(75 days)
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature.
The Vista Brite Tip Guiding Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Cordis Vista Brite Tip® Guiding Catheter":
It's important to note that this document is a Premarket Notification (510(k)) Summary of Safety and Effectiveness from 1997. At that time, the scope and requirements for demonstrating "acceptance criteria" and "study results" for medical devices, particularly regarding algorithmic performance (AI), were fundamentally different from today's standards. AI, as we understand it in medical devices now, did not exist in this context. The focus of this 510(k) is on demonstrating substantial equivalence to predicate devices through design, materials, and biocompatibility, rather than statistical performance against specific clinical endpoints derived from a study.
Therefore, many of the requested categories for AI/algorithm-based devices will not be directly applicable or present in this document. I will fill in the table and information based on what is provided and explain where information pertinent to AI/algorithm studies is missing due to the nature of the submission.
Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are interpreted as the successful completion of standard evaluations for medical devices of this type, primarily focusing on safety and equivalence. There are no quantifiable performance metrics in the way one would define for an AI algorithm (e.g., sensitivity, specificity, AUC).
| Acceptance Criteria Category | Specific Requirement (from document) | Reported Device Performance (from document) |
|---|---|---|
| Design & Construction | Similar in design and construction to commercially available Cordis guiding catheters. | "The Cordis Guiding Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters." (Implies successful comparison to predicates) |
| Indications for Use | Intended for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature. | "The Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature." (Confirms alignment with stated indication) |
| Biocompatibility | All appropriate biocompatibility tests for guiding catheters. | "All appropriate biocompatibility tests for the guiding catheters were successfully completed." |
| Predicate Device Equivalence (Overall) | Substantially equivalent (for indications for use) to devices marketed prior to May 28, 1976, or reclassified devices. Similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters (predicates listed: Cordis Vista Brite Tip, Cordis Endovascular Systems, ENVOY Guiding Catheters, DVI, Devices for Vascular Intervention). | "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)." |
| Material Properties (Implicitly met for equivalence) | Catheter features a nylon body with a tightly wound stainless braid wire and transition segments with nylons of different durometers. Brite Tip segment is polyurethane with a radiopaque filler (softest material). | Described features are part of the device description, implying they meet the engineering and design specifications that allow for equivalence. |
Study Information (as applicable to a 1997 510(k) for a physical device, NOT an AI algorithm)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. This document is a 510(k) submission for a physical medical device (guiding catheter) and does not describe a "test set" in the context of an algorithm or clinical study with patient data. The 'testing' would have primarily been bench testing for mechanical properties and biocompatibility. No specific sample sizes for such tests are detailed in this summary.
- Data Provenance: Not applicable. No clinical data or patient data is referenced that would have a provenance like 'country of origin'.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. "Ground truth" in the context of expert consensus for imaging or clinical diagnosis is not relevant to this device submission. The primary "ground truth" for a device like this would be engineering specifications and predicate device characteristics, not expert interpretation of cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication in the context of this 510(k) submission.
5. 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
- MRMC Study / AI Effect Size: Not applicable. This device is a physical guiding catheter, not an AI-powered diagnostic or assistive tool. No MRMC studies were performed, and AI was not a component of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: For a 510(k) of this nature, the "ground truth" is primarily based on engineering specifications, material science standards, biocompatibility testing results, and the established characteristics and performance of the identified predicate devices. There is no clinical or diagnostic "ground truth" from patient data involved in this summary.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device is not an AI algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there's no training set, there's no ground truth for it.
In summary: This 1997 510(k) submission demonstrates the substantial equivalence of a physical medical device (a guiding catheter) to existing, legally marketed predicate devices. The "acceptance criteria" are based on meeting design, material, and biocompatibility standards comparable to those predicates, and successfully satisfying the FDA's regulatory requirements for a Class II device. The modern concepts of "acceptance criteria" and "study results" as they pertain to AI algorithms are not present or applicable in this historical document.
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00-00008
K971572
Summary Of Safety And Effectiveness
JUL 1 4 1997
| General Provisions | The name of the device is: |
|---|---|
| -------------------- | ---------------------------- |
| Proprietary Name | Common or Usual Name |
|---|---|
| Cordis Vista Brite Tip® Guiding Catheter | Percutaneous Catheter |
| Predicate Device | The names of the predicate devices are: Cordis Vista Brite TipCordis Endovascular Systems, ENVOY Guiding CathetersDVI, Devices for Vascular Intervention |
|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Classification | The FDA has classified guiding catheters as Class II. |
|---|---|
| ---------------- | ------------------------------------------------------- |
| Performance Standards | There are no performance standards applicable under Section 514 of the Food, Drug, and Cosmetic Act for Angiographic Catheters. |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------------------------------------------------------------------- |
| Indications for Use | The Vista Brite Tip Guiding Catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary, peripheral, and neurovasculature. |
|---|---|
| --------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Device Description | The Vista Brite Tip Guiding Catheters are single lumen catheters which feature a nylon body with a tightly wound stainless braid wire. The braid wire extends from the hub into the Brite Tip segment. The transition segments of the catheter are designed with nylons of different durometers (stiffness) to provide a gradual decrease in material stiffness from the catheter body to the tip. The Brite Tip segment, located at the catheter's tip, is polyurethane with a radiopaque filler; this is the softest material in the catheter. |
|---|---|
| -------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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PREMARKET NOTIFICATION Cordis Corporation Vista Brite Tip® Catheter
Summary Of Safety And Effectiveness, Continued
| Biocompatibility | All appropriate biocompatibility tests for the guiding catheters were successfully completed. |
|---|---|
| Summary ofSubstantialEquivalence | The Cordis Guiding Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially available Cordis guiding catheters. |
1 Any statement of substantial equivalence to another product is required by 21 CFR 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 suuites." 42 Fed. Reg. (1977).
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUM V SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of thick, stylized lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacqueline Zimovan Regulatory Affairs & Clinical Research Associate Cordis Corporation JUL 1 4 1997 P.O. Box 025700 Miami, Florida 33102-5700
K971572 Re: Cordis Vista Brite Tip Catheters Requlatory Class: II (two) Product Code: DQY Dated: April 29, 1997 Received: April 30, 1997
Dear Ms. Zimovan:
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 reqistration, listinq 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. Existinq major requlations affectinq 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 Requlation (QS) for Medical Devices: General requlation (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.
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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. Callahan
Thomas J. Callahan, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
| 510(K) Number (if known): [To be assigned by the FDA] | |
|---|---|
| Device Name: | Vista Brite Tip® Guiding Catheter |
| Indications for Use: | The guiding catheter is intended for use for intravascularintroduction of interventional/diagnostic devices into the coronary,peripheral, and neurovasculature. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Taua A. hy
(Division Sign-Off)
Division of Cardion and Neurological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).