(258 days)
The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm. The device is supplied sterile and is intended for single use.
The document provided describes a medical device, the TXM Guiding Sheath, and its testing for substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, and therefore does not include details such as a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set specifics.
Here is an analysis of the acceptance criteria and study that was conducted:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a non-AI/ML medical device (catheter introducer), and its acceptance criteria are based on meeting performance standards for physical attributes, safety, and biocompatibility, rather than diagnostic accuracy metrics like sensitivity or specificity.
| Test Name | Applicable Standard or Internal Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Dimensional & Physical Attributes | ISO 10555 | Meet specified dimensions and physical characteristics | T=0;T=2 Pass (Met) |
| Lubricity of Hydrophilic Coating | Internal Test Method | Maintain sufficient lubricity for improved trackability | T=0;T=2 Pass (Met) |
| Dilator Guidewire and Sheath Catheter Compatibility | Internal Test Method | Compatible with specified guidewire and dilator | T=0;T=2 Pass (Met) |
| Liquid Leak | ISO 10555 | No liquid leakage from the device | T=0;T=2 Pass (Met) |
| Air Leak | ISO 10555 | No air leakage from the device | T=0;T=2 Pass (Met) |
| Seal Strength (Pouch) | ASTM F88/F88M-09 | Maintain sterile barrier integrity | T=0;T=2 Pass (Met) |
| Dye Penetration Test | ASTM-F1929-12 | No dye penetration into the sterile barrier | T=0;T=2 Pass (Met) |
| Radiopacity | ASTM-F640-12 | Sufficient visibility under fluoroscopy | T=0;T=2 Pass (Met) |
| In-Vitro Track Force | Internal Test Method | Acceptable track force through simulated vasculature | T=0;T=2 Pass (Met) |
| Kink Resistance | Internal Test Method | Resistance to kinking during use | T=0;T=2 Pass (Met) |
| Durability of Hydrophilic Coating | Internal Test Method | Maintain coating integrity and performance over time | T=0;T=2 Pass (Met) |
| Tensile Strength | ISO 10555 | Withstand specified tensile forces without breakage | T=0;T=2 Pass (Met) |
| Coating Integrity | Internal Test Method | Maintain integrity of the coating | T=0;T=2 Pass (Met) |
| Corrosion Resistance | ISO 10555 | Resistance to corrosion | T=0;T=2 Pass (Met) |
| Female Luer Verification | ISO 594 | Conformance to luer connector standards | T=0;T=2 Pass (Met) |
| Accelerated Aging | ASTM F1980-07 | Demonstrate performance equivalence after simulated aging | T=0;T=2 Pass (Met) |
| Biocompatibility Tests | All Met Predetermined Acceptance Criteria | ||
| Irritation (Intracutaneous Injection) | ISO10993-10 | No significant irritation | Pass (Met) |
| Sensitization (Kligman Maximization / Murine Local Lymph Assay) | ISO10993-10 | No significant sensitization | Pass (Met) |
| Systemic Toxicity (ISO Acute Systemic Toxicity) | ISO10993-11 | No significant systemic toxicity | Pass (Met) |
| Cytotoxicity (L929 Neutral Red Uptake) | ISO 10993-5 | No significant cytotoxicity | Pass (Met) |
| Pyrogenicity (Pyrogen Test in Rabbit) | USP <151> / ISO10993-11 | No pyrogenic response | Pass (Met) |
| Hemocompatibility (Hemolysis) | ISO10993-4 | Acceptable levels of hemolysis | Pass (Met) |
| Hemocompatibility (Complement Activation) | ISO10993-4 | No significant complement activation | Pass (Met) |
| Hemocompatibility (In-Vivo Thrombogenicity) | ISO10993-4 | No significant thrombogenicity | Pass (Met) |
| Sterilization Test | |||
| Ethylene Oxide Gas Sterilization | N/A (Internal validation) | Attain a Sterility Assurance Level (SAL) of 10^-6 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing and biocompatibility testing.
- Bench Testing: The sample sizes for each specific bench test are not explicitly stated in the provided text. However, it indicates that testing was performed on "non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2)." This implies a test set composed of new devices and aged devices. The provenance is internal laboratory testing.
