DeRoyal Angiography Kits are intended for use by licensed physicians. The intended use of individual medical products assembled in these kits will not be changed from the manufacturer's original intended use. These kits are assembled of devices used during cardiac catheterization laboratory procedures such as cardiac catheterization, angiography, arteriogram, etc.

Device Description

DeRoyal Angiography Kits (sometimes referred to as Challenge Kit or Standard Heart and Vascular Kit in this submission) are kits assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices-intended for prescription use during procedures occurring in the cardiac catheterization laboratory. The kits are assembled using DeRoyal and other manufacturer's medical devices. DeRoyal purchases the medical device components assembled in these kits bulk, non-sterile. DeRoyal assembles the kits, packages, and sterilizes the kits.

The DeRoyal Angiography Kit components intended use are unchanged from that of the original manufacturers intended use. These kits are assembled according to customer specifications who specify the contents, quantity of devices and placement of the devices in the kit. DeRoyal customers may request that certain components be bonded prior to placement in the kit for convenience purposes in reducing set up time prior to a procedure. The devices used in the DeRoyal Angiography Kits are standard items used in catheterization laboratory procedures. These kits are assembled in a controlled manufacturing environment and are sterilized by Ethylene Oxide.

AI/ML Overview

The provided text describes a 510(k) submission for DeRoyal Angiography Kits and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI or diagnostic device. As such, the typical structure for AI/diagnostic device studies (sample size, expert ground truth, MRMC, etc.) does not directly apply.

However, I can extract the relevant information regarding the testing performed to demonstrate the device meets its stated safety and effectiveness for a 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a medical kit (an assembly of existing devices), the "acceptance criteria" are primarily related to the manufacturing, sterilization, and material safety of the kit as a whole, focusing on demonstrating these aspects are equivalent to predicate devices and do not raise new safety or effectiveness concerns.

Feature/Test	Acceptance Criteria (Implied by 510(k) Process & Predicate Comparison)	Reported Device Performance
Intended Use	Must be the same as predicate devices (Navilyst Medical Angiography Syringe Kits - K933846, Merit Medical Systems, Inc. - Merit Custom Kits - K913682); individual components' intended uses must remain unchanged.	"Same as predicate" - "intended for use by licensed physicians... during cardiac catheterization laboratory procedures." Individual component intended uses are unchanged.
Contents	Must utilize legally marketed devices.	"Same as predicate" - "Various legally marketed devices." Kits are "assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices."
Assembly (Bonding)	Bonded components must maintain integrity; bonding process must not negatively affect the kit.	"Same as predicate" - "Bonded and non-bonded components." Bench testing performed: visual, pull test, and air leak test. Validation "insure there is not a negative effect on the kit." Specific results (e.g., bond strength values) are not reported in this summary, but the implication is that they met internal criteria.
Design	Customizability using currently marketed devices.	"Same as predicate" - "Custom contents using currently marketed devices and assembled at customer request."
Bonding Agents	Use of agents similar to or established as safe in predicate devices.	"Same as predicate" - "Methylene Chloride or Cyclohexanone or Methylene Chloride 50% and Cyclohexanone 50%."
Sterility	Achieve sterility via Ethylene Oxide (EO) equivalent to predicate devices.	"Same as predicate" - "Ethylene Oxide."
Packaging	Packaging methods equivalent to predicate devices.	"Same as predicate" - "Sterile Pouch."
Biocompatibility (of Kit Materials/Fluidic Path)	Materials must meet ISO 10993-1 for appropriate contact level; fluidic path of bonded components must be biocompatible. Limited patient-contacting materials' biocompatibility established through history of use of original components.	Biocompatibility testing conducted through the fluidic path of bonded components: ISO 10993-1, -5 (Cytotoxicity), -10 (Skin Irritation/Sensitization), -11 (Systemic Toxicity), and ASTM F756 (Hemolytic Properties). Implied successful completion.
Impact on Safety & Effectiveness	The proposed device/kits must not raise any new issues of safety and effectiveness compared to predicate devices.	"The proposed device/kits do not raise any new issues of safety and effectiveness." This is the ultimate conclusion derived from the substantial equivalence argument and testing.

