(262 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a guiding catheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as a "guiding catheter" intended for the "introduction of interventional/diagnostic devices." It facilitates the delivery of other devices rather than providing therapy itself.
No
Explanation: The device is described as a "guiding catheter" intended for the introduction of other devices into the vascular system. While it facilitates the use of "diagnostic devices," it is not itself described as performing a diagnostic function.
No
The device description clearly outlines a physical catheter with multiple material layers and components (shaft, tip, luer, etc.). The performance studies focus on bench testing of physical characteristics like flexibility, torque, and tensile strength, which are indicative of a hardware device. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems. This describes a device used within the body for procedural purposes, not for testing samples outside the body.
- Device Description: The description details a catheter with a shaft, tip, and luer, designed for insertion into blood vessels. This is consistent with an invasive medical device used for access and delivery, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes related to in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device is a tool used to facilitate procedures within the body.
N/A
Intended Use / Indications for Use
The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Product codes (comma separated list FDA assigned to the subject device)
DQY
Device Description
The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary or peripheral vascular systems
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Xcess Guiding Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent. The Xcess Guiding Catheters have been tested and shown to be compliant with the following standards documents:
- ISO 10555-1:2013- Intravascular catheters – Sterile, single-use intravascular catheters – Part 1: General requirements
- ISO 10993-1:2009- Biological evaluation of medical devices – Part 1: Evaluation and testing
- ISO 10993-3:2014- Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices -Part 4: Selection of tests for interactions with blood
- ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006- Biological testing of medical and dental materials and devices – Part 11: Tests for systemic toxicity
- ISO 10993-12:2012- Biological testing of medical and dental materials and devices – Part 12: Sample Preparation And Reference Materials
- ISO 11135: 2014 Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- EN ISO 11607-1: 2009(R2014)- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Performance Testing (bench testing recommendations outlined in the ISO 10555-1 Sterile, single-use intravascular catheters-Part 1: General requirement):
- Visual and dimension inspection
- Coating integrity and particulate evaluation
- Catheter usability
- Catheter shape retention
- Catheter freedom from leakage
- Catheter torque
- Catheter pressure integrity
- Catheter flexibility and kink
- Catheter joints tensile strength
- Corrosion resistance
- Radio-detectability
Biocompatibility Testing (in accordance with ISO 10993 and the FDA Guidance Document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" dated June 2016):
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)
Key results: The results of these tests demonstrate that the technological characteristics and performance criteria of the Xcess Guiding Catheter are adequate for its intended use, and that is substantially equivalent to the predicate device. The results from these tests demonstrate that the Xcess Guiding Catheter is biocompatible for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
VISTA BRITE TIP Guiding Catheter (K962830)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 14, 2018
Curatia Medical Co. % Breanne Butler Regulatory Affairs Consultant JCO Consulting 11218 Zest Court NE Blaine, Minnesota 55449
Re: K180797
Trade/Device Name: Xcess Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 15, 2018 Received: November 15, 2018
Dear Breanne Butler:
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 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.html; 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 medical devices and radiation-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.
Lydia S. Digitally signed by Lydia S. Glaw -S Date: 2018.12.14 Glaw -S 15:12:17 -05'00'
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) K180797
Device Name Xcess Guiding Catheter
Indications for Use (Describe)
The guiding catheter is intended to use for introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
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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3
510(k) Summary
510(k) SUMMARY K180797
| Submitter: | Curatia Medical Co.
3227 Kifer Road
Santa Clara, CA 95051
Establishment Number: 3008361782 |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person:
Phone:
Fax:
Email: | Jessica Chiu, VP
(408) 414-2188
(408) 413-3000
jchiu@curatiamed.com |
| Submission Correspondent:
Address:
Phone:
Email: | Breanne Butler, Regulatory Affairs Consultant
11218 Zest Ct. NE, Blaine, MN 55449
(860)-810-5594
breanne.sm.butler@gmail.com |
| Date Prepared: | December 13, 2018 |
| Proprietary Name: | Xcess Guiding Catheter |
| Common Name: | Percutaneous catheter |
| Product Code: | DQY |
| Device Classification: | Class II, 21 CFR 870.1250 - Percutaneous Catheter |
| Predicate Devices: | VISTA BRITE TIP Guiding Catheter (K962830) |
Device Description:
The Xcess guiding catheter is available in many different curve shapes and two sizes (5F and 6F). Each device consists of a catheter shaft, soft extension, soft tip, strain relief and luer. The catheter shaft is constructed with 3 layers: an outer layer of radiopaque Nylon/Pebax material, a middle layer of braided stainless steel, and an inner layer of PTFE tubing. The soft extension and soft tip consist of 2 layers: an outer layer of a radiopaque Nylon/Pebax material of differing hardness than the layer in the catheter shaft and an inner layer of PTFE. The strain relief at the proximal end of the catheter prevents kinking during catheter manipulation, and the luer is used to connect with either a hemostasis valve-linked accessory or 3-way connector. The distal ends of the guiding catheters are formed into a variety of shapes required to access differing vasculatures. The guiding catheters are provided with a hydrophilic coating on the catheter body. The guiding catheters are designed to accept a maximum of 0.038" (0.97mm) diameter guide wire.
