(24 days)
No
The summary describes a physical guidewire and its accessories, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and material properties.
No.
Explanation: This device is a guidewire, which is used to introduce and position other catheters and interventional devices, not to directly treat a medical condition.
No
Explanation: The device is a guidewire intended to introduce and position catheters and other interventional devices within the coronary and peripheral vasculatures. It is an interventional tool, not a diagnostic one.
No
The device description clearly details a physical guidewire made of metallic materials with coatings, a radiopaque marker coil, and includes physical accessories like a shaping mandrel, introducer, and torque device. The performance studies focus on physical properties and interactions.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices." This describes a device used in vivo (within the body) for medical procedures, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a physical guidewire designed to be inserted into blood vessels. It mentions features like a shapeable tip, radiopaque marker, and coatings to facilitate manipulation within the vasculature. These are characteristics of an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The device's function is purely mechanical and procedural.
Therefore, the CrossTorqTM 14 Guidewire is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.
Product codes
DQX
Device Description
Scientia Cardio Access’s CrossTorg™ 14 Guidewire is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel (to shape the flexible tip of the guidewire), an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculatures
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
Non-clinical performance tests were conducted, including biocompatibility, and various functional tests.
Leveraged tests from K173235 (Aristotle 14 Guidewire) and K183608 (Aristotle 18 Guidewire) include: Radiopacity (evaluated by physicians in human cadaver, acceptable radiopacity), Corrosion Resistance (per ISO 11070, no signs of corrosion), Chemical Compatibility (exposed to saline and contrast agent/saline, no degradation), Latex (tested per ASTM D6499-07, no detectable traces), Accessories Testing (compatibility of Torque Device and Shaping Mandrel evaluated in cadaver testing and simulated use, acceptance criteria met), Package Integrity (per ASTM D 4169:16, pouches maintained integrity), Sterilization Validation (100% EO to SAL of at least 10-6, results justified adoption into EO sterilization processing group), Sterilization Validation: EO and ECH Residuals (per AAMI/ANSI/ISO 10993-7, residuals below limits), Sterilization Validation: Bacterial Endotoxin Levels (LAL testing,
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is in blue and consists of the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the next line. To the left of the FDA logo is the Department of Health & Human Services logo. The Department of Health & Human Services logo is a symbol of a stylized human figure.
September 16, 2020
Scientia Cardio Access LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k, Saint Paul, Minnesota 55114
Re: K193194
Trade/Device Name: CrossTorq 14 Guidewire Regulation Number: 21 CFR 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX
Dear Prithul Bom:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 13, 2019. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Lydia Glaw, OHT2: Office of Cardiovascular Devices, 301-796-1456, Lydia.glaw@fda.hhs.gov.
| Sincerely, | |
|---|---|
| Lydia S. | |
| Glaw -S | Digitally signed by |
| Lydia S. Glaw -S | |
| Date: 2020.09.16 | |
| 10:45:14 -04'00' | |
| Lydia Glaw | |
| Assistant Director | |
| DHT2C: Division of Coronary | |
| and Peripheral Interventional Devices | |
| OHT2: Office of Cardiovascular Devices | |
| Office of Product Evaluation and Quality | |
| Center for Devices and Radiological Health |
1
Image /page/1/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size.
December 13, 2019
Scientia Cardio Access LLC % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k, Saint Paul, Minnesota 55114
Re: K193194
Trade/Device Name: CrossTorq 14 Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: November 18, 2019 Received: November 19, 2019
Dear Prithul Bom:
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 mav, 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
2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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-regulatory-assistance/contact-usdivision-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,
Image /page/2/Picture/6 description: The image shows the name "Lydia S. Glaw -S" in large, bold font on the left side of the image. On the right side, it says "Digitally signed by Lydia S. Glaw -S" followed by the date "Date: 2019.12.13" and the time "09:46:48 -05'00'". The text on the right side is smaller and less bold than the name on the left.
Lydia Glaw, Ph.D. Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K193194
Device Name CrossTorq 14 Guidewire
Indications for Use (Describe)
The CrossTorqTM 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorqTM 14 Guidewire is not intended for use in the neurovasculature.
| 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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4
Image /page/4/Picture/2 description: The image shows the logo for Scientia. The logo consists of a stylized blue "S" shape above the word "SCIENTIA" in a futuristic-looking font. The "S" shape is made up of three parallel lines that curve around each other.
