Dr. Amplatz Micro Plug

K182944 · Ka Medical, LLC · KRD · Apr 17, 2019 · Cardiovascular

Device Facts

• Record ID: K182944
• Device Name: Dr. Amplatz Micro Plug
• Applicant: Ka Medical, LLC
• Product Code: KRD · Cardiovascular
• Decision Date: Apr 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.

Device Story

Dr. Amplatz Micro Plug is a self-expanding braided Nitinol vascular occlusion implant; used for arterial embolization in peripheral vasculature. Device consists of a plug with radiopaque marker bands and screw attachment for delivery wire; supplied with a hydrophilic-coated delivery catheter, loader, torque device, and Tuohy Borst valve. Operated by physicians trained in vascular embolization under fluoroscopic guidance. Device is delivered via catheter to the target vessel; once deployed, it promotes embolization. Output is the physical occlusion of the vessel. Benefits include minimally invasive treatment of peripheral vascular conditions. Device is single-use and sterile.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and a chronic GLP animal study. Bench testing included simulated use (flushing, deployment, recapture), mechanical testing (tensile strength, radial force, torque, kink, burst, fatigue, leak), MRI compatibility, corrosion, nickel leaching, packaging, sterilization, and comprehensive biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, implantation, hemocompatibility, complement activation, pyrogenicity).

Technological Characteristics

Self-expanding braided Nitinol vascular occlusion implant. Materials: Nitinol, Platinum-iridium, Stainless Steel, Nylon, LDPE, PTFE, Pebax, Grilamed. Features radiopaque marker bands. Dimensions: 3-6 mm diameters. Delivery system includes 125 cm hydrophilic-coated catheter. Sterilization: Ethylene Oxide (SAL 10^-6). Single-use. Mechanical sensing/actuation via self-expansion upon deployment.

Indications for Use

Indicated for arterial embolization in the peripheral vasculature for patients requiring vascular occlusion.

Regulatory Classification

Identification

A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

Special Controls

*Classification.* Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).

Predicate Devices

• Amplatzer ® Vascular Plug (AVP 1) (K031810)

Reference Devices

• Amplatzer® Vascular Plug 4 (AVP 4) (K113658)
• Amplatzer ® Vascular Plug 2 (AVP 2) (K071125)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2019

KA Medical, LLC % John Oslund Vice President and General Manager 2890 Centre Pointe Drive Roseville, Minnesota 55113

Re: K182944

Trade/Device Name: Dr. Amplatz Micro Plug Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: March 15, 2019 Received: March 20, 2019

Dear Mr. Oslund:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(K) SUMMARY

| Applicant's Name: | KA Medical, LLC |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 2890 Centre Pointe Drive<br>Roseville, MN 55113<br>USA |
| Phone: | 651.256.0802 |
| Fax: | 651.925.0371 |
| Contact Person: | John Oslund<br>Vice President and General Manager<br>Email: [e-mail] |
| Alternate Contact: | Tim Bredahl<br>Director of Quality<br>Email: [e-mail] |
| Date of Summary<br>Prepared: | April 13, 2019 |
| Name of Device: | Dr. Amplatz Micro Plug |
| Common/Usual<br>Name: | Vascular Device for promoting embolization |
| Classification<br>Name: | Vascular embolization device |
| Classification: | Product Code: KRD<br>Regulation Number: 21 CFR 870.3300<br>Class: II |
| Predicate and<br>Reference<br>Device(s): | Predicate:<br>Amplatzer ® Vascular Plug (AVP 1) - K031810<br>Reference:<br>Amplatzer® Vascular Plug 4 (AVP 4) - K113658<br>Amplatzer ® Vascular Plug 2 (AVP 2) - K071125 |

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| Device Description: | The Dr. Amplatz Micro Plug includes the Micro Plug Device which is a self-expanding braided Nitinol vascular occlusion implant that is supplied with components used for implantation.<br><br>The Micro Plug Device has been designed with a material, size, configuration and shape that allows introduction through a catheter for the occlusion of blood vessels in the peripheral vasculature. The Micro Plug Devices are provided in four different diameters (3 mm - 6 mm) to treat different sized blood vessels in the peripheral vasculature. The Micro Plug Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Micro Plug Device is packaged collapsed within a Loader and attached to a 180 cm Delivery Wire that is provided within a hoop dispenser.<br><br>The delivery system includes a 125 cm Delivery Catheter that is provided within a hoop dispenser for delivery and implantation of the Device; the Delivery Catheter contains a standard luer hub adapter at the proximal end and a single radiopaque marker band at the distal end. The Delivery Catheter is hydrophilic coated. Tuohy Borst Valves are provided for flushing; a Torque Device is provided for releasing the Device.<br><br>The Dr. Amplatz Micro Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature by physicians trained in vascular embolization. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use: | The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature. |
| Comparison to Predicate Devices: | The Dr. Amplatz Micro Plug is substantially equivalent in its intended use/indications for use, technology/principal of operation, materials, and performance to the predicate device.<br><br>A comparison of the technological characteristics is summarized in the table below. |

