The subcutaneous needle infusion set consists of a sterile packaged kit including the infusion set and an adhesive dressing to hold the device in place. The unique Single, Bifurcated, Trifurcated, and Quadfurcated for the Sub-Q have a luer lock at one end and a 90 degree needle mounted to a butterfly stabilizer at the other end. The sets are convenient to use, associated with less trauma, and offer an opportunity to improve compliance cost-effectively through the use of a dedicated infusion set. The device is for single use only.

AI/ML Overview

This 510(k) summary (K082818) for the Marcal Medical Subcutaneous Needle Infusion Set is very brief and primarily focuses on establishing substantial equivalence to predicate devices. It does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, as would typically be found in a comprehensive clinical or performance study report.

The relevant section states:

"The Marcal Medical Subcutaneous Needle Infusion Set meets all established acceptance criteria for performance testing and design verification testing."

However, it does not list what those "established acceptance criteria" are or present any data from the "performance testing and design verification testing" themselves.

Therefore, I cannot fulfill all parts of your request with the provided text. Based on the information given, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The document only states that the device "meets all established acceptance criteria for performance testing and design verification testing" without specifying what those criteria or the actual performance results are.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. No specific test set, its sample size, or data provenance (country, retrospective/prospective) is mentioned.

3. 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. This type of detail is typical for studies involving expert review for ground truth, which is not described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. Adjudication methods are relevant when multiple experts are used to establish ground truth, which is not described.

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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study, nor is there any mention of AI assistance in the context of this device. This device is a physical medical device (infusion set), not a software or AI product.

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

There is no indication of a standalone algorithm performance study. This device is a physical medical device (infusion set), not an algorithm.

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

This information is not provided in the document. The document refers to "performance testing and design verification testing" but does not detail the methodology or what constituted "ground truth" for these tests, if applicable in the sense of clinical decision-making. For a physical device like an infusion set, "ground truth" might refer to engineering specifications or validated physical measurements rather than clinical diagnostic ground truth.

8. The sample size for the training set

This information is not provided in the document. The concept of a "training set" is typically associated with machine learning or AI models, which is not applicable to this physical medical device.

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

This information is not provided in the document. As with point 8, the concept of a "training set" for ground truth establishment is not relevant here.

Conclusion based on the provided text:

The provided 510(k) summary is extremely concise and focuses solely on stating that the device "meets all established acceptance criteria for performance testing and design verification testing" to demonstrate substantial equivalence. It does not disclose the specific acceptance criteria, the results of the performance testing, or any details about the methodologies used (e.g., sample sizes, expert involvement, ground truth establishment). For a physical medical device like an infusion set, performance testing typically involves engineering and bench testing (e.g., flow rate, tensile strength, sterility, biocompatibility) rather than clinical studies requiring expert consensus for ground truth or AI performance metrics. Such details would usually be found in the more comprehensive "performance data" or "test reports" section of the 510(k) submission, which is not included in this summary.

Summary

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K082818

page 1 of

510(K) SUMMARY (as required by 807.92(c))

DEC 2 3 2008

Regulatory Correspondent	AJW Technology Consultants Inc962 Allegro LaneApollo Beach, FL 33572awconsltng@aol.com
Submitter of 510(k):	Marcal Medical, Inc.1114 Benfield Blvd, Suite HMillersville, MD 21108USA
	Phone: (410) 987-4001Fax: (410) 987-4004
Contact Person:	Candace Keaton
Date of Summary:	6/17/08
Trade/Proprietary Name:	Subcutaneous Needle Infusion Set
Classification Name:	Set Administrative Intravascular
Product Code:	FPA

Intended Use:

The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the subcutaneous tissue

Device Description:

Predicate Device:

K020530 - Evans Medical, Inc - Evans Sub-Q, Model MC4206 K891072 - Multi-Med, Inc - Intravascular Administration Set.

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K$\phi$82818 page 2 of 2

Substantial Equivelance:

The Marcal Medical Subcutancous Needle Infusion Set meets all established acceptance criteria for performance testing and design verification testing. The components of the Sub-Q Set are substantially equivalent to the predicate device presented in this 510k.

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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 stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

DEC 2 3 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Marcal Medical, Incorporated C/O Mr. Arthur Ward President AJW Technology Consultants Incorporated 962 Allegro Lane Apollo Beach, Florida 33572

Re: K082818

Trade/Device Name: Subcutaneous Needle Infusion Set Regulation Number: 21 CFR 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 17, 2008 Received: September 30, 2008

Dear Mr. Ward:

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. Ward

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chris S. Liem, Ph.D.

Chiu S. Lin. Ph. D Division 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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K082818

Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Subcutaneous Needle Infusion Set

Indications for Use:

The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the subcutaneous tissue

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthong 2. Ownt

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

Page 1 of 1

510(k) Number: 482818

15 of 219

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.