(176 days)
The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.
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.
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.
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.
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.
The Dr. Amplatz Micro Plug is a vascular embolization device. The provided text outlines the performance data used to establish its substantial equivalence to a predicate device. However, the document does not contain a table of acceptance criteria and reported device performance values, nor does it describe a study involving human readers or a standalone AI algorithm. It focuses on non-clinical testing for equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Not provided in the document. The document lists various performance evaluations conducted (Simulated Use, Tensile Strength, Radial Force, etc.) and states that "Test results demonstrated that all acceptance criteria were met," but it does not specify the numerical acceptance criteria for each test or the actual performance values obtained.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for any individual test. The document refers to "evaluations" and "tests" but doesn't quantify the number of devices or samples used for each test (e.g., how many plugs were tested for tensile strength).
- Data Provenance: The studies were non-clinical (bench testing, material testing, and animal study).
- Country of Origin: Not specified.
- Retrospective or Prospective: Not applicable as these are laboratory and animal studies, not human data collection in the traditional sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not applicable. The "ground truth" for these tests would be established by the testing methodology and instruments, with interpretation by qualified engineers/scientists, rather than a panel of clinical experts determining "ground truth" on medical images or diagnoses.
4. Adjudication Method for the Test Set
- Not applicable. This concept typically relates to human-reviewed data where disagreements need resolution. For bench and animal testing, results are typically objective and follow pre-defined protocols and acceptance limits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no MRMC study, human reader comparison, or AI assistance evaluation was performed or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No. This device is a physical medical implant, not a software algorithm or AI-based diagnostic tool. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" is derived from:
- Established Test Standards/Protocols: Performance against industry standards (e.g., for tensile strength, fatigue, corrosion, MRI compatibility).
- Predicate Device Characteristics: Comparison against the known characteristics and performance of the predicate device (Amplatzer Vascular Plug).
- Biocompatibility Standards: Performance against ISO standards for biological evaluation of medical devices.
- Histopathological Analysis (for animal study): Tissue response and acute/chronic performance observed in the animal model.
8. Sample Size for the Training Set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set was used.
{0}------------------------------------------------
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
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
Please wait...
If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document.
You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download.
For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader.
Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries.
{3}------------------------------------------------
510(K) SUMMARY
| Applicant's Name: | KA Medical, LLC |
|---|---|
| Address: | 2890 Centre Pointe DriveRoseville, MN 55113USA |
| Phone: | 651.256.0802 |
| Fax: | 651.925.0371 |
| Contact Person: | John OslundVice President and General ManagerEmail: joslund@ka-medical.com |
| Alternate Contact: | Tim BredahlDirector of QualityEmail: tbredahl@ka-medical.com |
| Date of SummaryPrepared: | April 13, 2019 |
| Name of Device: | Dr. Amplatz Micro Plug |
| Common/UsualName: | Vascular Device for promoting embolization |
| ClassificationName: | Vascular embolization device |
| Classification: | Product Code: KRDRegulation Number: 21 CFR 870.3300Class: II |
| Predicate andReferenceDevice(s): | Predicate:Amplatzer ® Vascular Plug (AVP 1) - K031810Reference:Amplatzer® Vascular Plug 4 (AVP 4) - K113658Amplatzer ® Vascular Plug 2 (AVP 2) - K071125 |
{4}------------------------------------------------
| 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.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.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.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.A comparison of the technological characteristics is summarized in the table below. |
| DeviceCharacteristic | New Device: Dr. AmplatzMicro Plug | Predicate Device: Amplatzer ®Vascular Plug - K031810 |
|---|---|---|
| Product Code | KRD | Same |
| IntendedUse/Indicationsfor Use | indicated for arterialembolization in the peripheralvasculature | indicated for arterial and venousembolizations in the peripheralvasculature |
| DeviceComponents | • Micro Plug Device• Delivery Catheter• Delivery Wire• Loader• Torque Device• Tuohy Borst ValveIdentical component list toreference device K113658 | • Plug• Delivery Wire• Loader |
| DeviceCharacteristic | New Device: Dr. AmplatzMicro Plug | Predicate Device: Amplatzer ®Vascular Plug - K031810 |
| Design andDimensions | Micro Plug DeviceDevice contains 3 flat lobeswith 2 constrained centralregions.Reference device K0171125contains 2 flat lobes and acentral lobe with 2 constrained | Plug DeviceDevice is a single lobe - generallybarrel or tubular shaped with one flatand one tucked end.Device Diameter x Device Length4 mm x 7 mm |
| central regions.Reference device K071125diameter range (3 mm - 22mm) is inclusive of the subjectdevice diameter range. | 6 mm x 7 mm8 mm x 7 mm10 mm x 7 mm12 mm x 8 mm14mm x 8 mm16 mm x 8 mm | |
| Device Diameter x DeviceLength3 mm x 2.5 mm4 mm x 2.5 mm5 mm x 2.5 mm6 mm x 2.5 mm | ||
| Delivery CatheterOuter diameter 2.9 FInner diameter .028 inLength 125 cm | No delivery catheter is included in thepredicate set. Introduction through0.056 -0.088-inch inner diametercatheters is recommended. | |
| Materials | Micro Plug DeviceNitinolPlatinum-iridiumStainless Steel | PlugSame |
| Delivery SystemLoaderNylonLDPEPTFE | Delivery SystemLoaderPTFE | |
| Delivery WireNitinolStainless steel | Delivery WireNitinolStainless steel | |
| Delivery CatheterNylonPebaxStainless steel braidPTFE | Delivery CatheterN/A (Commercially available 0.056 - | |
| GrilamedPlatinum/IridiumHydrophilic coating | 0.088-inch inner diameter guidecatheters) | |
| Sterilization | Sterile/Ethylene Oxide SAL10-6 | Same |
| Shelf Life | Three Year | Same |
| Disposable SingleUse | Yes | Same |
{5}------------------------------------------------
K182944
Page 3 of 5
Page 3 of 5
{6}------------------------------------------------
- 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
- . Simulated Use
{7}------------------------------------------------
- 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.
§ 870.3300 Vascular embolization device.
(a)
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.(b)
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).