(85 days)
The Malleable Vent Catheter is intended for use during cardiopulmonary bypass Surgery to vent/drain the left ventricle.
The Malleable Vent Catheter is designed to vent/drain the left ventricular during coronary artery bypass surgery.
It consists of soft polyviny] chloride (PVC) tubing with a radius tip and vent holes 3.5 cm along the distal tip. The soft PVC tubing consists of two lumens; one large lumen for venting/drainage and one smaller lumen which encapsulates the stainless steel wire. The encapuslated stainless steel wire enables preshaping of the catheter prior to insertion and support during catheter placement. The proximal end of the catheter contains a rigid PVC connector and depth markings along the farge lumen.
The provided document is a 510(k) premarket notification for a medical device, the California Medical Laboratories Inc. Malleable Vent Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with defined acceptance criteria and detailed performance metrics as would be found in a Premarket Approval (PMA) application or a de novo submission.
Therefore, the document does not contain the acceptance criteria or reported device performance data from a study that proves the device meets those criteria in the way you've outlined. The information you are requesting is typically found in clinical trial reports or performance testing documentation, which are not usually included in full in a 510(k) summary that focuses on substantial equivalence.
Here's an explanation of why the requested information isn't available in this document and what is typically presented in a 510(k) for devices like this:
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Acceptance Criteria and Reported Performance: For a 510(k), particularly for a Class II device like a catheter, the "acceptance criteria" are primarily related to demonstrating that the new device has the same technological characteristics and same intended use as the predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" proving this often involves non-clinical testing (e.g., biocompatibility, sterility, material strength, dimensional accuracy) compared to established standards or the predicate device's specifications, rather than clinical efficacy studies with specific outcome metrics. The document explicitly states: "The California Medical Laboratories, Inc devices have technologic characteristics which are substantially equivalent to the predicate device."
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Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set, etc.: These concepts (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are highly relevant to complex diagnostic algorithms, AI/ML-based devices, or clinical efficacy trials for novel devices. They are not typically applicable to a mechanical device like a vent catheter seeking 510(k) clearance based on substantial equivalence to existing devices. For such devices, performance is usually assessed through engineering bench testing, material testing, and sometimes simulated-use testing.
In summary, the provided K981601 document does not contain the specific information requested in your bullet points because:
- It is a 510(k) submission focused on proving substantial equivalence to a predicate device, not on presenting novel clinical performance data against predefined acceptance criteria from a comprehensive clinical study.
- The device (a malleable vent catheter) is a mechanical device, and its safety and effectiveness are typically demonstrated through material testing, functional testing, and comparison of characteristics to a predicate, rather than through extensive clinical trials with the types of performance metrics and study designs relevant to AI/diagnostic devices (e.g., sensitivity, specificity, MRMC studies, training/test sets).
If this were a more complex diagnostic device or an AI-driven device, the 510(k) summary (or the full submission, if available) would contain much more detail on validation studies, potentially including some of the elements you've listed.
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111 28 1998
Summary of Safety and Effectiveness
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The California Medical Laboratories, Inc. devices are substantially equivalent to the DLP and Research Medical predicate device. The California Medical Laboratories, Inc. devices have substantially equivalent intended uses as the predicate device. The California Medical Laboratories, Inc. devices have technologic characteristics which are substantially equivalent to the DLP and Research Medical predicate device.
COMPANY AND CONTACT PERSON
California Medical Laboratories Inc. 2681 Kelvin Avenue Irvine. California 92614
Mehmet Bicakci President
DEVICE NAME
California Medical Laboratories Inc. Malleable Vent Catheter
NAME OF PREDICATE OR LEGALLY MARKETED DEVICE
The claim of substantial equivalence is based upon the following devices:
- Research Medical, Inc. Left Ventricular Vent Catheter .
- . DLP, Inc. Left Ventricular Malleable Vent Catheter
DESCRIPTION OF DEVICE
The Malleable Vent Catheter is designed to vent/drain the left ventricular during coronary artery bypass surgery.
It consists of soft polyviny] chloride (PVC) tubing with a radius tip and vent holes 3.5 cm along the distal tip. The soft PVC tubing consists of two lumens; one large lumen for venting/drainage and one smaller lumen which encapsulates the stainless steel wire. The encapuslated stainless steel wire enables preshaping of the catheter prior to insertion and support during catheter placement. The proximal end of the catheter contains a rigid PVC connector and depth markings along the farge lumen.
STATEMENT OF INTENDED USE
The Malleable Vent Catheter is intended for use during cardiopulmonary bypass Surgery to vent/drain the left ventricle.
STATEMENT OF INTENDED USE OF PREDICATE/MARKETED DEVICES
The predicate devices have the same intended use as stated above.
STATEMENT OF COMPARISON OF TECHNOLOGIC CHARACTERISTICS BETWEEN DEVICE AND PREDICATE DEVICE
The California Medical Laboratories, Inc devices have technologic characteristics which are substantially equivalent to the predicate device.
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Image /page/1/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, depicted with flowing lines to suggest movement or flight. The overall design is simple and symbolic, representing the department's role in health and human services.
JUL 2 8 1998
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Mehmet Bicakci President California Medical Laboratories, Inc. 2681 Kelvin Avenue Irvine, CA 92614
Re : K981601 Malleable Vent Catheter Regulatory Class: II (Two) Product Code: DWF Dated: Mav 1, 1998 Received: May 4, 1998
Dear Mr. Bicakci:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Mehmet Bicakci
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Also, please note the regulation Compliance at (301) 594-4639. entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K
Device Name: California Medical Laboratories Inc. Malleable Vent Catheter.
Indications For Use: The Malleable Vent Catheter is indicated for use during cardiopulmonary bypass surgery to vent/drain the left ventricle.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kira Kuiperle
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_k 98 160 /
X Prescription Use Per 21 CFR 801.109
OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).