(27 days)
The Steerable Guide Catheter is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum.
The Steerable Guide Catheter consists of a Steerable Guide Catheter (Guide) and a Dilator provided EO 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 two sealed Tyvek pouches, and boxed in a cardboard shelf-carton.
The provided text does not contain information about acceptance criteria or a study proving that an AI-based device meets these criteria. Instead, it is a 510(k) summary for a Steerable Guide Catheter, a physical medical device, and its associated FDA clearance letter.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, as these concepts are not applicable to the clearance of this type of physical device as presented in the document.
The document discusses bench testing for the physical device to demonstrate substantial equivalence to predicate devices, focusing on various performance characteristics related to the catheter's physical integrity and function (e.g., Guide Hemostasis, Tensile test, Torque test).
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Special 510(k)
510(k) SUMMARY
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| 510(k) SUMMARY | AUG 3 1 2011 | |
|---|---|---|
| Trade Name: | Steerable Guide Catheter | |
| Common Name: | Steerable Catheter | |
| Classification Name: | Class II, Catheter Introducer, 21 CFR 870.1280 | |
| Product Code: | DRA | |
| Manufacturer's Name: | Abbott Vascular Structural Heart | |
| Manufacturer's Address: | 4045 Campbell AvenueMenlo Park, CA 94025 | |
| Corresponding Official: | Cindy Morrow | |
| Title: | Principal Regulatory Affairs Associate | |
| Address: | 4045 Campbell AvenueMenlo Park, CA 94025 | |
| Phone: | (650) 833-1635 | |
| Date of Preparation: | August 3, 2011 | |
| Predicate: | K083793 Steerable Guide CatheterK091596 Steerable Guide CatheterK093866 Steerable Guide CatheterK100789 Steerable Guide Catheter | |
| Intended Use: | The Steerable Guide Catheter is used for introducing variouscardiovascular catheters into the left side of the heart through theinteratrial septum. | |
| Device Description: | The Steerable Guide Catheter consists of a Steerable GuideCatheter (Guide) and a Dilator provided EO sterile and for single-use only. The Steerable Guide Catheter consists of a distal andproximal catheter shaft, a radiopaque tip ring, a handle with asteering knob, a hemostasis valve with a luer lock flush port, anatraumatic distal tip, and a Dilator with a single central lumen.The central lumen of the Guide allows for aspiration of air andinfusion of fluids such as saline, and serves as a conduit duringintroduction and or exchange of the Dilator and ancillary devices(e.g. catheters) that have a maximum diameter of .204". Theatraumatic distal tip of the Steerable Guide Catheter is radiopaque |
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| to allow visualization under fluoroscopy. The Dilator consists of aradiopaque shaft, an echogenic feature at the distal tip, ahemostasis valve with a flush port and an internal lumen designedto accept ancillary devices that have a maximum diameter of0.035" (e.g. needles or guidewires). The Steerable Guide Catheter,Dilator and accessories are packaged in a tray enclosed in twosealed Tyvek pouches, and boxed in a cardboard shelf-carton. | |
|---|---|
| Comparison toPredicate: | The subject device is substantially equivalent to the predicatedevices with respect to intended use, indications for use, labeling,patient contacting materials, technological and performancecharacteristics, ergonomics of patient-user interface, overalldimensions, packaging, and sterilization. |
| SubstantialEquivalence: | Bench testing demonstrated that the subject device metperformance specifications and is substantially equivalent to thepredicate Steerable Guide Catheter and Dilator and was based inpart on the evaluation of the following performance characteristics:1. Guide Hemostasis: Initial Performance2. Guide Hemostasis: Column test with Dilator3. Guide Hemostasis: Short term column test after three insertionsand removals4. Guide Hemostasis: Long term column test5. Tensile test: Cap to Housing6. Tensile test shaft: Shaft to Housing7. Torque test for Luer |
| Conclusions: | The Steerable Guide Catheter and Dilator has the same indicationsfor use and technological characteristics and performs as well asthe predicate devices. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Abbott Vascular, Structural Heart
Re: K112239
Cynthia Morrow 4045 Campbell Ave. Menlo Park, CA 94025
Trade/Device Name: Steerable Guide Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: August 3, 2011 Received: August 4, 2011
Dear Ms. Morrow:
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.
AUG 3 1 2011
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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.ggv/AboutiFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Bram D. Zuckerman M.D.
Director 31 Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k) Number (if known): | K112239 |
|---|---|
| --------------------------- | --------- |
Device Name: ___ Steerable Guide Catheter
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.
Prescription Use X (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)
signature
Division Sign-Off) Division of Čardiovascular Devices
510(k) Number
§ 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).