(120 days)
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.
The CES Infusion Catheters contain a single lumen and a variable stiffness shaft in order to traverse and deliver agents to the coronary, peripheral and neurovasculatures. The outside of the shaft includes a hydrophilic coating and the lumen is lined with PTFE in order to increase lubricity and trackability. The proximal shaft is reinforced with a stainless steel braid to enhance pushability.
The provided text describes a medical device (CES Infusion Catheters) and its clearance through the FDA 510(k) pathway. This pathway establishes substantial equivalence to existing predicate devices, rather than proving device performance against specific, pre-defined acceptance criteria through a dedicated study.
Therefore, the information required to answer your questions regarding acceptance criteria, study details, and ground truth establishment is not available in this document.
Here's a breakdown of why this information is missing based on the provided text:
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Acceptance Criteria and Reported Device Performance:
- The document states: "Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act."
- This explicitly indicates that there are no formal performance (acceptance) criteria set by the FDA for this device type at the time of clearance. The clearance is based on substantial equivalence to predicate devices, implying similar safety and effectiveness without needing to meet new, specific performance metrics.
- The document's "Biocompatibility" section states "All applicable biocompatibility tests were successfully performed on the CES Infusion Catheters." While this indicates successful testing, the specific acceptance criteria for these tests (e.g., cytotoxicity levels, irritation scores) are not detailed, nor are the quantitative results.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set):
- The 510(k) pathway typically relies on comparison to existing predicate devices and may involve bench testing, animal studies, or limited human clinical data if necessary to demonstrate equivalence. It does not inherently require a prospective clinical study with a control group, expert adjudication, or formal ground truth establishment in the manner of a novel device approval that needs to prove efficacy against specific endpoints.
- The document only mentions "Biocompatibility" tests. It does not describe any other studies that would generate the kind of performance data (e.g., sensitivity, specificity, accuracy) typically associated with AI/algorithm performance.
- There is no mention of a test set, training set, experts, or ground truth in the context of device performance.
In summary, the provided document is a 510(k) clearance letter and associated summary information, which focuses on establishing "substantial equivalence" of a medical device to existing predicate devices. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert adjudication, MRMC studies) that would be present for a clinical trial or an AI/software device performance study proving efficacy against defined endpoints.
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Image /page/0/Picture/0 description: The image shows two lines of text. The first line reads "0-000016". The second line reads "K972518". The text appears to be handwritten in a bold, sans-serif font.
Summary of Safety and Effectiveness
NOV - 4 1997
| GeneralProvisions | Common or Usual Name: Continuous Flush Catheter |
|---|---|
| Trade Name: CES Infusion Catheters, including Transit™ Infusion Catheter RapidTransit™ Infusion Catheter Speedster™ Infusion Catheter Prowler™ Infusion Catheter |
| Predicate | The predicates are listed in the table below |
|---|---|
| Devices | Devices |
| Device | Company | 510(k) Number,Clearance Date | Product Code | Predicate for: |
|---|---|---|---|---|
| CES InfusionCatheters | Cordis EndovascularSystems, Inc. | K965181, 3/21/97 | KRA | Design, materials,sterilization andpackaging |
| Venture™ IIInfusion Catheter | Scimed Life Systems | K945904, 5/19/95 | KRA | Indications/claims |
| UltraFuse-X™Infusion/Guide WireExchange Catheter | Scimed Life Systems | K952872, 7/27/95 | KRA | Indications/claims |
Classification Class II
Performance Performance standards have not been established by the FDA under Standards Section 514 of the Food, Drug and Cosmetic Act.
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| Intended Use | CES Infusion Catheters are intended to be used as a mechanism forthe selective infusion of various diagnostic, embolic and therapeuticagents into the peripheral, coronary and neurovasculatures. Thecatheters can also be used to exchange one guidewire for another orprovide support to facilitate the placement of guidewires. |
|---|---|
| DeviceDescription | The CES Infusion Catheters contain a single lumen and a variablestiffness shaft in order to traverse and deliver agents to the coronary,peripheral and neurovasculatures. The outside of the shaft includes ahydrophilic coating and the lumen is lined with PTFE in order toincrease lubricity and trackability. The proximal shaft is reinforcedwith a stainless steel braid to enhance pushability. |
| Biocompatibility | All applicable biocompatibility tests were successfully performed onthe CES Infusion Catheters. |
| Summary ofSubstantialEquivalence | The CES Infusion Catheters are substantially equivalent* in design,materials, sterilization and indications for use to other commerciallyavailable catheters. |
* 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 seg. (1977).
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Image /page/2/Picture/10 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 abstract symbol resembling an eagle or a stylized human profile, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. . . . . . .
Ms. Lisa Wells Cordis Endovascular Systems, Inc. 14740 N.W. 60th Avenue Miami Lakes, Florida 33014
Re : K972518 CES Infusion Catheters Regulatory Class: II (two) Product Code: 74 KRA - -Dated: October 22, 1997 Received: October 23, 1997
Dear Ms. Wells:
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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 requlatory 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.
NOV - 4 1997
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Page 2 - Lisa Wells
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) 594-4639. 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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510(k) Number: K972518
INDICATIONS FOR USE
CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures. The catheters can also be used to exchange one guidewire for another or to provide support to facilitate the placement of guidewires.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
Tan A. Pr
(Division Sign-Off) Division of Cardinatoriatoria: Respiratory, and Neurological Devices 9725 18 510(k) Number _
§ 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).