ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109

K033099 · Applied Diabetes Research, Incorporated · FPA · Oct 16, 2003 · General Hospital

Device Facts

• Record ID: K033099
• Device Name: ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109
• Applicant: Applied Diabetes Research, Incorporated
• Product Code: FPA · General Hospital
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

Device Story

The ADR THINSet Insulin Infusion Set facilitates medication delivery from an external infusion pump to subcutaneous tissue. The device comprises a female luer, tubing (23 or 43 inch), a needle grip with a 26-gauge introducer needle, and a base assembly containing a 24-gauge cannula and adhesive dressing. The user or clinician connects the infusion set to the pump reservoir; the introducer needle penetrates the skin to place the cannula; the needle is removed, leaving the cannula for infusion. The connector allows the pump to be detached from the base. The device is intended for use in clinical or home settings to manage insulin delivery, potentially improving patient convenience and glycemic control.

Clinical Evidence

Bench testing only. Biocompatibility testing included cytotoxicity, intracutaneous reactivity, maximization sensitization, in vitro hemolysis, systemic toxicity, and pyrogen studies. Performance testing verified flow rate accuracy and mechanical integrity of the female luer lock per ISO 594-2 standards. Insulin compatibility was also verified.

Technological Characteristics

Subcutaneous infusion set; 26-gauge introducer needle; 24-gauge cannula; 23/43 inch tubing; female luer lock (ISO 594-2); medical grade adhesive dressing. Biocompatibility per ANSI/AAMI/ISO 10993-1:1997. Sterile, single-use.

Indications for Use

Indicated for subcutaneous infusion of medication, including insulin, from an external infusion pump. Contraindicated for use with blood or blood products.

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

• ADR SmartSet Insulin Infusion Set (K012429)

Submission Summary (Full Text)

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## OCT 1 6 2003

# K033099

510(k) Summary (As required by 21 CFR 807.92(a))

- Submitter Information A.
Applied Diabetes Research, Inc. 1740 South IH 35E. Suite 112 Carrollton, TX 75006

| Phone Number: | 972-446-9396 |
|--------------------|--------------------|
| Fax Number: | 972-446-9397 |
| Contact:Rick Lynch | |
| | President |
| Date: | September 26, 2003 |

- B. Device Information
ADR THINSet Insulin Infusion Set Trade/Proprietary Name:

Infusion Set

K012429

Common name of device:

Set, Administration, Intravascular

ADR SmartSet Insulin Infusion Set

Predicate 510(k) #:

Predicate Device:

Classification Name:

- D. Device Description:
C:

The ADR THINSet Insulin Infusion Set facilitates the flow of medication from an infusion pump reservoir into the subcutaneous tissue of the user. The infusion set consists of a female luer, tubing, Needle Grip with introducer needle and Base Assembly. The Base Assembly consists of three components: the Needle Grip, Connector and Base. The Needle Grip contains the 26 guage introducer needle that penetrates the subcutaneous tissue. The infusion set tubing attaches to the Connector. The Connector may be removed from the Base. The Base houses the 24 gauge Cannual and has a medical grade adhesive dressing attached to the bottom.

The infusion set is packaged sterile in a Tray Pack. The infusion set is available with 23 and 43 inch tubing lines and 6 and 9 mm Cannulas.

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#### ட் Intended Use:

The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

#### ட் Comparison of Required Technological Characteristics:

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the ADR THINSet Insulin Infusion Set and the cited predicate device.

#### Summary and Conclusion of Nonclinical and Clinical Tests: G.

Prior to testing, First Article Inspections were conducted on all components. In addition, material verification was performed on all components.

The ADR THINSet Insulin Infusion set was tested per the requirements of the ISO-FDA Modified Matrix. FDA/ODE General Program Memorandum -# G95-1 and ANSI/AAMI/ISO 10993-1:1997 for a External communicating device, Blood path, indirect for a period less than 30 days.

Biocompatibility testing included Cytotoxicity, Intracutaneous Reactivity, Maximization Sensitization Study, In Vitro Hemolysis Study, USP and ISO Systemic Toxicity Studies and USP Prorogen Study. In addition, insulin compatibility testing was performed.

The distal end of the infusion set has a standard Female Luer lock. As part of the performance testing, the Female Luer lock shall meet the requirements of the Gauging, Leakage, Separation force, Unscrewing torque. Ease of assembly. Resistance to overriding. Stress cracking tests detailed in ISO 594-2, Conical fittings with 6% (Luer) taper for reservoirs, needles and certain other medical equipment - Part 2: Lock fittings.

The accuracy of the flow rates through the ADR THINSet Insulin Infusion Set was verified by dose accuracy testing.

The intended use of the ADR THINSet Insulin Infusion Set is identical to that of the cited predicate device. Any differences in technological characteristics were insignificant and do not raise new issues of safety or effectiveness.

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Conclusion:

The ADR THINSet Insulin Infusion Set is substantially equivalent to the ADR SmartSet Insulin Infusion Set in indications for use and technological characteristics.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Applied Diabetes Research, Incorporated C/O Mr. Jim Barley JB & Associates 28481 La Falda Laguna Niguel, California 92677

Re: K033099

Trade/Device Name: THINSet Infusion Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Setg Regulatory Class: II Product Code: FPA Dated: September 26, 2003 Received: September 29, 2003

Dear Mr. Barley:

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. Barley

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,

Susa Ruinauz

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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510(k) Number (if known): K033099

Device Name:

Indications for Use:

The ADR THINSet Infusion Set is intended for the subcutaneous infusion of medicine, including insulin, from an external infusion pump. The set is not intended nor indicated for use with blood or blood products.

Patricio Lucenite

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

510(k) Number: K033099

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)