4
Indications for Use:
The guiding catheter is intended to use for intravascular introduction of interventional/diagnostic devices into the coronary or peripheral vascular systems.
Comparison to Predicate Devices:
The Xcess Guiding Catheter is substantially equivalent in design, construction, and performance characteristics to the following commercially available product: VISTA BRITE TIP Guiding Catheters (CORDIS - FDA registration No: K962830, 1996). Based on comparison and testing of the predicated device and the Xcess Guiding Catheter, the specifications of the Xcess Guiding Catheter (Curatia) are substantially equivalent to the predicate device, VISTA BRITE TIP Guiding Catheter (Cordis). The clinical, technical, material, and biological specifications of the Xcess Guiding Catheter are substantially equivalent to the predicate device.
Summary of Performance Data and Substantial Equivalence:
The Xcess Guiding Catheters were designed and verified in accordance with the risk analysis and product requirements. All tests confirmed the products met the pre-defined acceptance criteria. Curatia Medical has determined that the Xcess Guiding Catheters are substantially equivalent. The Xcess Guiding Catheters have been tested and shown to be compliant with the following standards documents:
- . ISO 10555-1:2013- Intravascular catheters – Sterile, single-use intravascular catheters – Part 1: General requirements
- ISO 10993-1:2009- Biological evaluation of medical devices – Part 1: Evaluation and testing
- ISO 10993-3:2014- Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
- . ISO 10993-4:2002+AMD1:2006-Biological testing of medical and dental materials and devices -Part 4: Selection of tests for interactions with blood
- ISO 10993-5: 2009- Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin ● sensitization
- ISO 10993-11:2006- Biological testing of medical and dental materials and devices – Part 11: Tests for systemic toxicity
- . ISO 10993-12:2012- Biological testing of medical and dental materials and devices – Part 12: Sample Preparation And Reference Materials
- . ISO 11135: 2014 Sterilization of health-care products-Ethylene oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices
- EN ISO 11607-1: 2009(R2014)- Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
Performance Testing:
To demonstrate substantial equivalence of the Xcess Guiding Catheter to the predicate device, the technological characteristics and performance criteria were evaluated using the bench testing recommendations outlined in the ISO 10555-1 Sterile, single-use intravascular catheters-Part 1: General requirement. The following performance tests were completed:
- . Visual and dimension inspection
- Coating integrity and particulate evaluation ●
- . Catheter usability
5
- Catheter shape retention ●
- Catheter freedom from leakage ●
- Catheter torque
- . Catheter pressure integrity
- Catheter flexibility and kink ●
- Catheter joints tensile strength ●
- Corrosion resistance
- . Radio-detectability
The results of these tests demonstrate that the technological characteristics and performance criteria of the Xcess Guiding Catheter are adequate for its intended use, and that is substantially equivalent to the predicate device.
Biocompatibility:
To demonstrate the biocompatibility of the materials in contact with the body and substantial equivalence of the Xcess Guiding Catheter to its predicate device, the following biocompatibility testing was performed in accordance with ISO 10993 and the FDA Guidance Document "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing"" dated June 2016:
- . Cytotoxicity
- . Sensitization
- Irritation or Intracutaneous Reactivity ●
- Acute Systemic Toxicity ●
- Material-Mediated Pyrogenicity
- Hemocompatibility (Hemolysis, Thrombogenicity, and Complement Activation)
The results from these tests demonstrate that the Xcess Guiding Catheter is biocompatible for its intended use.
Conclusion:
Based on comparison of indications for use, technological characteristics, performance testing, biocompatibility testing, the Xcess Guiding Catheter has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed predicate device.