(135 days)
No
The summary describes a standard mechanical medical device (a balloon catheter) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are bench tests of physical properties.
Yes
The device performs "Balloon dilatation of the femoral, popliteal and infra-popliteal arteries," which is a therapeutic intervention aimed at treating medical conditions.
No
Explanation: The device is described as a PTA catheter intended for balloon dilatation of arteries, which is a therapeutic (treatment) procedure, not a diagnostic one.
No
The device description clearly describes a physical catheter with a balloon, lumens, and a guidewire insertion point, indicating it is a hardware device. The performance studies also focus on physical characteristics and tests of the catheter.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Balloon dilatation of the femoral, popliteal and infra-popliteal arteries." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a physical catheter with a balloon for mechanical expansion within blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), or providing information about a patient's health status based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device is a therapeutic device used for a physical intervention.
N/A
Intended Use / Indications for Use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Product codes (comma separated list FDA assigned to the subject device)
LIT, DQY
Device Description
The Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
femoral, popliteal and infra-popliteal 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)
Bench Testing: The Sleek OTW bench testing validations consisted of the same and additional tests as the previous Bartam validation. All validation work for the Sleek OTW originally around the distal tip change as this was the only difference between the two products, however after a customer request this validation was extended to cover a wider range of tests. The Sleek OTW product is identical to the currently CE marked and FDA approved Bantam a product (K093139) except for the inclusion of a bridge tubing in the distal tip, the distal tip configuration has proven its safety and effectiveness and as such Sleek OTW and Bantam x are deemed to be substantially equivalent despite this addition of the bridge material. As everything up to the tip of the same for the Bantam x and the Sleek OTW, further testing would not have provided any further information.
Table 1 details testing performed for the Bantam validation, which was also referenced as part of the Bantam a project, and the corresponding testing done for the Sleek OTW. This includes:
- Visual and Functional Testing (Bantam a): PASS - VP494 [29 of 1.5x20x150], [29 of 5.0x120x150]; Also completed on VP421 - Pass (13 of 2.0x220), (13 of 2.5x220), (13 of 5.0x220), (42 of 6.0x220). (Sleek OTW): N/A (performed on line).
- Catheter Body Diameters (Bantam a): PASS - VP494 [29 of 1.5x20x150], [29 of 5.0x120x150]; Also completed on VP421 - Pass (13 of 2.0x220), (13 of 2.5x220), (13 of 5.0x220), (29 of 6.0x220). (Sleek OTW): N/A (dimensions are the same up to the distal tip).
- Inflation/Deflation Time (Bantam a): PASS - VP494 [29 of 5x120mmx150cm]; Also completed on VP421 - Pass (13 of 2.5x220), (13 of 5.0x220), (29 of 6.0x220). (Sleek OTW): PASS - VP577 [29 of 5x120mmx150cm].
- Introducer Sheath Withdrawal (Bantam a): PASS [29 of 5x120mmx150cm]; VP421 - Pass (13 of 5.0x220), (29 of 6.0x220). (Sleek OTW): PASS [29 of 5x120mmx150cm].
- Leak and Rated Burst Pressure (Bantam a): PASS [29 of 1.5x20mmx150cm], [29 of 5x120mmx150cm]; VP421 - Pass (13 of 2.5x220), (13 of 5.0x220), (29 of 6.0x220). (Sleek OTW): *PASS with deviation [29 of 1.25x15mmx150cm], [29 of 5x120mmx150cm].
- Tensile Test for Proximal Bond (Bantam a): VP/VR 338 - Pass (29 of 2x20 Pass), (29 of 2x120 Pass), (13 of 5x120 Pass), (29+13 of 9x60 Pass). (Sleek OTW): PASS [29 of 5x120mmx150cm].
- Tensile Test for Hub Bond (Bantam a): VP222 - Pass (29 of 2x60), (29 of 3x60), (29 of 5x60), (29 of 6x60), (29 of 8x60), (29 of 9x60). (Sleek OTW): PASS [29 of 5x120mmx150cm].
- Measurement of the Working Surface, OD and TL of the Balloon (Bantam a): VP 421 - Pass (13 2.0x220). (Sleek OTW): PASS [13 of 1.25x15mmx150cm], [13 of 5x120mmx150cm].
- Balloon Compliance Test (Bantam a): VP 421 - Pass (13 2.0x220), (13 6.0x220). (Sleek OTW): PASS [13 of 1.25x15mmx150cm], [16 of 5x120mmx150cm].
