(230 days)
Not Found
No
The description details a mechanical balloon catheter and its physical characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to dilate stenoses in various arteries and treat obstructive or synthetic arteriovenous dialysis fistulae, which are medical conditions, making it a therapeutic device.
No
The device, a PTA Balloon Dilatation Catheter, is intended to dilate stenoses and treat fistulae, which are therapeutic interventions, not diagnostic procedures.
No
The device description clearly details a physical catheter with a balloon, lumens, and ports, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this is a balloon dilatation catheter used for a procedure called percutaneous transluminal angioplasty (PTA). This is an in vivo procedure, meaning it is performed inside the body to physically dilate narrowed blood vessels.
- Lack of Mention of Samples or Testing: The document does not mention any analysis of biological samples or any form of diagnostic testing performed outside the body.
Therefore, the PTA 14 Balloon Dilatation Catheter OTW is a therapeutic medical device used for a procedure performed within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Product codes (comma separated list FDA assigned to the subject device)
LIT
Device Description
The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen.
The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath.
The device is supplied sterile and is intended for single use.
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; 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests were performed to evaluate the design elements and performance characteristics of the PTA 14 Balloon Dilatation Catheter OTW and to demonstrate substantial equivalence to the predicate devices. The PTA 14 Balloon Dilatation Catheter OTW met the predetermined acceptance criteria. Testing was performed on unaged and aged devices. Tests results show that the PTA 14 Balloon Dilatation Catheter OTW is substantially equivalent to the predicate devices.
The following bench tests were performed:
- Dimensional Analysis
- Trackability
- Kink Resistance
- Balloon Performance
- Balloon Fatigue and Leakage
- Balloon Burst Pressure
- Shaft Burst Pressure
- Catheter Joint Strength
- Hub Durability and Compatibility
- Torque Strength
- Coating Durability
- Coating Integrity
- Radiopacity
- Corrosion Resistance
- Packaging Integrity
- Sterilization Validation
Biocompatibility testing was performed in accordance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" (2009). All testing met the predetermined acceptance criteria.
The following biocompatibility tests were performed:
- Cytotoxicity - Test (Cytotoxicity – MEM Elution Test (ISO 10993-5:1999))
- Cytotoxicity - Test (Cytotoxicity – MTT Quantitative Evaluation (ISO 10993-5:2009))
- Sensitization - Test (Murine Local Lymph Node Assay (LLNA) (ASTM F2148))
- Irritation - Test (Intracutaneous Study (ISO 10993-10:2002))
- Systemic Toxicity - Test (Acute Systemic Toxicity Test (ISO 10993-11:2006))
- Hemocompatibility Test (Hemolysis (ASTM F756-00 and ISO 10993-4:2002))
- Hemocompatibility – Test (Partial Thromboplastin Time (ASTM F 2382 and ISO 10993-4:2002))
- Complement Activation - Test (Complement Activation C3a and SC5b-9 (ISO 10993-4:2002, 2006))
- In vivo Thrombogenicity - Test (Four Hour Thromboresistance Evaluation in Dogs (ISO 10993-4:2002, 2006))
- Pyrogenicity - Test (Pyrogen (USP 30 NF 25 and ISO 10993-11:2006))
Sterilization validation for Ethylene Oxide Gas resulted in a Pass for a Sterility Assurance Level (SAL) of 10^-6.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
Texas Medical Technologies, Inc. % Ms. Viviana Gonzalez Consultant Pomamed Consulting LLC PO Box 9818 San Juan, PR 00908-0818
Re: K142954
Trade/Device Name: PTA 14 Balloon Dilatation Catheter OTW Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: Mav 8. 2015 Received: May 8, 2015
Dear Ms. Gonzalez:
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. 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 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142954
Device Name
PTA 14 Balloon Dilatation Catheter OTW
Indications for Use (Describe)
The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive or synthetic arteriovenous dialysis fistulae.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
1 - Company Information & Contact Person
| Company Name: | Texas Medical Technologies, Inc. |
|---|---|
| Company Address: | 9005 Montana Ave., Suite A |
| El Paso, TX 79925 | |
| Telephone: | (915) 774-4321 |
| Fax: | (915) 774-4323 |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 4/28/2015 |
2 - Device Name & Classification
| Proprietary Name: | PTA 14 Balloon Dilatation Catheter OTW |
|---|---|
| Common Name: | Percutaneous Transluminal Angioplasty Catheter |
| Classification Name: | Percutaneous Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT |
| Device Class: | II |
3 - Predicate Devices
Legally Marketed Substantially Equivalent Predicate Devices
| Proprietary Name: | Amphirion Deep 0.014” OTW PTA Balloon Catheter |
|---|---|
| Company Name: | Invatec Innovative Technologies, s.r.l. |
| Common Name: | Catheter |
| Classification Name: | Diagnostic Intravascular Catheter |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | LIT |
| Device Class: | II |
| Primary Predicate | |
| 510(k) Number: | K042624 |
| Secondary Predicate | |
| 510k Number: | K050073, K052791 |
4 – Device Description
The PTA 14 Balloon Dilatation Catheter OTW is a 0.014" Over-The-Wire (OTW) PTA Balloon Dilatation Catheter with a semi-compliant inflatable balloon mounted on the distal end of the catheter. It is designed for carrying out percutaneous transluminal angioplasty (PTA) in the peripheral vessels. The balloon catheter has a coaxial shaft design. The outer lumen is used for balloon inflation and the inner lumen (guide wire
4
lumen) permits the use of a guide wire with a maximum outer diameter of 0.014 inch. The proximal segment of the catheter includes one female luer-lock port connected to the inflation lumen, and one female luer-lock for the guide wire lumen.
