(128 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a guide sheath, with no mention of AI or ML.
No.
The device is used to introduce other interventional and diagnostic devices, but it does not perform a therapeutic function itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "indicated to be used for introduction of interventional and diagnostic devices," meaning it facilitates the use of other devices, but is not itself a diagnostic device.
No
The device description clearly outlines a physical medical device consisting of a sheath, dilator, valves, and other hardware components. There is no mention of software as a component of this device.
No, 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 within the body to facilitate other procedures, not a device used to test samples outside the body.
- Device Description: The description details a physical device with components like a sheath, dilator, valve, and side port, designed for insertion into blood vessels. This is consistent with an invasive medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
This device is clearly an invasive medical device used in interventional and diagnostic procedures within the vascular system.
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.
Product codes (comma separated list FDA assigned to the subject device)
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 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 of its distal 20cm.
The Catapult Guide Sheath was previously cleared under K221914 in 4 French, 5 French, 7 French and 8 French sizes, each with effective lengths of 15 cm, 60 cm or 90 cm. This 510(k) adds a 130 cm length which is available in 4 French, 5 French and 6 French sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral (and coronary) vasculature
Indicated Patient Age Range
Not Found
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 were used to demonstrate that the new 130cm version of Catapult ™ Guide Sheath is substantially equivalent to the predicate:
- . Mechanical testing, including tests required under relevant international standards, and usability test performed to verify and validate the design.
- . Biocompatibility Risk Assessment (BRA) and performed biocompatibility device testing to demonstrate biocompatibility.
- Sterilization information to support adoption of the device into the existing sterilization 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 1.
- Visual and Dimensional Evaluation (Test Type: Visual)
- Sheath/dilator fit test (Test Type: Mechanical/Visual)
- Sheath pull out test (Test Type: Mechanical/Visual)
- Coating integrity (Test Type: Mechanical/Visual)
- Sheath Liquid Leakage / Liquid leakage through hemostasis valve (Test Type: Mechanical/Visual)
- Coating integrity - Particle evaluation test (Test Type: Mechanical/Visual)
- Sheath kink resistance test (Test Type: Mechanical)
- Sheath force at break test / Sheath creep to break test / Dilator hub bond strength (Test Type: Mechanical)
- Sheath Stiffness test (Test Type: Mechanical)
- Usability evaluation / Simulated use test (Test Type: Usability Study)
- Accelerated Age Study (Test Type: Mechanical/ External Laboratory)
- Biocompatibility testing / Cytotoxicity test / Biological Risk Assessment (Test Type: External Laboratory / Documented assessment)
- Sterilization adoption (Test Type: Documented assessment / External laboratory testing)
- Visibility of the sheath under X-ray (Test Type: Documented assessment)
- Packaging integrity assessment (Test Type: External laboratory testing)
The results of performed testing demonstrated that the new 130cm version of Catapult ™ Guide Sheath has substantially equivalent performance to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2024
Contract Medical International GmbH Jan Kubicek Regulatory Affairs Manager Lauensteiner Strasse 37 Dresden, Saxony 01277 Germany
Re: K240957
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: April 8, 2024 Received: July 17, 2024
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" (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).
1
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.
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 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,
Digitally signed by Finn E. Finn E. Donaldson -S Donaldson -S Date: 2024.08.14
10:25:20 -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
2
Enclosure
3
Indications for Use
510(k) Number (if known) K240957
Device Name Catapult Guide Sheath
Indications for Use (Describe)
The Catapult TM Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
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
Submitter 1.1
| Submitter: | Contract Medical GmbH |
|---|---|
| Lauensteiner Strasse 37 | |
| 01277 Dresden | |
| Germany | |
| Contact Person: | Juliana Vaz Nuernberger, |
| Position: | Global Head of Regulatory Affairs |
| Phone: | +49 351 210 747-19 |
| Email: | juliana.nuernberger@heraeus.com |
| Date Summary Prepared: | 8th April 2024 |
1.2 Device
Catapult ™ Guide Sheath Device Trade Name: Introducer Sheath Device Common Name: Introducer Catheter, and Classification Name: Dilator, Vessel, For Percutaneous Catheterization Device Class: = Product Code: DYB, DRE
1.3 Predicate Device
The predicate device is the Catapult ™ Guide Sheath Introducer Sheath System (K221914).