- Biocompatibility Testing: The sample sizes (e.g., number of animals for in-vivo tests or replicates for in-vitro tests) are not explicitly stated. The provenance is internal laboratory testing following ISO standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is a medical device, not an AI/ML diagnostic or prognostic tool. The "ground truth" for these performance tests is defined by meeting physical specifications, regulatory standards (ISO, ASTM), and biological safety parameters, which are assessed by technical personnel and validated according to established test methodologies.
4. Adjudication Method for the Test Set
Not applicable. This is a medical device performance and safety evaluation against predefined standards, not a diagnostic assessment requiring expert adjudication of results. Each test outcome (e.g., pass/fail, quantitative measure) is evaluated against its specific acceptance criterion.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study (comparing human readers with and without AI assistance) is relevant for AI/ML-powered diagnostic devices, not for a physical medical device like a guiding sheath.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This concept applies to AI/ML algorithms, not physical medical devices.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is defined by:
- Pre-established engineering specifications (e.g., dimensions, strength).
- Compliance with recognized international standards (e.g., ISO 10555, ASTM F88, ISO 10993 for biocompatibility) and internal test methods that align with these standards.
- Biological responses in validated in-vitro and in-vivo models (for biocompatibility).
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML algorithm involved that would require a training set. The device itself is the product being tested.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2016
Texas Medical Technologies, Inc. % EJ Smith Consultant Smith Associates Crofton, Maryland 21114
Re: K153771
Trade/Device Name: TXM Guiding Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 7, 2016 Received: September 7, 2016
Dear EJ Smith:
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 devicerelated 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.
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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" (21 CFR 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,
Brian D. Pullin -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) K153771
Device Name TXM Guiding Sheath
Indications for Use (Describe)
The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
| 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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5.1 - Company Information & Contact Person
| Company Name: | Texas Medical Technologies Inc. |
|---|---|
| Company Address: | 9005 Montana Ave. Ste. AEl Paso, Texas 79925 |
| Telephone: | (915) 774-4321 |
| Fax: | (915) 774-4323 |
| Contact Person: | Cesar Rios, Quality Assurance & Regulatory Manager |
| Date Prepared: | 09/08/2016 |
5.2 - Device Name & Classification
| Proprietary Name: | TXM Guiding Sheath |
|---|---|
| Common Name: | Catheter introducer |
| Classification Name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Device Class: | II |
5.3 - Predicate Device
Legally Marketed Substantially Equivalent Predicate Device
| Proprietary Name: | Arrow Fischell Kink Resistance Percutaneous SheathIntroducer Set |
|---|---|
| Company Name: | Arrow International Inc. |
| Common Name: | Catheter introducer |
| Classification Name: | Catheter introducer |
| Regulation Number: | 21 CFR 870.1340 |
| Product Code: | DYB |
| Device Class: | II |
| 510(k) Number | K924607 |
5.4 - Device Description
The Guiding Sheath is intended for intravascular use for the introduction of interventional/diagnostic devices to the human vasculature. The Guiding Sheath is designed to work as a vessel introducer and a guiding catheter. It consists of a lubricous inner liner made from Teflon, and a stainless steel coil over the inner liner. The outer shaft consists of colored Polyether block amide. A Radiopaque Marker band is attached to the distal end of the shaft for radiopacity. The Distal end of the shaft is atraumatic. The Proximal end of the catheter is attached to a Hemostatic Valve. The device is available in
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three inner diameter sizes of 4Fr, 5Fr, and 6Fr; consisting of 0.063", 0.076" and 0.087" (throughout the shaft) respectably. A lubricious hydrophilic coating shall be applied to the outer diameter of the Catheter Sheath for improved trackability through the vasculature. The device contains a separate Dilator shaft made of two different materials depending on the size. For the 4Fr, Grilamid is used for the body and the Luer attached to the proximal end as well. For the 5Fr and 6F, high densiy polyethylene (HDPE) is used for the body and the Luer attached to the proximal end as well. The distal end of the Dilator is tapered for ease of access to the vessel. The device is available in lengths of 45cm and 90cm.
