AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060

K030504 · Idev Technologies, Inc. · MCW · Sep 16, 2003 · Cardiovascular

Device Facts

• Record ID: K030504
• Device Name: AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
• Applicant: Idev Technologies, Inc.
• Product Code: MCW · Cardiovascular
• Decision Date: Sep 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4875
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AKónya Eliminator™ Mechanical Thrombectomy Device is indicated for use in the mechanical declotting of synthetic dialysis grafts.

Device Story

Mechanical thrombectomy device for synthetic dialysis grafts; consists of outer member, inner member, and woven/braided stainless steel thrombasket. Operated by physician during surgical procedure to remove clots. Device utilizes mechanical action via thrombasket to declot grafts. Includes hemostasis Y-connector for flushing and Tuohy-Borst connector for hypotube handling. Benefits patient by restoring graft patency. No software or automated algorithms involved.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical performance testing including accelerated aging, packaging/shipping integrity, dimensional/flexibility/pushability analysis, tensile strength testing, fatigue life determination, biocompatibility assessment, and an animal study to evaluate safety, efficacy, and operational characteristics.

Technological Characteristics

Catheter-based mechanical thrombectomy device. Components: outer member, inner member, and woven/braided stainless steel wire thrombasket. Features: hemostasis Y-connector, Tuohy-Borst connector. Mechanical operation. No energy source, software, or connectivity. Sterilization method not specified.

Indications for Use

Indicated for mechanical declotting of synthetic dialysis grafts in patients requiring thrombectomy.

Regulatory Classification

Identification

An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)

Predicate Devices

• Arrow-Trerotola™ Percutaneous Thrombolytic Device (PTD) (K970080, K990829)

Submission Summary (Full Text)

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# AKónya Eliminator™ Mechanical Thrombectomy Device 510(k) Summary

| Submitter: | IDev Technologies, Inc.<br>1110 NASA Road One, Suite 311<br>Houston, Texas 77058 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ms. Lynne A. Davies<br>Regulatory Affairs Manager<br>[phone] x 223 - Phone<br>[phone] - Mobile<br>[phone] - Fax |
| Date Prepared: | February 17, 2003 |
| Trade Name: | AKónya EliminatorTM Mechanical Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification<br>Name: | Catheter, Peripheral, Atherectomy (21 CFR 870.4875) |
| Product Code: | MCW |
| Predicate Device: | Arrow-Trerotola TM Percutaneous Thrombolytic Device (PTD) (K970080,<br>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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# 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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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 [phone]. 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 [phone] or [phone] 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

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## 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<br>Device is indicated for use in the mechanical declotting of<br>synthetic dialysis grafts. |

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Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)

Prescription Use Only

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Climita 510(k) Number