The Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

Device Description

The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

2- 65 ml syringes (K935668)
96" Low Pressure Connector Tube/T-connector assembly (K943189) .
. Fluid Delivery Device (Spike) - (K810624)
Normally closed check-valve B. Braun/Burron (K790062) ●
Female/Female Luer Adapter B.Braun/Burron (K942391) .
The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.
The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.
The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.
All other components of the kit are identical to those in K943189.
The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.

AI/ML Overview

Here's an analysis of the provided text regarding the Medrad Disposable MRI Kit with Check Valve, focusing on acceptance criteria and the supporting study information:

It's important to note that this document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. As such, the level of detail regarding comprehensive studies and acceptance criteria is different from what might be found in a full efficacy study report for a new drug or high-risk medical device. The focus here is on demonstrating that the new device does not raise new issues of safety or effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly present acceptance criteria in a quantitative, pass/fail table format, nor does it detail a standalone study proving the device meets specific performance metrics with numerical results for each criterion regarding its primary function (fluid delivery). Instead, it demonstrates substantial equivalence by comparing features and performing validation tests related to manufacturing and safety attributes.

However, we can infer some "acceptance criteria" based on the validation tests performed and the comparison to the predicate devices. The "reported device performance" is primarily stated as compliance with established standards and equivalence to the predicate.

Acceptance Criterion (Inferred from Validation/Comparison)	Reported Device Performance
Sterility (Microbial Challenge-Overkill Method)	Achieves a Sterility Assurance Level (SAL) of $10^{-6}$ using biological indicators of Bacillus Subtilis var. niger ($1 \times 10^6$ spores per indicator).
Residual Ethylene Oxide (EtO) Levels	< 4 ppm after 8 days outgassing (via simulated-use aqueous extractions).
Residual Ethylene Chlorohydrin Levels	< 4 ppm after 8 days outgassing (via aqueous extraction).
Residual Ethylene Glycol Levels	< 18 ppm after 8 days outgassing (via aqueous extraction).
Pyrogenicity	Complies with USP Rabbit Testing and/or USP Limulus Amebocyte Lysate (LAL) test methods.
Biocompatibility	Complies with ANSI-AAMI(ISO) 10993-1 through 11 and US Pharmacopoeia XXII, <87 & 88> Biological Reactivity Test (Invitro and Invivo) for Cytotoxicity, Sensitization, Systemic Tox, Intracutaneous Tox, Pyrogen Mat'l Mediated, Hemolysis, Particulate analysis, Bacterio-/Fungistasis, Physicochemical analysis (aqueous/non-aqueous), and Infrared analysis.
Packaging Compatibility with Sterilization	The polystyrene tray and Tyvek lid are heat-sealed and compatible with an EtO Sterilization Cycle.
Shelf Life	Confirmed at least a two-year shelf life from the date of sterilization using an accelerated aging sequence (1 week at 130°F/70-80% RH, 1 day at -4°F, 1 week at 130°F/<15% RH, equivalent to 6 months normal aging). Ongoing testing aims for a five-year shelf life. Flow tests, pressure tests, and ARO tests (likely refers to "Air Removal" or similar functional test) are conducted to ensure product efficacy after accelerated aging. Specific results are not provided.
Standard Luer Fitting (Female/Female Luer Adapter)	"Yes - ANSI 70.1" (implies compliance with the standard).
Standard Luer Fitting (LLPCT)	"ANSI 70.1" (implies compliance with the standard).
Functionality of Check-Valve	Restricts flow in one of two directions, "normally closed requiring a minimum amount of force to open." Prevents contrast trickle during saline flush from the 'B' syringe.

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

Sterility Validation:
- Sample Size: 50 test products per half-cycle verification run. There were three half-cycle verification runs, totaling 150 test products.
- Data Provenance: Not explicitly stated as retrospective or prospective, or country of origin, but it is implied to be internal testing conducted by Medrad, Inc. as part of their sterilization validation process for a new device submission. This would be prospective testing for the specific device.
Residual Levels:
- Sample Size: Not specified for the pre-release testing.
- Data Provenance: Implied as internal prospective testing.
Shelf Life Testing:
- Sample Size: Not specified for the accelerated aging tests or the subsequent flow/pressure/ARO tests.
- Data Provenance: Implied as internal prospective testing.
Biocompatibility/Pyrogenicity:
- Sample Size: Not specified.
- Data Provenance: Implied as internal prospective testing.

For the functional aspects of the check-valve and luer adapter, the document states "Device Verification and Validation Testing has been performed" but does not provide details on sample sizes or specific test results, instead relying on a comparison of features to the predicate device and the fact that other components are identical to a previously cleared device (K943189).

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

This type of information is not applicable to the provided document. The Medrad Disposable MRI Kit with Check Valve is a hardware device (disposable kit) for fluid delivery, not a diagnostic algorithm or a device requiring expert interpretation of results. Therefore, there's no "ground truth" in the medical imaging or diagnostic sense established by human experts for the device's functional performance or safety. The "ground truth" for the device's properties (like sterility, biocompatibility, luer fitting compliance) is established through technical standards, laboratory tests, and reference protocols.

