(267 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a sizing catheter with marker bands for manual measurement, with no mention of AI/ML capabilities or image processing for automated analysis.
No
The device, a sizing catheter, is used in angiographic procedures for anatomical measurements and does not describe any therapeutic action, but rather a diagnostic or interventional support function.
No
The device is described as a sizing catheter used in angiographic procedures for anatomical measurements. Its primary function is to provide physical dimensions, rather than to detect, diagnose, treat, or prevent a disease or condition. The performance studies listed are related to mechanical and material properties, not diagnostic accuracy.
No
The device description clearly outlines physical components such as a nylon shaft, luer lock adapter, connecting cap, and gold marker bands, indicating it is a physical medical device, not software-only.
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 "angiographic procedures" and "anatomical measurements" using marker bands. This is an in-vivo procedure, meaning it's used within the living body.
- Device Description: The description details a physical catheter with marker bands, designed for insertion into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVDs are used to provide information about a physiological or pathological state, or to monitor therapeutic measures, by testing these specimens.
This device is a medical device used for a diagnostic procedure performed directly on the patient, not an in-vitro diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
Sizing catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Sizing catheters have marker bands that can be used for anatomical measurements.
Product codes
DOO
Device Description
The Sizing Catheters are sterile, single use devices designed for use in angiographic procedures. There are three categories of Sizing Catheters that differ based on the number and spacing of the marker bands, these categories include: White Sizing Catheters, Aurous Centimeter Sizing Catheters, and Cava Vessel Sizing Catheters. All Sizing Catheters are 5.0 French and are manufactured in lengths of 65, 70, 90, and 100 centimeters. Each configuration includes a nylon luer lock adapter and connecting cap, gold marker bands, and a nylon shaft.
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
physicians trained and experienced in angiographic techniques
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)
The Sizing Catheters, subject of this submission, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI ANSI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
- Tensile Testing of the Hub to Shaft Joint Testing verified that under proper clinical use of the catheter, the peak load value of the hub-to-shaft connection shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Liquid Leakage Testing – Testing verified that under proper clinical use of the catheter, there shall be no liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met.
- Air Leakage Testing Testing verified that under proper clinical use of the catheter, there shall be no air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- Static Burst Testing Testing successfully characterized the catastrophic failure pressure for the catheter is accordance with BS EN ISO 10555-1:2013, Annex F.
- Dimensional Verification Testing Testing verified that the outer diameter, inner diameter, and marker band spacing of the device is within a specified tolerance. The predetermined acceptance criteria were met.
- Tensile Testing of the Marker Bands Testing verified that under proper clinical use of the catheter, the peak load value of the marker bands shall be sufficient for clinical use. The predetermined acceptance criterion was met.
- Tensile Testing of the Sideports Testing verified that under proper clinical use of the catheter, the peak load values of the sideported area of the catheter shaft shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Flow Rate Testing Testing successfully characterized the flow rates of the device at designated injection pressures using saline and contrast.
- Acute Performance Testing verified the performance parameters were acceptable for clinical use. The predetermined acceptance criteria were met.
- Corrosion Testing - Testing verified that the device will not show observable signs of corrosion after being tested in accordance with BS EN ISO 10555-1, Annex A. The predetermined acceptance criterion was met.
In conclusion, the results of these tests support a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
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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 26, 2017
Cook Incorporated Jessica Swafford Regulatory Affairs Specialist 750 Daniels Way, Bloomington, IN 47402 US
Re: K162448
Trade/Device Name: White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: April 14, 2017 Received: April 17, 2017
Dear Jessica Swafford:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in 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/Resourcesfor You/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,
Fernando Aguel
Fernando Aguel
-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) K162448
Device Name
White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter
Indications for Use (Describe)
Sizing catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Sizing catheters have marker bands that can be used for anatomical measurements.
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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Image /page/3/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".