510(K) SUMMARY (Per 21 CFR 807.92)
SCIENTIA CARDIO ACCESS LLC
| 510(k) Sponsor: | Scientia Cardio Access LLC
3487 West 2100 South Suite 100
West Valley City, UT 84119
Tel: (775) 657-6330 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Amy McManus, Regulatory Affairs Manager
Phone: 1 (888) 385-9016
Email: amcmanus@scientiavascular.com) |
| Date Prepared: | December 6, 2019 |
| Prepared by: | Ryan O'Callaghan, MS, RAC
Phil Triolo and Associates LC
Tel: 801.573.2651
Fax: 801.328.2399
E-mail: ryano@philt.com |
| Trade Name: | CrossTorqTM 14 Guidewire |
| Common Name: | Guidewire |
| Classification Name | Catheter Guide Wire per 21 CFR 870.1330 |
| Product Code: | DQX |
| Predicate Devices: | KinetixTM Guidewire (K081021) |
| | HornetTM Guidewire, HornetTM 10 Guidewire, and HornetTM 14 Guidewire
(K152231) |
| Reference Devices: | Aristotle 14 Guidewire (K173235) |
| | Aristotle 18 Guidewire (K183608) |
5
DEVICE DESCRIPTION
Scientia Cardio Access's CrossTorg™ 14 Guidewire is a 0.014" diameter steerable guidewire with a shapeable tip to aid in accessing vasculature. The guidewire is supplied sterile and is for single use only. It is provided with the 4 different tip loads, or tip stiffnesses: 1 gram. 10 gram, and 15 gram. These tip stiffnesses are referred to as Soft, Standard, Support, and Extra Support. respectively. The product is offered in lengths of 200cm and 300cm.
The distal portion of the guidewire tip includes a radiopaque platinum wire marker coil to facilitate fluoroscopic visualization. The guidewire has a hydrophilic polymer coating on the distal portion and a polytetrafluoroethylene (PTFE) coating on the proximal portion to reduce friction during manipulation in vessels.
The guidewire is provided with a shaping mandrel (to shape the flexible tip of the guidewire), an introducer (to aid with the insertion of the guidewire into a catheter hub and/or a hemostasis valve) and a torque device (to attach to the proximal portion to facilitate gripping and manipulation of the guidewire during use). The shaping mandrel, introducer and torque accessory devices are included to facilitate use of the guidewire and are not intended to contact the patient's body.
The CrossTorg 14 Guidewire is substantially equivalent with respect to technological characteristics, design and materials to Boston Scientific's currently marketed Kinetix™ Guidewire cleared under K081021 and Boston Scientific's Hornet™ Guidewire, Hornet™ 10 Guidewire, and Hornet™ 14 Guidewire (also referred to as the Hornet Guidewire Series in this summary) cleared under K152231.
INDICATIONS FOR USE
The CrossTorq™ 14 Guidewire is intended for general vascular use within the coronary and peripheral vasculatures to introduce and position catheters and other interventional devices. The CrossTorg™ 14 Guidewire is not intended for use in the neurovasculature.
TECHNOLOGICAL CHARACTERISTICS
As shown in the table below, the technological characteristics of the CrossTorg 14 Guidewire are equivalent to those of the predicate devices, the Kinetix Guidewire and Boston Scientific Hornet Guidewire Series. Both of the predicate devices have intended use; however, the Kinetix Guidewire is only offered in soft tip stiffness profiles, while the Hornet Guidewire Series and the CrossTorq 14 Guidewire are offered in a wider range of stiffness profiles. The CrossTorq 14 Guidewire combines the stiffness profiles offered by the Kinetix and Hornet Guidewire Series guidewires.
6
| Comparison of Technological Characteristics between Subject Device and Predicate Devices | ||||
|---|---|---|---|---|
| Characteristic | Subject Device | |||
| CrossTorqTM 14 | ||||
| Guidewire | Primary Predicate | |||
| Device | ||||
| KinetixTM Guidewire | ||||
| (K081021) | Predicate Device | |||
| Boston Scientific Hornet | ||||
| Guidewire Series | ||||
| (K152231) | Comparison | |||
| Anatomical | ||||
| Location | Coronary and | |||
| peripheral vasculature | Coronary and | |||
| peripheral vasculature | Coronary and peripheral | |||
| vasculature | Same | |||
| Dimensions | O.D. : 0.014" | |||
| (0.36mm) | ||||
| Length : 200cm or | ||||
| 300cm | O.D. : 0.014" | |||
| (0.36mm) | ||||
| Length : 180cm or | ||||
| 300cm | O.D. : 0.014" (0.36mm) | |||
| Length : 190cm or | ||||
| 300cm | Equivalent | |||
| Core Wire | Stainless Steel | Nitinol | Stainless Steel | Equivalent |
| Distal Tip | Shapeable straight tip | |||
| Length : 35 cm | ||||
| Material : Nitinol | Shapeable straight tip | |||
| or preshaped "J" tip | ||||
| Length : 18 cm | ||||
| Material : Nitinol | Shapeable straight tip | |||
| Length : 15 cm | ||||
| Material : Stainless Steel | Equivalent | |||
| Stiffness | ||||
| Profiles | Range from | |||
| Soft(1gram) to Extra | ||||
| Support (15gram) | Range from Moderate | |||
| Support(0.8 gram) to | ||||
| Plus(1.3gram) | Range from 1gram to 14 | |||
| gram tip stiffness | Equivalent | |||
