(226 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a balloon catheter, with no mention of AI or ML capabilities.
Yes
The device is used for percutaneous transluminal angioplasty (PTA) to treat obstructive lesions in the vascular system, which is a therapeutic intervention.
No
The device description clearly states its purpose is for "percutaneous transluminal angioplasty (PTA)," which is a therapeutic procedure involving the dilation of blood vessels, not for diagnosing conditions.
No
The device description clearly outlines multiple physical components (tip tube, inner tube, balloon, marker bands, outer tube, stress release tube, hub) and describes their physical properties and functions. This is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for a medical procedure (angioplasty) performed within the body to treat vascular issues. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health.
- Device Description: The description details a physical catheter with a balloon designed to be inserted into blood vessels. This is consistent with an interventional medical device, not a diagnostic test performed on a sample.
- Anatomical Site: The specified anatomical sites are internal blood vessels. IVDs typically interact with biological samples.
- Performance Studies: The performance studies described are bench tests evaluating the physical properties and functionality of the catheter, such as balloon inflation, burst pressure, and flexibility. These are relevant to the safety and efficacy of a medical device used in a procedure, not the analytical performance of a diagnostic test.
In summary, the device is a therapeutic medical device used for a procedure within the body, not a diagnostic device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Product codes
LIT
Device Description
The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube, inner tube, balloon, marker bands, outer tube, stress release tube and hub. Among them the balloon is the most important part of the catheter. In order to dilate different stenosis, the balloon should be dilated to difference dimension by inflating different pressure. The soft tip at the end of the balloon is to make the balloon catheter more easily to push to the stenosis position. The inner tubing which connects to the tip tubing is for guide wire passage and the pushing road. The two marker bands which wrapping on the inner tubing are for positioning the balloon location by cooperating in vitro monitoring equipment. The distal of the outer tube is connected with the balloon by a variable-diameter stretching structure, which can make the balloon get smaller winding diameter. The proximal of the outer tube is connected with the hub as the inflation passage and the pushing shaft. The hub is for connecting the outer pressure filling equipment. The stress release tubing is for protecting the outer tube from bending. The outer surface of the catheter is coated with a hydrophilic coating that ranges 400mm in length from the tip tube to the proximal end of the balloon, including part of the outer tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
iliac, femoral, popliteal, infra-popliteal and renal arteries, and arteriovenous dialysis fistulae
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
Bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:
- Visual inspection
- Dimensional verification
- Hydration test
- Leakage test
- Balloon inflation and deflation time
- Balloon fatigue
- Radiopacity
- Simulated use test/guidewire and introducer sheath compatibility test
- Tip pull strength
- Catheter bond strength
- Torque strength
- Balloon rated burst pressure
- Balloon compliance
- Catheter body burst pressure
- Flexibility and kinking
- Coating integrity
- Particulate evaluation
- Infusion flow rate
- Corrosion resistance test
- Packaging performance Test (Visual inspection, Sealing strength, Sealing integrity, Sterility)
- Shelf life testing
The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020).
Biocompatibility testing was performed in accordance with 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk mangement process'; draft 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions'. Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance), materialmediated pyrogenicity were conducted. The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 14, 2022
Kossel Medtech (Suzhou) Co., Ltd. Ron Lv Regulatory Affair Engineer BLDG 6, No. 8, Jinfeng Road Suzhou, Jiangsu Province 215163 China
Re: K221245
Trade/Device Name: PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: November 1, 2022 Received: November 7, 2022
Dear Ron Lv:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by
Gregory W. Gregory W. O'connell -
S
O'connell -S Date: 2022.12.14
13:02:23 -05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221245
Device Name PTA Balloon Dilatation Catheter
Indications for Use (Describe)
The PTA balloon dilatation catheter is indicated for the percutaneous transluminal angioplasty (PTA) of the peripheral vascular system, including the iliac, femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) SUMMARY
| Submitter: | Kossel Medtech (Suzhou) Co., Ltd.
BLDG 6, No. 8 Jinfeng Road
Suzhou New District, Jiangsu Province, China |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ron Lv
F3, BLDG 6, No. 8 Jinfeng Road
Suzhou New District,
Jiangsu Province, China
Phone: +86 150 5142 9102
Mail:lvxin@kosselmed.com |
| Date Prepared: | November 22, 2022 |
| Trade Name: | PTA Balloon Dilatation Catheter |
| Common Name: | Percutaneous Transluminal Angioplasty (PTA) Catheter |
| | Classification Name: Catheter, Angioplasty, Peripheral, Transluminal (21 CFR 870.1250), Class II
(special controls) |
| Product Code: | LIT |
| Predicate Device: | Predicate Device:
SABER .018 Percutaneous Transluminal Angioplasty (PTA) Dilatation
Catheter (K133843, cleared May 19, 2014) |
| Device Description: | The 0.0180" PTA balloon dilatation catheter is mainly composed of tip tube,
inner tube, balloon, marker bands, outer tube, stress release tube and hub.
Among them the balloon is the most important part of the catheter. In order to
dilate different stenosis, the balloon should be dilated to difference dimension
by inflating different pressure. The soft tip at the end of the balloon is to make
the balloon catheter more easily to push to the stenosis position. The inner
tubing which connects to the tip tubing is for guide wire passage and the
pushing road. The two marker bands which wrapping on the inner tubing are
for positioning the balloon location by cooperating in vitro monitoring
equipment. The distal of the outer tube is connected with the balloon by a
variable-diameter stretching structure, which can make the balloon get smaller
winding diameter. The proximal of the outer tube is connected with the hub as
the inflation passage and the pushing shaft. The hub is for connecting the outer
pressure filling equipment. The stress release tubing is for protecting the outer
tube from bending.
