(118 days)
Not Found
No
The description focuses on the mechanical components and function of a steerable catheter and dilator, with no mention of AI or ML capabilities.
No.
The device is a guide catheter used to introduce other catheters and medical devices; it does not directly treat a disease or condition itself.
No
Explanation: The device is described as a Steerable Guide Catheter used for introducing other catheters into the heart. Its function is to facilitate the placement of other devices, not to diagnose a condition itself. While it allows for visualization under fluoroscopy and aspiration of air/infusion of fluids, these are part of its function as a guide, not a diagnostic tool.
No
The device description clearly outlines physical components such as a catheter shaft, handle, steering knob, valves, and a dilator, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "introducing various catheters into the left side of the heart through the interatrial septum." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device (catheter, dilator, handle, etc.) used for accessing and navigating within the heart. It does not describe reagents, test strips, or equipment used to analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical/interventional tool used for accessing and facilitating procedures within the heart.
N/A
Intended Use / Indications for Use
The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DRA
Device Description
The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
Anatomical Site
left side of the heart through the interatrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Testing was performed to support substantial equivalence, including:
- Biocompatibility
- Sterilization
- Packaging Performance
- Shelf Life
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.
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
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 29, 2019
Abbott Ms. Ekta Lad Sr. Specialist Regulatory Affairs 3200 Lakeside Drive Santa Clara, California 95054
Re: K190167
Trade/Device Name: Steerable Guide Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: April 29, 2019 Received: May 1, 2019
Dear Ms. Lad:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
for Nicole Ibrahim Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190167
Device Name Steerable Guide Catheter
Indications for Use (Describe)
The Steerable Guide Catheter is used for introducing various catheters into the left side of the heart through the interatrial septum.
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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3
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR §807.92(c) and the requirements of the Safe Medical Device Act (SMDA) of 1990.
| 1. | Submitter's Name | Abbott Vascular |
|---|---|---|
| 2. | Submitter's Address | 3200 Lakeside Drive Santa Clara, CA 95054 |
| 3. | Telephone | (408) 845-8132 |
| 4. | Fax | (408) 845-3734 |
| 5. | Contact Person | Ekta Lad |
| 6. | Date Prepared | May 22, 2019 |
| 7. | Device Trade Name | Steerable Guide Catheter |
| 8. | Device Common Name | Steerable Catheter |
| 9. | Classification | Regulation Number: 21 CFR 870.1280 |
| 10. | Product Code | DRA |
| 11. | Predicate Device Name | K172394 Steerable Guide Catheter |
12. Device Description
The Steerable Guide Catheter consists of a Guide and a Dilator provided EtO sterile and for single use only. The Steerable Guide Catheter consists of a distal and proximal catheter shaft, a radiopaque tip ring, a handle with a steering knob, a hemostasis valve with a luer lock flush port, an atraumatic distal tip, and a Dilator with a single central lumen. The central lumen of the Guide allows for aspiration of air and infusion of fluids such as saline, and serves as a conduit during introduction and or exchange of the Dilator and ancillary devices (e.g. catheters) that have a maximum diameter of 0.204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under fluoroscopy. The Dilator consists of a radiopaque shaft, an echogenic feature at the distal tip, a hemostasis valve with a flush port and an internal lumen designed to accept ancillary devices that have a maximum diameter of 0.035" (e.g. needles or guidewires). The Steerable Guide Catheter, Dilator and accessories are packaged in a tray that is individually pouched in a Tyvek/Nylon corner peel pouch, heat-sealed one time, and the single sealed pouch is placed into a cardboard nest and top-loading box.
13. Indication for Use
The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
4
14. Comparative Technology Characteristics
A comparison of the characteristics of the proposed device and predicate device show the Steerable Guide Catheter to have the same technological characteristics to the current cleared predicate device. Equivalence is based upon intended use, indications for use, principles of operation and fundamental technology.
The subject and predicate device have similar or identical materials of composition, dimensions, and sterilization. Changes between the device and predicate include a minor design modification, packaging, and shelf life.
15. Performance Data
Testing was performed to support substantial equivalence, including:
- Biocompatibility Sterilization Packaging Performance Shelf Life
16. Conclusion
The subject Steerable Guide Catheter is equivalent to the predicate device. This conclusion is based upon the fact that the devices have an equivalent intended use, and there are no differences that raise different questions of safety and effectiveness.