Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and material properties of a guide sheath, with no mention of software, algorithms, or data processing that would indicate AI/ML.

Therapeutic

No
The device is described as an "introducer sheath" used for the introduction of other diagnostic and interventional devices, not for therapeutic action itself.

Diagnostic

No

Explanation: The "Intended Use / Indications for Use" section states that the device is used for the "introduction of interventional and diagnostic devices". This suggests the device itself is a tool to facilitate diagnostic procedures, rather than performing the diagnosis directly. The "Device Description" also details mechanisms for introducing other devices and preventing blood leakage, not for collecting diagnostic data.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components such as a coil reinforced introducer sheath, dilator, valves, and tubing, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature." This describes a device used in vivo (within the body) to facilitate other procedures, not a device used in vitro (outside the body) to examine specimens from the body.
Device Description: The description details a physical device designed for insertion into blood vessels, including components like a sheath, dilator, hemostasis valve, and side port for flushing. These are all characteristics of a device used directly on a patient.
Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.

In summary, the Catapult Guide Sheath is a medical device used for accessing the vascular system during medical procedures, which is distinct from an In Vitro Diagnostic device used for testing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

Product codes

DYB, DRE

Device Description

The Catapult Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface up to 20cm on the distal portion.

The System consists of the following components:

A One Introducer Sheath) with hemostasis valve
A One dilator or
A Two dilators for 15 cm version

The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are fixated onto a packaging pad. Products are sealed inside a medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.

The Catapult Guide Sheath is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is suitable for placement in patients for up to 24 hours.

Devices are sterilized using ethylene oxide. Maximum levels of remaining tested sterilant residuals meet requirement limits EO

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 29, 2022

Contract Medical International s.r.o. Jan Kubicek Senior Regulatory Specialist Vazni 848 Hradec Kralove. 50011 Czech Republic

Re: K221914

Trade/Device Name: Catapult Guide Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: June 27, 2022 Received: June 30, 2022

Dear Jan Kubicek:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Finn Donaldson Team Lead DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221914

Device Name Catapult Guide Sheath

Indications for Use (Describe)

The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter 1.1

Submitter: Contract Medical GmbH Lauensteiner Strasse 37 01277 Dresden Germany Contact Person: Juliana Vaz Nuernberger, Position: Global Head of Regulatory Affairs +49 351 210 747-19 Phone: Email: juliana.nuernberger@heraeus.com Date Summary Prepared: 28th July 2022

1.2 Device

Device Trade Name:	Catapult Guide Sheath
Device Common Name:	Introducer Sheath
Classification Name:	Introducer Catheter, and
Dilator, Vessel, For Percutaneous Catheterization
Device Class:	II
Product Code:	DYB, and DRE

1.3 Predicate Device

Predicate device: DuraSheath Introducer Sheath System (K181463)

Reference device: R2P Destination Slender Guiding Sheath (K193125)

1.4 Device Description

The Catapult Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface up to 20cm on the distal portion.

The System consists of the following components:

A One Introducer Sheath) with hemostasis valve
A One dilator or
A Two dilators for 15 cm version

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The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are fixated onto a packaging pad. Products are sealed inside a medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.

The Catapult Guide Sheath is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is suitable for placement in patients for up to 24 hours.

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Table 3 - Testing overview

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1.10 Conclusions

Based on the intended use, technological characteristics, and performance data provided, the Catapult Guide Sheath is considered appropriate for the intended use. The technological and material differences between the subject and predicate devices do not raise new questions of safety or effectiveness. The subject Catapult Guide Sheath device is considered to be substantially equivalent to the predicate DuraSheath Introducer Sheath System (K181463).