(19 days)
No
The device description focuses on mechanical components and manual steering, with no mention of AI/ML capabilities or related performance metrics.
No.
This device is described as a steerable guide catheter used for introducing other catheters and ancillary devices into the heart, rather than directly treating a condition itself.
No
Explanation: The device is a steerable guide catheter used for introducing other catheters into the heart. Its function is to facilitate access and delivery of other instruments, not to diagnose a condition. While it allows visualization under fluoroscopy, this is for guidance during the procedure, not primary diagnosis.
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 catheters into the left side of the heart through the interatrial septum. This is a procedure performed in vivo (within the living body).
- Device Description: The description details a physical device (catheter, dilator, handle, etc.) used for a surgical or interventional procedure.
- 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.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing in vitro (outside the living body) on biological samples. This device is clearly designed for a direct medical intervention within the body.
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
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 .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 enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.
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
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 Steerable Guide Catheter is equivalent in fundamental scientific design to the predicate Steerable Guide Catheter, and therefore, meets the same performance specifications as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K083793, K091596, K093866, K100789, K112239
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 07, 2016
Abbott Vascular Makena Mc Gowan Regulatory Affairs Associate 3200 Lakeside Drive Santa Clara, California 95054
Re: K161985
Trade/Device Name: Steerable Guide Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: July 18, 2016 Received: July 19, 2016
Dear Ms. Mc Gowan:
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 (QS) 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,
M.A. Hilleman
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) K161985
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) |
|---|
| ------------------------------------------------- |
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
The 510(k) Summary is submitted in accordance with 21 CFR §807.1280 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) 845-0937 |
| 4. | Fax | (408) 845-3734 |
| 5. | Contact Person | Makena Mc Gowan |
| 6. | Date Prepared | August 4, 2016 |
| 7. | Device Trade Name | Steerable Guide Catheter |
| 8. | Device Common Name | Steerable Catheter |
| 9. | Device Classification Name | Catheter, Steerable |
| 10. | Predicate Device Name | K083793 Steerable Guide Catheter |
| K091596 Steerable Guide Catheter | ||
| K093866 Steerable Guide Catheter | ||
| K100789 Steerable Guide Catheter | ||
| K112239 Steerable Guide Catheter |
11. 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 .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 enclosed in a sealed Tyvek pouch and boxed in a cardboard shelf-carton.
4
12. 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.
13. Technological Characteristics
Comparison of the new device and predicate device demonstrate that the technological characteristics such as design, material, and indications for use are substantially equivalent to the current marketed predicate device.
14. Performance Data
The Steerable Guide Catheter is equivalent in fundamental scientific design to the predicate Steerable Guide Catheter, and therefore, meets the same performance specifications as the predicate device.
15. Conclusions
The Steerable Guide Catheter has the same indications for use and technological characteristics and is substantially equivalent to the predicate device.