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 Description

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.

AI/ML Overview

The provided 510(k) summary for the ADR THINSet Insulin Infusion Set (K033099) describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria values or detailed performance metrics in a quantified format as requested by the user for a comprehensive table.

Instead, the document primarily focuses on qualifying the testing performed and stating that the device "meets the requirements" or that "differences were insignificant." It also lacks details about ground truth establishment, expert qualifications, sample sizes for specific tests, or a multi-reader multi-case (MRMC) study.

Therefore, the response below will reconstruct the information available as closely as possible to the requested format, clearly indicating where specific numerical data is absent in the original document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Requirement	Acceptance Criteria (Stated or Implied)	Reported Device Performance/Conclusion
Biocompatibility	Cytotoxicity	Meet requirements of ISO-FDA Modified Matrix, FDA/ODE G95-1, ANSI/AAMI/ISO 10993-1:1997 for an External communicating device, Blood path, indirect for < 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. All these tests were performed, and the implication is that the device met the requirements.
	Intracutaneous Reactivity	(Same as above)	(See above)
	Maximization Sensitization Study	(Same as above)	(See above)
	In Vitro Hemolysis Study	(Same as above)	(See above)
	USP and ISO Systemic Toxicity Studies	(Same as above)	(See above)
	USP Pyrogen Study	(Same as above)	(See above)
Material Compatibility	Insulin Compatibility	(Implied to be compatible with insulin)	Insulin compatibility testing was performed. The implication is that the device demonstrated compatibility.
Luer Lock Performance	Gauging	Meet requirements of ISO 594-2, "Conical fittings with 6% (Luer) taper for reservoirs, needles and certain other medical equipment - Part 2: Lock fittings."	The Female Luer lock shall meet the requirements of Gauging, Leakage, Separation force, Unscrewing torque, Ease of assembly, Resistance to overriding, and Stress cracking tests detailed in ISO 594-2. The implication is that the device met these requirements.
	Leakage	(Same as above)	(See above)
	Separation force	(Same as above)	(See above)
	Unscrewing torque	(Same as above)	(See above)
	Ease of assembly	(Same as above)	(See above) ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
	Resistance to overriding	(Same as above)	(See above) ----------
	Stress cracking	(Same as above)	(See above) -----
Flow Performance	Dose accuracy (of flow rates)	(Implied to be accurate/meet acceptable limits for infusion sets)	The accuracy of the flow rates through the ADR THINSet Insulin Infusion Set was verified by dose accuracy testing. The implication is that the accuracy was found to be acceptable.
Mechanical Integrity	First Article Inspections	All components meet specifications.	First Article Inspections were conducted on all components.
	Material Verification	All materials meet specifications.	Material verification was performed on all components.

2. Sample size used for the test set and the data provenance

The document does not specify the numerical sample sizes for any of the tests (biocompatibility, luer lock, or flow rate testing). It only states that tests were "performed" or "conducted."

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied to be data collected specifically for the regulatory submission of this new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The study involves laboratory-based testing of the device's physical and biological properties against established standards (ISO, USP, FDA guidance), rather than clinical studies requiring expert ground truth for diagnostic or clinical outcomes.

4. Adjudication method for the test set

This information is not applicable and not provided. The testing described is objective, standards-based verification, not subjective interpretation requiring adjudication among experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable and no such study was conducted or mentioned. The device is an insulin infusion set, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a medical device (infusion set), not an algorithm. Performance testing was done on the physical device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed is the established requirements and specifications outlined in the referenced standards (e.g., ISO 594-2, ISO-FDA Modified Matrix, ANSI/AAMI/ISO 10993-1, USP). The device's performance was measured against these objective, predefined criteria.

8. The sample size for the training set

This is not applicable as the device is a physical medical device and does not involve AI or machine learning models that require training sets. The testing performed is physical and chemical verification.

9. How the ground truth for the training set was established

This is not applicable for the same reason as in point 8.

Summary

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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 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:

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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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three wavy lines representing snakes or ribbons intertwined around a central staff.

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 (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,

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:

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)

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.