(21 days)
The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels.
Not Found
This document discusses a Special 510(k) submission for the VascuMetrix Dilators, which are vessel dilators for percutaneous catheterization. The submission focuses on modifications to an existing device, the Gelbfish Vascular Dilators (K0012256).
Here's an analysis of the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria or quantitative performance metrics for the VascuMetrix Dilators. Instead, the submission relies on a comparison to a predicate device and a statement of "substantial equivalence."
Acceptance Criteria (Inferred from comparison to predicate):
| Criterion | Acceptance Metric (Implied) | Reported Device Performance (VascuMetrix Dilators) |
|---|---|---|
| Shaft Lumen Size | Must accommodate guidewires ≤ 0.035" | Accommodates 0.018" and/or 0.014" guidewires |
| Tip Outer Diameter | Must be within range 2.0 mm to 7.0 mm | Ranges from 1.0 mm to 10.0 mm |
| Markings/Etchings | Device size not marked (for predicate) | Device size laser etched on the tip |
| Physical Properties | Substantially equivalent to predicate | Deemed substantially equivalent |
| Performance Characteristics | Substantially equivalent to predicate | Deemed substantially equivalent |
| Intended Use | Substantially equivalent to predicate | "To be used over a guidewire to dilate or calibrate blood vessels" (same as predicate) |
Note: The phrase "substantially equivalent" in regulatory contexts implies that the new device is as safe and effective as the predicate device, and does not raise new questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance
The document does not mention any specific test set, clinical data, or sample sizes used to demonstrate the performance of the modified device. The submission appears to be based on a comparison of device specifications and intended use against a legally marketed predicate device. This is typical for a Special 510(k) for minor device modifications, where new clinical data might not be required if the changes do not significantly affect safety or effectiveness.
Therefore, there is no information on data provenance (country of origin, retrospective/prospective) as no specific study data is presented.
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 and not provided. Since no test set or clinical study is described, there's no mention of experts establishing a ground truth. The "ground truth" in this context is the performance and safety profile of the predicate device, to which the modified device is compared.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided for the reasons stated above (no test set described).
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
This information is not applicable and not provided. The device in question is a physical medical device (vascular dilators), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. As explained above, the device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device submission (physical medical device with minor modifications relying on substantial equivalence), the "ground truth" is fundamentally the established safety and effectiveness profile of the predicate device as previously cleared by the FDA, along with engineering and manufacturing specifications. The FDA's determination of substantial equivalence (as stated in the letter) means they found adequate evidence (likely through bench testing, material comparisons, and engineering analysis, although not detailed here) that the modified device's performance aligns with the predicate's.
8. The sample size for the training set
This information is not applicable and not provided. Training sets are relevant for machine learning or AI models, which is not the case for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as point 8.
In summary, the provided document describes a regulatory submission for a physical medical device based on substantial equivalence to a predicate device, focusing on changes in dimensions and markings. It does not detail specific acceptance criteria in a quantitative sense for novel testing, nor does it present any clinical study data, expert reviews, or AI-related performance metrics.
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NOV 8 2002
Summary of 510(k) Submission Section 11
11.1 Type of Submission
Special 510(k) Date of Submission: October 15, 2002
11.2 Manufacturer
VascuMetrix, LLC 2824 N. Power Rd. Suite 113-278 Mesa, AZ 85215 (480) 807-6300 Fax: (480) 807-6307
11.3 Contact Person
Nick Raible President
11.4 Device
| 510(k) Number: | K023507 |
|---|---|
| Proprietary Name: | VascuMetrix Dilators |
| Generic Name: | Dilator, Vessel, For Percuteneous Catheterization |
| Classification: | Class II |
| Relevant Section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | These devices are intended to be used over a guidewire todilate or calibrate blood vessels. |
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11/623507
11.5 Predicate Device
| 510(k) Number: | K0012256 |
|---|---|
| Proprietary Name: | Gelbfish Vascular Dilators |
| Generic Name: | Dilator, Vessel, For Percuteneous Catheterization |
| Classification: | Class II |
| Relevant Section: | 870.1310 |
| Product Code: | DRE |
| Intended Use: | These devices are intended to be used over a guidewire todilate or calibrate blood vessels. |
11.6 Comparison to Predicate Device
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- The original 510(k) on these dilators limited the shaft size to a shaft with "a lumen large enough to slide over an 0.035" guidewire." The modified devices will have shatts with smaller lumens. The modified devices will accommodate 0.018" and/or 0.014" guidewires.
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- The original 510(k) on these dilators limited the tip size to an outer diameter size range of 2.0 mm to 7.0 mm. The modified devices will have tip sizes that range from 1.0 mm to 10.0 mm.
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- The current device does not have any markings or etchings. The modified device will have the device size laser etched on the tip.
11.7 Conclusion
Comparison of the original device with the modified device for physical properties, performance characteristics and intended use, indicate that these devices are substantially equivalent and that there are no additional safety issues.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three curved lines that resemble a human figure. The text is in all capital letters and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 8 2002
VascuMetrix, LCC Mr. Nick Raible President 2824 N. Power Rd., Suite 113-278 Mesa, AZ 85215
Re: K023507
Trade/Device Name: VascuMetrix Gelbfish Vascular Dilators Regulation Number: 21 CFR 870.1310 Regulation Name: Dilator, Vessel, For Percutaneous Catheterization Regulatory Class: Class II Product Code: DRE Dated: October 15, 2002 Received: October 18, 2002
Dear Mr. Raible:
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.
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
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Page 2 - Mr. Nick Raible
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4586. 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). 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.gov/cdrh/dsma/dsmamain.html.
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 Section 10
The VascuMetrix Vascular Dilators are to be used over a guidewire to dilate or calibrate blood vessels. .
Nick Raible
Nick Raible
Date: 11-6-02
Prescription Use
(Per 21 CFR 801.109) ✓
Division of Cardiovascular & Respiratory Devices
510(k) Number _______________________________________________________________________________________________________________
Ashley Barrant for DCD
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).