(174 days)
Not Found
No
The 510(k) summary describes a standard balloon dilatation catheter and does not mention any AI or ML components, algorithms, or functionalities. The performance studies focus on physical characteristics and equivalence to a predicate device.
Yes
The device is a balloon dilatation catheter used to treat conditions within the peripheral vascular system, which implies a therapeutic intervention (dilating vessels to improve blood flow).
No
The device is a peripheral balloon dilatation catheter used for therapeutic intervention (dilating vessels), not for diagnosing conditions.
No
The device description clearly describes a physical catheter with a balloon, lumens, and marker bands, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description: The provided description clearly states that the Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are used within the peripheral vascular system to dilate vessels. This is an in vivo procedure (performed inside the body).
- Intended Use: The intended use is for therapeutic intervention (balloon dilatation) within the body, not for diagnostic testing of specimens.
The device is a medical device used for a therapeutic procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.
The Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in angioplasty of the peripheral vascular system. The catheter is recommended for use in the following vessels: renal, tibial, popliteal, femoral, and peroneal. The catheter is not for use in coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
74 LIT
Device Description
The Vas-Cath Ultraverse™ PTA Catheter is a duai lumen catheter with a balloon mounted on its distal tip. One lumen accomodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system, renal, tibial, popliteal, femoral, and peroneal vessels. Not for use in coronary arteries.
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)
The design, materials and manufacturing processes for the predicate and proposed devices are the same. The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics: balloon minimum burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joint strength, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The proposed product is substantially equivalent to the current Ultraverse™ Catheters marketed under 510(k) concurrence K925485.
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
§ 870.1250 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).
0
MAY 2 8 1997
Image /page/0/Picture/2 description: The image shows the logo for "va-cath. INCORPORATED". The logo is in black and white, with the text "va-cath." in a bold, stylized font. Below the main text, the word "INCORPORATED" is written in a smaller, less bold font. The logo appears to be for a company or organization named "va-cath."
510(k) SUMMARY of SAFETY AND EFFECTIVENESS
FOR THE
ULTRAVERSE™ PTA BALLOON DILATATION CATHETERS
| A. | Submitter Information: | Vas-Cath Incorporated |
|---|---|---|
| Address: | 2380 Tedlo Street | |
| Mississauga, Ontario L5Z 3V3 | ||
| Canada | ||
| Telephone Number: | (905) 848-5800 | |
| Fax Number: | (905) 848-6638 | |
| Contact Person: | Dolores McGirr | |
| Date of Preparation: | August 23, 1996 | |
| B. | Device Name: | UltraverseTM Angioplasty Catheter |
| 3.5F Opti-Plast Catheter | ||
| Common/Usual Name: | Peripheral Angioplasty Catheter | |
| Classification Name: | Surgical Vessel Dilator | |
| C. | Predicate Device Name: | UltraverseTM Angioplasty Catheter (K925485) |
| Trade Name: | Ultraverse |
D. Device Description:
The Vas-Cath Ultraverse™ PTA Catheter is a duai lumen catheter with a balloon mounted on its distal tip. One lumen accomodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.
E. Intended Use:
The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.
- Technological Characteristics Summary: Summarized in Table 1. F.
2380 Tedlo Street Mississauga, Ontario Canada, L5A 3V3
Tel. (905) 848-5800 Fax (905) 848-6638
1
Image /page/1/Picture/0 description: In the image, there are two objects that appear to be round. The object on the left is white, while the object on the right is black. The black object is larger than the white object. The image is a black and white photograph.
TABLE 1 : COMPARISON OF DEVICES
| Characteristics | Predicate K925485
Vas-Cath
Ultraverse™ PTA Catheter | Proposed New Sizes for Vas-Cath
Ultraverse™ PTA Catheter |
|-------------------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | PTA of renal, tibial, popliteal,
femoral, and peroneal vessels | PTA of renal, tibial, popliteal,
femoral, and peroneal vessels |
| Catheter Shaft Material | Nylon | Nylon |
| Catheter Shaft Diameter | 3.5 French | 3.5 French |
| Inflated Balloon Diameters | 2, 3, 4, 5 mm | 2, 3, 4, 5 mm |
| Balloon Material | Nylon | Nylon |
| Maximum Recommended
Inflation Pressure | 8 atmospheres | 8 atmospheres |
| Guidewire Capability | 0.016 inch diameter | 0.016 inch diameter |
| Shaft configuration | Double lumen | Double lumen |
| Radiopaque | Yes | Yes |
| Marker Bands | Yes | Yes |
| Balloon Leg Length | 7 cm | 7 cm |
| Distal Leg Length | 5.5 cm | 5.5 cm |
| Rated Burst Pressures | 2mm by 2cm is 15atm
3mm by 2cm is 15atm
4mm by 2cm is 12 atm
5mm by 2cm is 12 atm | 2mm by 6cm is 15 atm
3mm by 6cm is 15 atm
4mm by 6cm is 12 atm
5mm by 3,4,5 or 6cm is 10 atm |
| Differences | | |
| Inflated Balloon Length | 2 cm | 3, 4, 5, 6 cm |
| Catheter Shaft Length | 75 - 100 cm | 75 - 150 cm |
G. Performance Data
The design, materials and manufacturing processes for the predicate and proposed devices are the same. The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics: balloon minimum burst strength, balloon distensibility, balloon inflation/deflation time, balloon fatigue, joint strength, catheter shaft and balloon profile, introducer sheath compatibility, catheter flow/maximum pressure, trackability/ deflatability, and tip torque. The proposed product is substantially equivalent to the current Ultraverse™ Catheters marketed under 510(k) concurrence K925485.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 28 1997
Ms.. Dolores McGirr Vas-Cath, Inc. 2380 Tedlo Street Canada, L5A 3V3
Re : K964881 Ultraverse™ 3.5F PTA Catheters Regulatory Class: II (two) Product Code: 74 LIT Dated: April 2, 1997 Received: April 15, 1997
Dear Ms. McGirr:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: Ceneral (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Dolores McGirr
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requilation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATION(S) STATEMENT* SECTION 1. D
I state in my capacity as Manager of Quality Assurance and Regulatory Affairs of Vas-Cath Inc. that this premarket notification 510(k) for the Ultraverse™ 3.5 French Angioplasty Catheter is indicated for the following.
The Ultraverse™ Small Vessel PTA Balloon Dilatation Catheter is recommended for use in angioplasty of the peripheral vascular system. The catheter is recommended for use in the following vessels: renal, tibial, popliteal, femoral, and peroneal. The catheter is not for use in coronary arteries.
Signature of 510(k) Submitter
Signature of 510(k) Submitter
Janet Shaw Printed Name of Submitter
96/11/15
Date
*Suggested language and format to meet the requirements of sections 513(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and sections 807.92(a)(5) and 801.4 of the code of Federal Regulations, Title 21.
CONCURRENCE OF OFFICE OF DEVICE EVALUATION
510(k) Number
Ta A. R
Division Sign-Off Office of Device Evaluation