| Coatings | Distal End : | |||
| Hydrophilic | ||||
| Proximal End : | ||||
| PTFE | Distal End : | |||
| Hydrophilic | ||||
| Proximal End : PTFE | Distal End : Hydrophilic | |||
| Proximal End : PTFE | Same | |||
| Radiopaque | ||||
| Marker | Radiopaque marker at | |||
| distal tip | Radiopaque marker at | |||
| distal tip | Radiopaque marker at | |||
| distal tip | Same | |||
| Accessories | The following | |||
| accessories are | ||||
| provided with the | ||||
| guidewire: | ||||
| • Shaping Mandrel | ||||
| • Torque Device | ||||
| • Plastic Introducer | No accessories are | |||
| provided with the | ||||
| predicate device. | ||||
| The predicate device's | ||||
| IFU references use of | ||||
| the guidewire with the | ||||
| following accessories: | ||||
| • Shaping instrument | ||||
| • Torque device | ||||
| • Insertion tool | No accessories are | |||
| provided with the | ||||
| predicate device. | ||||
| The predicate device's | ||||
| IFU references use of the | ||||
| guidewire with the | ||||
| following accessories: | ||||
| • Shaping instrument | ||||
| • Torque device | ||||
| • Insertion tool | Equivalent | |||
| Comparison of Technological Characteristics between Subject Device and Predicate Devices | ||||
| Characteristic | Subject Device | |||
| CrossTorqTM 14 | ||||
| Guidewire | Primary Predicate | |||
| Device | ||||
| KinetixTM Guidewire | ||||
| (K081021) | Predicate Device | |||
| Boston Scientific Hornet | ||||
| Guidewire Series | ||||
| (K152231) | Comparison | |||
| Sterilization | ||||
| Method | 100% Ethylene Oxide | |||
| (EO) | 100% Ethylene Oxide | |||
| (EO) | 100% Ethylene Oxide | |||
| (EO) | Same |
7
As shown in the Table above, the CrossTorq 14 Guidewire differs from the predicate guidewire in the following ways:
The CrossTorq 14 core wire is constructed of stainless steel, while the Kinetix core wire is constructed of Nitinol. The Hornet Guidewire Series guidewires are all built using the same stainless steel material as the CrossTorq 14. Stainless steel is a commonly used core wire material and the functionality and performance characteristics of the stainless steel core wire are similar to those of the Nitinol core wire used in the construction of the Kinetix Guidewire.
An accessory kit (consisting of a shaping mandrel, a torque device, and an introducer) is provided as part of the subject device, whereas the predicate devices do not provide an accessory kit as part of their finished product. Although the accessories are not provided in the packaging, the Kinetix and Hornet Guidewire Instructions For Use mentions the use of a shaping instrument, insertion tool, and torque device, which are equivalent to the accessories provided with the CrossTorq 14.
The tip stiffness profiles available for the CrossTorq 14 Guidewire are: 1gram, 6 gram, and 15 gram. These tip stiffnesses are referred to in reports and this document as Soft. Standard, Support, and Extra Support, respectively. The predicate Kinetix Guidewire is only available in 0.8 gram and 1.3 gram tips, however, the predicate Hornet Guidewire series is available in 1 gram, 10 gram, and 14 gram tips, and thus can be used to determine values for comparative testing of Tip Stiffness and Column Buckling.
Results of tests performed on the new CrossTorq 14 Guidewire demonstrate that the new guidewire performs as well as the predicate devices and/or meets requirements of relevant standards. Further, any differences in technological characteristics of the CrossTorq 14 Guidewires when compared with predicate device characteristics do not raise different questions of safety and effectiveness.
8
Scientia Cardio Access LLC Traditional_510(k) CrossTorq™ 14 Guidewire
Additionally, the indications for use statement of the subject device is equivalent to that of the predicate devices and the differences in wording are not critical to the intended therapeutic, diagnostic, prosthetic, surgical or other use of the device. The differences do not affect the safety and effectiveness of the device when used as labeled, as the same intent is documented for the predicate devices and the new device.
NON-CLINICAL PERFORMANCE TESTS
Biocompatibility
The materials and processing of the CrossTorq 14 Guidewires are identical to those of the reference Aristotle 18 Guidewire (manufactured by Scientia Cardio Access LLC's sister company, Scientia Vascular LLC, and cleared under K183608); in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, color additives, cleaning agents, mold release agents) with the exception that the outer diameter of the CrossTorg 14 Guidewire is smaller than that of the Aristotle 18 Guidewire. The dimensional change does not alter the chemical or physical properties of the medical device in its final finished form, and therefore, results from the Aristotle 18 Guidewire can be applied to the medical device in its final finished form.