4. Adjudication Method for the Test Set

This is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical image reading) to resolve discrepancies. This device does not involve such human interpretation in its primary function or testing for a 510(k) submission.

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. An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of human readers, sometimes comparing performance with and without AI assistance for tasks like disease detection or classification. This device is a fluid delivery kit and does not involve AI or human diagnostic reading in its function.

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

This is not applicable. This device is a physical medical kit, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established reference for the characteristics being tested. For this device, the ground truth types are:

Technical Standards and Reference Protocols: For sterility (ANSI/AAMI ST27-1988), residual levels (ANSI/AAMI ST29-1988 and ST30-1989), pyrogenicity (USP Rabbit Testing, USP LAL), biocompatibility (ANSI-AMMI/ISO 10993-1 through 11, USP XXII <87 & 88>), and luer fitting compliance (ANSI 70.1). These external, validated standards serve as the "ground truth" for compliance.
Predicate Device Characteristics: The existing Medrad Qwik-Fit MRI Disposables Kit (K943189) and its components serve as a ground truth for substantial equivalence, specifically for features that are identical or closely matched.
Functional Specifications: The intended behavior of the check-valve (restricting flow, preventing trickle) and the luer adapter (fluid transfer) define the functional "ground truth" against which device performance is validated internally.

8. The Sample Size for the Training Set

This is not applicable. A "training set" refers to data used to train a machine learning algorithm. This device is not an AI/ML product.

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

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

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "MEDRAD" in a stylized, bold, sans-serif font. The letters are all capitalized and appear to be slightly slanted to the right. A circled "R" symbol, indicating a registered trademark, is positioned to the upper right of the letter "D".

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SS
K980417

Submitters Name: Submitters Address: Phone Number: Fax Number: Contact Person: Date:

Medrad, Inc. One Medrad Drive Indianola, PA 15051 (412) 767-2400, ext. 3212 (412) 767-8899 Sandra A. Pavlovic January 30, 1998

Classification Name: Common Name: Proprietary Name:

Unknown Sterile Disposables Kit Medrad Disposable MRI Kit with Check Valve

Substantial Equivalence: The Medrad Disposable MRI Kit with Check valve is substantially equivalent to the current Medrad Qwik-Fit MRI Disposables Kit (K943189). The Medrad Disposable MRI Kit with Check valve has the same intended use as the predicate device - to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates in an MR application. The kit may consist of one or all of the following:

2- 65 ml syringes (K935668)
96" Low Pressure Connector Tube/T-connector assembly (K943189) .
. Fluid Delivery Device (Spike) - (K810624)
Normally closed check-valve B. Braun/Burron (K790062) ●
Female/Female Luer Adapter B.Braun/Burron (K942391) .

The only difference between this kit and the predicate device is that this kit contains a normally closed check valve and a female/female luer Adapter. Device Verification and Validation Testing has been performed.

The normally closed check-valve is a attached to the 96" LLPCT at the Tconnector (K943189) and is used to restrict flow in one of two directions. The device is normally closed requiring a minimum amount of force to open. The check-valve attaches to the 'A' syringe and remains closed during saline flush from the 'B' syringe to prevent contrast trickle during this process.

Image /page/0/Picture/15 description: The image shows a stylized letter Q in white against a dark, textured background. Below the letter, there is some faint text that is difficult to read due to its small size and blurriness. The text appears to be in a sans-serif font and is arranged in two lines.

MAY

{1}------------------------------------------------

The Female/Female Luer Adapter is a disposable device used to provide a fluid path between two vessels with male luer terminations. This device can be compared to the Medrad Ouick Fill Tube (K800823) which is also a filling device.

All other components of the kit are identical to those in K943189.

The devices are sterilized using Ethylene Oxide gas. Validation is performed according to AAMI guidelines.

Medrad believes that the Medrad Disposable MRI Kit with Check valve and individual components introduces no new safety or efficacy concerns. It is my hope that the information provided here is sufficient to determine substantial equivalence for these devices.

STERILIZATION DATA

The Medrad Disposable MRI Kit with Check-valve and its components are sterilized by Medrad, Inc. using Oxyfume 2000 (8.4 % Ethylene Oxide and 91.6 % HCFC-124). The sterilization process is the same one used to sterilize the complete line of Medrad sterile disposable devices.

Sterility Validation:

The sterilization validation is done using a Microbial Challenge-Overkill Method as described in the "Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices," by the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI). Reference ANSI/AAMI ST27-1988.

Annual re-validations are performed for established cycles of master product/load configurations as well as periodic product sterility determinations for fluid pathways, following routine sterilization's.

Sterility Assurance Level (SAL):

The Microbial Challenge System is represented by packaged product containing commercially prepared biological indicators of Bacillus Subtilis var. niger with spores numbering 1 x 10°. Fifty test products are sterilized in each of three half cycle verification runs in the full load configuration. A Sterility Assurance Level (SAL) of 10to is established.

{2}------------------------------------------------

Sterility Product Safety:

Residual levels: Residual Ethylene Oxide measurements are made to ensure patient safety and the safety of attending medical personnel. Measurements for Ethylene Oxide, Ethylene Chlorohydrin, and Ethylene Glycol by:

1). Simultated-use aqueous extractions for product safety considerations.