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

Sample Size: The document mentions "The validation was conducted on the DeRoyal Angiography Kit 77-400980". This implies at least one specific kit configuration was tested for bench testing (visual, pull, air leak). Specific numbers of individual samples (e.g., how many bonds were pulled, how many kits were tested for air leaks) are not specified in this summary.
Data Provenance: This is internal company bench testing. No country of origin for external data is mentioned, as it's not a clinical study involving patients. It is retrospective in the sense that it's performed on manufactured kits to validate the manufacturing process.

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

Not applicable. This is not a study requiring expert ground truth in the context of diagnostic accuracy. The "ground truth" for manufacturing and material safety is established by compliance with recognized standards (ISO, ASTM) and successful completion of bench tests.

4. Adjudication method for the test set

Not applicable for this type of submission. Bench tests typically involve direct measurement against a predefined specification.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving human interpretation of clinical data, which is not the nature of an angiography kit 510(k) submission.

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

No, a standalone performance study (algorithm only) was not done. This is not an AI or algorithm-based device. The "device" is a physical medical kit.

7. The type of ground truth used

The "ground truth" for this submission revolves around:

Compliance with recognized standards: ISO 10993 series and ASTM F756 for biocompatibility.
Successful completion of bench tests: Visual inspection, pull tests for bonded components, and air leak tests. These tests would have internal specifications representing acceptable manufacturing quality and safety.
Substantial equivalence: The primary ground truth is demonstrating that the kit's characteristics (intended use, contents, assembly, sterilization, etc.) are fundamentally the same as legally marketed predicate devices and thus do not raise new questions of safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable, for the same reason as above.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or a cape. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 25, 2016

DeRoyal Industries, Inc. Elizabeth Wheeler Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, TN 37849

Re: K152978

Trade/Device Name: DeRoyal Angiography Kits Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic injector and syringe Regulatory Class: Class II Product Code: DXT Dated: February 15, 2016 Received: February 16, 2016

Dear Elizabeth Wheeler:

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. However, you 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., sterilize) vou must submit a new 510(k) before including these components in your kit. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K152978

Device Name DeRoyal Angiography Kits

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Image /page/3/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the company name "DeRoyal" in blue, stylized font. A registered trademark symbol is located to the right of the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

DeRoval Industries, Inc. Traditional 510(K) Submission - Angiography Kits October 8, 2015

510(k) Summary

Original Date prepared:	October 8, 2015
Revised Date:	March 22, 2016

510(k) Owner:

DeRoyal Industries, Inc. 200 DeBusk Lane Powell, TN 37849 Owner/Operator #1044833

510(k) Contact: Elizabeth Wheeler Senior Requlatory Affairs Specialist 865-362-2333 ewheeler@deroyal.com

Manufacturer:

1501 East Central Ave. LaFollette, TN 37766 FDA Registration Number: 3005011024

DeRoyal Industries, Inc.

DeRoyal Angiography Kits Trade Name:

Common Name: Angiography Kits

Classification: Anqiographic Injector and Syringe

Device Product Code: Primary: DXT

Substantial Equivalency: Navilyst Medical Angiography Syringe Kits - K933846

Merit Medical Systems, Inc. Merit Custom Kits - K913682

Indications for Use:

Device Description:

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Image /page/4/Picture/0 description: The image shows the logo for DeRoyal. The logo features a blue swoosh design on the left side, followed by the company name "DeRoyal" in blue lettering. A registered trademark symbol is located to the right of the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

DeRoval Industries. Inc. Traditional 510(K) Submission - Angiography Kits October 8, 2015

intended for prescription use during procedures occurring in the cardiac catheterization laboratory. The kits are assembled using DeRoyal and other manufacturer's medical devices. DeRoyal purchases the medical device components assembled in these kits bulk, non-sterile. DeRoyal assembles the kits, packages, and sterilizes the kits.

DeRoyal Angiography Kits are substantially equivalent to kits and/or trays marketed by Navilyst Medical and Merit Medical. The predicate kits marketed are comprised of similar devices from other manufacturers, undergo the same assembly procedures including bonding of certain devices and they have the same intended use.

