(176 days)
No
The device description and performance studies focus on the physical properties and mechanical performance of a vascular occlusion implant and its delivery system. There is no mention of AI or ML in the intended use, device description, or performance data.
Yes
The device is indicated for "arterial embolization in the peripheral vasculature," which involves occluding blood vessels to treat a medical condition or prevent bleeding, thus directly addressing a therapeutic purpose.
No
The device is indicated for arterial embolization in the peripheral vasculature, which is a therapeutic intervention, not a diagnostic one. It is used to occlude blood vessels, not to provide diagnostic information.
No
The device description clearly details a physical implant (Micro Plug Device) and associated hardware components for delivery and implantation, indicating it is a hardware medical device, not software-only.
Based on the provided information, the Dr. Amplatz Micro Plug is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "arterial embolization in the peripheral vasculature." This describes a therapeutic procedure performed within the body to block blood vessels.
- Device Description: The device is a physical implant (a self-expanding braided Nitinol vascular occlusion implant) designed to be placed inside blood vessels. It is delivered using a catheter and delivery wire.
- Function: The device's function is to physically occlude (block) blood vessels.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used to diagnose, monitor, or screen for diseases or conditions.
The Dr. Amplatz Micro Plug is a therapeutic medical device used for interventional procedures, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for Use
The Dr. Amplatz Micro Plug is indicated for arterial embolization in the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
KRD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians trained in vascular embolization
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: 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
- 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.
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.
Amplatzer ® Vascular Plug (AVP 1) - K031810
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.
Amplatzer® Vascular Plug 4 (AVP 4) - K113658, Amplatzer ® Vascular Plug 2 (AVP 2) - K071125
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
§ 870.3300 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).
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
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510(K) SUMMARY
| Applicant's Name: | KA Medical, LLC |
|---|---|
| Address: | 2890 Centre Pointe Drive |
| Roseville, MN 55113 | |
| USA | |
| Phone: | 651.256.0802 |
| Fax: | 651.925.0371 |
| Contact Person: | John Oslund |
| Vice President and General Manager | |
| Email: joslund@ka-medical.com | |
| Alternate Contact: | Tim Bredahl |
| Director of Quality | |
| Email: tbredahl@ka-medical.com | |
| Date of Summary | |
| Prepared: | April 13, 2019 |
| Name of Device: | Dr. Amplatz Micro Plug |
| Common/Usual | |
| Name: | Vascular Device for promoting embolization |
| Classification | |
| Name: | Vascular embolization device |
| Classification: | Product Code: KRD |
| Regulation Number: 21 CFR 870.3300 | |
| Class: II | |
| Predicate and | |
| Reference | |
| Device(s): | Predicate: |
| Amplatzer ® Vascular Plug (AVP 1) - K031810 | |
| Reference: | |
| Amplatzer® Vascular Plug 4 (AVP 4) - K113658 | |
| Amplatzer ® 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. |
| Device
Characteristic | New Device: Dr. Amplatz
Micro Plug | Predicate Device: Amplatzer ®
Vascular Plug - K031810 |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | KRD | Same |
| Intended
Use/Indications
for Use | indicated for arterial
embolization in the peripheral
vasculature | indicated for arterial and venous
embolizations in the peripheral
vasculature |
| Device
Components | • Micro Plug Device
• Delivery Catheter
• Delivery Wire
• Loader
• Torque Device
• Tuohy Borst Valve
Identical component list to
reference device K113658 | • Plug
• Delivery Wire
• Loader |
| Device
Characteristic | New Device: Dr. Amplatz
Micro Plug | Predicate Device: Amplatzer ®
Vascular Plug - K031810 |
| Design and
Dimensions | Micro Plug Device
Device contains 3 flat lobes
with 2 constrained central
regions.
Reference device K0171125
contains 2 flat lobes and a
central lobe with 2 constrained | Plug Device
Device is a single lobe - generally
barrel or tubular shaped with one flat
and one tucked end.
Device Diameter x Device Length
4 mm x 7 mm |
| | central regions.
Reference device K071125
diameter range (3 mm - 22
mm) is inclusive of the subject
device diameter range. | 6 mm x 7 mm
8 mm x 7 mm
10 mm x 7 mm
12 mm x 8 mm
14mm x 8 mm
16 mm x 8 mm |
| | Device Diameter x Device
Length
3 mm x 2.5 mm
4 mm x 2.5 mm
5 mm x 2.5 mm
6 mm x 2.5 mm | |
| | Delivery Catheter
Outer diameter 2.9 F
Inner diameter .028 in
Length 125 cm | No delivery catheter is included in the
predicate set. Introduction through
0.056 -0.088-inch inner diameter
catheters is recommended. |
| Materials | Micro Plug Device
Nitinol
Platinum-iridium
Stainless Steel | Plug
Same |
| | Delivery System
Loader
Nylon
LDPE
PTFE | Delivery System
Loader
PTFE |
| | Delivery Wire
Nitinol
Stainless steel | Delivery Wire
Nitinol
Stainless steel |
| | Delivery Catheter
Nylon
Pebax
Stainless steel braid
PTFE | Delivery Catheter
N/A (Commercially available 0.056 - |
| | Grilamed
Platinum/Iridium
Hydrophilic coating | 0.088-inch inner diameter guide
catheters) |
| Sterilization | Sterile/Ethylene Oxide SAL
10-6 | Same |
| Shelf Life | Three Year | Same |
| Disposable Single
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
- . 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.