PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS

K070430 · Unomedical A/S · FPA · Apr 4, 2007 · General Hospital

Device Facts

• Record ID: K070430
• Device Name: PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS
• Applicant: Unomedical A/S
• Product Code: FPA · General Hospital
• Decision Date: Apr 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Device Story

Paradigm Quick-Set II and Quick-Set II are subcutaneous infusion sets designed for delivery of medication, including insulin, from compatible infusion pumps. Device facilitates fluid path between pump and patient subcutaneous tissue. Used in clinical or home settings by patients or caregivers. Device serves as interface for continuous subcutaneous insulin infusion (CSII) therapy. Benefits include reliable medication delivery for patients requiring pump-based therapy.

Clinical Evidence

Bench testing only.

Technological Characteristics

Subcutaneous infusion set; intravascular administration set (21 CFR 880.5440). Class II device. Technological characteristics identical to previously marketed predicate devices.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, from compatible infusion pumps.

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

• Paradigm Quick-Set (K011071)
• Quick-Set (K991759)

Submission Summary (Full Text)

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K070430

510(K) SUMMARY 8.0 Date Prepared: January 25 2007

APR - 4 2007

- SUMMARY OF SAFETY AND EFFECTIVENESS 8.1 John M. Lindskog Submitted By: General Manager Unomedical A/S Infusion Devices Aaholmvei 1-3, Osted DK-4000 Roskilde, Denmark
- Paradigm Quick-Set® Il and Quick-8.2 Trade/Proprietary Name: Set® II Subcutaneous Infusion Sets
- Subcutaneous Infusion Set 8.3 Common/Usual Name

Classification Name 8.4

Intravascular Administration Set

#### 8.5 Substantial Equivalence

The Paradigm Quick-Set® II sets are substantially equivalent to the current Paradigm Quick-Set® (K011071) sets. The Quick-Set® II sets are substantially equivalent to the current Quick-Set® (K991759) sets.

- Classification 8.6
Class: II Panel: 80 Product Code: 80FPA Cite: 21 CFR 880.5440

### Technological Characteristics 8.7

The Quick-Set® I Infusion Sets have the same technological characteristics as the current marketed products.

- 8.8 Performance Data
Verification testing confirmed the product meets their specifications.

### 8.9 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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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

APR - 4 2007

Re: K070430

Trade/Device Name: Paradigm Ouick-Set® II and Ouick-Set II® Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 25, 2007 Received: February 14, 2007

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 vours.

Chiu Lin, 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

K070430 510(k) Number:

K070430

Paradigm Quick-Set® II and Quick-Set® II

Indications For Use:

Device Name:

These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

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)

C

cion of Anesthesiology, General Hospital, ാഥാ Control, Dental Devices

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:.2(k) Number: k470434