Physical testing confirmed the covers met their specifications.

### 8.9 Conclusion

Unomedical A/S concludes based on the information presented that the modified product is substantially equivalent to products currently legally marketed in the USA.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR = 1 2004

Unomedical A/S Mr. John M. Lindskog General Manager Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark

Re: K040633

Trade/Device Name: Click-on™ Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: March 5, 2004 Received: March 10, 2004

Dear Mr. Lindskog:

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. Lindskog

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 vour 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/dsma/dsmamain.html

Sincerely yours,

Clue Le

Chiu 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: | K040633 |
|----------------|-----------|
| Device Name: | Click-on™ |

The Subcutaneous Infusion Sets with Indwelling Catheters Indications for Use: are indicated for the infusion and/or injection of fluids into the body below the surface of the skin.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Irene Lawrence for Adec 4/1/04

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

K 040633 510(k) Number ..

... . . . . . . . . . .

ﺳﮯ Prescription Use

or

Over-the-Counter Use __________

(Per 21 CFR 801.109)