(174 days)
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 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.
Here's a breakdown of the acceptance criteria and study information for the Ultraverse™ PTA Balloon Dilatation Catheters, based on the provided document.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative manner as typically seen in modern regulatory submissions (e.g., "sensitivity must be > X%", "accuracy must be > Y%"). Instead, the acceptance criteria are implicitly defined by demonstrating that the new catheter sizes maintain the same performance characteristics as the predicate device (K925485). The "reported device performance" refers to the results of the tests conducted to confirm this consistency.
| Characteristic Tested | Predicate Device (K925485) Performance / Implicit Acceptance Criterion (Same performance as predicate) | Proposed New Sizes (K964881) Reported Device Performance |
|---|---|---|
| Balloon Minimum Burst Strength | Consistent with predicate (implied to meet predicate's burst pressures) | Tested and found to be consistent with predicate |
| Balloon Distensibility | Consistent with predicate | Tested and found to be consistent with predicate |
| Balloon Inflation/Deflation Time | Consistent with predicate | Tested and found to be consistent with predicate |
| Balloon Fatigue | Consistent with predicate | Tested and found to be consistent with predicate |
| Joint Strength | Consistent with predicate | Tested and found to be consistent with predicate |
| Catheter Shaft and Balloon Profile | Consistent with predicate | Tested and found to be consistent with predicate |
| Introducer Sheath Compatibility | Consistent with predicate | Tested and found to be consistent with predicate |
| Catheter Flow/Maximum Pressure | Consistent with predicate | Tested and found to be consistent with predicate |
| Trackability/Deflatability | Consistent with predicate | Tested and found to be consistent with predicate |
| Tip Torque | Consistent with predicate | Tested and found to be consistent with predicate |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact numerical sample sizes for each characteristic test. It generally states that "The additional balloon and shaft sizes proposed in this submission were tested for the following characteristics." This implies a sufficient number of units were tested to demonstrate consistency.
- Data Provenance: Not explicitly stated, but given the device manufacturer is Vas-Cath Incorporated from Canada, the testing likely occurred internally or at a contracted lab. The data is retrospective in the sense that it's a report of completed tests for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a medical instrument (catheter), and its performance evaluation involves engineering and material testing, not subjective expert assessment of images or clinical outcomes to establish a "ground truth" in the way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable. As described above, the evaluation is based on objective measurements from engineering tests, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a medical device (catheter) for angioplasty, not an AI diagnostic algorithm. Therefore, an MRMC comparative effectiveness study involving human readers is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. This is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by engineering specifications, material properties, and established performance characteristics of the predicate device. For example, the "ground truth" for burst strength would be the pressure at which the balloon is designed to withstand before bursting. The comparison is made against known and accepted standards for such devices and the performance of the previously cleared predicate.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #8)
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MAY 2 8 1997
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510(k) SUMMARY of SAFETY AND EFFECTIVENESS
FOR THE
ULTRAVERSE™ PTA BALLOON DILATATION CATHETERS
| A. | Submitter Information: | Vas-Cath Incorporated |
|---|---|---|
| Address: | 2380 Tedlo StreetMississauga, Ontario L5Z 3V3Canada | |
| 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 Catheter3.5F 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
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TABLE 1 : COMPARISON OF DEVICES
| Characteristics | Predicate K925485Vas-CathUltraverse™ PTA Catheter | Proposed New Sizes for Vas-CathUltraverse™ 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 RecommendedInflation 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 15atm3mm by 2cm is 15atm4mm by 2cm is 12 atm5mm by 2cm is 12 atm | 2mm by 6cm is 15 atm3mm by 6cm is 15 atm4mm by 6cm is 12 atm5mm 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
§ 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).