(114 days)
Not Found
No
The description focuses on mechanical operation and does not mention any computational or data-driven features.
Yes
The device is intended to treat a medical condition (remove plaque deposits from arteries), which aligns with the definition of a therapeutic device.
No.
The device's intended use is to "remove plaque deposits from arteries," which describes a therapeutic rather than a diagnostic function. It is an endarterectomy device, which is a surgical tool for removing arterial buildup.
No
The device description clearly describes a physical, tubular device with a mechanical component (expanding helical element controlled by a sliding tab on the handle). This is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "remove plaque deposits from arteries." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical device designed for mechanical intervention within the arteries.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside of the body, which is the core function of an IVD. The device is used in vivo (within the living body).
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.
Product codes (comma separated list FDA assigned to the subject device)
DWX
Device Description
The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire.
The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
arteries
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)
Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths. All product met specification.
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
OCT 3 0 2003
510(k) Summary
General Information
| Classification | Class II |
|---|---|
| Trade Name | EndoHelix™ Endarterectomy Device |
| Submitter | ENDARx Inc. |
| 3270 Alpine Road | |
| Portola Valley, CA 94028 | |
| 650-926-9335 |
Contact
Scott Adams President
Intended Use
The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.
Predicate Devices
- Transluminal Endarterectomy Device K904944 from Baxter Healthcare Corporation
- Periscope Device from Vascular Architects K003719
Device Description
The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire.
The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.
1
Materials
All materials used in the manufacture of the EndoHelix Endarterectomy Device are suitable for this use and have been used in numerous previously cleared products.
Testing
Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths.
All product met specification.
Summary of Substantial Equivalence
The EndoHelix Endarterectomy Device is equivalent to the predicate devices. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. ENDARx Inc. believes the EndoHelix Endarterectomy Device is substantially equivalent to existing legally marketed devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
EndarX, Inc. c/o Mr. J. Scott Adams 3270 Alpine Road Portola Valley, CA 94028
Re: K032105
EndoHelix™ Endarterectomy Device Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: DWX Dated: October 20, 2003 Received: October 22, 2003
Dear Mr. Adams:
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. 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.
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Page 2 - Mr. J. Scott Adams
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained 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.qov/cdrh/dsma/dsmamain.html
Sincerely vours,
Ashley B. Evans
$\int_{0}^{1}$
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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Indications for Use
| 510(k) Number (if known): | This application |
|---|---|
| Device Name: | EndoHelixTM Endarterectomy Device |
| Indications for Use: | The EndoHelix Endarterectomy Device is |
| intended to remove plaque deposits from | |
| arteries. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use / OR Over-The-Counter Use _
(Per 21 CFR 801.109) (Optional Format 1-2-96)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number /C032105
: