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. The reservoir is not intended for use with blood or blood products.

Device Description

The ThinSet Reservoir is a single use piston style syringe available with a capacity of 1.8 mil or 3.0 mil. It consists of a hollow barrel with a male Luer lock fitting at the distal end, and a plunger with o-rings. This device is designed to deliver medication, including insulin, subcutaneously. The male Luer lock fitting of the reservoir is placed in an external infusion pump. The ThinSet Reservoir comes with a 22 gauge cannula.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the THINSet 1.8 ml and 3.0 ml Reservoirs, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Test)	Reported Device Performance
Scale Accuracy	Measures the accuracy of the dose markings on the syringe scale.
Plunger Exercise Test	Conducted per ISO 7886-1:1993(E) Annex G. Measures the forces required to initiate plunger action and move the plunger within the barrel.
Dose Accuracy Testing	Conducted similar to the requirements of ANSI/AAMI ID26:1998, using Infusion Pumps for testing (instead of a motorized test fixture).

Note: The document only describes what the tests measure, not the specific quantitative thresholds or results obtained (e.g., "scale accuracy within +/- 5%"). It states that the performance testing consisted of these tests to demonstrate substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for each specific test (Scale Accuracy, Plunger Exercise, Dose Accuracy) within the test set.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, as it's part of a 510(k) submission, it's generally assumed industrial testing performed by the device manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. The tests described are objective performance tests of the device's physical properties and function, not typically relying on expert interpretation for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable/provided. The tests described are objective measurements rather than subjective assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes engineering performance tests of the device itself, not studies involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone study was not done. This device is a physical medical device (infusion pump reservoir), not an algorithm or software. Therefore, the concept of "standalone performance" in the context of AI algorithms does not apply.

7. The Type of Ground Truth Used:

The ground truth for the tests described is based on established engineering and regulatory standards and the physical properties of the device.

Scale Accuracy: Ground truth would be the actual measured volume against the marked scale.
Plunger Exercise Test: Ground truth would be the force measured by a calibrated instrument against specified force ranges in the ISO standard.
Dose Accuracy Testing: Ground truth would be the volume of fluid dispensed by the infusion pump against the programmed dose, measured by calibrated equipment, and compared to the requirements of ANSI/AAMI ID26:1998.

8. The Sample Size for the Training Set:

This information is not applicable/provided. This device is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI. The performance testing described is for verification and validation of the device's design and manufacturing.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/provided for the same reason as point 8.

Summary

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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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).