(150 days)
The ENABLER-P Catheter 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 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 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 provided text describes the 510(k) summary for the EndoCross ENABLER-P Catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a de novo clinical study with specific acceptance criteria related to disease detection or diagnosis based on imaging or other data.
Therefore, many of the requested categories for AI/diagnostic device studies are not applicable to this submission, as it concerns a physical medical device (a catheter) and its mechanical/biocompatibility performance, not an AI or diagnostic algorithm.
Here's an analysis based on the provided text, indicating where information is not applicable (N/A):
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Performance Requirements) | Reported Device Performance |
|---|---|
| Biocompatibility (materials are safe for biological systems) | Biocompatibility test results indicate that the device materials are biocompatible. (Statement from "Biocompatibility And Performance Data") |
| Functional performance requirements (related to intended use: accessing peripheral vasculature, guidewire exchange, distal anchoring, support guidewire advancement) | Performance test results indicate that the device satisfies functional performance requirements when used as indicated. (Statement from "Biocompatibility And Performance Data") |
| Sterility | Provided "STERILE" (Implicitly meets sterility requirements) |
| Non-pyrogenicity | Provided "Non-pyrogenic" (Implicitly meets non-pyrogenicity requirements) |
| Mechanical performance (similar to predicate devices) | The ENABLER-P Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices. Performance data demonstrate that the ENABLER-P Catheter is substantially equivalent to the ENABLER-P Support Catheter and the Asahi Tornus Support Catheter. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for performance testing. The text mentions "in vitro bench studies and animal studies" but does not quantify the sample sizes for these studies.
- Data Provenance: Not explicitly stated. The applicant, EndoCross Ltd, is located in Israel, but the location of the studies is not specified. The studies are likely prospective, as they are conducted to evaluate the new device.
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)
- N/A. This device is a catheter, not a diagnostic or AI device that requires expert-established ground truth for interpretation. Performance is assessed through engineering bench tests, animal studies, and biocompatibility testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically for subjective assessments or discrepancy resolution in diagnostic studies. This is a physical device with objective performance metrics (e.g., tensile strength, burst pressure, maneuverability in a model, biocompatibility assay results).
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
- N/A. This is a physical medical device (catheter), not an AI or diagnostic tool. MRMC studies are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device. "Standalone performance" in the context of AI applies to algorithms making decisions independently, which is not relevant for a catheter's performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relies on objective measurements from in vitro bench testing (e.g., mechanical properties, functional operation in models) and biological responses observed in biocompatibility tests and animal studies. It's not a diagnostic ground truth like pathology.
8. The sample size for the training set
- N/A. There is no "training set" in the context of evaluating a physical medical device like a catheter. This term applies to machine learning algorithms.
9. How the ground truth for the training set was established
- N/A. As there is no training set, this is not applicable.
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1683832
510(k) SUMMARY
EndoCross's ENABLER-P Catheter
Applicant's Information
| Date Prepared: | December 23, 2008 |
|---|---|
| Name and Address: | EndoCross LtdNew Industrial Park, Building 7P.O.B 620, Yoqneam 20692, Israel |
| Contact Person: | Yaron EshelTel: + 972-4-9090030Fax: + 972-4-9090055 |
Device Information
| Classification: | DQY |
|---|---|
| Trade Name: | ENABLER-P Catheter |
| Common Name: | Percutaneous Catheter |
MAY 2 2 2009Percutaneous Catheter, DQY / 21 CFR 870.1250
Predicate Devices
Classification Name:
- . ENABLER-P Support Catheter manufactured by Endocross (K082339)
- Asahi Tornus Support Catheter manufactured by Asahi Intecc (K051772) .
Intended Use / Indications for Use
The ENABLER-P Catheter 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 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 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-P Catheter is similar in basic materials, design, construction and mechanical performance to a combination of the predicate devices.
Biocompatibility And Performance Data
Biocompatibility testing, in vitro bench studies and animal studies were conducted to evaluate the biological and performance characteristics of the ENABLER-P Catheter. Biocompatibility test results indicate that the device materials are biocompatible. Performance test results indicate that the device satisfies functional performance requirements when used as indicated.
Substantial Equivalence
The ENABLER-P Catheter is substantially equivalent to the ENABLER-P Support Catheter manufactured by EndoCross and the Asahi Tornus Support Catheter manufactured by Asahi Intecc.
The ENABLER-P Catheter has the same intended use as the ENABLER-P Support Catheter and the Asahi Tornus Support Catheter and identical technological characteristics as the ENABLER-P Support Catheter. Performance data demonstrate that the ENABLER-P Catheter is substantially equivalent to the ENABLER-P Support Catheter and the Asahi Tornus Support Catheter ..
Thus, the ENABLER-P Catheter is substantially equivalent.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2009
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
Re: K083833
Trade/Device Name: ENABLER-P Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: April 10, 2009 Received: April 10, 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.
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Page 2 - John J. Smith, M.D., J.D.
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); 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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/cdrh/industry/support/index.html.
Sincerely yours,
i
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 K083833
510(k) Number (if known):
Device Name: ENABLER-P Catheter
Intended Use / Indications for Use:
The ENABLER-P Catheter 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 1 (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 Cardlovascular Devices
§ 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).