- Average Burst Pressure Testing (Bantam a): VP 421 - Pass (13 2.0x220), (13 6.0x220). (Sleek OTW): PASS [13 of 1.25x15mmx150cm], [13 of 5x120mmx150cm].
Conclusion: All products had acceptable balloon fatigue performance, noted deviation accepted.
Table 2 details additional tests carried out for Sleek OTW:
- Profile Measurements of Distal Tip: PASS – VP577 [29 of 1.25x15x150], [29 of 5.0x120x150].
- Tensile Test of the Distal Tip: PASS [29 of 1.25x15mmx150cm], [29 of 5x120mmx150cm].
The only extra testing deemed necessary for Sleek OTW was testing relating to the distal tip due to the bridge tubing addition. All testing of the distal tip passed specification. All testing was done in compliance with ISO 10555-1 and ISO 10555-4 requirements. Due to the minor nature of the change and the fact that all subsequent testing on the Sleek passed requirements the products are deemed substantially equivalent.
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.
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).
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Special 510(k) Submission - ClearStream Technologies Ltd
510(k) Summary
Technologies Ltd
K102035
DEC
1 2010
Applicant Information
Date Prepared: September 8th 2010 Submitter: ClearStream Technologies Ltd
Address: Moyne Upper, Enniscorthy, Co.Wexford, Ireland.
Establishment Registration No: 9616666
Contact Person: Fiona Ní Mhulláin, RA Manager
Telephone Number: +353 (0) 53 9237111 Fax Number: + 353 (0) 53 9237100
Device Information
Trade Name: Sleek OTW PTA Catheter Common Name: OTW PTA Catheter Classification Name: Percutaneous Catheter Classification: Class II, 21 CFR 870.1250 Product Code: LIT
Predicate Device:
ClearStream Technologies Ltd, proposes its Bantam a PTA Catheter cleared through the following 510(k) number submission: K093139, as the predicate device for this submission.
Device Description:
The Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal
1
tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.
Raw Materials
| Materials | Usage |
|---|---|
| Pebax | Bridge tubing |
| Co-extruded Nylon/Pebax | Shaft Inner Material |
| Blue colorant | Colorant for Inner tube |
| Nylon/ Pebax blend | Balloon tubing |
| Platinum / Iridium band | Marker band |
| Nylon / Pebax Blend | Shaft Outer Material: |
| 1.25mm & 1.5mmx15mm | |
| Nylon blend | 1.5mmx20mm - 5.0mmx120mm |
| Loctite | Hub bond.glue |
| Pebax | Strain Relief |
| Polycarbonate | Y- Connector |
| Polycarbonate | Luer hub |
| Nylon/Pebax Blend | Reinforcement Material |
| Teflon | Balloon Sleeve |
| Stainless steel | Flexible Shipping mandrel |
| Domino Amjet Ink | Print on hub and strain relief |
| Silicon | SiLX coating |
| HDPE | Hoop |
| Polyester / Polyethylene / Tyvek | Pouch |
2
The Product Specifications of the Sleek OTW PTA Catheter is as follows:
| Balloon | |
|---|---|
| Nominal pressure | 6Atm |
| Rated burst pressure 1.25mm and 1.5mm by 15 mm | 14Atm |
| Rated burst pressure 1.5mm by 20-220mm | 16Atm |
| Rated burst pressure 2.0-4.0mm by 20-40mm | 16Atm |
| Rated burst pressure 5.0mm by 20-60mm | 14Atm |
| Rated burst pressure 2.0 - 4.0mm by 80 - 220mm | 15Atm |
| Rated burst pressure 5.0mm by 80-220mm | 13Atm |
| Average burst pressure 1.25mm by 15 mm | 23Atm |
| Average burst pressure 1.5mm by 15 mm | 21Atm |
| Average burst pressure 1.5mm by 20-220mm | 22Atm |
| Average burst pressure 2.0 - 4.0mm by 20 - 40mm | 22Atm |
| Average burst pressure 5.0mm by 20-40mm | 20Atm |
| Average burst pressure 2.0 - 4.0mm by 80 - 220mm | 21Atm |
| Average burst pressure 5.0mm by 80-220mm | 19Atm |
| Average compliance 1.25mm and 1.50mm | 10% ± 4% |
| Average compliance | 8% ± 4% |
| Deflation time |