The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use X

Device Description

The EZ Regular consists of components commonly found on intravascular administration sets and extension sets. EZ Regular set consists of various components such as: air vented bag spike, drip chamber with filter or without filter, roller clamp, tubing, flow controller, Y-connector, needle-less Y-connector, luer lock end catheter, manifold filter.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "EZ Regular," which is an intravascular administration set. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria in the typical sense for an AI/CADe device.

Therefore, many of the requested sections (e.g., specific acceptance criteria table, sample sizes, expert qualifications, MRMC study, ground truth details, training set size) are not applicable or extractable from this submission, as it pertains to a physical medical device (administration set) and not an AI/CADe system. The performance evaluation discussed is related to bench testing of a physical product.

Here's an attempt to answer the extractable information based on the provided text, with clear indications where information is not available or not relevant for an AI/CADe context:

1. Table of Acceptance Criteria and Reported Device Performance

For an intravascular administration set, the "acceptance criteria" are related to mechanical integrity, biocompatibility, and sterility, rather than metrics like sensitivity, specificity, or F1-score used for AI.

Acceptance Criteria Category	Reported Device Performance (Summary)	Notes
Biocompatibility	Bench tests demonstrated "safe, effective"	The document states "Bench testing included biocompatibility." It implies the device met the necessary standards for biocompatibility for an intravascular device, allowing it to be considered substantially equivalent. Specific pass/fail criteria and results are not detailed.
Mechanical Testing	Bench tests demonstrated "safe, effective"	The document states "Bench testing included...mechanical testing." This would typically involve tests for tensile strength, leak integrity, flow rates, etc. The submission indicates these tests were successfully passed to demonstrate substantial equivalence. Specific details are not provided.
Sterility Testing	Bench tests demonstrated "safe, effective"	The document states "Bench testing included...sterility testing including EO residues." This would verify that the device is sterile and that residual ethylene oxide (EO) levels are within acceptable limits. Specific details are not provided.
Functional Equivalence	"Technological characteristics...identical...perform the same way as common intravascular administration sets."	This is the core claim for substantial equivalence, meaning the device functions as intended and similarly to the predicate device.

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

Sample Size: Not specified. "Bench tests were performed" typically refers to testing a certain number of manufactured units, but the exact count is not provided.
Data Provenance: Not applicable in the context of clinical data. This refers to physical product testing.

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

Not Applicable: This is a physical device, not an AI/CADe algorithm where expert ground truth is established for image interpretation. The "ground truth" here is compliance with engineering and biological safety standards, verified through laboratory testing.

4. Adjudication method for the test set

Not Applicable: Adjudication is relevant for reconciling expert disagreements in clinical data interpretation. For physical device testing, standards and test methods dictate pass/fail criteria.

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

Not Applicable: This device is an intravascular administration set, not an AI system. No MRMC study was conducted.

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

Not Applicable: This is a physical medical device, not a standalone AI algorithm.

7. The type of ground truth used

Engineering Standards and Biocompatibility Test Results: The "ground truth" for this device's performance is adherence to established engineering specifications (e.g., mechanical strength, leak rates, flow rates) and successful completion of biocompatibility and sterility tests as per recognized standards (e.g., ISO, ASTM, USP).

8. The sample size for the training set

Not Applicable: There is no "training set" in the context of physical medical device manufacturing and testing as described here.

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

Not Applicable: As there is no training set, this question is not relevant.

In summary: The provided document is a 510(k) summary for a relatively low-risk Class II physical medical device seeking substantial equivalence. It does not contain the type of AI/CADe-specific performance study details (e.g., clinical trial data, reader studies, AI metrics) that would necessitate the information requested in points 1-9 in that context. The "performance" section refers to standard bench testing for safety and effectiveness of the physical product.

Summary

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510(K) Summary

K08030 3

AUG - 6 2008

MEINNTECH CO., LTD. # 502, Pyeongchon IT B/D, 1113-1, Daran-dong, dongan-gu, Anyang-si, gyeonggi-do, Korea

Contact person: Contact : Ui-soo Kim, Overseas Sales Manager Korea Telephone : +82 31 381 7077 Fax +82 31 381 7053 E-mail: peter@meinntech.com Date Prepared: February 1, 2008

1. Trade Name: EZ Regular Common Name: Intravascular administration set. Classification Name: Intravascular administration set. Product code FPA, Regulation: 880.5440 Class of device: Class II.
1. The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : Kipp Group Intravascular Administration Set (K991932)
1. Description of device: The EZ Regular consists of components commonly found on intravascular administration sets and extension sets.

EZ Regular set consists of various components such as:

air vented bag spike. .
drip chamber with filter or without filter, .
roller clamp, tubing. .
flow controller. .
Y-connector, .
needle-less Y-connector, .
luer lock end catheter, .
manifold filter. .
1. Intended use: The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. Prescription Use.
1. The EZ Regular Administration Sets and the predicate Technological characteristics: devices have identical technological characteristics and perform the same way as common intravascular administration sets. They are EO sterilized.
1. Performance: Bench tests were performed. Bench testing included biocompatibility. mechanical testing, sterility testing including EO residues. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 2008

Meinntech Company, Limited C/O Mr. Daniel Kamm Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K080303

Trade/Device Name: EZ Regular Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 29, 2008 Received: August 1, 2008

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.

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Page 2 - Mr. Kamm

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,

MKormels-Verdi-forll

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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Indications for Use

510(k) Number (if known):_K08 ○ 30 3

Device Name: _ EZ Regular

Indications For Use:

The EZ Regular set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Jot All der Daomin

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

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.