5.0 510(k) Summary
Sizing Catheters Traditional 510(k) Summary 21 CFR §807.92
COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 812.339.2235 TOLL FREE: 800.457.4500 WWW.COOKMEDICAL.COM
Submitter Information
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | Jessica Swafford |
| Email: | RegSubmissions@cookmedical.com |
| Contact Phone Number: | 812-335-3575 ext. 104260 |
| Contact Fax Number: | 812-332-0281 |
| Date Prepared: | August 31, 2016 |
| Device Information | |
| Trade Name: | White Sizing Catheter |
| Aurous Centimeter Sizing Catheter | |
| Cava Vessel Sizing Catheter | |
| Common Name: | Sizing Catheters |
| Classification Name: | Catheter, Intravascular, Diagnostic |
| DOO (21 CFR §870.1200) |
Predicate Device
The Sizing Catheters are substantially equivalent to the Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937.
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Image /page/4/Picture/0 description: The image shows the Cook Medical logo. The logo is set against a red background. The word "COOK" is written in white, block letters in the upper portion of the logo. Below the word "COOK" is the word "MEDICAL" in smaller, white letters.
OK INCORPORATED WW.COOKMEDICAL.COM
Comparison to Predicate
It has been demonstrated that the Sizing Catheters and the predicate device are substantially equivalent in terms of intended use, duration of use, principles of operation, fundamental technological characteristics, and insertion method. The design, dimensions, manufacture, and materials of the subject device is either similar to the materials of the predicate device or have been used in other cleared devices. The predicate device is available in 4.0-5.0 French sizes, 40-150 centimeter lengths, and is compatible with a 0.035 or 0.038 inch wire guide; the subject device is available in 4.0 and 5.0 French sizes, 65-100 centimeter lengths, and is compatible with a 0.035 inch wire guide. Therefore, the specifications of the subject device generally fall within the range of specifications of the predicate device in terms of French size, catheter length, and wire guide compatibility. The differences between the subject device and the predicate device, including presence of sideports and addition of a peel-away straightener, do not raise new questions of safety and effectiveness as demonstrated by performance testing.
Device Description
The Sizing Catheters are sterile, single use devices designed for use in angiographic procedures. There are three categories of Sizing Catheters that differ based on the number and spacing of the marker bands, these categories include: White Sizing Catheters, Aurous Centimeter Sizing Catheters, and Cava Vessel Sizing Catheters. All Sizing Catheters are 5.0 French and are manufactured in lengths of 65, 70, 90, and 100 centimeters. Each configuration includes a nylon luer lock adapter and connecting cap, gold marker bands, and a nylon shaft.
Intended Use
Sizing catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed. Sizing catheters have marker bands that can be used for anatomical measurements.
5
Image /page/5/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in white, large, bold, sans-serif font. Below that, the word "MEDICAL" is in a smaller, white, sans-serif font.
W.COOKMEDIC
Test Data
The Sizing Catheters, subject of this submission, were subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI ANSI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
- Tensile Testing of the Hub to Shaft Joint Testing verified that under proper . clinical use of the catheter, the peak load value of the hub-to-shaft connection shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- . Liquid Leakage Testing – Testing verified that under proper clinical use of the catheter, there shall be no liquid leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex C. The predetermined acceptance criterion was met.
- Air Leakage Testing Testing verified that under proper clinical use of the ● catheter, there shall be no air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- Static Burst Testing Testing successfully characterized the catastrophic failure ● pressure for the catheter is accordance with BS EN ISO 10555-1:2013, Annex F.
- Dimensional Verification Testing Testing verified that the outer diameter, inner . diameter, and marker band spacing of the device is within a specified tolerance. The predetermined acceptance criteria were met.
- Tensile Testing of the Marker Bands Testing verified that under proper clinical ● use of the catheter, the peak load value of the marker bands shall be sufficient for clinical use. The predetermined acceptance criterion was met.
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Image /page/6/Picture/1 description: The image shows the Cook Medical logo. The logo has a red background with the word "COOK" in white, sans-serif font. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font. The lower left corner of the red background has a diagonal cut.
- Tensile Testing of the Sideports Testing verified that under proper clinical use . of the catheter, the peak load values of the sideported area of the catheter shaft shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Flow Rate Testing Testing successfully characterized the flow rates of the . device at designated injection pressures using saline and contrast.
- Acute Performance Testing verified the performance parameters were . acceptable for clinical use. The predetermined acceptance criteria were met.
- . Corrosion Testing - Testing verified that the device will not show observable signs of corrosion after being tested in accordance with BS EN ISO 10555-1, Annex A. The predetermined acceptance criterion was met.
In conclusion, the results of these tests support a determination of substantial equivalence.