(209 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
Yes
The device is a therapeutic device because its intended use is for the mechanical declotting of synthetic dialysis grafts, which is a treatment for a medical condition.
No
The device is a mechanical thrombectomy device indicated for mechanical declotting, which is a treatment procedure, not a diagnostic one.
No
The device description clearly outlines physical components (outer member, inner member, thrombasket) made of materials like stainless steel wire, indicating it is a hardware device, not software-only. The performance studies also focus on physical characteristics and testing of these hardware components.
Based on the provided information, the AKónya Eliminator™ Mechanical Thrombectomy Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "mechanical declotting of synthetic dialysis grafts." This describes a physical intervention within the body to remove a clot, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a mechanical tool designed to physically interact with a clot. It does not involve reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as sample collection, analysis of biomarkers, or diagnostic results.
Therefore, the AKónya Eliminator™ is a medical device used for a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The AKónya Eliminator™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting of synthetic dialysis grafts.
Product codes
MCW
Device Description
The AKónya Eliminator™ Mechanical Thrombectomy Device is comprised of three discrete elements:
- " An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure.
- An inner member, connected distally to the distal end of the thrombasket. Proximally, the inner member is connected to a handle.
- . A thrombasket, composed of woven or braided stainless steel wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Non-clinical Performance Testing:
The AKónya Eliminator™ Mechanical Thrombectomy Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:
- Accelerated Aging / Packaging - to determine effects of time & environment on device and packaging materials, to substantiate 1-year shelf life. Tests include package Seal Peel, Burst, Dye Penetration, and device functionality after aging.
- Packaging / Shipping Integrity - to determine possible adverse effects of shipping & transportation environments on survivability of device packaging and construction materials.
- 8 Dimensional / Flexibility / Pushability - to evaluate and compare in a quantitative manner pushability and trackability of AKónya Eliminator design to the predicate device and to insure that the device met dimensional requirements, as defined in the product specification.
- Tensile - to verify AKónya Eliminator design meets minimum tensile strength requirements at all joints, as defined in product specification.
- Fatigue - to determine the fatigue life of the AKónya Eliminator.
- Biocompatibility - to determine the potential toxicity resulting from contact of the component materials of the device with the body.
- Animal Study - to evaluate the safety and efficacy of a proposed AK onya Eliminator™, and evaluate operational characteristics of the device with respect to utilization of a predicate device.
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
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
AKónya Eliminator™ Mechanical Thrombectomy Device 510(k) Summary
| Submitter: | IDev Technologies, Inc.
1110 NASA Road One, Suite 311
Houston, Texas 77058 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Lynne A. Davies
Regulatory Affairs Manager
(281) 333-1998 x 223 - Phone
(832) 455-1952 - Mobile
(281) 333-4008 - Fax |
| Date Prepared: | February 17, 2003 |
| Trade Name: | AKónya EliminatorTM Mechanical Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification
Name: | Catheter, Peripheral, Atherectomy (21 CFR 870.4875) |
| Product Code: | MCW |
| Predicate Device: | Arrow-Trerotola TM Percutaneous Thrombolytic Device (PTD) (K970080,
K990829) |
Device Description:
The AKónya Eliminator™ Mechanical Thrombectomy Device is comprised of three discrete elements:
- " An outer member, connected distally to the proximal end of the thrombasket. The proximal end is connected to a hemostasis Y-connector, having a side port for flushing, and a Tuohy-Borst connector on the central port for securing to hypotube, as an aid for handling during the surgical procedure.
- An inner member, connected distally to the distal end of the thrombasket. Proximally, the inner member is connected to a handle.
- . A thrombasket, composed of woven or braided stainless steel wire.
Intended Use:
The AKónya Eliminator™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting of synthetic dialysis grafts.
1
KC3X504
Page 2 of 2
Technological Characteristics Compared to Predicate:
IDev Technologies, Inc. considers the AKónya Eliminator™ as substantially equivalent to the Arrow-Trerotola™ PTD as listed in the following:
- 트 Indication
- . Size
- 파 Proximal
- drive mechanism .
- . contrast port
- 트 Distal
- basket radiopaticity .
- . working profile
- basket diameter .
- . basket diameter variability
- mechanism of action .
- soft distal tip ●
Non-clinical Performance Testing:
The AKónya Eliminator™ Mechanical Thrombectomy Device has successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device. The testing is described below:
- Accelerated Aging / Packaging - to determine effects of time & environment on device and packaging materials, to substantiate 1-year shelf life. Tests include package Seal Peel, Burst, Dye Penetration, and device functionality after aging.
- 트 Packaging / Shipping Integrity - to determine possible adverse effects of shipping & transportation environments on survivability of device packaging and construction materials.
- 8 Dimensional / Flexibility / Pushability - to evaluate and compare in a quantitative manner pushability and trackability of AKónya Eliminator design to the predicate device and to insure that the device met dimensional requirements, as defined in the product specification.
- 로 Tensile - to verify AKónya Eliminator design meets minimum tensile strength requirements at all joints, as defined in product specification.
- Fatigue - to determine the fatigue life of the AKónya Eliminator.
- Biocompatibility - to determine the potential toxicity resulting from contact of the component materials of the device with the body.
- Animal Study - to evaluate the safety and efficacy of a proposed AK onya Eliminator™, and evaluate operational characteristics of the device with respect to utilization of a predicate device.
Conclusion:
IDev Technologies, Inc. considers the AKónya Eliminator™ Mechanical Thrombectomy Device to be substantially equivalent to the Arrow-Trerotola ™ Percutaneous Thrombolytic Device based on design and technological characteristics.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 6 2003
IDev Technologies Inc. c/o Lynne A. Davies Regulatory Affairs Manager 1110 NASA Road One, Suite 311 Houston, TX 77058
K030504 Re:
Trade/Device Name: AKonya Eliminator™ Mechanical Thrombectomy Device Regulation Number: 21 CFR 870.4875 Regulation Name: Intralumnial artery stripper. Regulatory Class: Class II Product Code: MCW Dated: June 17, 2003 Received: June 18, 2003
Dear Ms. Davies:
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 16 rate exaction 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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Lynne A. Davies
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4536. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
M. Bram D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1
Indications for Use Statement
、
| Applicant: | IDev Technologies, Inc. |
|---|---|
| 510(k) Number (if known): | unknown |
| Device Name: | AKónya Eliminator™ Mechanical Thrombectomy Device |
| Indications for Use: | The AKónya Eliminator™ Mechanical Thrombectomy |
| Device is indicated for use in the mechanical declotting of | |
| synthetic dialysis grafts. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)
Prescription Use Only
1 2
. '
$\mathcal{X}$ Q. $\mathcal{G}$ $\mathcal{M}$
Climita 510(k) Number