(230 days)
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.
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.
The document is a 510(k) premarket notification for the "PTA 14 Balloon Dilatation Catheter OTW". This type of submission is for medical devices, and focuses on demonstrating substantial equivalence to a predicate device, rather than proving clinical efficacy or diagnostic accuracy for an AI/ML product. As such, the information typically requested for AI/ML device evaluations (e.g., sample size for test/training sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance) is not applicable or provided in this document.
The document details performance and safety testing directly related to the physical characteristics and interaction of the catheter with the human body.
Here's the information parsed from the document based on the provided categories, with a clear indication that many categories relevant to AI/ML are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a "Testing Summary" (Section 7) and a "Bench Testing Table" (Table 7.1.1) along with a "Summary of Biocompatibility Testing" (Table 7.2.1). For each test, the acceptance criteria are implied by the "Pass" result and the "Applicable Standard or Internal Test Method" column. The reported device performance is that all tests "Passed" the predetermined acceptance criteria. Specific quantitative acceptance criteria are not detailed in this summary, but are referred to by the internal test methods or referenced standards.
| Test # | Test Name | Applicable Standard or Internal Test Method | Test Results (Reported Device Performance) | Acceptance Criteria (Implied by Pass and Standard) |
|---|---|---|---|---|
| 1 | Dimensional Analysis | Internal Test Method | T=0 Pass, T=2 Pass | Met specified dimensions (details not provided) |
| 2 | Trackability | Internal Test Method | T=0 Pass, T=2 Pass | Met specified trackability requirements (details not provided) |
| 3 | Kink Resistance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified kink resistance requirements (details not provided) |
| 4 | Balloon Performance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified balloon performance requirements (details not provided) |
| 5 | Balloon Fatigue and Leakage | Internal Test Method | T=0 Pass, T=2 Pass | No fatigue or leakage observed within specified limits (details not provided) |
| 6 | Balloon Burst Pressure | Internal Test Method | T=0 Pass, T=2 Pass | Withstood specified burst pressure (details not provided) |
| 7 | Shaft Burst Pressure | Internal Test Method | T=0 Pass, T=2 Pass | Withstood specified shaft burst pressure (details not provided) |
| 8 | Catheter Joint Strength | Internal Test Method | T=0 Pass, T=2 Pass | Met specified joint strength requirements (details not provided) |
| 9 | Hub Durability and Compatibility | ISO 594-1, ISO 594-2 | T=0 Pass, T=2 Pass | Complied with ISO 594-1 and ISO 594-2 standards |
| 10 | Torque Strength | FDA Guidance 1608 | T=0 Pass, RT=5 Pass | Met specified torque strength requirements (details not provided) |
| 11 | Coating Durability | Internal Test Method | T=0 Pass, T=2 Pass | Met specified coating durability requirements (details not provided) |
| 12 | Coating Integrity | Internal Test Method | T=0 Pass, T=2 Pass | Met specified coating integrity requirements (details not provided) |
| 13 | Radiopacity | Internal Test Method | T=0 Pass, T=2 Pass | Met specified radiopacity requirements (details not provided) |
| 14 | Corrosion Resistance | Internal Test Method | T=0 Pass, T=2 Pass | Met specified corrosion resistance requirements (details not provided) |
| 15 | Packaging Integrity | ASTM F88-09, ASTM F1929-98, ASTM D4169-05 | T=0 Pass, T=2 Pass | Complied with ASTM F88-09, ASTM F1929-98, and ASTM D4169-05 standards |
| 16 | Sterilization Validation | ISO 11135-1 | T=0 Pass, T=2 Pass | Complied with ISO 11135-1 standard (Sterility Assurance Level (SAL) of 10^-6) |
Biocompatibility Tests (All Met Predetermined Acceptance Criteria)
| Test Name | Test Description | Acceptance Criteria (Implied by Pass and Standard) |
|---|---|---|
| Cytotoxicity - Test | Cytotoxicity – MEM Elution Test (ISO 10993-5:1999) | No evidence of cytotoxicity (as per ISO standard) |
| Cytotoxicity - Test | Cytotoxicity – MTT Quantitative Evaluation (ISO 10993-5:2009) | No evidence of cytotoxicity (as per ISO standard) |
| Sensitization - Test | Murine Local Lymph Node Assay (LLNA) (ASTM F2148) | No evidence of sensitization (as per ASTM standard) |
| Irritation - Test | Intracutaneous Study (ISO 10993-10:2002) | No evidence of irritation (as per ISO standard) |
| Systemic Toxicity - Test | Acute Systemic Toxicity Test (ISO 10993-11:2006) | No evidence of systemic toxicity (as per ISO standard) |
| Hemocompatibility Test | Hemolysis (ASTM F756-00 and ISO 10993-4:2002) | No significant hemolysis (as per ASTM and ISO standards) |
| Hemocompatibility – Test | Partial Thromboplastin Time (ASTM F 2382 and ISO 10993-4:2002) | No significant effect on coagulation (as per ASTM and ISO standards) |
