THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A

K041152 · Applied Diabetes Research, Inc. · FRN · May 24, 2004 · General Hospital

Device Facts

• Record ID: K041152
• Device Name: THINSET 1.8 ML RESERVOIR, MODEL 326A; THINSET 3.0 ML RESERVOIR, MODEL 332A
• Applicant: Applied Diabetes Research, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 24, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ThinSet Reservoir is indicated for use for the infusion of medicine, including insulin, from an insulin pump. The reservoir is not intended for use with blood or blood products.

Device Story

THINSet 1.8 ml and 3.0 ml Reservoirs are single-use, piston-style syringes; consist of hollow barrel, plunger with o-ring, and male Luer lock fitting at distal end. Device functions as a reservoir for medication, including insulin, placed within an external infusion pump. Includes 22-gauge cannula. Used in clinical or home settings to deliver subcutaneous medication. Healthcare providers or patients load reservoir into pump; pump mechanism drives plunger to deliver precise medication doses. Benefits include reliable, controlled subcutaneous delivery of insulin or other medications.

Clinical Evidence

Bench testing only. Testing included scale accuracy, plunger exercise force testing per ISO 7886-1:1993(E) Annex G, and dose accuracy testing using infusion pumps.

Technological Characteristics

Piston-style syringe; 1.8 ml or 3.0 ml capacity; male Luer lock fitting; 22-gauge cannula. Materials include barrel, plunger, and o-ring. Mechanical operation via external infusion pump. Complies with ISO 7886-1:1993(E) for plunger force.

Indications for Use

Indicated for patients requiring infusion of medicine, including insulin, via an external infusion pump. Not for use with blood or blood products.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• THINSet 3.0 ml Reservoir (K024056)

Submission Summary (Full Text)

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# MAY 2 4 2004

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: | 972-446-8406 |
|---------------|--------------------|
| Fax Number: | 972-446-9397 |
| Contact: | Rick Lynch |
| | Regulatory Affairs |
| Date: | April 29, 2004 |

- Device Information B.

| Trade/Proprietary Name: | THINSet 1.8 ml and 3.0 ml Reservoirs |
|-------------------------|--------------------------------------|
| Common name of device: | Infusion Pump Syringe |
| Classification Name: | Pump, Infusion |
| Predicate Device: | THINSet 3.0 ml Reservoir |
| Predicate 510(k) #: | K024056 |

- Device Description: D.
C:

The ThinSet Reservoir is a single use piston style syringe available with a The ThirlSet Reservoir is a binglo eise place pieca hollow barrel with a male Luer capacity of 1.8 mil of 5.0 mil. It consiste of and plunger with o-most . This lock illuling at the distar end, romovations, including insulin, subcutaneously. device is designed to deliver mediodation, finalianly finale Luer The male Luer lock inting of the reservoir is placed in an external infusion nump. The ThinSet Reservoir comes with a 22 gauge cannula.

- Intended Use: E.
The THINSet 1.8 ml and 3.0 ml Reservoirs are indicated for use for the infusion of medicine, including insulin, from an external infusion pump. influsion of medioms, including for use with blood or blood products.

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#### Comparison of Required Technological Characteristics: ட்.

Information was submitted to demonstrate that there are no significant Information was submitted to demonstration between the THINSet 1.8 ml
differences in technological characteristics between the THINSet 1.8 ml
e submitted in technological cha differences in teonnological the cited predicate device.

- Summary and Conclusion of Nonclinical and Clinical Tests: G.
The intended use of the THINSet 1.8 ml and 3.0 ml Reservoirs is identical The Intended use of the TFMYOCL 1.0 An and entre entraliances in technological to that of the cited predicate actrice. They issues of safety of effectiveness.

Performance testing consisted of the following:

### Scale Accuracy

This test measures the accuracy of the dose markings on the svringe scale.

## Plunger Exercise Test

This test was conducted per ISO 7886-1:1993(E) Annex G. This This test was ochadeled initiate plunger action as well as the test measures the forces required to move the plunger within the Barrel.

## Dose Accuracy Testing

Accuracy testing will be conducted similar to the requirements of Accuracy testing will be certicular requirements for the safety of ANSIANNI ID:20:1000, Furnitus. Instead of a motorized test figure, Infusion Pumps were used for the dose accuracy tests.

#### Conclusion:

The THINSet 1.8 ml and 3.0 ml Reservoirs are substantially equivalent to the THINSet 3.0 ml Reservoir in indications for use and technological characteristics.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized symbol that resembles three abstract human figures or flowing lines. The symbol is black, and the text is also in a dark color, likely black or a dark shade of blue.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2004

Mr. Rick Lynch Regulatory Affairs Applied Diabetes Research, Incorporated 1740 South IH 35E, Suite 112 Carrollton, Texas 75006

Re K041152

Trade/Device Name: ThinSet 1.8 Ml and ThinSet 3.0 ml Reservoir Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 29, 2004 Received: May 3, 2004

Dear Mr. Lynch:

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 Fedcral Register.

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Page 2 - Mr. Lynch

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/dsma/dsmamain.html

Sincerely yours,

Susan Kumar

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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K041152

# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

ThinSet 1.8 ml and ThinSet 3.0 ml Reservoir Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ThinSet Reservoir is indicated for use for the infusion of medicine, including insulin, from an insulin pump. The reservoir is not intended for use with blood or blood products.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Arne Naess for ADW

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

510(k) Number: K041152