(63 days)
Not Found
No
The device description and performance studies focus on the physical properties and mechanical performance of a wire guide, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
Explanation: The device is intended to facilitate the placement of other devices used during diagnostic and interventional procedures, rather than providing direct therapy itself.
No
The device is a wire guide intended to facilitate the placement of other devices used during diagnostic and interventional procedures, but it is not itself performing a diagnostic function.
No
The device description clearly states it is a physical wire guide constructed of stainless steel, not software. The performance studies also focus on physical properties like fracture, tensile strength, corrosion, and flex testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate placement of devices used during diagnostic and interventional procedures." This describes a tool used during a procedure, not a device used to perform a diagnostic test on a sample taken from the body.
- Device Description: The description details a physical wire guide used for navigation and placement of other devices within the body. This is consistent with an interventional or procedural device, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
- Performance Studies: The performance studies focus on the physical properties and safety of the wire guide itself (fracture, tensile strength, corrosion, flex, biocompatibility, packaging integrity), not on the accuracy or reliability of a diagnostic test.
In summary, the Heavy Double Flexible Tipped Wire Guide is a medical device used to assist in procedures performed on a patient, not a device used to perform diagnostic tests on samples from a patient.
N/A
Intended Use / Indications for Use
The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.
Product codes
DQX
Device Description
The Heavy Double Flexible Tipped Wire Guide is constructed of stainless steel coils surrounding a stainless steel mandril. It is a 0.032 inch diameter, 60 cm long wire guide with two flexible tips and four sets of centimeter markings etched at 10 cm intervals along the wire shaft. The device is supplied sterile, packaged within a Tyvek peel pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
- Fracture Testing: Testing verified that there will be no signs of fracture after manipulation, excluding the region of fixation and the first turn. The predetermined acceptance criterion was met.
- Tensile Testing: Testing verified that there will be no sign of loosening of any unions after an appropriate level of force defined by ISO 11070:1999 is applied. The predetermined acceptance criterion was met.
- Corrosion Resistance: Testing verified that there will be no signs of corrosion that will affect the functional performance or biocompatibility of the wire guide. The predetermined acceptance criterion was met.
- Flex Testing: Testing verified that there will be no signs of defects or damage when the wire guide is subjected to repeated flexing. The predetermined acceptance criterion was met.
- Acute Performance Evaluation: The testing confirmed that the wire guide is rated as acceptable for normal clinical practice for the performance parameters evaluated. The predetermined acceptance criterion was met.
- Bubble Leak (Packaging): The package shall show no signs of pin holes or imperfect seals indicated by bubbles created from the pressurized air leaking into the surrounding solution. The predetermined acceptance criterion was met.
- Seal Strength (Packaging): All specimens must have a mean seal force that exceeds 0.50 lbf. The predetermined acceptance criterion was met.
- Biocompatibility Testing: Per ISO 10993-1:2009, the subject devices are categorized as external communicating devices in contact with circulating blood for a limited (≤24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, and hemocompatibility.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 28, 2015
Cook, Inc. Ms. Julia Ferguson Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47404
Re: K150802
Trade/Device Name: Heavy Double Flexible Tipped Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: March 25, 2015 Received: March 26, 2015
Dear Ms. Ferguson:
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
1
the quality systems (OS) 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" (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,
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) K150802
Device Name
Heavy Double Flexible Tipped Wire Guide
Indications for Use (Describe)
The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Heavy Double Flexible Tipped Wire Guide 21 CFR §870.1310 Date Prepared: May 26, 2015
Submitted By:
Applicant: | Cook Incorporated |
---|---|
Contact: | Julia Ferguson |
Applicant Address: | Cook Incorporated |
750 Daniels Way | |
Bloomington, IN 47404 | |
Contact Phone Number: | (812) 335-3575 x104554 |
Contact Fax Number: | (812) 332-0281 |
Device Information:
Trade Name: | Heavy Double Flexible Tipped Wire Guide |
---|---|
Common Name: | Catheter Wire Guide |
Classification Name: | Wire, Guide, Catheter |
Regulation: | 21 CFR §870.1330 |
Product Code: | DQX |
Predicate Device:
The predicate device is the Cardiovascular Spring Guides (Lake Region Mfg., Inc., K770977).
Device Description:
The Heavy Double Flexible Tipped Wire Guide is constructed of stainless steel coils surrounding a stainless steel mandril. It is a 0.032 inch diameter, 60 cm long wire guide with two flexible tips and four sets of centimeter markings etched at 10 cm intervals along the wire shaft. The device is supplied sterile, packaged within a Tyvek peel pouch.
Intended Use:
The Heavy Double Flexible Tipped Wire Guide is intended to facilitate placement of devices used during diagnostic and interventional procedures.
Comparison to Predicates:
Cook Incorporated's Heavy Double Flexible Tipped Wire Guide is substantially equivalent to the predicate device, the Cardiovascular Spring Guides (K770977), in that these devices have identical designs, methods of construction and operation, and indications for use.
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Technological Characteristics:
The following tests have been conducted to ensure reliable design and performance under the specified design requirements.
- Fracture Testing: Testing verified that there will be no signs of fracture after . manipulation, excluding the region of fixation and the first turn. The predetermined acceptance criterion was met.
- Tensile Testing: Testing verified that there will be no sign of loosening of any unions . after an appropriate level of force defined by ISO 11070:1999 is applied. The predetermined acceptance criterion was met.
- Corrosion Resistance: Testing verified that there will be no signs of corrosion that will . affect the functional performance or biocompatibility of the wire guide. The predetermined acceptance criterion was met.
- Flex Testing: Testing verified that there will be no signs of defects or damage when the . wire guide is subjected to repeated flexing. The predetermined acceptance criterion was met.
- . Acute Performance Evaluation: The testing confirmed that the wire guide is rated as acceptable for normal clinical practice for the performance parameters evaluated. The predetermined acceptance criterion was met.
- Bubble Leak (Packaging): The package shall show no signs of pin holes or imperfect . seals indicated by bubbles created from the pressurized air leaking into the surrounding solution. The predetermined acceptance criterion was met.
- Seal Strength (Packaging): All specimens must have a mean seal force that exceeds 0.50 . lbf. The predetermined acceptance criterion was met.
- Biocompatibility Testing: Per ISO 10993-1:2009, the subject devices are categorized as . external communicating devices in contact with circulating blood for a limited (≤24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: cytotoxicity, sensitization, irritation/intracutaneous reactivity, systemic toxicity, and hemocompatibility.
Conclusion:
The results of these tests support a conclusion that the Cook Incorporated Heavy Double Flexible Tipped Wire Guide met the design input requirements based on its intended use. The results also support the conclusion that these devices do not raise new questions of safety or effectiveness and are substantially equivalent to the predicate device, the Cardiovascular Spring Guides (K770977).