(162 days)
Not Found
No
The summary describes a mechanical catheter system and an optional automated inflation unit, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device is used to access discrete regions of the peripheral vasculature and for guidewire exchange, not to treat a condition or disease.
No.
The device's intended use is to access and exchange guidewires within the peripheral vasculature and provide support for guidewire advancement, not to diagnose medical conditions.
No
The device description explicitly lists hardware components such as a catheter, a pressure control unit, and accessories like a syringe and manifold.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access discrete regions of the peripheral vasculature and for guidewire exchange. This is a procedural, interventional use within the body.
- Device Description: The device is a catheter system used for accessing blood vessels and manipulating guidewires. This is a medical device used for a procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is purely mechanical and procedural.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The ENABLER-P Catheter System does not fit this description.
N/A
Intended Use / Indications for Use
The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Product codes
DQY
Device Description
The ENABLER-P Catheter System is comprised of the ENABLER-P Catheter, the ENABLER Pressure Control Unit (PCU), and accessories including a sterile cover, syringe, manifold and extension tube.
The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Catheter, using a distal balloon, can provide distal anchoring and support the advancement of the guidewire.
The ENABLER-P Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The ENABLER Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon. The PCU is single use and supplied non sterile with a specially designed sterile cover to allow proper use in sterile areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
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)
Biocompatibility testing, in vitro bench studies, and in vivo studies were conducted to evaluate the biological and performance characteristics of the ENABLER-P Catheter. Biocompatibility test results indicate that the device is biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082339, K083833, K024000, K942269
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
EndoCross ENABLER-P Catheter System 510(k)
510(k) SUMMARY
EndoCross's ENABLER-P Catheter System
Applicant's Information
| Date Prepared: | July 17, 2009 |
|---|---|
| DEC 30 2009 | |
| Name and Address: | EndoCross Ltd |
| New Industrial Park, Building 7 | |
| P.O.B 620, Yoqneam 20692, Israel | |
| Contact Person: | Yaron Eshel |
| Tel: +972-4-9090030 | |
| Fax: +972-4-9090055 |
Device Information
| Classification: | DQY |
|---|---|
| Trade Name: | ENABLER-P Catheter System |
| Common Name: | Percutaneous Catheter System |
| Classification Name: | Percutaneous Catheter, DQY / 21 CFR 870.1250 |
Predicate Devices
- ENABLER-P Catheter manufactured by Endocross (K082339, K083833) .
- Metricath System manufactured by Angiometrx Inc (K024000) .
- Everest 20cc Inflation Device manufactured by Medtronic (K942269)
Intended Use / Indications for Use
The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
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Technological Characteristics
The ENABLER-P Catheter System is comprised of the ENABLER-P Catheter, the ENABLER Pressure Control Unit (PCU), and accessories including a sterile cover, syringe, manifold and extension tube.
The ENABLER-P Catheter is a dual-lumen intravascular catheter intended for percutaneous use. It is designed for use in conjunction with a 0.035" guidewire to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the ENABLER-P Catheter, using a distal balloon, can provide distal anchoring and support the advancement of the guidewire.
The ENABLER-P Catheter is packaged in a Tyvek/Poly pouch to form a sterile barrier. The packaged catheter is sterilized by ethylene oxide gas. The ENABLER-P Catheter is provided "STERILE" and "Non-pyrogenic", and is intended for single use only.
The ENABLER Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon. The PCU is single use and supplied non sterile with a specially designed sterile cover to allow proper use in sterile areas.
Biocompatibility And Performance Data
Biocompatibility testing, in vitro bench studies, and in vivo studies were conducted to evaluate the biological and performance characteristics of the ENABLER-P Catheter. Biocompatibility test results indicate that the device is biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.
Substantial Equivalence
. İ
The ENABLER-P Catheter System is substantially equivalent to the cleared ENABLER-P Catheter manufactured by EndoCross, the Medtronic Everest 20cc Inflation Device and the Angiometrx Metricath System.
The ENABLER-P Catheter System has the same intended use as the cleared ENABLER-P Catheter and similar technological characteristics as the cleared ENABLER-P Catheter, the Medtronic Everest 20cc Inflation Device and the Angiometrx Inc., Metricath System. Any differences in technological characteristics or principles do not raise new questions of safety or efficacy.
Thus, the ENABLER-P Catheter System is substantially equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle, there is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
EndoCross, Ltd. c/o John J. Smith, M.D., J.D. Hogan & Hartson LLP Columbia Square 555 Thirteenth Street N.W. Washington, D.C. 20004
DEC 3 0 2009
Re: K092174
Trade/Device Name: ENABLER-P Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 22, 2009 Received: December 22, 2009
Dear Dr. Smith:
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 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
3
Page 2 - John J. Smith, M.D., J.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
| 510(k) Number (if known): | K092174 |
|---|---|
| --------------------------- | --------- |
Device Name: ENABLER-P Catheter System
Intended Use / Indications for Use:
The ENABLER-P Catheter System is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
Prescription Use ﮨﮯ۔ (Part 21 C.F.R. 801 Subpart D) AND/OR
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page
of
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K92174 92074
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