(27 days)
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The intended use and predicate device suggest a mechanical dilator.
Yes
The device is intended to dilate blood vessels, which is a therapeutic intervention. The predicate device, Gelbfish Vascular Dilators, further supports its classification as a therapeutic device.
No
The device is intended to dilate or calibrate blood vessels, which are therapeutic actions, not diagnostic ones. There is no mention of it being used to identify or analyze a disease or condition.
No
The intended use describes a physical device (dilator) used over a guidewire, which is a hardware component. The summary does not mention any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "dilate or calibrate blood vessels." This is a direct intervention on the patient's body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis.
The device described is a medical device used for a therapeutic procedure (dilation/calibration of blood vessels). The predicate device listed (Gelbfish Vascular Dilators) also confirms this as dilators are medical devices, not IVDs.
N/A
Intended Use / Indications for Use
These devices are intended to be used over a guidewire todilate or calibrate blood vessels.
Product codes (comma separated list FDA assigned to the subject device)
DRE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
blood vessels
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
030260
Summary of 510(k) Submission Section 11
FEB 2 0 2003
11.1 Type of Submission
Special 510(k) Date of Submission: January 9, 2003
11.2 Manufacturer
VascuMetrix, LLC 1058 N. Higley Rd. Suite 204 Mesa, AZ 85205 (480) 807-6300 Fax: (480) 807-6307
Establishment Registration Number: 2032423 Owner/Operator Number: 9046947
11.3 Contact Person
Nick Raible President
11.4 Device
| 510(k) Number: | Not yet assigned |
|---|---|
| Proprietary Name: | Gelbfish Flex Vascular Dilator |
| 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 to |
| dilate or calibrate blood vessels. |
1
11.5 Predicate Device
| 510(k) Number: | K012256 |
|---|---|
| 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 to |
| dilate or calibrate blood vessels. |
11.6 Comparison to Predicate Device
-
- The original 510(k) on these dilators limited the shaft material to stainless steel. The modified device has a polyurethane shaft.
-
- The original device uses laser welding to bond the tip to the shaft. The modified device will use a medical grade adhesive to bond the tip to the shaft.
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.
2
Image /page/2/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle, following its curvature.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2003
Mr. Nick Raible President VascuMetrix, LLC 1058 N Higley Rd., Suite 204 Mesa, AZ 85205
Re: K030260
Trade/Device Name: Gelbfish Flex Vascular Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catherterization Regulatory Class: Class II Product Code: DRE Dated: January 8, 2003 Received: January 24, 2003
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
3
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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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 vours,
J.Q. Carter
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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Page of /
| 510(k) Number (if known): | K030260 |
|---|---|
| Device Name: | Gelbfish Flex Vasalar Dilator |
Indications For Use:
Statement of Indented Use Section 2
These devices are intended to be used over a guidewire to dilate or calibrate blood vessels.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K030260
Image /page/4/Picture/7 description: The image shows the words "Prescription Use" followed by the text "(Per 21 CFR 801.109)". There is a check mark above the text, indicating that the prescription use option has been selected. The text is in a simple, sans-serif font and is easy to read.
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)