(160 days)
The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.
The Applied Medical Dual Lumen Graft Cleaning Catheter is a single-use catheter intended for removal of thromboemboli from vascular grafts.
The provided text describes a 510(k) submission for the Applied Medical latis™ Dual Lumen Graft Cleaning Catheter. This regulatory submission process is focused on demonstrating substantial equivalence to a previously marketed device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/ML device might.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, MRMC studies, standalone performance with AI, training set details) are not applicable to this type of medical device submission as described in the provided document. The "study" here is primarily a set of mechanical and biocompatibility tests to show the device is safe and performs comparably to its predicates.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Safety | Demonstrated to be comparable to predicate devices (K910372, K950586, K970762). |
| Structural Integrity | Demonstrated to be comparable to predicate devices (K910372, K950586, K970762). |
| Material Safety | Demonstrated to be comparable to predicate devices (K910372, K950586, K970762). |
| Biocompatibility | Tests were performed to verify material safety and the device was found to introduce no new safety and effectiveness issues compared to predicate devices. |
Detailed Information (Not all applicable to this type of device submission):
-
Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not specified for clinical or performance data as this submission relies on demonstrating substantial equivalence through mechanical safety and biocompatibility tests, not a clinical trial with a "test set" of patients in the context of AI/ML evaluation.
- Data Provenance: Not applicable in the context of human data. The tests were likely conducted in a lab setting by the manufacturer.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not Applicable. The "ground truth" for this device's submission is primarily established through engineering tests (mechanical, functional, biocompatibility) and comparison to predicate devices, not through expert consensus on diagnostic images or patient outcomes.
-
Adjudication Method for the Test Set:
- Not Applicable. See point 2.
-
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:
- Not Applicable. This is not an AI/ML device, nor is it a device that is intended to assist human readers in interpretation. It's a physical medical catheter.
-
If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- Not Applicable. This is not an algorithm or AI system.
-
The Type of Ground Truth Used:
- The "ground truth" in this context is the successful completion of mechanical safety tests and biocompatibility tests, and the demonstration of comparability to the predicate devices. This is based on engineering specifications and established test methodologies for medical devices.
-
The Sample Size for the Training Set:
- Not Applicable. This device does not use a "training set" in the context of machine learning.
-
How the Ground Truth for the Training Set Was Established:
- Not Applicable. See point 7.
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APPENDIX VIII
510(k) SUMMARY
FEB 1 9 1998
510(k) NUMBER:
PENDING
SUBMITTED BY:
Applied Medical Resources Corporation 26051 Merit Circle, #103 Laguna Hills, California 92653 (714) 582-6120 EXT. 326
Mary Jo Stegwell CONTACT PERSON:
DATE OF PREPARATION: September 10, 1997
Dual Lumen Graft Cleaning Catheter NAME OF DEVICE:
Embolectomy Catheter CLASSIFICATION NAME:
Applied Medical latis™ Dual Lumen Graft Cleaning Catheter TRADE NAME:
SUMMARY STATEMENT:
The Applied Medical Dual Lumen Graft Cleaning Catheter is a single-use catheter intended for removal of thromboemboli from vascular grafts.
Mechanical safety and biocompatibility tests were performed to verify functional safety, structural integrity and material safety. All testing demonstrated that the Applied Medical Graft Cleaning Catheter is comparable to the predicate devices (K910372, K950586, K970762) and introduces no new safety and effectiveness issues when used as indicated.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 9 1998
Ms. Mary Jo Stegwell Vice President, Regulatory Affairs Applied Medical Resources 26051 Merit Circle, #104 Laguana Hills, CA 92653
Re : K973465 Applied Medical latis™ Dual Lumen Graft Cleaning Catheter Requlatory Class: II (Two) Product Code: DXE Dated: November 20, 1997 November 21, 1997 Received:
Dear Ms. Stegwell:
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 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 A substantially equivalent determination assumes compliance with 895. the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 requlation 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 - Ms. Mary Jo Steqwell
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 regulation (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 Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K973465
Device Name: _ Applied Medical latis™ Dual Lumen Graft Cleaning Catheter
Indications For Use: The Applied Medical latis™ Dual Lumen Graft Cleaning Catheter is a disposable catheter intended for use in the removal of thrombus from vascular grafts and for occlusion and infusion of fluids into a graft.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bera R. Bimpere
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K973465
Prescription Use_V (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-9θ) ··································
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).