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 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 of its distal 20cm.
The Catapult ™ Guide Sheath was previously cleared under K221914 in 4 French, 5 French, 7 French and 8 French sizes, each with effective lengths of 15 cm, 60 cm or 90 cm. This 510(k) adds a 130 cm length which is available in 4 French, 5 French and 6 French sizes.
Indications for Use 1.5
The Catapult ™ Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.
5
K240957 Page 2 of 3
Comparison of Technological Characteristics with the Predicate Device 1.6
The differences in technological characteristics between the subject device and the predicate are the following:
- . The maximum usable length was extended with the new version to 130 cm.
- . Shaft Luer hub and Dilator resin material changed from PEBAX to RILSAMID.
1.7 Performance Data
Performance data were used to demonstrate that the new 130cm version of Catapult ™ Guide Sheath is substantially equivalent to the predicate:
- . Mechanical testing, including tests required under relevant international standards, and usability test performed to verify and validate the design.
- . Biocompatibility Risk Assessment (BRA) and performed biocompatibility device testing to demonstrate biocompatibility.
- Sterilization information to support adoption of the device into the existing sterilization 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 1.
| No. | Verification / Validation Activity | Test Type | Applicable Standard(s) |
|---|---|---|---|
| 1 | Visual and Dimensional | ||
| Evaluation | Visual | Internal requirement | |
| 2 | Sheath/dilator fit test | Mechanical/Visual | Internal requirement |
| 3 | Sheath pull out test | Mechanical/Visual | ISO 10555-1:2013/AMD1:2017 |
| IEC 62366-1:2020 | |||
| Internal requirement | |||
| 4 | Coating integrity | Mechanical/Visual | Internal requirement |
| 5 | Sheath Liquid Leakage | ||
| Liquid leakage through | |||
| hemostasis valve | Mechanical/Visual | ISO 11070:2014 | |
| ISO 10555-1:2013/AMD1:2017 | |||
| ISO 80369-1:2018 | |||
| ISO 80369-7:2021 | |||
| 6 | Coating integrity - Particle | ||
| evaluation test | Mechanical/Visual | AAMI TIR42 | |
| ISO 8536-4 USP |
Table 1 - Performance Testing Oerview
6
| 7 | Sheath kink resistance test | Mechanical | EN 13868:2002
Internal requirement |
|----|---------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| 8 | Sheath force at break test
Sheath creep to break test
Dilator hub bond strength | Mechanical | ISO 10555-1:2013/AMD1:2017
ISO 11070:2014
Internal requirement |
| 9 | Sheath Stiffness test | Mechanical | Internal requirement |
| 10 | Usability evaluation
Simulated use test | Usability Study | IEC 62366-1:2020Internal
requirement |
| 11 | Accelerated Age Study | Mechanical/ External
Laboratory | ASTM F1980-16
Various per performed tests |
| 12 | Biocompatibility testing
Cytotoxicity test
Biological Risk Assessment | External Laboratory
Documented assessment | ISO 10993-1:2018
ISO 10993-4:2017
ISO 10993-5:2009
ISO 14971:2019 |
| 13 | Sterilization adoption | Documented assessment /
External laboratory testing | ISO 10993-7:2008
ISO 11737-1:2018/AMD1:2021
ISO 11135:2014
ISO 10993-1:2018 AAMI
TIR28:2009 |
| 14 | Visibility of the sheath under X-
ray | Documented assessment | ASTM F640-20
ISO 11070:2014 |
| 15 | Packaging integrity assessment | External laboratory testing | EN 868-5:2018
ASTM F88/F88M-21
ISO 11607-1 Second edition
2019-02 |
1.8 Conclusions
The results of performed testing demonstrated that the new 130cm version of Catapult ™ Guide Sheath has substantially equivalent performance to the predicate. The new Catapult ™ Guide Sheath is substantially equivalent to the predicate device in terms of intended use, design and materials, technological characteristics, and principle of operation.