(30 days)
The Evalve 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 (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, 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 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 two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
The provided text describes a 510(k) premarket notification for a medical device called the "Evalve Steerable Guide Catheter." This submission focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing of performance characteristics and biocompatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Specification) | Reported Device Performance |
|---|---|
| 1. Functional Testing | Met performance specifications |
| 2. Luer to Hemostasis Valve Housing Torque Strength | Met performance specifications |
| 3. Handle Interface Hypotube (Distal) to Shaft Tensile Strength | Met performance specifications |
| 4. Handle Interface Hypotube (Proximal) and Hemostasis Valve Housing to Shaft Tensile Strength | Met performance specifications |
| 5. Force to Curve (75°±5°) | Met performance specifications |
| 6. Force to Curve (Hard Stop) | Met performance specifications |
| 7. Packaging Inspection | Met performance specifications |
| 8. Bubble Emission | Met performance specifications |
| 9. Seal Strength | Met performance specifications |
| 10. Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity: Systemic Injection, Acute Systemic Toxicity: Material Mediate Pyrogen, Hemocompatibility: Hemolysis, Hemocompatibility, Coagulation: Partial Thrombolplastin Time (PTT), Hemocompatibility, Complement Activation:C3a and SC5b-9. | Met performance specifications for all listed biocompatibility tests. |
Study Details
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Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the functional, mechanical, packaging, or biocompatibility tests. It only states that "Bench testing demonstrated that the subject device met performance specifications." The data provenance is not explicitly mentioned as being from a specific country, but the submission is to the U.S. FDA, and the manufacturer is based in Menlo Park, CA, USA, implying the testing likely occurred in or for a U.S. context. All testing described is retrospective (bench testing of manufactured devices) rather than prospective clinical data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the described study is bench testing of a physical device, not related to expert evaluation of medical images or patient data. Ground truth for these tests would be objective measurements against predefined engineering specifications. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as there is no human interpretation or adjudication involved in the objective bench tests described. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was performed. This submission is for a physical medical device (a catheter) and does not involve AI or human readers for diagnostic interpretation. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This submission is for a physical medical device and does not involve an algorithm or AI. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the ground truth would be pre-defined engineering specifications, material standards, and industry-accepted testing methodologies for device performance (e.g., tensile strength values, force to bend within a certain range, biochemical test results). -
The sample size for the training set:
Not applicable. This submission is for a physical medical device and does not involve an AI algorithm with a training set. -
How the ground truth for the training set was established:
Not applicable. As there is no AI algorithm, there is no training set or ground truth for a training set.
In summary, the provided document describes a 510(k) submission for a steerable guide catheter, demonstrating substantial equivalence to predicate devices through a series of bench tests. The "study" is a compilation of these bench tests, which objectively evaluate the physical and functional properties of the device against engineering specifications and biocompatibility requirements. It does not involve clinical trials, human subject data, or AI components.
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510(k) SUMMARY
| Trade Name: | Steerable Guide Catheter | APR 21 2010 |
|---|---|---|
| Common Name: | Steerable Catheter | |
| ClassificationName: | Class II, Catheter Introducer, 21 CFR 870.1280 | |
| Device Code: | DRA | |
| Manufacturer's Name: | Evalve, Inc. | |
| Manufacturer'sAddress: | 4045 Campbell AvenueMenlo Park, CA 94025 | |
| CorrespondingOfficial:Title:Address: | Karuna VelusamySenior Regulatory Affairs Associate4045 Campbell AvenueMenlo Park, CA 94025 | |
| Phone: | (650) 330-8100 | |
| Date of Preparation: | March 17, 2010 | |
| Predicate | K083793 Evalve Steerable Guide CatheterK091596 Evalve Steerable Guide CatheterK093866 Evalve Steerable Guide Catheter | |
| Intended Use: | The Evalve Steerable Guide Catheter is used forintroducing various cardiovascular catheters into theleft side of the heart through the interatrial septum. | |
| Device Description: | The Steerable Guide Catheter consists of a SteerableGuide (Guide) and a Dilator provided EO sterile andfor single-use only. The Steerable Guide Catheterconsists of a distal and proximal catheter shaft, aradiopaque tip ring, a handle with a steering knob, ahemostasis valve with a luer lock flush port, a Dilatorwith a single central lumen and an atraumatic distaltip. The central lumen of the Guide allows foraspiration of air and infusion of fluids such as saline,and serves as a conduit during introduction and orexchange of the Dilator and ancillary devices (e.g.catheters) that have a maximum diameter of .204".The atraumatic distal tip of the Steerable Guide. |
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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 two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
The subject device is substantially equivalent to the Comparison to Predicate: predicate devices with respect to intended use, indications for use, labeling, patient contacting materials. Co technological and performance characteristics, ergonomics of patient-user interface, overall dimensions, packaging, and sterilization.
Bench testing demonstrated that the subject device Substantial Equivalence: met performance specifications and is substantially equivalent to the predicate Steerable Guide Catheter and Dilator and was based in part on the evaluation of the following performance characteristics:
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- Functional Testing
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- Luer to Hemostasis Valve Housing Torque Strenath
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- Handle Interface Hypotube (Distal) to Shaft Tensile Strength
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- Handle Interface Hypotube (Proximal) and Hemostasis Valve Housing to Shaft Tensile Strenath
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- Force to Curve (75°±5°)
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- Force to Curve (Hard Stop)
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- Packaging Inspection
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- Bubble Emission
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- Seal Strength
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- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity: Systemic Injection, Acute Systemic Toxicity: Material Mediate Pyrogen, Hemocompatibility: Hemolysis, Hemocompatibility, Coagulation: Partial Thrombolplastin Time (PTT), Hemocompatibility, Complement Activation:C3a and SC5b-9.
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Conclusions:
The Evalve Steerable Guide Catheter and Dilator have the same indications for use and technological characteristics and perform as well as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with its wings forming a human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Evalve Inc. c/o Ms. Karuna Velusamy Senior Regulatory Affairs Specialist 4045 Campbell Ave. Menlo Park, CA 94025
APR 2 1 2010
Re: K100789
Trade/Device Name: Evalve Steerable Catheter Common Name: Catheter, Steerable Regulation Number: 21 CFR 870.1280 Regulatory Class: II Product Code: DRA Dated: March 19, 2010 Received: March 22, 2010
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 Foond, Or v, 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
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Page 2 - Ms. Karuna Velusamy
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 (OS) 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.gov/AboutFDA/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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
vinar R. Lechner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _K100789
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 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)
bunna R. V. hnes
(Division Sign-Off) (Division Olyn Sign Singles
Page 1 of 1
510/k) Number_K100789
§ 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).