(30 days)
Not Found
No
The device description and performance studies focus on mechanical, biocompatibility, and sterilization aspects of a physical introducer sheath system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is intended to introduce other interventional and diagnostic devices, not to directly treat or diagnose a condition itself.
N/A
No
The device description clearly outlines physical components such as a coil reinforced introducer sheath, hemostasis valve, side port, dilator, and a 3-way stopcock valve, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are used for the introduction of interventional and diagnostic devices into the vasculature. This describes a tool used during a medical procedure, not a device that performs a diagnostic test on a biological sample in vitro (outside the body).
- Device Description: The description details a physical device (sheath, dilator, valves) designed to facilitate access to blood vessels. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological fluids, nor any indication of providing diagnostic information based on such analysis.
The device is a medical device used for accessing the vascular system to allow other diagnostic or interventional devices to be used. This is a procedural device, not an in vitro diagnostic device.
N/A
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.
The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.
Product codes
DYB, DRE
Device Description
The Introducer Sheath System devices consist 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 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 in length of 20cm on the distal portion.
The System consists of the following components:
- A One Introducer Sheath with hemostasis valve
- A One or two dilator(s)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral (and coronary) vasculature, femoral, popliteal and infrapopliteal arteries
Indicated Patient Age Range
pediatric population (for COMPASS Guiding Introducer Sheath)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data demonstrate that the modification of the Introducer Sheath System devices is substantially equivalent to the predicate. The following performance data from non-clinical tests were provided in support of the substantial equivalence determination:
- . Mechanical testing, including tests required under relevant international standards were performed to verify and validate the design.
- . Biocompatibility Risk Assessment (BRA) and performed biocompatibility device testing to demonstrate biocompatibility.
- . Sterilization information to confirm sterility of the device upon exposure to the selected sterilization EO cycle.
- . Accelerated aging testing to confirm product performance at the end of the shelf life.
The results of performed testing based on risk analysis demonstrate that the new modification of Introducer Sheath System devices perform comparably with the predicate and other legally marketed devices. The modified Introducer Sheath System devices with is substantially equivalent to the predicate device in terms of intended use, design and materials, technological characteristics, and principle of operation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Contract Medical International GmbH Jan Kubicek Senior Regulatory Affairs Manager, Europe Lauensteiner Str. 37 Dresden, Saxony 01277 Germany
Re: K250439
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: February 14, 2025 Received: February 14, 2025
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Digitally signed by Sevan R. Sevan R. Oungoulian -S Oungoulian -S 13-51-42-04'00' 13:51:42 -04'00'
For
Misti Malone Assistant Director 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
3
Indications for Use
510(k) Number (if known) K250439
Device Name
Catapult Guide Sheath Introducer Sheath System; COMPASS Guiding Introducer Sheath; Fortress Introducer Sheath System
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.
The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wres, catheters and other devices into the femoral, popliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) SUMMARY
1.1 Submitter
| Submitter: | Contract Medical GmbH |
|---|---|
| Lauensteiner Strasse 37 | |
| 01277 Dresden | |
| Germany | |
| Contact Person: | Jan Kubicek, |
| Position: | Regulatory Affairs Manager |
| Phone: | +420494949556 |
| Email: | jan.kubicek@heraeus.com |
| Date Summary Prepared: | 14th February 2025 |
1.2 Device
| Device Trade Name: | Catapult Guide Sheath | |
|---|---|---|
| Device Common Name: | Introducer Sheath | |
| Modification: | Introduction of internally sourced HVA | |
| Classification Name: | Introducer Catheter, and | |
| Dilator, Vessel, For Percutaneous Catheterization | ||
| Device Class: | II | |
| Product Code: | DYB, and | |
| DRE |
1.3 Predicate Device
The predicate device is the Catapult Guide Sheath Introducer Sheath System (K240957).
1.4 Device Description
The Introducer Sheath System devices consist 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 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 in length of 20cm on the distal portion.
The System consists of the following components:
- A One Introducer Sheath with hemostasis valve
- A One or two dilator(s)
5
1.5 Indications for Use for introducer sheath systems of the Manufacturer
The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
The COMPASS Guiding Introducer Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature. The device is also intended to be used within a pediatric population.
The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining haemostasis during diagnostic and interventional procedures.
1.6 Comparison of Technological Characteristics with the Predicate Device
Regarding the design, device features, method of sterilization, and mode of operation, the modification of Introducer Sheath System device does not differ from the predicate device.
Device size configurations and shapes for the modified Introducer Sheath System devices are unchanged.
Materials used for manufacture of the modified Introducer Sheath System devices are or very similar as those contained in the predicate device with exception of the insourced HVA (Hemostasis Valve Adaptor).
