(248 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a catheter and associated components, with no mention of AI or ML.
No
The device is described as an Arterial Pressure Monitoring Set Tray intended for arterial blood pressure monitoring and blood sampling, not for treating a disease or condition.
No
This device is intended for arterial blood pressure monitoring and blood sampling, which are procedures for measurement and collection, not for diagnosis.
No
The device description clearly outlines physical components like catheters, wire guides, needles, and syringes, and the performance studies focus on the physical properties and biocompatibility of these hardware components. There is no mention of software as a component or its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for arterial blood pressure monitoring and blood sampling in adult and pediatric patients." This describes a device used in vivo (within the body) for physiological monitoring and obtaining samples, not for testing samples in vitro (outside the body).
- Device Description: The description details a catheter, wire guide, needle, and syringe used for insertion into the vasculature. This is consistent with an invasive medical device used for direct access to the arterial system.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the catheter and its components, which are relevant to an invasive medical device. There are no studies related to the analytical or diagnostic performance of testing biological samples.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to access the arterial system for monitoring and sampling, not to perform the diagnostic testing itself.
N/A
Intended Use / Indications for Use
The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.
- 5.0 French catheters are intended for patients aged 12 years and older
Product codes
DQO
Device Description
The Arterial Pressure Monitoring Set/Tray consists of a pressure monitoring catheter, wire guide, access needle, and syringe. The catheter is inserted into the vasculature using the Seldinger technique. The subject device is sterilized by ethylene oxide and intended for one-time use.
The subject device catheter is a single lumen intravascular catheter manufactured from nylon tubing and is designed with a pre-molded proximal winged hub. The catheter is 5.0 French with a length of 15 centimeters and has an endhole diameter of 0.035 inches. Additionally, the catheter is manufactured with one-centimeter incremental ink markings along the shaft. The wire guide is manufactured from stainless steel, has an outer diameter of 0.035 inches, and a length of 50 centimeters. The access needle is manufactured from stainless steel. Additional set configurations may contain convenience accessories, including lidocaine, PVP ointment, silk suture, Monoject needles, thumb scalpel, gauze, drapes, a filter straw, and ChloraPrep antiseptic.
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
Adult and pediatric patients. 5.0 French catheters are intended for patients aged 12 years and older.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject device, Arterial Pressure Monitoring Set/Tray was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
Performance Testing:
- . Catheter Shaft Tensile (Aged) – The peak tensile load for the shaft section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Hub-to-Shaft Tensile (Aged) The peak tensile load for the hub-to-shaft . section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Liguid Leakage (Aged) No part of the catheter shall leak liquid when . tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
- . Catheter Air Leakage (Aged) – No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.
- Catheter Kink Length (Aged) The catheter shall not kink (flowrate reduced by 50%) . at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
- Catheter Gravity Flow Rate (Time-Zero) The flow rate shall be a minimum of 90% . of the flow rate stated by the manufacturer when tested in accordance with Annex E of BS EN ISO 10555-1. The acceptance criterion was met.
- Visual Inspection & Dimensional Analysis (Aged) Test was conducted to . demonstrate that the catheter dimensions are within the specified tolerances and the catheter and wire guide are compatible.
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.
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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November 30, 2018
Cook Incorporated Johnathan Liu Regulatory Affairs Team Lead 750 Daniels Way Bloomington, Indiana 47404
Re: K180792
Trade/Device Name: Arterial Pressure Monitoring Set/Tray Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: October 19, 2018 Received: October 22, 2018
Dear Johnathan Liu:
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. 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
- 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) K180792
Device Name
Arterial Pressure Monitoring Set/Tray
Indications for Use (Describe)
The Arterial Pressure Monitoring Set Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.
- 5.0 French catheters are intended for patients aged 12 years and older
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 Cook Medical logo. The logo consists of the word "COOK" in white, block letters on a red background. Below the word "COOK" is the word "MEDICAL" in white, block letters on a red background. The bottom red background is angled.
2.0 510(k) SUMMARY
K180792 Arterial Pressure Monitoring Set/Tray 21 CFR §807.92 Date Prepared: October 19, 2018
Submitted By:
| Submission: | Traditional 510(k) Premarket Notification |
|---|---|
| Applicant: | Cook Incorporated |
| Applicant Address: | Cook Incorporated |
| 750 Daniels Way | |
| Bloomington, IN 47404 | |
| Contact: | Johnathan Liu |
| Chelsea Woods | |
| Secondary Contact: | Andrew Breidenbach, PhD, RAC |
| Email: | regsubmissions@cookmedical.com |
| Contact Phone Number: | (812) 335-3575 x104509 |
| Contact Fax Number: | (812) 332-0281 |
Device Information:
| Trade Name: | Arterial Pressure Monitoring Set/Tray |
|---|---|
| Common Name: | Catheter, Intravascular, Diagnostic |
| Classification Name: | Diagnostic intravascular catheter |
| Regulation: | 21 CFR §870.1200 |
| Product Code: | DQO |
| Device Class: | II |
| Classification Panel: | Cardiovascular |
Predicate Device:
The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the following device: Cook Pressure Monitoring Catheter (K002254, Cook Incorporated) cleared on March 16, 2001.
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Device Description:
The Arterial Pressure Monitoring Set/Tray consists of a pressure monitoring catheter, wire guide, access needle, and syringe. The catheter is inserted into the vasculature using the Seldinger technique. The subject device is sterilized by ethylene oxide and intended for one-time use.