The PTA 14 Balloon Dilatation Catheter is compatible with a 4 Fr. introducer sheath.
The device is supplied sterile and is intended for single use.
The following table lists the models and sizes available for the PTA 14 Balloon Dilatation Catheter.
| Model Numbers | Usable Length (cm) | Balloon Diameter (mm) | Balloon Length (mm) |
|---|---|---|---|
| PDC14-120-2004 | 120 | 2 | 40 |
| PDC14-120-2008 | 120 | 2 | 80 |
| PDC14-120-2012 | 120 | 2 | 120 |
| PDC14-120-2015 | 120 | 2 | 150 |
| PDC14-120-2504 | 120 | 2.5 | 40 |
| PDC14-120-2508 | 120 | 2.5 | 80 |
| PDC14-120-2512 | 120 | 2.5 | 120 |
| PDC14-120-2515 | 120 | 2.5 | 150 |
| PDC14-120-3004 | 120 | 3.0 | 40 |
| PDC14-120-3008 | 120 | 3.0 | 80 |
| PDC14-120-3012 | 120 | 3.0 | 120 |
| PDC14-120-3015 | 120 | 3.0 | 150 |
| PDC14-120-3504 | 120 | 3.5 | 40 |
| PDC14-120-3508 | 120 | 3.5 | 80 |
| PDC14-120-3512 | 120 | 3.5 | 120 |
| PDC14-120-3515 | 120 | 3.5 | 150 |
| PDC14-120-4004 | 120 | 4.0 | 40 |
| PDC14-120-4008 | 120 | 4.0 | 80 |
| PDC14-120-4012 | 120 | 4.0 | 120 |
| PDC14-120-4015 | 120 | 4.0 | 150 |
| PDC14-150-2004 | 150 | 2 | 40 |
| PDC14-150-2008 | 150 | 2 | 80 |
| PDC14-150-2012 | 150 | 2 | 120 |
| PDC14-150-2015 | 150 | 2 | 150 |
| PDC14-150-2504 | 150 | 2.5 | 40 |
| PDC14-150-2508 | 150 | 2.5 | 80 |
| PDC14-150-2512 | 150 | 2.5 | 120 |
| PDC14-150-2515 | 150 | 2.5 | 150 |
| PDC14-150-3004 | 150 | 3.0 | 40 |
| PDC14-150-3008 | 150 | 3.0 | 80 |
| PDC14-150-3012 | 150 | 3.0 | 120 |
| PDC14-150-3015 | 150 | 3.0 | 150 |
| PDC14-150-3504 | 150 | 3.5 | 40 |
| PDC14-150-3508 | 150 | 3.5 | 80 |
| PDC14-150-3512 | 150 | 3.5 | 120 |
| PDC14-150-3515 | 150 | 3.5 | 150 |
| PDC14-150-4004 | 150 | 4.0 | 40 |
| PDC14-150-4008 | 150 | 4.0 | 80 |
| PDC14-150-4012 | 150 | 4.0 | 120 |
| PDC14-150-4015 | 150 | 4.0 | 150 |
Table 4.1. PTA 14 Balloon Dilatation Catheter Models and Sizes.
5
5 - Indications for Use
The PTA 14 Balloon Dilatation Catheter OTW is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
6 – Summary of Technological Characteristics Comparison
The PTA 14 Balloon Dilatation Catheter OTW is similar to the predicate device with respect to intended use and fundamental design characteristics such as principle of operation, components, materials, and dimensions. Furthermore, the PTA14 Balloon Dilatation Catheter OTW performs similarly to the predicate device and passed the predetermined acceptance criteria for mechanical and biocompatibility testing. Therefore, the PTA 14 Balloon Dilatation Catheter OTW is substantially equivalent to the predicate device.
