Amplatz Goose Neck Snare Kit

K241259 · Medtronic, Inc. · MMX · Jun 3, 2024 · Cardiovascular

Device Facts

• Record ID: K241259
• Device Name: Amplatz Goose Neck Snare Kit
• Applicant: Medtronic, Inc.
• Product Code: MMX · Cardiovascular
• Decision Date: Jun 3, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.

Device Story

Amplatz Goose Neck Snare Kit consists of a snare, snare catheter, snare introducer, and torque device. Used in cardiovascular system for retrieval and manipulation of foreign bodies. Physician operates device percutaneously under imaging guidance. Snare features nitinol cable and gold-plated tungsten loop; superelastic construction allows loop to be introduced through catheters without deformation. Snare catheter includes platinum-iridium radiopaque marker band for visualization. Device enables removal of misplaced or embolized intravascular devices or foreign objects, potentially avoiding open surgery.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993 series), design verification (catheter dimensions, guide catheter compatibility), packaging validation, and sterilization validation (ISO 11135).

Technological Characteristics

Nitinol cable snare; gold-plated tungsten loop; platinum-iridium radiopaque marker band. Superelastic construction. Sterilization via ISO 11135 overkill half-cycle approach. Mechanical retrieval device; no energy source or software.

Indications for Use

Indicated for use in the cardiovascular system to retrieve and manipulate foreign bodies in patients requiring percutaneous retrieval.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Amplatz™ Goose Neck Snare Kit/Catheter (K972511)

Submission Summary (Full Text)

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June 3, 2024

Medtronic, Inc. Erin Roquemore International Regulatory Affairs Specialist 710 Medtronic Pkwy NE Minneapolis, Minnesota 55432

Re: K241259

Trade/Device Name: Amplatz™ Goose Neck Snare Kit Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: MMX, DXE Dated: May 3, 2024 Received: May 6, 2024

## Dear Erin Roquemore:

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).

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Gregory W. Digitally signed by Gregory W. O'connell -S ○'connell -S Date: 2024.06.03
15:39:37 -04'00'

Gregory O'Connell 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

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# Indications for Use

510(k) Number (if known) K241259

Device Name Amplatz™ Goose Neck Snare Kit

Indications for Use (Describe)

The Amplatz Goose Neck Snare kit is intended for use in the cardiovascular system to retrieve and manipulate foreign bodies.

| 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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# 510(k) Summary

| Applicant/ Submitter | Medtronic, Inc.<br>4600 Nathan Lane N<br>Plymouth, MN 55442 | |
|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person | Erin Roquemore<br>International Regulatory Affairs Specialist<br>Tel: [phone]<br>Email: [e-mail] | |
| Date Prepared | May 2024 | |
| Device Trade Name | Amplatz™ Goose Neck Snare Kit | |
| Device Common Name | Intravascular Retrieval Devices | |
| Classification Name | Percutaneous Retrieval Device | |
| Regulation Number | 21 CFR 870.5150 | |
| Classification | Class II | |
| Classification Panel | Device, Percutaneous Retrieval | |
| Product Code | MMX | |
| Product Code | DXE | |
| Predicate Device | Amplatz™ Goose Neck Snare Kit/Catheter | |
| Predicate 510(k) Number | K972511 | |
| Device Description | The Amplatz Goose Neck Snare kit (Snare device) contains the snare, snare<br>catheter, snare introducer, and torque device. The snare is made of a<br>nitinol cable and a gold-plated tungsten loop. The preformed snare loop<br>can be introduced through catheters without risk of snare deformation<br>because of the snare's superelastic construction. The snare catheter<br>contains a platinum-iridium, radiopaque marker band. | |
| Indications for Use | The Amplatz Goose Neck Snare kit is intended for use in the<br>cardiovascular system to retrieve and manipulate foreign bodies. | |
| Comparison of<br>Technological<br>Characteristics with the<br>Predicate Device | The proposed device has the same characteristics as the predicate device,<br>with the exception of the following modifications:<br>• Indications for use - narrowed anatomical sites of intended use to<br>cardiovascular system<br>• Change in packaging dimensions<br>• Updates to labeling to meet latest International Standards<br>• Specification change for tensile force | |

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Performance data The following performance data were provided in support of substantial equivalence determination:

#### · Biocompatibility

- ISO MEM Elution Using L-929 Mouse Fibroblast Cells o
- ISO Guinea Pig Maximization Sensitization Test O
- ISO Intracutaneous Irritation Test O
- ISO Acute Systemic Injection Test O
- ISO Materials Mediated Rabbit Pyrogen O
- O ASTM Hemolysis Assay - Direct Contact Method
- Complement Activation SC5b-9 Assay O
- ISO Standard Thrombogenicity in Canine O
- ISO Standard Thrombogenicity in Ovine O

### · Design Verification

- o Snare Catheter Length
- о Snare Catheter OD
- Snare Catheter Tip OD o
- O Guide Catheter Compatibility

### • Packaging Validation

- Visual Inspection (Gross Physical Damage to Package O System)
- Visual Inspection (Label Legibility and Adhesion) o
- Visual Inspection (Carton) O
- IFU / eIFU Leaflet (Legibility) O
- Visual Inspection (Device) o
- o Visual Inspection (Sterile Barrier Seal Integrity and Width)
- O Package Integrity (Bubble Test)
- Peel-Open/Aseptic Presentation O
- O Seal Strength Test
- Shelf Life
- O Catheter Visual Inspection
- Snare Catheter Tip Configuration O
- Snare Catheter ID and OD O
- Snare Catheter Length O
- Snare OD O
- O Functional
- Catheter Shaft Tensile Strength O
- O Hub Bond Tensile Strength
- Snare Catheter Tip OD O
- Guide Catheter Compatibility O

### · Sterilization

- Sterilization validation per ISO 11135, overkill half cycle o approach
- Sterilization Residuals Testing о

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Animal testing was not required for the determination of substantial equivalence.

Clinical testing was not required for the determination of substantial equivalence.

The testing conducted demonstrates that all acceptance criteria were met, and the device meets product specifications.

- Based on the same general intended use, technological characteristics, and Conclusion substantially equivalent performance profile as demonstrated by the testing in this submission, Medtronic, Inc. concludes the proposed Amplatz Goose Neck Snare Kit to be substantially equivalent to the predicate Amplatz Goose Neck Snare Kit.