| Device<br>Characteristic | New Device: Dr. Amplatz<br>Micro Plug | Predicate Device: Amplatzer ®<br>Vascular Plug - K031810 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KRD | Same |
| Intended<br>Use/Indications<br>for Use | indicated for arterial<br>embolization in the peripheral<br>vasculature | indicated for arterial and venous<br>embolizations in the peripheral<br>vasculature |
| Device<br>Components | • Micro Plug Device<br>• Delivery Catheter<br>• Delivery Wire<br>• Loader<br>• Torque Device<br>• Tuohy Borst Valve<br>Identical component list to<br>reference device K113658 | • Plug<br>• Delivery Wire<br>• Loader |
| Device<br>Characteristic | New Device: Dr. Amplatz<br>Micro Plug | Predicate Device: Amplatzer ®<br>Vascular Plug - K031810 |
| Design and<br>Dimensions | Micro Plug Device<br>Device contains 3 flat lobes<br>with 2 constrained central<br>regions.<br>Reference device K0171125<br>contains 2 flat lobes and a<br>central lobe with 2 constrained | Plug Device<br>Device is a single lobe - generally<br>barrel or tubular shaped with one flat<br>and one tucked end.<br>Device Diameter x Device Length<br>4 mm x 7 mm |
| | central regions.<br>Reference device K071125<br>diameter range (3 mm - 22<br>mm) is inclusive of the subject<br>device diameter range. | 6 mm x 7 mm<br>8 mm x 7 mm<br>10 mm x 7 mm<br>12 mm x 8 mm<br>14mm x 8 mm<br>16 mm x 8 mm |
| | Device Diameter x Device<br>Length<br>3 mm x 2.5 mm<br>4 mm x 2.5 mm<br>5 mm x 2.5 mm<br>6 mm x 2.5 mm | |
| | Delivery Catheter<br>Outer diameter 2.9 F<br>Inner diameter .028 in<br>Length 125 cm | No delivery catheter is included in the<br>predicate set. Introduction through<br>0.056 -0.088-inch inner diameter<br>catheters is recommended. |
| Materials | Micro Plug Device<br>Nitinol<br>Platinum-iridium<br>Stainless Steel | Plug<br>Same |
| | Delivery System<br>Loader<br>Nylon<br>LDPE<br>PTFE | Delivery System<br>Loader<br>PTFE |
| | Delivery Wire<br>Nitinol<br>Stainless steel | Delivery Wire<br>Nitinol<br>Stainless steel |
| | Delivery Catheter<br>Nylon<br>Pebax<br>Stainless steel braid<br>PTFE | Delivery Catheter<br>N/A (Commercially available 0.056 - |
| | Grilamed<br>Platinum/Iridium<br>Hydrophilic coating | 0.088-inch inner diameter guide<br>catheters) |
| Sterilization | Sterile/Ethylene Oxide SAL<br>10-6 | Same |
| Shelf Life | Three Year | Same |
| Disposable Single<br>Use | Yes | Same |

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## K182944
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- Performance Data: Safety and performance evaluations used to establish substantial equivalence of the subject device to the predicate device include the following:
- . Simulated Use
- o Flushing
- Advancement O
- Deployment Force O
- o Apposition
- Recapture o
- Release o
- Tensile Strength
- Radial Force ●
- Torque to Failure ●
- Kink to Failure ●
- Burst
- Fatique ●
- Leak Test .
- MRI Compatibility ●
- Interactions o
- o Heating
- o Artifacts
- Corrosion ●
- Nickel Leaching ●
- Packaging ●
- Seal Peel Strength o
- Visual O
- Bubble Leak Test o
- Sterilization
- o Fractional Cycle
- Half Cycle O
- Full Cycle o
- Biocompatibility ●
- Toxicological Risk Assessment o
- Cytotoxicity o
- o Sensitization
- Irritation O
- Systemic Toxicity o
- Implantation O
- Hemocompatibility O
- Complement Activation O
- Pyrogenicity o

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- Shelf Life ●
- . Chronic GLP Animal Study
- o Acute performance
- o Chronic performance
- o Tissue response

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

Test results demonstrated that all acceptance criteria were met; Conclusion: therefore, the device conforms to established product specifications and intended use. Based upon the same intended use and principle of operation, technology, and nonclinical testing it is concluded that the Dr. Amplatz Micro Plug is substantially equivalent to the predicate device.