(69 days)
The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
The VasCon Polaris™ Guiding Catheters are single lumen catheters, incorporating a nylon body reinforced with a stainless steel wire braid, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes. The technological characteristics are equivalent to the predicate device.
Here's an analysis of the provided information regarding acceptance criteria and device performance:
Unfortunately, the provided document does not contain the specific information required to complete the detailed table and answer most of the questions about acceptance criteria and the study that proves the device meets them.
The document is a 510(k) Summary for a medical device (VasCon Polaris™ Guiding Catheter) and the FDA's clearance letter. While it mentions "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications," it does not elaborate on what those specifications (acceptance criteria) were, nor does it provide any specific performance data from the testing.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (VasCon Polaris™ Guiding Catheters, 510(k) K033633) based on similar technological characteristics and intended use, rather than a detailed performance study with explicit acceptance criteria and results.
Therefore, I cannot fill in the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement.
Here's what I can provide based on the given text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|
| Mechanical Properties: (e.g., Tensile strength, kink resistance, burst pressure, torque response, pushability) | "Laboratory testing has been performed on the VasCon Polaris™ Guiding Catheters to assure compliance to the specifications." - Specific performance data not provided. |
| Biocompatibility: (e.g., Cytotoxicity, sensitization, irritation, hemocompatibility) | (Implied to be equivalent to predicate, but no specific testing results or criteria mentioned.) |
| Sterility: (e.g., Sterility Assurance Level) | (Standard for medical devices, but specific criteria/results not mentioned.) |
| Radiopacity: (Ability to be visualized under fluoroscopy) | "soft radiopaque tip" - No quantitative performance data. |
| Lubricity of Inner Lumen: (Ease of device passage) | "PTFE lubricious inner lumen" - No quantitative performance data. |
| Dimensional Specifications: (e.g., Diameter, length, French size) | "available in 5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length" - No specific performance data on precision or variability. |
| Functional Performance for Intended Use: (e.g., Ability to safely introduce and guide devices) | "safe and effective for its intended use" - No specific performance data or clinical study results. |
Summary of Device Performance (as stated in the document):
- Conclusion: "The testing as discussed above demonstrate that, like the predicate device, the VasCon Polaris™ Guiding Catheters are safe and effective for its intended use."
- Technological Characteristics: "The technological characteristics are equivalent to the predicate device."
Missing Information:
The document lacks the specific numerical acceptance criteria and the actual performance results from the laboratory testing. It states that testing was performed to assure compliance but does not detail the compliance itself.
Regarding the specific questions:
- 2. Sample sized used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no external expert review or ground truth establishment is described for performance testing of this type of device in the provided text. Device performance is typically assessed by engineers/technicians in a lab setting against technical specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as this refers to clinical interpretation by experts, not laboratory testing of a guiding catheter.
- 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: Not applicable. This device is a guiding catheter, not an AI-assisted diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a guiding catheter, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For guiding catheters, "ground truth" would typically be derived from engineering specifications and physical measurements, rather than clinical consensus or pathology. The document only states "compliance to the specifications."
- 8. The sample size for the training set: Not applicable, as this refers to a machine learning context.
- 9. How the ground truth for the training set was established: Not applicable.
In conclusion, while the document confirms that laboratory testing was performed and concluded the device is safe and effective and substantially equivalent to a predicate, it does not provide the detailed acceptance criteria or performance data of those tests.
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FEB 1 6 2005
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510(k) SUMMARY
| Submitter's Information | VasCon LLC9344 NW 13 StreetMiami, Florida 33172 USATelephone: 1.305.477.2406Fax: 1.305.592.6605Contact: Stephen F. Vadas, Ph.D. |
|---|---|
| Preparation Date | 08 December 2004 |
| Name of Device | Common Name: Guiding CatheterClassification Name: Percutaneous CatheterTrade Name: VasCon Polaris™ Guiding Catheter |
| Predicate Device | VasCon Polaris™ Guiding Catheters, 510(k) K033633 |
| Intended Use | The guiding catheter is intended for use for intravascular introductionof interventional / diagnostic devices into the coronary or peripheralvascular systems. |
| Device Description andSummary ofTechnologicalCharacteristics | The VasCon Polaris™ Guiding Catheters are single lumencatheters, incorporating a nylon body reinforced with a stainlesssteel wire braid, a PTFE lubricious inner lumen, and a softradiopaque tip to reduce potential vessel injury. They are available in5Fr, 6Fr, 7Fr, and 8Fr, 100 cm in length, and in a variety of shapes.The technological characteristics are equivalent to the predicatedevice. |
| Testing Summary | Laboratory testing has been performed on the VasCon Polaris™Guiding Catheters to assure compliance to the specifications. |
| Conclusions | The testing as discussed above demonstrate that, like the predicatedevice, the VasCon Polaris™ Guiding Catheters are safe andeffective for its intended use. |
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 6 2005
Stephen F. Vadas, Ph.D., P.E. Vice President, Product Assurance and Regulatory Affairs VasCon LLC 9344 NW 13 Street Miami, FL 33172
K043387 Re:
Trade/Device Name: VasCon Polaris™ Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: DQY Dated: December 8, 2004 Received: December 9, 2004
Dear Dr. Vadas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Stephen F. Vadas, Ph.D., P.E.
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lokel with and in 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dana R. Lachner
Bram D. Zuckerman, M.D. SD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ¥043387
VasCon Polaris™ Guiding Catheter Device Name: The guiding catheter is intended for use for Indications For Use: intravascular introduction of interventional / diagnostic devices into the coronary or peripheral vascular systems.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
DIANNA R. Ladner
(Divisi 1 Sign-Off) (Division of Cardiovascular Devices
16111 Number_K043383
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§ 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).