(90 days)
CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.
The MassTRANSIT is a single lumen catheter designed to access small, tortuous vasculature for the delivery of diagnostic, embolic and therapeutic agents. The shaft tapers from 3.0F proximal to 2.8F distally. The catheter has a hydrophilic coating to provide lubrication for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices.
The provided text describes a 510(k) premarket notification for the CES MassTRANSIT Infusion Catheter, focusing on its substantial equivalence to predicate devices rather than specific performance studies with acceptance criteria for device accuracy or effectiveness.
Therefore, many of the requested elements for describing "the acceptance criteria and the study that proves the device meets the acceptance criteria" are not explicitly available in the provided document. This document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document mentions "acceptance criteria stipulated in the test protocols" for biocompatibility. For the overall device, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to predicate devices.
- Reported Device Performance: The document states:
- "All appropriate biocompatibility tests have been performed according to the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols."
- "The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction, indication for use and performance characteristics to the predicate devices."
Table (based on available information):
| Criterion Type | Acceptance Criteria (as per document) | Reported Device Performance (as per document) |
|---|---|---|
| Biocompatibility | Meeting acceptance criteria stipulated in test protocols (ISO-10993 Modified Matrix) | Catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria. |
| Overall Device | Demonstrate "substantial equivalence" to predicate devices in design, construction, indications for use, and performance characteristics. | The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction, indication for use and performance characteristics to the predicate devices (CES TRANSIT, FasTRACKER ® 325, JETSTREAM® 327). The FDA concurred with this determination of substantial equivalence (K974222). |
Missing Information (not detailed in this 510(k) Summary):
The document does not provide specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, resolution, throughput, etc.) with corresponding acceptance criteria usually associated with studies designed to prove performance for a novel device. As a 510(k) claiming substantial equivalence, such detailed performance studies with quantifiable acceptance criteria are often not required if the device is sufficiently similar to existing legally marketed devices.
Regarding your specific questions (2-9):
Since this is a 510(k) submission focused on substantial equivalence rather than a de novo clinical or performance study for a novel device, the following points are largely not applicable or not extractable from the provided text:
- Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as there are no detailed performance studies on a "test set" described for this device. Biocompatibility tests were performed, but details on sample size or data provenance for these are not provided in this summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of device performance studies (like for diagnostic AI) is not relevant here.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is an infusion catheter, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this regulatory submission is the established safety and effectiveness of the predicate devices.
- The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
- How the ground truth for the training set was established: Not applicable.
In summary:
The document serves as a regulatory notification for a medical device (infusion catheter) achieving market clearance through the 510(k) pathway by demonstrating substantial equivalence to already approved predicate devices. It relies on a comparison to existing devices and performance of standard biocompatibility tests, rather than presenting a novel clinical study with detailed performance metrics and acceptance criteria as might be seen for entirely new device types, especially in areas like diagnostics or AI.
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Appendix A - Summary of Safety and Effectiveness
Appendix A - Summary of Safety and Effectiveness and K974222
FEB 1 0 1998
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Image /page/1/Picture/0 description: The image shows two lines of handwritten text. The first line contains the string "K974222", while the second line contains the string "0-000030". The text appears to be written in black ink on a white background. The handwriting is somewhat stylized, with some of the characters having unique shapes.
510(k) Summary of Safety and Effectiveness
The predicate devices are listed in the table below. Predicate Devices
| Device | Company | 510 (k) Number, Concurrence Date | Product Code |
|---|---|---|---|
| CES TRANSIT | Cordis Endovascular Systems, Inc. | K952874, K936260K936282, K965181,K972518 | DQOKRA |
| FasTRACKER ® 325 | Target Therapeutics | K960806* | DQO* |
| JETSTREAM® 327 | Medtronic | K953900, K953892* | DQOKRA |
- This information is assumed based on our best current knowledge.
| Classification | Class II |
|---|---|
| PerformanceStandard | Performance standards have not been established by the FDA under Section 514 ofthe Food, Drug and Cosmetic Act. |
| Intended use | The MassTRANSIT is indicated for the infusion of various diagnostic, therapeutic andembolic agents in the peripheral, coronary, and neurovasculature. |
| DeviceDescription | The MassTRANSIT is a single lumen catheter designed to access small, tortuousvasculature for the delivery of diagnostic, embolic and therapeutic agents. The shafttapers from 3.0F proximal to 2.8F distally. The catheter has a hydrophilic coating toprovide lubrication for navigation of vessels. The inner lumen is lined with PTFE tofacilitate movement of guidewires and other devices. |
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510(k) Summary of Safety and Effectiveness (col
| Biocompatibility | All appropriate biocompatibility tests have been performed according to the FDAmodified matrix of ISO-10993 (Blue Book Memorandum G95-1). The cathetersdemonstrated compatibility with biological tissue by meeting the acceptancecriteria stipulated in the test protocols. |
|---|---|
| Summary ofSubstantialEquivalence | The CES MassTRANSIT Infusion Catheter is similar in its basic design, construction,indication for use and performance characteristics to the predicate devices.2 |
2 A statement of substantial equivalence to another product is required by 21CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent, and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the Commissioner of the FDA has stated, " ... a determination of substantial equivalence under the federal Food, Drug, and Cosmetic Act relates to the fact that the product can lawfully be marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatever on the resolution of patent infringement suits" 42 Fed. Reg. 42,520, et seq. (1977).
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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1998
Ms. Ariel MacTavish Sr. · Requlatory Affairs Associate Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Re : K974222 CES Mass Transit™ Infusion Catheter Regulatory Class: II (two) Product Code: 74 KRA Dated: November 7, 1997 November 12, 1997 Received:
Dear Ms. MacTavish:
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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with 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 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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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. Callahon
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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K974222 510 (k) Number:_______________________________________________________________________________________________________________________________________________________________
Indications for Use Statement
CES MassTRANSIT Infusion Catheters are indicated for the selective infusion of various diagnostic, therapeutic and embolic agents into the peripheral, coronary and neurovasculatures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Tan A Ra
(Division Sign-O)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K974222
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).