| Complement Activation - Test | Complement Activation C3a and SC5b-9 (ISO 10993-4:2002, 2006) | No significant complement activation (as per ISO standards) |
| In vivo Thrombogenicity - Test | Four Hour Thromboresistance Evaluation in Dogs (ISO 10993-4:2002, 2006) | No significant thrombogenicity (as per ISO standards) |
| Pyrogenicity - Test | Pyrogen (USP 30 NF 25 and ISO 10993-11:2006) | No pyrogenic response (as per USP and ISO standards) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is Not Applicable as this document describes performance testing for a physical medical device (catheter), not an AI/ML software. The "test set" refers to physical samples of the device itself (both unaged and aged), which were subjected to various bench and biocompatibility tests. No human patient data or imaging data is involved.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is Not Applicable. Ground truth, in the context of AI/ML, refers to expert-labeled data. For a physical device, performance is evaluated against engineering specifications and established standards, not expert consensus on data interpretation.
4. Adjudication method for the test set
This information is Not Applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve discrepancies among expert readers when establishing ground truth for data interpretation. This is not relevant for the bench and biocompatibility testing of a physical medical device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is Not Applicable. An MRMC study is a type of clinical study used to evaluate the diagnostic accuracy of a reader (human or AI) on multiple cases, often comparing different reading paradigms (e.g., with or without AI assistance). This document is for a physical medical device and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is Not Applicable. This concept applies to AI/ML algorithms where performance is evaluated without human intervention. The device in question is a physical catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is Not Applicable in the AI/ML sense. For this device, the "ground truth" aligns with the acceptance criteria derived from engineering specifications and recognized international standards (e.g., ISO, ASTM, FDA Guidance). Device performance is measured directly against these defined physical, mechanical, and biological benchmarks.
8. The sample size for the training set
This information is Not Applicable. "Training set" refers to data used to train an AI/ML model. This device is a physical product and does not involve AI/ML.
9. How the ground truth for the training set was established
This information is Not Applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.
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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
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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
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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)
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1 - Company Information & Contact Person
| Company Name: | Texas Medical Technologies, Inc. |
|---|---|
| Company Address: | 9005 Montana Ave., Suite AEl 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 Predicate510(k) Number: | K042624 |
| Secondary Predicate510k 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
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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.
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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 orInternal Test Method | Test Results |
|---|---|---|---|
| 1 | Dimensional Analysis | Internal Test Method | T=0 PassT=2 Pass |
| 2 | Trackability | Internal Test Method | T=0 PassT=2 Pass |
| 3 | Kink Resistance | Internal Test Method | T=0 PassT=2 Pass |
| 4 | Balloon Performance | Internal Test Method | T=0 PassT=2 Pass |
| 5 | Balloon Fatigue and Leakage | Internal Test Method | T=0 PassT=2 Pass |
| 6 | Balloon Burst Pressure | Internal Test Method | T=0 PassT=2 Pass |
| 7 | Shaft Burst Pressure | Internal Test Method | T=0 PassT=2 Pass |
| 8 | Catheter Joint Strength | Internal Test Method | T=0 PassT=2 Pass |
| 9 | Hub Durability and Compatibility | ISO 594-1, ISO 594-2 | T=0 PassT=2 Pass |
Table 7.1.1. Bench Testing Performed on the PTA 14 Balloon Dilatation Catheter OTW.
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| and Internal Test Method | T=2 Pass | ||
|---|---|---|---|
| 10 | Torque Strength | FDA Guidance 1608 | T=0 PassRT=5 Pass |
| 11 | Coating Durability | Internal Test Method | T=0 PassT=2 Pass |
| 12 | Coating Integrity | Internal Test Method | T=0 PassT=2 Pass |
| 13 | Radiopacity | Internal Test Method | T=0 PassT=2 Pass |
| 14 | Corrosion Resistance | Internal Test Method | T=0 PassT=2 Pass |
| 15 | Packaging Integrity | ASTM F88-09, ASTMF1929-98, ASTM D4169-05 | T=0 PassT=2 Pass |
| 16 | Sterilization Validation | ISO 11135-1 | T=0 PassT=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 |
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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.
§ 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).