COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS

K051264 · Unomedical A/S · FPA · Sep 1, 2005 · General Hospital

Device Facts

• Record ID: K051264
• Device Name: COMFORT AND INSET SUBCUTANEOUS INFUSION SETS FOR USE WITH ABBOTT INFUSION PUMPS
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Device Story

Subcutaneous infusion sets; designed for delivery of fluids from reservoir to body; used in conjunction with Abbott pump; facilitates subcutaneous fluid administration; device consists of tubing and cannula interface; provides pathway for fluid flow; used in clinical or home settings; operated by patients or healthcare providers; enables continuous or intermittent fluid delivery; supports therapeutic fluid management.

Clinical Evidence

Bench testing only; no clinical data presented.

Technological Characteristics

Subcutaneous infusion set; includes tubing and cannula for fluid delivery; compatible with Abbott pump; design and materials identical to predicate devices.

Indications for Use

Indicated for subcutaneous infusion of fluids into the body via attachment 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

• Unomedical Comfort™ (K972135)
• Inset® (K032854)

Submission Summary (Full Text)

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SEP - 1 2005

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8.0 510(K) SUMMARY Date Prepared: March 18, 2005

- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 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: Comfort™ and Inset™ Subcutaneous Infusion Sets For Use with the Abbot Pump
- 8.3 Common/Usual Name Subcutaneous Infusion Set
- 8.4 Classification Name Intravascular Administration Set

### 8.5 Substantial Equivalence

The Comfort™ and Inset™ Subcutaneous Infusion Sets for use with the Abbott Pump are substantially equivalent to the Unomedical Comfort™ (K972135) and Inset® (K032854) sets.

## Technological Characteristics 8.6

The Comfort™ and Inset™ Subcutaneous Infusion Sets for use with the Abbott Pump have the same technological characteristics of the current marketed products.

### 8.7 Performance Data

Verification testing confirmed the product meets their specifications.

### 8.8 Conclusion

Unomedical A/S concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA.

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Public Health Service

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: K051264

Trade/Device Name: Comfort TM and Inset™ Subcutaneous Infusiou Sets For Use with the Abbot Pump Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: II Product Code: FPA Dated: August 4, 2005 Received: August 10, 2005

SEP - 1 2005

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 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.

Suette Y. Micham Davis

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

Business Unit Infusion Devices

510(k) Number (if known): K051264

Device Name: COMFORT and INSET Subcutaneous Infusion Sets for Use With the Abbott Pump

Indications For Use: These sets are indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

image

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

510(k) Number _ Kus 1264

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Unomedical a/s Aholmvej 1-3, Osted 4000 Roskilde Denmark

Tel [phone] Fax [phone] E-mail [e-mail] www.unomedical.com

CVR No. 64 15 33 15