"Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.

Device Description

The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set. This document evaluates the device's substantial equivalence to a legally marketed predicate device, the Minimed MMT-106 (and related models).

However, the provided text does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that proves the device meets specific acceptance criteria in the manner requested.

The document from Ko20530 is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with performance metrics against acceptance criteria. It states that "Testing was performed according to internal company standards to verify device performance. Testing verifies that the actual device performance satisfies the design intent." but it does not provide the specifics of these tests or their results in a quantitative manner.

Therefore, many of the requested fields cannot be directly extracted or inferred from the provided text. I will fill in what can be gathered and explicitly state when information is not available.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance (as inferred or stated in document)
Safety	e.g., Biocompatibility, Sterility, Freedom from manufacturing defects, Secure attachment to skin, Material integrity over time	"Testing was performed according to internal company standards to verify device performance... actual device performance satisfies the design intent."
Effectiveness	e.g., Reliable medication delivery, Flow rate consistency, Luer lock integrity, Needle insertion characteristics, Tubing integrity	"substantially equivalent to several similar devices" in materials, packaging, and indications for use. "actual device performance satisfies the design intent."
Material Responsibility	e.g., Lack of adverse material reactions, Durability	"In all material respects" substantially equivalent to predicate.
Sterility	e.g., Maintenance of sterility until use	"Packed sterile for single patient use" (same as predicate)
Packaging	e.g., Integrity of sterile barrier, clear labeling	"Packed sterile for single patient use" (same as predicate)

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Testing was performed according to internal company standards," but does not detail the sample size for any specific tests.
- Data Provenance: Not specified. It's likely internal company data given the statement, but no country of origin or retrospective/prospective nature is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided in the document. The filing is a 510(k) premarket notification relying on substantial equivalence, and as such, it does not typically detail expert panel reviews or ground truth establishment in this manner for its "internal company standards" testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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:
- No. An MRMC comparative effectiveness study was not conducted according to the document. This device is a physical medical device (infusion set), not an AI/software device, so such a study would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm, so this concept is not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The document implies that the ground truth for "design intent" and "device performance" was established through engineering specifications and internal company standards. It does not refer to clinical outcomes, pathology, or expert consensus in the context of a validation study as might be seen for diagnostic devices. The primary "ground truth" for marketing authorization in this document is the predicate device, against which substantial equivalence is claimed.
The sample size for the training set:
- This concept is not applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- This concept is not applicable as there is no training set for this type of device.

Summary

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Ko20530

APR 2 9 2002

EXHIBIT 2

Evans Medical, Inc. 295 Old Limekiln Road Chalfont, PA 18914 Phone 215-249-4882 Fax 215-249-4883 Contact: Paul Lambert January 7, 2002

510(k) Summary of Safety and Effectiveness

1. Identification of the Device: Proprietary-Trade Name: "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set Classification Name: FPA Common/Usual Name: I.V. Administration Set
1. Equivalent legally marketed device: This device is similar in design and in function to the Minimed MMT-106. MMT-107, MMT-133, K961474.
1. Indications for Use (intended use): "Evans Sub-Q" (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe. (The device is supplied sterile, for single use only. It is a prescription device)
1. Description of the device: The device consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The infusion set has a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end, connected by 42" of 2mm medical grade tubing. The luer lock connects to the infusion pump device. The device is for single use.

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1. Safety and Effectiveness, comparison to predicate device:

Comparison Areas	Minimed MMT-106. MMT-107, MMT-133, K961474;	"Evans Sub-Q" (Catalog #MC4206) WingedSubcutaneous TissueInfusion Set
Indications for use	Intended to providesubcutaneous infusion ofmedicine from an externalinfusion pump	Intended to providesubcutaneous infusion ofmedicine from an externalInfusion pump or syringe
Materials	Medical grade plastics andstainless steel needle	SAME
Packaging	Packed sterile for singlepatient use	SAME

1. Testing information and Conclusion
  1 esting information and Coxectars Sub-Q'' (Catalog # MC4206) Winged In an material respons, are is substantially equivalent to several similar devices Subculancous Intusion between betting was performed according to internal company ancady on the OD mance. Testing many was actual device performance satisfies the design intent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2002

Evans Medical, Incorporated C/O Mr. Daniel Kamm Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K020530

Trade/Device Name: Evans SUB-Q ( Catalog MC4206) Winged Subcutaneous Tissue Infusion Set Regulation Number: 880.5440 Regulation Name: I.V. Adminstration Set Regulatory Class: II Product Code: FPA Dated: February 18, 2002 Received: February 19, 2002

Dear Mr. Kamm:

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.

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

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Page 2 - Mr. Daniel Kamm

of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal buts requirements, including, but not limited to: registration Touring (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 OF R Part 007), as clima (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the qualify is a 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to 310(K) promised notificate 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 II you desire specific act 100 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618 . Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. ad vertibing or joint on entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and the ret may be volumer 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,

Timothy W. Klatowski

Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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K020530

j) Indications for Use

510(k) Number K020530

510(k) Namber K02053 -Evalis Sub-Q (Catalog in IPO 1200) Nation of medicine from an external infusion pump or syringe. .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_

Over the Counter Use__________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Patrice Cucenile

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number _

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.