2). Headspace for process characterization.

Reference: ANSI/AAMI ST29-1988 and ST30-1989. Limits are as practiced in industry and as presented in the Federal Register, Vol. 43, No. 122 - June 23,

Pre-release testing for EtO residuals have shown the following levels after 8 days of outgassing:

Ethylene Oxide (vis simulated-use aqueous extractions) = < 4ppm Ethylene Chlorohydrin (via aqueous extraction) =< 4ppm Ethylene Glycol (via aqueous extraction) = < 18 ppm

Pvrogenicity: Pyrogen (Endotoxin) testing is conducted per USP Rabbit Testing and/or USP Limulus Amebocyte Lysate (LAL) test methods. Reference US Pharmacopeia XXII, <151> Pyrogen Test, and <85> Bacterial Endotoxin Test.

Biocompatibility: ANSI-AMMI(ISO) testing as well as USP testing is conducted to assure Biocompatibility of sterile product with living biological systems. Reference: ANSI/AMMI/ISO 10993-1 through 11 and US Pharmacopoeia XXII, <87 & 88> Biological Reactivity Test Invitro and Invivo.

· Cytotoxicity MEM
· Sensitization
· Systemic Tox
· Intracutaneous Tox
· Pyrogen Mat'l Mediated
· Hemolysis
· Particulate analysis
· Bacterio-/Fungistasis
· Physiochemical analysis

-aqueous

-non-aqueous

. Infrared analysis - ID "fingerprint"

{3}------------------------------------------------

Packaging:

The packaging used for the Medrad Disposable MRI Kit with Check-valve consists of a polystyrene tray and a coated Tyvek lid that is heat sealed to the styrene tray. The entire package is compatible with an EtO Sterilization Cycle.

Shelf Life:

At this point the ongoing Shelf Life testing process has confirmed that the kit has at least a two year Shelf Life from the date of sterilization. The testing will continue until it can be concluded that the product has a five year Shelf Life, which is standard for all Medrad sterile products.

The Shelf Life test method is based on the "Ethox Protocol for Accelerated aging" tests and uses the following sequence to simulate ambient storage:

1 week at 130° and 70-80% RH 1 day at -4°F 1 week at 130°F and <15% RH

This accelerated sequence is equivalent to 6 months of normal aging. The following tests will be conducted to ensure product efficacy:

Flow tests Pressure tests

ARO tests

{4}------------------------------------------------

COMPARISON DATA FEMALE/FEMALE LUER ADAPTER

FEATURE	FEMALE/FEMALELUER ADAPTER	QUICK FILL TUBE
Intended use	Fluid transfer from one vessel having a male termination to a syringe with a male termination.	Transfer of fluid from a bottle or vial to a syringe.
Material	Transparent ABS	Polyethylene
Disposable	Yes	Yes
Standard Luer Fitting	Yes - ANSI 70.1	No
Where used	MRI	MRI, CT, Angiography, Cardiology
Sterilized	Yes	Yes
Single Use	Yes	Yes

1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 - 1999 -

{5}------------------------------------------------

COMPARISON DATA LOW PRESSURE CONNECTOR TUBE WITH CHECK VALVE

FEATURE	Medrad 96" LLPCT	Medrad 96" LLPCT withCheck Valve
Intended Use	Disposable deviceconnected to a syringeand IV catheter for theadministration of contrastmedia and flushingsolutions.	Disposable deviceconnected to a syringeand IV catheter for theadministration of contrastmedia and flushingsolutions.
Luer fitting	ANSI 70.1	ANSI 70.1
T- connector	Yes	Yes
Tubing Material	Clear Polyvinyl Chloride	Clear Polyvinyl Chloride
Luer Fitting Material	Clear Polycarbonate	Clear Polycarbonate
Check-valve	No	Yes
Where used	MRI	MRI
Sterilized	Yes	Yes
Single Use	Yes	Yes
Disposable	Yes	Yes

{6}------------------------------------------------

Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

1 1998 MAY

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sandra A. Pavlovic Senior Regulatory Affairs Associate MEDRAD, Inc. One Medrad Drive Indianola. Pennsylvania 15051

Re: K980417 Disposable MRI Kit with Check Valve Dated: February 3, 1998 Received: February 3, 1998 Regulatory Class: II 21 CFR 892.1000/Procode: 90 LNH

Dear Ms. Pavlovic:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, vou are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterlize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.

{7}------------------------------------------------

Page -2 - Ms. Sandra Pavlovic

Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

David A. Legum

Lillian Yin, Ph.D. Director, Divsion of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

{8}------------------------------------------------

Page 1 of 1

510(k) NUMBER (IF KNOWN): K980417

DEVICE NAME: Medrad Disposable MRI Kit with Check Valve

INDICATIONS FOR USE:

ThE Medrad Disposable MRI Kit with Check Valve is indicated for use in an MRI environment. The components of the kit are used to assist in filling and delivering intravascular contrast media and common flushing agents at various volumes and flow rates.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.}

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

David le Seymour

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

Regulation Number and Section

N/A