DeRoyal Angiography Kits

K152978 · Deroyal Industries, Inc. · DXT · Mar 25, 2016 · Cardiovascular

Device Facts

• Record ID: K152978
• Device Name: DeRoyal Angiography Kits
• Applicant: Deroyal Industries, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Mar 25, 2016
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

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 Story

DeRoyal Angiography Kits consist of collections of legally marketed, non-sterile medical device components assembled into a single kit for use in cardiac catheterization laboratories. Components are sourced from various manufacturers and may be bonded using solvent agents (Methylene Chloride/Cyclohexanone) per customer specifications to reduce procedure setup time. The kits are assembled in a controlled environment, packaged, and sterilized via Ethylene Oxide. The device is operated by physicians or clinical staff in a catheterization lab. The kit provides all necessary tools for a procedure in one package, streamlining clinical workflow and ensuring availability of required instruments. The device does not alter the intended use of the individual components.

Clinical Evidence

No clinical studies were performed. Bench testing was conducted to validate the bonding process, including visual inspection, pull tests, and air leak tests. Biocompatibility testing was performed on the fluidic path of bonded components per ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), ISO 10993-11 (systemic toxicity), and ASTM F756 (hemolysis).

Technological Characteristics

Kits contain various legally marketed medical devices. Bonding agents: Methylene Chloride and/or Cyclohexanone. Sterilization: Ethylene Oxide. Packaging: Sterile pouch. Materials meet ISO 10993-1 requirements for limited patient contact (<24 hours).

Indications for Use

Indicated for use by licensed physicians during cardiac catheterization laboratory procedures, including cardiac catheterization, angiography, and arteriogram.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Navilyst Medical Angiography Syringe Kits (K933846)
• Merit Medical Systems, Inc. Merit Custom Kits (K913682)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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)

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#### FOR FDA USE ONLY

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

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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 [e-mail]

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:

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-

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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.

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.

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 Device<br>Navilyst Medical-<br>Angiography Syringe<br>Kits<br>K933846 | Predicate Device<br>Merit Medical<br>Systems, Inc.-Merit<br>Custom Kit<br>K913682 | Proposed Device<br>DeRoyal Angiography<br>Kit |
|-------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------|
| Intended<br>Use | Procedures occurring<br>in Cardiac<br>Catheterization Lab | Procedures occurring<br>in Cardiac<br>Catheterization Lab | Same as predicate |
| Contents | Various legally<br>marketed devices | Various legally<br>marketed devices | Same as predicate |
| Assembly | Bonded and non-<br>bonded components | Bonded and non-<br>bonded components | Same as predicate |
| Design | Custom contents using<br>currently marketed<br>devices and assembled<br>at customer request | Custom contents using<br>currently marketed<br>devices and assembled<br>at customer request | Same as predicate |
| Bonding<br>Agents | Methylene Chloride or<br>Cyclohexanone or<br>Methylene Chloride<br>50% and<br>Cyclohexanone 50% | Methylene Chloride or<br>Cyclohexanone or<br>Methylene Chloride<br>50% and<br>Cyclohexanone 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 Device<br>Navilyst Medical-<br>Angiography Syringe<br>Kits<br>K933846 | Predicate Device<br>Merit Medical<br>Systems, Inc.-Merit<br>Custom Kit<br>K913682 | Proposed Device<br>DeRoyal Angiography<br>Kit |
|-----------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------|
| 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.

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. The proposed device/kits do not raise any new issues of safety and effectiveness.

## 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.