(162 days)
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.
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 Pressure Control Unit (PCU) an optional accessory used to automate the inflation and deflation of the catheter's balloon.
The provided 510(k) summary for the EndoCross ENABLER-P Catheter System describes a device intended for use in the peripheral vasculature. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance criteria in the way that would typically be presented for an AI/ML medical device.
This document is for a traditional medical device (catheter system) and the regulatory pathway is focused on demonstrating "substantial equivalence" to predicate devices, rather than establishing performance against pre-defined metrics in a clinical study with a ground truth.
Therefore, many of the requested sections (acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types/establishment for training sets) are not applicable to this specific 510(k) submission.
Here's a breakdown based on the information provided and what is implied by a traditional medical device submission:
1. Table of acceptance criteria and the reported device performance
- Not Applicable. The submission emphasizes "substantial equivalence" to predicate devices rather than meeting specific quantifiable performance criteria like sensitivity, specificity, or accuracy that would be found in an AI/ML device submission. The performance assessment is qualitative, stating that "Performance test results indicate that the device satisfies functional performance requirements when used as indicated."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This device is a catheter system, and its performance is evaluated through bench testing and in vivo studies, not typically against a "test set" of clinical data in the way an AI/ML algorithm would be. The document mentions "in vitro bench studies, and in vivo studies" but does not provide specific sample sizes or data provenance for these studies in the context of a "test set."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth in the context of expert consensus on clinical data is not relevant for this type of traditional device submission. Performance is assessed through engineering tests and non-clinical studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods for a "test set" are not relevant here as the performance evaluation is not based on interpreting clinical data where human expert disagreement would need resolution.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. MRMC studies are specific to evaluating diagnostic systems, particularly AI/ML-assisted ones. This is a catheter system, not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device (catheter system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For a physical device like this, "ground truth" would relate to engineering specifications, material properties, and biological responses (e.g., biocompatibility). The document states: "Biocompatibility test results indicate that the device is biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated." This suggests that the "ground truth" is defined by pre-determined engineering and biological standards.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the Study (as described in the 510(k) document):
The submission for the ENABLER-P Catheter System relies on "Biocompatibility testing, in vitro bench studies, and in vivo studies" to demonstrate the device's characteristics. The primary argument for clearance is Substantial Equivalence to legally marketed predicate devices (ENABLER-P Catheter manufactured by Endocross, Medtronic Everest 20cc Inflation Device, and Angiometrx Metricath System). The rationale is that the device has the "same intended use" and "similar technological characteristics" as the predicates, and that "[a]ny differences in technological characteristics or principles do not raise new questions of safety or efficacy."
Therefore, the "study" proving the device meets its requirements is essentially the set of these non-clinical tests and the comparative analysis against the predicate devices to establish substantial equivalence under the 510(k) pathway. Specific performance metrics, acceptance criteria, or clinical study endpoints as would be required for an AI/ML device are not detailed as they are not typically part of this type of submission.
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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 LtdNew Industrial Park, Building 7P.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.
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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
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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
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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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§ 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).