The following modification exist between the subject and predicate devices:
| HVA Part | Predicate HVA materials | Subject HVA Materials | |
|---|---|---|---|
| Hemostasis valve | |||
| material | HVA Cap: | ||
| Polycarbonate | HVA Cap: | ||
| Copolyester | |||
| HVA Body: | |||
| Polycarbonate | HVA Body: | ||
| Copolyester | |||
| Valve membrane: | |||
| Silicone | Valve membrane: | ||
| Silicone | |||
| Swivel Nut: | |||
| Copolyester | Swivel Nut: | ||
| Polycarbonate | |||
| O-Ring: | |||
| N/A | O-Ring: | ||
| Silicone | |||
| Lubricant: | |||
| Silicone | Lubricant: | ||
| Silicone | |||
| Stopcock and | |||
| extension line | |||
| material | Stopcock Body: | ||
| Polycarbonate | Stopcock Body: | ||
| Polycarbonate | |||
| Stopcock Handle: | |||
| Acetal | Stopcock Handle: | ||
| HDPE | |||
| Stopcock Cap: | |||
| ABS | Stopcock Cap: | ||
| Polypropylene | |||
| Tubing: | |||
| TPU - Tecothane | Tubing: | ||
| TPU - Elastollan |
- . New insourced HVA as complete assembly
Table 1 – HVA material comparison between subject and predicate device
6
Performance Data 1.7
Performance data demonstrate that the modification of the Introducer Sheath System devices is substantially equivalent to the predicate. The following performance data from non-clinical tests were provided in support of the substantial equivalence determination:
- . Mechanical testing, including tests required under relevant international standards were performed to verify and validate the design.
- . Biocompatibility Risk Assessment (BRA) and performed biocompatibility device testing to demonstrate biocompatibility.
- . Sterilization information to confirm sterility of the device upon exposure to the selected sterilization EO cycle.
- . Accelerated aging testing to confirm product performance at the end of the shelf life.
The list of tests performed in support of determination of substantial equivalence is provided in Table 2.
| No. | Verification / Validation Activity | Test Type | Applicable Standard(s)
(Recognized Consensus # if
applicable] |
|-----|--------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Dimensional Evaluation | Visual | Internal requirement based on
predicate performance |
| 2 | Insertion Force | Mechanical/Visual | Internal requirement based on
predicate performance |
| 3 | Valve / Dilator snap-in fit test | Mechanical/Visual | Internal requirement based on
predicate performance
IEC 62366-1:2020 (5-129) |
| 4 | Air leakage during aspiration | Mechanical | ISO 10555-1:2013/AMD1:2017
(6-408) |
| 5 | Liquid leakage through
hemostasis valve | Mechanical | ISO 11070:2014
ISO 10555-1:2013/AMD1:2017
(6-408)
ISO 80369-1:2018 (5-121)
ISO 80369-7:2021 (5-133) |
| 6 | Tensile properties evaluation | Mechanical | ISO 11070:2014
ISO 10555-1:2013/AMD1:2017
(6-408) |
| 7 | Kink stability | Mechanical | EN 13868:2002 (N/A)
Internal requirement based on
predicate performance |
| 8 | Flow-rate | Mechanical | ISO 10555-1:2013/AMD1:2017
(6-408) |
| No. | Verification / Validation Activity | Test Type | Applicable Standard(s)
(Recognized Consensus # if
applicable] |
| 9 | Luer Connector | Mechanical | ISO 80369-1:2018 (5-121)
ISO 80369-7:2021 (5-133) |
| 10 | Particle evaluation test | Mechanical/Visual/External | AAMI TIR42 (3-172)
ISO 8536-4 (6-447)
USP |
| 11 | Packaging integrity assessment | External laboratory testing | EN 868-5:2018
ASTM F88/F88M-21(14-573)
ISO 11607-1 Second edition
2019-02 (14-530) |
| 12 | Biocompatibility testing
Biological Risk Assessment | External Laboratory
Documented assessment | ISO 10993-1:2018 (2-258)
ISO 10993-4:2017 (2-248)
ISO 10993-5:2009 (2-245)
ISO 10993-10:2021 (2-296)
ISO 10993-11:2017 (2-255)
ISO 10993-12:2021 (2-289)
ISO 14971:2019 (5-125)
FDA Guidance Use of
International Standard ISO
10993-1 |
| 13 | Chemical stability assessment | Documented assessment | Internal requirement based on
predicate performance |
| 14 | Sterilization adoption | Documented assessment /
External laboratory testing | ISO 10993-7:2008 (2-275)
ISO 11737-1:2018/AMD1:2021
(14-577)
ISO 11135:2014 (14-529)
ISO 10993-1:2018 (2-258)
AAMI TIR28:2009 (N/A) |
| 15 | Accelerated Age Study | Mechanical/ External
Laboratory | ASTM F1980-16 (14-497)
Various per performed tests |
7
Table 2 - Testing overview
Conclusions 1.8
The results of performed testing based on risk analysis demonstrate that the new modification of Introducer Sheath System devices perform comparably with the predicate and other legally marketed devices. The modified Introducer Sheath System devices with is substantially equivalent to the predicate device in terms of intended use, design and materials, technological characteristics, and principle of operation.