CONTACT DETACH

K041545 · Unomedical A/S · FPA · Jun 30, 2004 · General Hospital

Device Facts

• Record ID: K041545
• Device Name: CONTACT DETACH
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Contact Detach™ is indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Device Story

Contact Detach is a subcutaneous infusion set used to deliver fluids from a reservoir into the body. It functions as an intravascular administration set. The device is intended for prescription use. It facilitates the connection between a fluid source and the patient's subcutaneous tissue.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Subcutaneous infusion set. Intravascular administration set (Product Code FPA). No changes to technological characteristics compared to predicate devices.

Indications for Use

Indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

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

• Contact™ sets (unmodified)
• Comfort Sets™
• Maersk Medical Paradigm Quick Set Infusion set (K011071)
• Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K972135)

Submission Summary (Full Text)

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- 8.0 510(K) SUMMARY Date Prepared: May 20, 2004
K041545

- 8.1 SUMMARY OF SAFETY AND EFFECTIVENESS Submitted By: John M. Lindskog General Manager Unomedical A/S Infusion Devices Aaholmvej 1-3, Osted DK-4000 Roskilde, Denmark
- 8.2 Trade/Proprietary Name: Contact Detach TM
- 8.3 Common/Usual Name Subcutaneous Infusion Set
- 8.4 Classification Name Intravascular Administration Set

## 8.5 Substantial Equivalence

The modified sets are substantially equivalent to the unmodified Contact™ sets and the Comfort Sets™, the Maersk Medical Paradigm Quick Set Infusion set (K011071) and the Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K972135).

### 8.6 Technological Characteristics

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

### 8.7 Performance Data

Verifications testing has confirmed the product meets their specifications.

### 8.8 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 a stylized image of an eagle with its wings spread.

Public Health Service

JUN 3 0 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041545

Trade/Device Name: Contact Detach™ Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 1, 2004 Received: June 9, 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.

Olin L. Ph.D.

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:

K041545

Device Name:

Contact Detach™

Indications for Use:

The Contact Detach™ is indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

or

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Arthur Lemay

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________