There are no additional biologic interactions that need to be considered in order to use the cleared guidewires in the coronary vasculature. Consequently, no additional evaluations are needed to determine that the subject guidewires present a low and acceptable biological and toxicological risk when used in accordance with their intended and indicated uses, and no additional biological safety information is provided in this 510(k).
9
Г
Test Results Leveraged from Premarket Notifications K173235 (Aristotle 14 Guidewire) and K183608 (Aristotle 18 Guidewire)
Results for following tests, performed on the reference Aristotle 14 Guidewires and reference Aristotle 18 Guidewires, were included in Scientia Vascular LLC's premarket notifications K173235 and K183608 for the Aristotle 14 Guidewire and Aristotle 18 Guidewire, respectively. The results from these tests are also applicable to CrossTorq 14 Guidewire, as the materials and processing of the CrossTorq 14 Guidewires are identical to those of the Aristotle 14 and Aristotle 18 Guidewires.
| Summaries of Leveraged Functional Tests Conducted to Support this Premarket
| Notification | ||
|---|---|---|
| Test | Test Method Summary | Results |
| Radiopacity | Guidewires evaluated by | |
| physicians in human cadaver | Guidewires exhibited acceptable | |
| radiopacity. | ||
| Corrosion | ||
| Resistance | Test for corrosion resistance per | |
| ISO 11070 | There were no signs of corrosion on | |
| guidewires after soaking in typical | ||
| end-use solutions. | ||
| Chemical | ||
| Compatibility | Guidewires were exposed to saline | |
| and contrast agent/saline solutions | ||
| and examined for degradation. | All guidewires showed no signs of | |
| degradation, corrosion or physical | ||
| decomposition after exposure. | ||
| Latex | Tested for trace latex proteins per | |
| ASTM D6499-07 | No detectable traces of latex were | |
| found. | ||
| Accessories | ||
| Testing | Compatibility of Torque Device | |
| and Shaping Mandrel with | ||
| Aristotle Guidewires was | ||
| evaluated in cadaver testing and | ||
| simulated use evaluations. | ||
| Various tests on Shaping Mandrel | ||
| per ISO 11070: biocompatibility, | ||
| visual inspection, corrosion | ||
| resistance, tensile testing, luer | ||
| taper dimensions | Acceptance criteria of all tests were | |
| met | ||
| Package | ||
| Integrity | Simulated transportation test per | |
| ASTM D 4169:16. Pouch | ||
| evaluated for seal strength per | ||
| ASTM F 88-15 and leak tests | ||
| (bubble test) per ASTM F 2096-11 | Following exposure to typical | |
| storage and transportation | ||
| conditions, all sterile barrier | ||
| pouches maintained their integrity | ||
| and labeling remained affixed and | ||
| legible. | ||
| Summaries of Leveraged Functional Tests Conducted to Support this Premarket | ||
| Notification | ||
| Test | Test Method Summary | Results |
| Sterilization | ||
| Validation | 100% EO is used to sterilize the | |
| device to achieve a SAL of at least | ||
| 10-6. The device was adopted into | ||
| an EO sterilization processing | ||
| group in accordance with AAMI | ||
| TIR 28:2009. Validation of the EO | ||
| sterilization cycle was performed | ||
| using the Half-cycle, overkill | ||
| approach described in Section | ||
| B.1.2 of ISO11135:2007 Annex B. | Results justified adoption into the | |
| EO sterilization processing group: | ||
| Comparative and Bioburden | ||
| Resistance study results | ||
| demonstrated that PCDs are more | ||
| difficult to sterilize than devices; | ||
| Bioburden Enumeration and | ||
| Extraction Efficiency tests were | ||
| used to enumerate the CFUs present | ||
| on devices; and Bacteriostasis/ | ||
| Fungistasis test results demonstrated | ||
| that the product does not inhibit the | ||
| growth of organisms. | ||
| Sterilization | ||
| Validation: | ||
| EO and ECH | ||
| Residuals | Measured EO and ECH residuals | |
| per AAMI/ANSI/ISO 10993-7 | The residual traces of EO and ECH | |
| remaining in the CrossTorq 14 | ||
| Guidewire after exposure to the EO | ||
| sterilization process are well below | ||
| the limits specified in ISO 10993-7. | ||
| Sterilization | ||
| Validation: | ||
| Bacterial | ||
| Endotoxin | ||
| Levels | LAL testing was conducted in | |
| accordance with ANSI/AAMI | ||
| ST72:2011/(R)2016, USP , | ||
| and USP , using the kinetic | ||
| chromogenic method. |