(282 days)
Not Found
No
The device description and performance studies focus on mechanical components and pre-clinical animal data, with no mention of AI or ML.
Yes
The device is described as a "Mechanical Thrombectomy Device" indicated for "mechanical declotting" of AV fistulae and dialysis grafts, which are therapeutic interventions.
No
This device is a mechanical thrombectomy device designed to remove clots, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components (outer member, inner member, thrombasket made of stainless steel wire) which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The AKónya Eliminator Plus™ is a mechanical device used inside the body (in vivo) to physically remove blood clots from blood vessels. It does not analyze or test any bodily fluids or tissues.
- Intended Use: The intended use clearly states it's for "mechanical declotting" of AV fistulas and grafts, which is a therapeutic procedure, not a diagnostic test.
Therefore, based on the provided information, the AKónya Eliminator Plus™ is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AKónya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.
Product codes (comma separated list FDA assigned to the subject device)
QEW, KRA, DXE
Device Description
The AKónya Eliminator Plus™ 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.
- 트 An inner member, connected distally to the distal cnd of the thrombasket. Proximally, the inner member is connected to a handle.
- 트 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
native arterio-venous (AV) fistula and synthetic dialysis grafts
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)
The expanded indication for use to include native arterio-venous (AV) fistula is based on the pre-clinical animal data presented in the performance section of this 510(k) submission.
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.
AKónya Eliminator™ Mechanical Thrombectomy Device (K030504), Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) (K011056)
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
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 8, 2021
Idev Technologies, Inc. Shannon Hurd Regulatory Affairs Manager 1110 Nasa Rd., Suite 311 Houston, Texas 77058-3345
Re: K041374
Trade/Device Name: Akonya Eliminator Plus Mechanical Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEW, KRA
Dear Shannon Hurd:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 02, 2005. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2021.10.08
10:26:22 -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
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are represented by three parallel, curved lines that resemble a stylized wave or flowing hair.
MAR 2 - 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Idev Technologies, Inc. c/o Ms. Shannon Hurd Quality Manager 1110 NASA Road, Suite 311 Houston, TX 77058
Re: K041374
Trade Name: AKonya Eliminator Mechanical Thrombectomy Device Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy Catheter Regulatory Class: Class II Product Code: DXE Dated: February 24, 2005 Received: February 25, 2005
Dear Ms. Hurd:
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 for ass marce 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. 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, I'DA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Shannon Hurd
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 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 (240) 276-0120. 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/cdrl/industry/support/index.html.
Sincerely yours,
Dilara R. Lechner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| 510(k) Number (if known): | K041374 |
|---|---|
| Device Name: | AKónya Eliminator Plus™ Mechanical Thrombectomy |
| Device | |
| Indications For Use: | The AKónya Eliminator Plus™ Mechanical Thrombectomy |
| Device is indicated for use in the mechanical declotting | |
| native arterio-venous (AV) fistula and synthetic dialysis | |
| grafts. |
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danna R. Vechner
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number Ko41374
4
K 041374
MAR 2 - 2005
510(k) Summary
| Submitter: | IDev Technologies, Inc.
1110 NASA Road One, Suite 311
Houston, Texas 77058 |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Shannon Hurd
Quality Manager
(281) 333-1998 x 224 - Phone
(281) 333-4008 - Fax
BACKUP:
Mr. Jeffery Sheldon
President & CEO
(281) 333-1998 x 228 - Phone
(281) 333-4008 - Fax |
| Date Prepared: | November 19, 2004 |
| Trade Name: | AKónya Eliminator Plus™ Mechanical Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification
Name: | Catheter, Embolectomy (21 CFR 870.5150) |
| Product Code: | DXE |
| Predicate Device: | AKónya Eliminator™ Mechanical Thrombectomy Device (K030504)
Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD)
(K011056) |
| Device Description: | |
The AKónya Eliminator Plus™ 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.
- 트 An inner member, connected distally to the distal cnd of the thrombasket. Proximally, the inner member is connected to a handle.
- 트 A thrombasket, composed of woven or braided stainless steel wire.
5
Intended Use:
The AKonya Eliminator Plus™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting native arterio-venous (AV) fistula and synthetic dialysis grafts.
Technological Characteristics Compared to Predicate:
The AKonya Eliminator Plus™ has the same technological characteristics as the predicate devices.
Non-clinical Performance Testing:
The expanded indication for use to include native arterio-venous (AV) fistula is based on the pre-clinical animal data presented in the performance section of this 510(k) submission.
Conclusion:
IDev Technologics, Inc. considers the AKónya Eliminator Plus™ Mechanical Thrombectomy Device to be substantially equivalent to the AKónya Eliminator™ Mechanical Thrombectomy Device and the Arrow-Trerotola ™ Percutaneous Thrombolytic Device based on design and technological characteristics.