The outer surface of the catheter is coated with a hydrophilic coating that ranges
400mm in length from the tip tube to the proximal end of the balloon, including
part of the outer tube. |
4
Image /page/4/Figure/1 description: The image shows a diagram of a medical device, specifically a balloon catheter. The different parts of the catheter are labeled, including the tip tube, balloon tube, outer tube, hub, stylet, marker band, stress release, and inner tube. The catheter has a long, thin shape with a balloon at the end, and the hub is located at the opposite end.
Intended Use/ The PTA balloon dilatation catheter is indicated for the percutaneous Indications transluminal angioplasty (PTA) of the peripheral vascular system, including the for Use: iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
- Comparisons of the new and predicate devices show that the technological Technological Characteristics: characteristics such as product performance, design, and intended use are substantially equivalent to the currently marketed predicate devices.
The following table lists the material and size comparisons between the subject device and the predicate device.
| Technological
Characteristics | PTA Balloon Dilatation Catheter | Predicate Device
SABER® PTA Dilatation Catheter
K133843 | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Balloon material | Nylon12 | Nylon12 | Identical |
| Coating | Hydrophilic | Hydrophilic | Identical |
| Balloon Diameters
(mm) | 2.07.0 | 2.010.0 | Equivalent |
| Balloon lengths
(mm) | 20300 | 20300 | Identical |
| Balloon compliance | Semi-Compliant | Semi-Compliant | Identical |
| Catheter Type | OTW | OTW | Identical |
| Guide wire size (inch) | 0.018" | 0.018" | Identical |
| Sheath Compatibility | 6F | 6F | Identical |
| Proximal shaft diameter | 4.0F(1.32mm)/4.7F(1.55mm) | 3.9F/4.7F | Equivalent |
| Distal shaft diameter | 4.0F(1.32mm)/4.7F(1.55mm) | 3.9F/4.7F | Equivalent |
| Catheter length
(cm) | 90/150 | 90/150 | Identical |
| Rated burst Pressure
(atm) | 16atm (ø2.0-2.5×20-120mm);
14atm (ø2.0-2.5×150-300mm,
ø5.0-6.0×20-120mm);
12atm (ø5.0-6.0×150-300mm, ø7.0×20-120mm);
10atm (ø7.0×150-300mm) | 18atm (ø2.0-2.5mm, ø3.0-4.0×20-100mm);
16atm(ø5.0-6.0×20-100mm);
14atm (ø7.0mm, ø3.0-6.0×150-300mm);
12atm (ø8.0mm);
10atm (ø9.0-10.0mm) | Equivalent |
The following table lists the material and device and the predicate device.
5
| Technological
| Characteristics | PTA Balloon Dilatation Catheter | Predicate Device | Comparison | |
|---|---|---|---|---|
| SABER® PTA Dilatation Catheter | ||||
| K133843 | ||||
| Nominal pressure | ||||
| (atm) | 6 | 6/8 | Equivalent | |
| Sterilization Method | EO | EO | Identical |
The PTA Balloon Dilatation Catheter and predicate device have following same technological elements:
- Operating principle balloon dilatation of stenotic portion by pressurization of inflation ● medium
- Fundamental catheter design balloon, shaft, radiopaque marker, hub, coating
- Balloon Length
- Balloon compliance - Semi-Compliant
- Catheter type - OTW
- Guide wire size
- Sheath Compatibility
- Catheter effective length
- Sterilization Ethylene oxide
There are following minor technological differences between PTA Balloon Dilatation Catheter and predicate device:
- Combination of balloon diameter
- Proximal/Distal shaft diameters
- Pressure - Nominal Pressure and Rated Burst Pressure
Any differences that exist between the PTA Balloon Dilatation Catheter and the predicate device did not raise any new questions of safety or effectiveness.
6
Performance Data: Bench testing was performed on the subject device to determine substantial equivalence. The testing performed is as follows:
- Visual inspection
- Dimensional verification
- Hydration test
- Leakage test
- Balloon inflation and deflation time
- . Balloon fatigue
- Radiopacity
- Simulated use test/guidewire and introducer sheath compatibility test
- . . . . . Tip pull strength
- Catheter bond strength
- Torque strength
- Balloon rated burst pressure
- Balloon compliance
- Catheter body burst pressure
- . . . . Flexibility and kinking
- Coating integrity
- Particulate evaluation
- Infusion flow rate
- Corrosion resistance test
- Packaging performance Test (Visual inspection, Sealing strength,
- Sealing integrity, Sterility)
- Shelf life testing ●
The results met all acceptance criteria and ensure that the Balloon Dilatation Catheter design and construction are suitable for its intended use as recommended by the draft Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions (FDA; January 13, 2020).
- Biocompatibility To demonstrate the biological safety of the body-contacting materials, the following biocompatibility testing, which was performed in accordance with 'Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk mangement process'; draft 'Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions' were followed. Cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, partial thromboplastin time, complement activation, and in vivo thromboresistance), materialmediated pyrogenicity were conducted. The results of the testing show that the subject device included in this submission met all acceptance criteria and the subject device is biocompatible.
- Conclusion: This information supports a determination of substantial equivalence between the PTA Balloon Dilatation Catheter and the predicate device described above.