Feature	Predicate DeviceNavilyst Medical-Angiography SyringeKitsK933846	Predicate DeviceMerit MedicalSystems, Inc.-MeritCustom KitK913682	Proposed DeviceDeRoyal AngiographyKit
IntendedUse	Procedures occurringin CardiacCatheterization Lab	Procedures occurringin CardiacCatheterization Lab	Same as predicate
Contents	Various legallymarketed devices	Various legallymarketed devices	Same as predicate
Assembly	Bonded and non-bonded components	Bonded and non-bonded components	Same as predicate
Design	Custom contents usingcurrently marketeddevices and assembledat customer request	Custom contents usingcurrently marketeddevices and assembledat customer request	Same as predicate
BondingAgents	Methylene Chloride orCyclohexanone orMethylene Chloride50% andCyclohexanone 50%	Methylene Chloride orCyclohexanone orMethylene Chloride50% andCyclohexanone 50%	Same as predicate

Summary of Technological Characteristics:

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Image /page/5/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the text "DeRoyal" in blue, with a registered trademark symbol to the upper right of the word "Royal". The logo is clean and professional, with a modern design.

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

DeRoval Industries. Inc. Traditional 510(K) Submission - Angiography Kits October 8, 2015

Feature	Predicate DeviceNavilyst Medical-Angiography SyringeKitsK933846	Predicate DeviceMerit MedicalSystems, Inc.-MeritCustom KitK913682	Proposed DeviceDeRoyal AngiographyKit
Sterility	Ethylene Oxide	Ethylene Oxide	Same as predicate
Packaging	Sterile Pouch	Sterile Pouch	Same as predicate

Basis for Substantial Equivalence:

DeRoyal Angiography Kits are kits assembled of legally marketed medical devices- either exempt, marketed according to a 510(k), or pre-amendment devices-intended for prescription use during procedures occurring in the cardiac catheterization laboratory. The kits are assembled using DeRoyal and other manufacturer's medical devices. DeRoyal purchases the medical device components assembled in these kits bulk, non-sterile. DeRoyal assembles the kits, packages, and sterilizes the kits.

Clinical Studies:

Clinical Testing was not performed for this device as it is not a high risk, class III device for which clinical evaluations are needed.

Summary of Testing Performed:

Bench testing was performed to demonstrate the three methods of bonding used in the assembly of kit components for the DeRoyal Angiography Kits to one another using solvent agents to secure bonds. The validation was conducted on the DeRoyal Angiography Kit 77-400980 after the bonding process to insure there is not a negative effect on the kit. The tests performed were identified as visual, pull test, and air leak test.

The DeRoyal Angiography Kits are manufactured with materials that meet the ISO 10993-1: Biological Evaluation of Medical Device-Part 1: Evaluation and testing within a risk management process for their appropriate contact level. The materials used in these devices are classified as either non-patient contacting or blood path, indirect, externally communicating devices of less than 24 hours limited patient contacting. Biocompatibility testing was completed through the fluidic path of the bonded components only. The following Biocompatibility Testing was conducted:

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Image /page/6/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the text "DeRoyal" in blue. The "R" in "Royal" has a registered trademark symbol next to it.

Corporate

200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

DeRoyal Industries, Inc. Traditional 510(K) Submission - Angiography Kits October 8, 2015

ISO 10993-1: Biological Evaluation of Medical Devices-● Evaluations of Medical Devices
ISO 10993-5: Biological Evaluation of Medical Devices-Part 5-In Vitro Cytotoxicity
. ISO 10993-10: Biological Evaluation of Medical Devices-Part 10- Tests for Skin Irritation and Sensitization
ISO 10993-11: Biological Evaluation of Medical Devices-Part . 11- Tests for Systemic Toxicity
ASTM F756: Standard Practice for Assessment of Hemolytic ● Properties of Materials

Biocompatibility for the limited patient contacting materials have been established through history of use in the individual medical device components of the kits as cleared through their original manufacturers 510(k) or are exempt from the 510(k) process based on their classification.

Regulation Number and Section

§ 870.1650 Angiographic injector and syringe.

(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.