(99 days)
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
This submission K092298 for the Modified HD Guide Catheter is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with detailed performance metrics. For devices like this catheter, the acceptance criteria are generally related to demonstrating that the new device is as safe and effective as a legally marketed predicate device.
Here's a breakdown based on the provided text, addressing the points where information is available or inferable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Suitable for intended use | "performs as designed, is suitable for its intended use" |
| Substantially equivalent to predicate device | "is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site." |
| Does not raise new safety or effectiveness issues | "Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness." |
| Materials are suitable for intended use | "All materials used...are suitable for the intended use of the device and have been used in numerous previously cleared products." |
2. Sample sized used for the test set and the data provenance
The document states "The results of verification and validation conducted on the Modified HD Guide Catheter..." However, it does not provide details on specific sample sizes, the nature of the test set (e.g., patient data), or data provenance (e.g., country of origin, retrospective or prospective). Given that this is a catheter and the mention of "verification and validation," it's highly probable that the "testing" refers to bench testing and possibly animal studies, not human clinical trials with a test set of patient data in the context of AI/diagnostic device evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable or provided in the context of this 510(k) submission. Establishing ground truth by medical experts is typically relevant for diagnostic devices (especially those using AI) where expert consensus, pathology, or outcomes data are needed to evaluate diagnostic accuracy. This submission is for a medical catheter, a therapeutic/interventional device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or provided. Adjudication methods are typically used in clinical trials for diagnostic accuracy or efficacy, which is not the type of study described for this device.
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
An MRMC comparative effectiveness study is not applicable and was not done for this device. This type of study is relevant for diagnostic devices that either incorporate AI or are intended to assist human readers in interpretation. The Modified HD Guide Catheter is an interventional/delivery device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, ground truth would typically be established through engineering specifications, material science standards, and performance benchmarks as demonstrated through bench testing (e.g., tensile strength, burst pressure, lubricity, device dimensions) and potentially animal studies for biological compatibility and in-vivo performance. The document explicitly mentions "All materials used... are suitable for the intended use of the device and have been used in numerous previously cleared products," implying that material safety and suitability are established. "Verification and validation" results demonstrate performance as designed.
8. The sample size for the training set
This information is not applicable or provided. Training sets are relevant for machine learning models.
9. How the ground truth for the training set was established
This information is not applicable or provided.
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K0922987
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
General Information
NOV - 5 2009
| Trade Name | Modified HD Guide Catheter |
|---|---|
| Common Name | Percutaneous Catheter |
| Classification | Percutaneous Catheter, 21CFR 870.1250 – Class II |
| Submitter | Concentric® Medical, Inc.301 E. Evelyn AvenueMountain View, CA 94041Tel 650-938-2100Fax 650-938-2700 |
| Contact | Kirsten ValleySenior Vice President, Technology & Regulatory Affairs |
Intended Use
The Modified HD Guide Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary or neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Predicate Device
HD Guide Catheter, K080583
Device Description
The Modified HD Guide Catheter consists of a single lumen, braided, variable stiffness shaft with a radiopaque marker on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. A rotating hemostatic valve with side-arm adapter is provided with each catheter.
Materials
1
All materials used in the manufacture of the Modified HD Guide Catheter are suitable for the intended use of the device and have been used in numerous previously cleared products.
Testing Summary
The results of verification and validation conducted on the Modified HD Guide Catheter demonstrate that it performs as designed, is suitable for its intended use and is substantially equivalent to the predicate device.
Summary of Substantial Equivalence
The Modified HD Guide Catheter is substantially equivalent to the predicate device with regard to device design, intended use, patient population and anatomical site. Any differences in technological characteristics between the Modified HD Guide Catheter and the predicate device do not raise any new issues of safety or effectiveness.
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Image /page/1/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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head turned to the side.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV - 5 2009
Concentric Medical c/o Ms. Kirsten Valley 301 East Evelyn Avenue Mountain View, CA 94041
Re: K092298
Trade/Device Name: Modified HD Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: October 22, 2009 Received: October 27, 2009
Dear Ms. Valley:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Kirsten Valley
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
uma R. bulmer
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 K092298 |
|---|---|
| Device Name: | Modified HD Guide Catheter |
| Indications for Use: | The Modified HD Guide Catheter is indicated for use infacilitating the insertion and guidance of an occlusion catheterinfusion catheter or other appropriate microcatheter into aselected blood vessel in the peripheral, coronary or neurovascular systems. It may also be used as a diagnosticangiographic catheter. |
Prescription Use _X (Per 21 CFR 801.109) AND/OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
D.R.V
Division Sign-Off
(Division Sign-Off) (Division Sign-Off)
(Division Sign-Off)
Division of Cardiovascular Devices (L.S.
Division of
510(k) Number K092298
§ 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).