(126 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a steerable catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is described as a guide catheter used for introducing other cardiovascular catheters, acting as a conduit rather than providing direct therapy.
No
The device is described as a steerable guide catheter used for introducing other cardiovascular catheters, which is a procedural and interventional function, not a diagnostic one.
No
The device description clearly outlines physical components like 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 to introduce other cardiovascular catheters into the heart. This is a procedural device used in vivo (within the body) for a medical intervention.
- Device Description: The description details a physical catheter and dilator designed for insertion into the body.
- 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 to perform tests on biological samples outside of the body. This device is clearly designed for direct use within the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Product codes
DYB, DRA
Device Description
The Steerable Guide Catheter consists of a Steerable Guide (Guide) and a Dilator. 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, a Dilator with a single central lumen and an atraumatic distal tip. 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 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).
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
Testing of the Steerable Guide Catheter was completed to demonstrate that the device meets the specifications and performance characteristics, and is substantially equivalent to the predicate devices. The testing included Steerable Guide torque, bending range and leakage testing. In addition, biocompatibility studies and sterilization validation were completed for the Steerable Guide Catheter.
Key Metrics
Not Found
Predicate Device(s)
K043084, K034025, K002054, K970229, K052644
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
510(k) SUMMARY
APR 2 7 2009
| Trade Name: | Steerable Guide Catheter |
|---|---|
| Common Name: | Catheter Introducer |
| Classification | |
| Name: | Class II, Catheter Introducer, 21 CFR 870.1340 |
| Device Code: | DYB |
| Manufacturer's Name: | Evalve, Inc. |
| Manufacturer's | |
| Address: | 4045 Campbell Avenue |
| Menlo Park, CA 94025 | |
| Corresponding | |
| Official: | |
| Title: | |
| Address: | |
| Phone: | Karuna Velusamy |
| Senior Regulatory Affairs Specialist | |
| 4045 Campbell Avenue | |
| Menlo Park, CA 94025 | |
| (650) 330-8100 | |
| Predicate | |
| Device(s): | K043084 Velocimed Premere™ Delivery Sheath |
| K034025 NMT Medical Transseptal Sheath Set | |
| K002054 Appriva Medical X-SEPT Transseptal | |
| Sheath and Transition | |
| K970229 Arrow Transseptal Super Arrow-Flex™ | |
| Percutaneous Sheath Introducer Set | |
| K052644 St. Jude Swartz™ Braided Transseptal | |
| Guiding Introducer | |
| Indication for Use: | The Evalve Steerable Guide Catheter is used for |
| introducing various cardiovascular catheters into the | |
| left side of the heart through the interatrial septum. | |
| Device Description: | The Steerable Guide Catheter consists of a Steerable |
| Guide (Guide) and a Dilator. 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, a | |
| Dilator with a single central lumen and an atraumatic | |
| distal tip. 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. |
1
catheters) that have a maximum diameter of .204". The atraumatic distal tip of the Steerable Guide Catheter is radiopaque to allow visualization under The Dilator consists of a shaft, an fluoroscopy. 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).
Testina: Testing of the Steerable Guide Catheter was completed to demonstrate that the device meets the specifications and performance characteristics, and is substantially equivalent to the predicate devices. The testing included Steerable Guide torque, bending range and leakage testing. For a complete list, please see Section 18. In addition, biocompatibility studies and sterilization validation were completed for the Steerable Guide Catheter.
The Steerable Guide Catheter will be provided sterile Sterilization: and is intended for single use only.
Guide Catheter is packaged Packaging and Labeling: The Steerable individually in a packaging tube followed by a double sealed Tyvek pouch, and boxed in a shelf-cardboard carton. Four Steerable Guide Catheter shelf-cartons are packaged together in a shipping-carton prior to being shipped to the sterilizer.
Substantial Equivalence: The design, dimensional and physical characteristics and indication for use submitted in this pre-market notification demonstrate that the Steerable Guide Catheter is substantially equivalent to the predicate devices cleared under K043084, K034025, K002054, K970229 and K052644. The bench testing conducted on the device demonstrates that the Steerable Guide Catheter is safe and effective for its intended use.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 2009
Evalve, Inc.. c/o Ms. Karuna Velusamy Senior Regulatory Affairs Specialist 4045 Campbell Ave. Menlo Park, CA 94025
Re: K083793
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 17, 2009 Received: April 20, 2009
Dear Ms. Velusamy:
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. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
3
Page 2 - Ms. Karuna Velusamy
forth in 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
D. Lachner
Image /page/3/Picture/5 description: The image contains two distinct elements. On the left, there's a hand-drawn symbol that resembles a stylized letter or abstract design. To the right of this symbol, the letters 'B' and 'D' are vertically stacked, suggesting they might be initials or part of a larger text.
A Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): _ K0 83 7 93
Device Name: ____ Steerable Guide Catheter
Indication for Use:
The Evalve Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
Prescription Use × (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dummer R. Wachner
(Division Sign-Off) Division or Cardiovascular Devices
510(k) Number_K083793
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