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.

AI/ML Overview

The provided text describes the AKónya Eliminator™ Mechanical Thrombectomy Device and its 510(k) summary for substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study designed to directly prove the device meets specific performance criteria in a quantitative manner that would be typically presented in a table.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Arrow-Trerotola™ PTD) through comparisons of technological characteristics and successful completion of various non-clinical performance tests.

Here's a breakdown of the information that can be extracted, and where the requested details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned above, the submission does not present a table of quantitative acceptance criteria with corresponding performance metrics for the AKónya Eliminator™ in the context of clinical efficacy or specific functional thresholds beyond basic engineering tests.

The document discusses "functional and safety testing requirements to ensure substantial equivalence," and lists several non-clinical tests:

Acceptance Criteria (Implied)	Reported Device Performance
Accelerated Aging / Packaging:	Device and packaging materials sustained 1-year shelf life. Tests
- Effects on device & packaging	included Seal Peel, Burst, Dye Penetration, and device functionality post-aging.
- 1-year shelf life substantiated
- Package Seal Peel, Burst, Dye Penetration, device functionality
Packaging / Shipping Integrity:	Successfully withstood shipping & transportation environments.
- Survivability of device packaging & construction materials
Dimensional / Flexibility / Pushability:	Met dimensional requirements as defined in product specification.
- Pushability and trackability comparable to predicate
- Dimensional requirements from product specification met
Tensile:	Met minimum tensile strength requirements at all joints as defined in product specification.
- Minimum tensile strength at all joints met
Fatigue:	Fatigue life determined (no specific value given, but implied met requirements).
- Fatigue life determined
Biocompatibility:	Potential toxicity from component materials evaluated (implied acceptable).
- Potential toxicity evaluated
Animal Study:	Evaluated safety and efficacy, and operational characteristics with respect to predicate device.
- Safety and efficacy
- Operational characteristics vs. predicate

Note: The "acceptance criteria" here are implied by the successful completion of the tests and the statement of substantial equivalence. No specific numerical thresholds or target values are provided in this document.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated for any clinical or direct performance test. The submission mentions an "Animal Study" which would involve a sample size of animals, but this size is not provided.
Data Provenance: The tests listed are explicitly non-clinical performance testing and an Animal Study. This indicates the data is from laboratory and animal model environments, not human data. The geographical origin of these studies is not specified, but given the submitter's location (Houston, Texas) and the FDA filing, it's likely U.S.-based. The studies appear to be prospective in nature, as they involve testing the new device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This section is relevant for studies involving human interpretation (e.g., radiologist reads) where a "ground truth" needs to be established, typically through expert consensus or biopsy. Since the primary evidence presented is non-clinical (engineering tests, animal study), there is no mention of experts establishing ground truth for a test set in this context. The "ground truth" for these tests would be the physical properties and performance measured by the testing equipment.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this concept typically applies to human-read studies where discrepancies between readers might occur and need resolution. For non-clinical and animal studies, adjudication methods in the sense of expert consensus on interpretations are not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not mention any clinical study, let alone an MRMC study, comparing human readers with and without AI assistance for this mechanical thrombectomy device. This type of study is not relevant for this device submission which focuses on substantial equivalence through non-clinical and animal testing.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This device is a mechanical thrombectomy device, meaning it is a physical instrument for medical intervention, not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept for this product.

7. Type of Ground Truth Used

For the non-clinical tests (Accelerated Aging, Packaging, Dimensional, Tensile, Fatigue, Biocompatibility), the "ground truth" is established by physical measurements, material analysis, and adherence to predefined product specifications and industry standards.

For the Animal Study, the "ground truth" would be established by direct observation of safety and efficacy within the animal model, possibly through histological analysis or outcome measures specific to the animal study design (which are not detailed here).

8. Sample Size for the Training Set

Not applicable. This question pertains to machine learning models. The AKónya Eliminator™ is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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AKónya Eliminator™ Mechanical Thrombectomy Device 510(k) Summary

Submitter:	IDev Technologies, Inc.1110 NASA Road One, Suite 311Houston, Texas 77058
Contact Person:	Ms. Lynne A. DaviesRegulatory 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
ClassificationName:	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.

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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.

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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

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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

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K030504

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 ThrombectomyDevice is indicated for use in the mechanical declotting ofsynthetic 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

Regulation Number and Section

§ 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).