The device is supplied sterile and is intended for single use
The following table lists the models and sizes available for TXM Guiding Sheath.
Table 5.4.1. TXM Guiding Sheath Models and Sizes
| CommercialModel Number | Frenchsize | ShaftLength (cm) | InnerDiameter(inches) | Marker BandMaterial | HemostaticValve |
|---|---|---|---|---|---|
| GS-445-CS | 4 | 45 | 0.063 | Platinum-Iridium | Cross Cut |
| GS-445-TS | 4 | 45 | 0.063 | Platinum-Iridium | Tuohy Borst |
| GS-490-CS | 4 | 90 | 0.063 | Platinum-Iridium | Cross Cut |
| GS-490-TS | 4 | 90 | 0.063 | Platinum-Iridium | Tuohy Borst |
| GS-545-CS | 5 | 45 | 0.076 | Platinum-Iridium | Cross Cut |
| GS-545-TS | 5 | 45 | 0.076 | Platinum-Iridium | Tuohy Borst |
| GS-590-CS | 5 | 90 | 0.076 | Platinum-Iridium | Cross Cut |
| GS-590-TS | 5 | 90 | 0.076 | Platinum-Iridium | Tuohy Borst |
| GS-645-CS | 6 | 45 | 0.087 | Platinum-Iridium | Cross Cut |
| GS-645-TS | 6 | 45 | 0.087 | Platinum-Iridium | Tuohy Borst |
| GS-690-CS | 6 | 90 | 0.087 | Platinum-Iridium | Cross Cut |
| GS-690-TS | 6 | 90 | 0.087 | Platinum-Iridium | Tuohy Borst |
5.5 - Indications for Use
The Guiding Sheath Introducer is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various devices into veins and/or arteries in a variety of diagnostic and therapeutic procedures.
- 5.5.1 The Indications for Use are identical, the devices are both intended for intravascular use and the Indications for Use do not change the intended use of the TXM Guiding Sheath when compared to the predicate device.
5.6 - Summary of Technological Characteristics Comparison
Based on a comparison of the indications for use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging, it is determined that the TXM Guiding Sheath is substantially equivalent to the predicate device.
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Table 5.6 below provides a comparison of the TXM Guiding Sheath and the predicate.
| Technical Characteristics/ Principle of Operation | TXM Guiding Sheath | Super Arrow Flex®PercutaneousSheath IntroducerSet | SubstantiallyEquivalent? |
|---|---|---|---|
| Sheath Length | 45 cm - 90 cm | 11 cm, 24 cm, 45 cm,65 cm, 90 cm | Yes |
| Sheath Size | 4 Fr, 5 Fr and 6 Fr | 5 Fr, 6 Fr, 7 Fr, 8 Fr, 9 Fr,10 Fr | Yes |
| Shape | Straight | Straight | Yes |
| Inner Liner Material | Polytetrafluoroethylene(PTFE) | Unknown | Yes |
| Wire ReinforcementMaterial | Stainless Steel | Stainless Steel | Yes |
| Radiopaque Marker | Platinum/Iridium marker band | Radiopaque marker band | Yes |
| Outer Shaft Material | Polyeter Block Amide | Polyurethane | Yes |
| Luer Material | Polycarbonate | Not Applicable | Yes |
| Cross Cut Valve with threeway stopcock | Polycarbonate/Silicon Valve | Unknown | Yes |
| Touhy Borst Adapeter withside arm extension | Polycarbonate, Polyurethane | Unknown | Yes |
| Luer Connector | Female Luer Connector | Female Luer Connector | Yes |
| Hydrophilic Coated | Yes* | Yes | Yes |
| Anatomical Site Use | Percutaneous access | Percutaneous access | Yes |
| Delivery to Site | Over dilator and Over the wire | Over dilator and Over the | Yes |
| Dilator | HDPE and Nylon | Polymer | Yes |
| Guidewire Compatibility | Maximum 0.038" | Maximum 0.038" | Yes |
| Packaging | Tyvek Pouch | Tyvek Pouch | Yes |
| Sterilization | EtO Gas | EtO Gas | Yes |
Table 5.6.1 Comparison of the TXM Guiding Sheath and the Predicate Device.