7 - Testing Summary
The following bench tests were performed to evaluate the design elements and performance characteristics of the PTA 14 Balloon Dilatation Catheter OTW and to demonstrate substantial equivalence to the predicate devices. The PTA 14 Balloon Dilatation Catheter OTW met the predetermined acceptance criteria. Testing was performed on unaged and aged devices. Tests results show that the PTA 14 Balloon Dilatation Catheter OTW is substantially equivalent to the predicate devices.
7.1- Bench Testing Table
Table 7.1.1 below provides a summary of the bench testing performed on the PTA 14 Balloon Dilatation Catheter OTW.
| Test # | Test Name | Applicable Standard or
Internal Test Method | Test Results |
|--------|----------------------------------|------------------------------------------------|----------------------|
| 1 | Dimensional Analysis | Internal Test Method | T=0 Pass
T=2 Pass |
| 2 | Trackability | Internal Test Method | T=0 Pass
T=2 Pass |
| 3 | Kink Resistance | Internal Test Method | T=0 Pass
T=2 Pass |
| 4 | Balloon Performance | Internal Test Method | T=0 Pass
T=2 Pass |
| 5 | Balloon Fatigue and Leakage | Internal Test Method | T=0 Pass
T=2 Pass |
| 6 | Balloon Burst Pressure | Internal Test Method | T=0 Pass
T=2 Pass |
| 7 | Shaft Burst Pressure | Internal Test Method | T=0 Pass
T=2 Pass |
| 8 | Catheter Joint Strength | Internal Test Method | T=0 Pass
T=2 Pass |
| 9 | Hub Durability and Compatibility | ISO 594-1, ISO 594-2 | T=0 Pass
T=2 Pass |
Table 7.1.1. Bench Testing Performed on the PTA 14 Balloon Dilatation Catheter OTW.
6
| and Internal Test Method | T=2 Pass | ||
|---|---|---|---|
| 10 | Torque Strength | FDA Guidance 1608 | T=0 Pass |
| RT=5 Pass | |||
| 11 | Coating Durability | Internal Test Method | T=0 Pass |
| T=2 Pass | |||
| 12 | Coating Integrity | Internal Test Method | T=0 Pass |
| T=2 Pass | |||
| 13 | Radiopacity | Internal Test Method | T=0 Pass |
| T=2 Pass | |||
| 14 | Corrosion Resistance | Internal Test Method | T=0 Pass |
| T=2 Pass | |||
| 15 | Packaging Integrity | ASTM F88-09, ASTM | |
| F1929-98, ASTM D | |||
| 4169-05 | T=0 Pass | ||
| T=2 Pass | |||
| 16 | Sterilization Validation | ISO 11135-1 | T=0 Pass |
| T=2 Pass |
7.2 – Biocompatibility
The PTA 14 Balloon Dilatation Catheter OTW is classified as an Externally Communicating Device, Circulating Blood, Limited Contact (≤24 hours). Biocompatibility testing was performed in accordance with ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" (2009). Table 7.2.1 below describes the testing performed to determine biocompatibility. All testing met the predetermined acceptance criteria.
Table 7.2.1. Summary of Biocompatibility Testing for the PTA 14 Balloon Dilatation Catheter OTW.
| Test Name | Test Description |
|---|---|
| Cytotoxicity - Test | Cytotoxicity – MEM Elution Test (ISO 10993-5:1999) |
| Cytotoxicity - Test | Cytotoxicity – MTT Quantitative Evaluation (ISO 10993-5:2009) |
| Sensitization - Test | Murine Local Lymph Node Assay (LLNA) (ASTM F2148) |
| Irritation - Test | Intracutaneous Study (ISO 10993-10:2002) |
| Systemic Toxicity - Test | Acute Systemic Toxicity Test (ISO 10993-11:2006) |
| Hemocompatibility Test | Hemolysis (ASTM F756-00 and ISO 10993-4:2002) |
| Hemocompatibility – Test | Partial Thromboplastin Time (ASTM F 2382 and ISO 10993-4:2002) |
| Complement Activation - Test | Complement Activation C3a and SC5b-9 (ISO 10993-4:2002, 2006) |
| In vivo Thrombogenicity - Test | Four Hour Thromboresistance Evaluation in Dogs (ISO 10993-4:2002, 2006) |
| Pyrogenicity - Test | Pyrogen (USP 30 NF 25 and ISO 10993-11:2006) |
8 - Sterilization Testing Summary
| Validation Sterilization Process | Sterility Assurance Level (SAL) | Validation Result |
|---|---|---|
| Ethylene Oxide Gas | $10^{-6}$ | Pass |
7
9 – Conclusion
The PTA 14 Balloon Dilatation Catheter OTW is substantially equivalent in intended use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging to the predicate devices. Differences between the devices do not raise any new issues of safety or effectiveness.