The subject device catheter is a single lumen intravascular catheter manufactured from nylon tubing and is designed with a pre-molded proximal winged hub. The catheter is 5.0 French with a length of 15 centimeters and has an endhole diameter of 0.035 inches. Additionally, the catheter is manufactured with one-centimeter incremental ink markings along the shaft. The wire guide is manufactured from stainless steel, has an outer diameter of 0.035 inches, and a length of 50 centimeters. The access needle is manufactured from stainless steel. Additional set configurations may contain convenience accessories, including lidocaine, PVP ointment, silk suture, Monoject needles, thumb scalpel, gauze, drapes, a filter straw, and ChloraPrep antiseptic.
Indications for Use:
The Arterial Pressure Monitoring Set/Tray is intended for arterial blood pressure monitoring and blood sampling in adult and pediatric patients.
- -5.0 French catheters are intended for patients aged 12 years and older
Comparison to Predicate Device:
The Arterial Pressure Monitoring Set/Tray is substantially equivalent to the predicate device, Cook Pressure Monitoring Catheter (K002254), in that these devices are identical in intended use, principle of operation, catheter design (single lumen, straight tip), and packaging. The differences between the subject device and the predicate device, including pediatric indication, materials, and dimensions, do not raise different questions of safety and/or effectiveness when compared to the predicate. The substantial equivalence comparison of the subject device to the predicate is provided in the table below.
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| PREDICATE DEVICE | SUBJECT DEVICE | ||
|---|---|---|---|
| Cook Pressure Monitoring Catheter | |||
| (K002254) | Arterial Pressure Monitoring Set/Tray | ||
| Regulation | 21 CFR §870.1200 | IDENTICAL TO PREDICATE | |
| Product Code | DQO – Catheter, Intravascular, Diagnostic | IDENTICAL TO PREDICATE | |
| Classification | II | IDENTICAL TO PREDICATE | |
| Indications for Use | The Cook Pressure Monitoring Catheter is | ||
| used for arterial pressure monitoring and | |||
| blood sampling. It is provided sterile in | |||
| peel-open packages and intended for one- | |||
| time use. | The Arterial Pressure Monitoring Set/Tray | ||
| is intended for arterial blood pressure | |||
| monitoring and blood sampling in adult and | |||
| pediatric patients. | |||
| 5.0 French catheters are intended for | |||
| patients aged 12 years and older. | |||
| Device is for One- | |||
| time use | Yes | IDENTICAL TO PREDICATE | |
| Catheter Placement | |||
| Method | Percutaneously via Seldinger technique | IDENTICAL TO PREDICATE | |
| Shaft | |||
| Material | Polyurethane | Nylon | |
| Hub | |||
| Material | Polyurethane | Nylon | |
| Outer | |||
| Diameter | 3.0 French | 5.0 French | |
| Catheter | Length | 2.5, 5.0, 7.5, 8.0, 12.0, 22.0 cm | 15 cm |
| Number of | |||
| Lumens | Single Lumen | IDENTICAL TO PREDICATE | |
| Distal Tip | |||
| Design | Straight Tip | IDENTICAL TO PREDICATE | |
| Ink | |||
| Markings | Yes | IDENTICAL TO PREDICATE | |
| Packaging | Tray w/ Tyvek lidstock | IDENTICAL TO PREDICATE | |
| Sterilization | |||
| Method | EtO | IDENTICAL TO PREDICATE | |
| Sterility Assurance | |||
| Level | 10-6 | IDENTICAL TO PREDICATE |
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Technological Characteristics:
The subject device, Arterial Pressure Monitoring Set/Tray was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters:
Performance Testing:
- . Catheter Shaft Tensile (Aged) – The peak tensile load for the shaft section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Hub-to-Shaft Tensile (Aged) The peak tensile load for the hub-to-shaft . section of the catheter shall be greater than or equal to 10 N in accordance with BS EN ISO 10555-1:2013. The acceptance criterion was met.
- Catheter Liguid Leakage (Aged) No part of the catheter shall leak liquid when . tested in accordance with Annex C of BS EN ISO 10555-1. The acceptance criterion was met.
- . Catheter Air Leakage (Aged) – No air shall enter the hub when tested in accordance with Annex D of BS EN ISO 10555-1. The acceptance criterion was met.
- Catheter Kink Length (Aged) The catheter shall not kink (flowrate reduced by 50%) . at a specified kink (circumferential) length when tested in accordance with Annex B of BS EN 13868. The acceptance criterion was met.
- Catheter Gravity Flow Rate (Time-Zero) The flow rate shall be a minimum of 90% . of the flow rate stated by the manufacturer when tested in accordance with Annex E of BS EN ISO 10555-1. The acceptance criterion was met.
- Visual Inspection & Dimensional Analysis (Aged) Test was conducted to . demonstrate that the catheter dimensions are within the specified tolerances and the catheter and wire guide are compatible.
Biocompatibility Testing:
- Per ISO 10993-1 and FDA guidance, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, material-mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, and hemocompatibility were performed to ensure the biocompatibility of the subject device set.
7
Conclusion:
The results of these tests confirm that the Arterial Pressure Monitoring Set/Tray meets the design input requirements based on the intended use and support the conclusion that this device does not raise different questions of safety and/or effectiveness and is substantially equivalent to the predicate device, the Cook Pressure Monitoring Catheter (K002254).