- Denotes a patient-contacting material.
5.7 - Testing Summary
The following bench tests were performed to evaluate the design elements and performance characteristics of the TXM Guiding Sheath and to demonstrate substantial equivalence to the predicate device. The TXM Guiding Sheath met the predetermined acceptance criteria. Testing was performed on non-aged devices (T=0) as well as on devices subject to 2 years of accelerated aging (T=2). Tests results show that the TXM Guiding Sheath is substantially equivalent to the predicate device.
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5.7.1- Bench Testing Table
Table 5.7.1 below provides a summary of the bench testing performed on the TXM Guiding Sheath.
| Test# | Test Name | ApplicableStandardor InternalTestMethod | TestResults(T=2) | Test# | Test Name | ApplicableStandardor InternalTestMethod | TestResults(T=2) |
|---|---|---|---|---|---|---|---|
| 1 | Dimensional& PhysicalAttributes | ISO 10555 | T=0;T=2Pass | 9 | In-Vitro TrackForce | InternalTestMethod | T=0;T=2Pass |
| 2 | Lubricity ofHydrophilicCoating | InternalTestMethod | T=0;T=2Pass | 10 | KinkResistance | InternalTestMethod | T=0;T=2Pass |
| 3 | DilatorGuidewireand SheathCatheterCompatibility | InternalTestMethod | T=0;T=2Pass | 11 | Durability ofHydrophilicCoating | InternalTestMethod | T=0;T=2Pass |
| 4 | Liquid Leak | ISO 10555 | T=0;T=2Pass | 12 | TensileStrength | ISO 10555 | T=0;T=2Pass |
| 5 | Air Leak | ISO 10555 | T=0;T=2Pass | 13 | CoatingIntegrity | InternalTestMethod | T=0;T=2Pass |
| 6 | Seal Strength(Pouch) | ASTMF88/F88M-09 | T=0;T=2Pass | 14 | CorrosionResistance | ISO 10555 | T=0;T=2Pass |
| 7 | DyePenetrationTest | ASTM-F1929-12 | T=0;T=2Pass | 15 | Female LuerVerification | ISO 594 | T=0;T=2Pass |
| 8 | Radiopacity | ASTM-F640-12 | T=0;T=2Pass | 16 | AcceleratedAging | ASTMF1980-07 | T=0;T=2Pass |
Table 5.7.1. Bench Testing Performed on TXM Guiding Sheath.
5.7.2 - Biocompatibility
The TXM Guiding Sheath 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 5.7.2 below describes the testing performed to determine biocompatibility. All testing met the predetermined acceptance criteria.
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| Biological Effect | Test | Compliance Standard |
|---|---|---|
| Irritation | Intracutaneous Injection - ISO | ISO10993-10 |
| Sensitization | Kligman MaximizationMurine Local Lymph Assay | ISO10993-10 |
| Systemic Toxicity | ISO Acute Systemic Toxicity Test | ISO10993-11 |
| Cytotoxicity | L929 Neutral Red Uptake Cytotoxicity Test | ISO 10993-5 |
| Pyrogenicity | Pyrogen Test in Rabbit | USP<151>ISO10993-11 |
| Hemocompatibility | Hemolysis-Complete (Direct and Indirect) | ISO10993-4 |
| Hemocompatibility | Complement Activation | ISO10993-4 |
| Hemocompatibility | In-Vivo Thrombogenicity | ISO10993-4 |
Table 5.7.2. Summary of Biocompatibility Testing for the TXM Guiding Sheath.
5.8 - Sterilization Testing Summary
| Validation Sterilization Process | Sterility Assurance Level (SAL) | Adoption CycleResult |
|---|---|---|
| Ethylene Oxide Gas | 10-6 | Pass |
5.9 – Conclusion
The TXM Guiding Sheath is substantially equivalent in intended use, fundamental design, technology and principles of operation, materials, performance, sterilization, and packaging to the predicate device. Differences between the devices do not raise any new issues of safety or effectiveness.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).