(27 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 and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
The provided text describes a 510(k) submission for a medical device called the "Evalve Steerable Guide Catheter." This document primarily focuses on demonstrating "substantial equivalence" to predicate devices through bench testing. It does not describe an AI/ML-enabled device or a clinical study that proves the device meets specific performance criteria in a clinical setting with human readers.
Therefore, many of the requested elements are not applicable to the provided text.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format that would typically be found for an AI/ML device's performance. Instead, it refers to "performance specifications" being met through bench testing. The general acceptance criterion implied is "substantial equivalence" to predicate devices, meaning it performs as well or better.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance specifications for physical properties. | Bench testing demonstrated that the subject device met performance specifications. |
| Substantially equivalent to predicate devices (K083793 and K091596). | The subject device met performance specifications and is substantially equivalent to the predicate devices. |
| Performs as well as or better than predicate devices. | Performs as well or better than the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The study described is bench testing of a physical medical device, not an AI/ML algorithm evaluated on a data set. There is no "test set" in the context of image data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI/ML algorithm requiring expert-established ground truth on a test set.
4. Adjudication Method for the Test Set
Not applicable. No test set of data with ground truth requiring adjudication is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. This document does not mention an MRMC study or any study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm. The device is a physical catheter.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by bench testing against predetermined engineering specifications and comparison to the performance of predicate devices. This involves physical measurements and observations of the catheter's properties (e.g., steerability, lumen patency, material integrity, etc.) rather than medical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML algorithm. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML algorithm. There is no "training set" or corresponding ground truth.
Summary of the Study:
The "study" referenced in this document is a series of bench tests (laboratory testing) conducted on the physical "Evalve Steerable Guide Catheter." The purpose of these tests was to demonstrate that the device meets its own performance specifications and is "substantially equivalent" to two previously cleared predicate devices (K083793 and K091596). This approach is standard for 510(k) submissions of non-AI/ML medical devices where clinical efficacy studies may not be required if substantial equivalence to a legally marketed device can be shown through non-clinical means.
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510(k) SUMMARY
| Trade Name: | Steerable Guide Catheter |
|---|---|
| Common Name: | Steerable Catheter |
| ClassificationName: | Class II, Catheter Introducer, 21 CFR 870.1280 |
| Device Code: | DRA |
| Manufacturer's Name: | Evalve, Inc. |
| JAN 1 3 2010 | |
| Manufacturer'sAddress: | 4045 Campbell AvenueMenlo Park, CA 94025 |
| CorrespondingOfficial: | Sevrina Ciucci |
| Title:Address: | Regulatory Affairs Consultant4045 Campbell AvenueMenlo Park, CA 94025 |
| Phone: | (408) 316-4837 |
| Date of Preparation: | December 16, 2009 |
| Predicate: | K083793 and K091596 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 GuideCatheter is radiopaque to allow visualization under |
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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 and Dilator are packaged in two sealed Tyvek pouches, and boxed in a shelf-cardboard carton.
Comparision The subject device is substantially equivalent to the to Predicate: predicate devices with respect to intended use, indications for use, labeling, patient contacting materials. technological and performance characteristics, ergonomics of patient-user interface, overall dimensions, packaging, and sterilization.
- Substantial Equivalence: Bench testing demonstrated that the subject device met performance specifications and is substantially equivalent to the predicate devices.
- Conclusions: The Evalve Steerable Guide Catheter and Dilator has the same indications for use and technological characteristics and performs as well or better than the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird with outstretched wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Evalve Inc. c/o Ms. Sevrina Ciucci Evalve Regulatory Consultant 4045 Campbell Ave. Menlo Park, CA 94025
JAN 1 3 2010
Re: K093866
Trade/Device Name: Evalve Steerable Guide Catheter Common Name: Catheter, Steerable Regulation Number: 21 CFR 870.1280 Regulatory Class: II Product Code: DRA Dated: December 16, 2009 Received: December 17, 2009
Dear Ms. Ciucci:
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.
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
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Page 2 - Ms. Sevrina Ciucci
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.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" (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 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,
R. Vainer
Image /page/3/Picture/7 description: The image contains a handwritten letter 'f' in a cursive style. The letter is written in black ink and has a slightly irregular shape. The top part of the 'f' is more curved, while the bottom part extends downwards with a loop.
A 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): _KO93866
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)
Duane R. Van Ausdal
ാivision Sign-Off) ് Vision of Cardiovascular Devices
5100g) Number_Kog
§ 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).