(126 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. 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).
Here's an analysis of the provided text regarding the acceptance criteria and study for the Steerable Guide Catheter, structured according to your request:
Acceptance Criteria and Study for the Steerable Guide Catheter (K083793)
This 510(k) summary describes a traditional device submission. For such medical devices, "acceptance criteria" typically refer to the successful completion of a series of performance tests against pre-defined specifications rather than algorithmic performance metrics found in AI/ML submissions. Similarly, the "study" is a set of bench tests confirming the device's physical and functional properties. Since this is a physical medical device and not an AI/ML algorithm, many of the requested fields are not applicable (N/A) or have interpretations in the context of device engineering rather than software performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Performance | Steerable Guide Torque | Met specifications | Detailed specifications are not provided in this summary, but the device passed. |
| Bending Range | Met specifications | Detailed specifications are not provided in this summary, but the device passed. | |
| Leakage Testing | Met specifications | Detailed specifications are not provided in this summary, but the device passed. | |
| Biocompatibility | Biocompatibility Studies | Met specifications | Implies that the materials are suitable for contact with the body. |
| Sterilization | Sterilization Validation | Met specifications | Confirms the device can be consistently sterilized. |
| Dimensional/Physical | Dimensional Characteristics | Substantially Equivalent | Compared to predicate devices. |
| Physical Characteristics | Substantially Equivalent | Compared to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of devices tested for each bench test (torque, bending, leakage, etc.). However, for mechanical performance testing of physical devices, multiple units are typically tested to establish statistical confidence in meeting design specifications.
- Data Provenance: The testing was conducted by the manufacturer, Evalve, Inc., in the United States (Menlo Park, CA). The study is prospective in the sense that the tests were designed and executed to validate the performance of the newly manufactured device according to its design specifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device submission. For a steerable guide catheter, "ground truth" is established by engineering specifications and objective measurements (e.g., measuring torque values, bending angles, or leakage rates against defined thresholds) rather than expert consensus on medical images or clinical outcomes. The "experts" involved would be the design engineers, quality assurance personnel, and test technicians who developed and executed the test protocols.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists, pathologists) when establishing a ground truth for diagnostic studies. For mechanical and performance bench testing of a physical device, results are typically objective measurements against predefined acceptance criteria, and any discrepancies would be resolved through re-testing or investigation into the testing methodology or device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging systems or AI algorithms where human reader performance is being evaluated, often with and without AI assistance. The Steerable Guide Catheter is a physical instrument, and its performance is assessed via bench testing, not human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The Steerable Guide Catheter is a physical medical device, not an algorithm. Its performance is inherent in its physical properties and mechanical function, which were tested in a "standalone" fashion (i.e., the device itself was subjected to tests).
7. The Type of Ground Truth Used
The "ground truth" for this device is based on engineering specifications and objective physical measurements. For example:
- Torque: Measured in units like N·cm, with acceptance based on a defined range.
- Bending Range: Measured in degrees or specific angles, with acceptance based on the ability to achieve a certain steerability.
- Leakage: Measured by observing fluid passage under pressure, with acceptance based on the absence of leakage.
- Biocompatibility: Confirmed through established biological safety tests (e.g., ISO 10993 series) which have defined pass/fail criteria.
- Sterilization: Validated through standard microbiological methods (e.g., ISO 11137 for radiation sterilization) with defined sterility assurance levels (SAL).
This "ground truth" is not derived from expert consensus, pathology, or outcomes data in the medical sense, but rather from scientific and engineering principles applied to device design and manufacturing.
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical instrument, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior device knowledge, but not by a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this physical medical device. The "ground truth" for its design and performance specifications would be established through:
- Engineering design requirements: Based on the intended use and predicate device characteristics.
- Regulatory standards: Adhering to relevant ISO standards for medical devices, biocompatibility, and sterilization.
- Pre-clinical testing: Early prototypes undergoing various tests to optimize design.
The overall submission demonstrates that the device's design, dimensional and physical characteristics met predetermined specifications and are substantially equivalent to existing predicate devices based on the bench testing performed.
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510(k) SUMMARY
APR 2 7 2009
| Trade Name: | Steerable Guide Catheter |
|---|---|
| Common Name: | Catheter Introducer |
| ClassificationName: | Class II, Catheter Introducer, 21 CFR 870.1340 |
| Device Code: | DYB |
| Manufacturer's Name: | Evalve, Inc. |
| Manufacturer'sAddress: | 4045 Campbell AvenueMenlo Park, CA 94025 |
| CorrespondingOfficial:Title:Address:Phone: | Karuna VelusamySenior Regulatory Affairs Specialist4045 Campbell AvenueMenlo Park, CA 94025(650) 330-8100 |
| PredicateDevice(s): | K043084 Velocimed Premere™ Delivery SheathK034025 NMT Medical Transseptal Sheath SetK002054 Appriva Medical X-SEPT TransseptalSheath and TransitionK970229 Arrow Transseptal Super Arrow-Flex™Percutaneous Sheath Introducer SetK052644 St. Jude Swartz™ Braided TransseptalGuiding Introducer |
| Indication for 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. The Steerable GuideCatheter consists of a distal and proximal cathetershaft, a radiopaque tip ring, a handle with a steeringknob, a hemostasis valve with a luer lock flush port, aDilator with a single central lumen and an atraumaticdistal tip. 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. |
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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
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A Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
Enclosure
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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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§ 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).