(948 days)
The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
The VasCon Roamer Microcatheters are single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. They are available in French sizes of 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105 cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019, 0.021, and 0.027 inches. They have a hydrophilic coating to provide lubricity during use.
The provided text describes a 510(k) summary for the VasCon Roamer Microcatheter, a medical device. This document is a premarket notification for a medical device and does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML powered device.
The text focuses on establishing substantial equivalence to a predicate device based on technological characteristics and laboratory testing to assure compliance to specifications and biocompatibility. There is no mention of an AI or ML component, therefore, the specific questions related to AI/ML device performance (sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, standalone performance, etc.) are not applicable to this document.
However, I can extract information regarding the device's summary and the testing performed to demonstrate its safety and effectiveness based on the provided text.
Here's a breakdown of what can be extracted:
- Device Name: VasCon Roamer Microcatheter
- Intended Use: The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
- Predicate Device: Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14)
- Summary of Technological Characteristics: Single lumen catheters, incorporating a Pebax body reinforced with stainless steel and platinum wire, a PTFE lubricious inner lumen, and a soft radiopaque tip to reduce potential vessel injury. Available in various French sizes and lengths. Hydrophilic coating for lubricity.
- Testing Summary: "Laboratory testing has been performed on the VasCon Roamer Microcatheter to assure compliance to the specifications. In addition, laboratory testing has been performed on the materials to assure biocompatibility."
- Conclusions: "The testing as discussed above demonstrates that, like the predicate devices, the VasCon Roamer Microcatheters are safe and effective for its intended use."
Since the request is specifically for elements related to acceptance criteria and a study proving device meets acceptance criteria in the context of AI/ML, and this document does not refer to an AI/ML device, I cannot directly answer most of the questions.
However, if we interpret "acceptance criteria" and "study" in a general medical device context (not AI/ML specific), this is what the document implies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to specifications | Laboratory testing performed assured compliance to the specifications. |
| Biocompatibility of materials | Laboratory testing performed assured biocompatibility of the materials. |
| Safety and effectiveness for intended use (comparable to predicate) | Testing demonstrated that the device is safe and effective for its intended use, like predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Information Not Provided: The document states "laboratory testing has been performed" but does not specify sample sizes for these tests, the type of data, or its provenance.
3. 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 (No AI/ML): This question is relevant for AI/ML device validation involving expert review. This medical device documentation does not mention such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable (No AI/ML): This is for AI/ML ground truth establishment by experts.
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 (No AI/ML): This is for AI/ML device performance evaluation in collaboration with humans.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (No AI/ML): This question relates to AI/ML algorithm-only performance.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable (No AI/ML): Ground truth for this type of device would likely be derived from physical measurements against design specifications and material safety standards through laboratory bench testing, rather than clinical "ground truth" as described (e.g., pathology).
8. The sample size for the training set
- Not Applicable (No AI/ML): No training set as there is no AI/ML component.
9. How the ground truth for the training set was established
- Not Applicable (No AI/ML): No training set as there is no AI/ML component.
In summary, the provided 510(k) summary describes a traditional medical device (a microcatheter) and its path to market based on substantial equivalence and non-AI/ML related laboratory testing. It does not provide the detailed information requested for an AI/ML powered device.
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KD 53210
510(k) SUMMARY
| Submitter'sInformation | VasCon LLC9344 NW 13 StreetMiami, Florida 33172 USATelephone: 1.305.477.2406Fax: 1.305.592.6605Contact: Stephen F. Vadas, Ph.D.JUL - 3 2008 |
|---|---|
| Preparation Date | 18 November 2005 |
| Name of Device | Classification Name: Continuous Flush CatheterTrade Name: VasCon Roamer Microcatheter |
| Predicate Device | Cordis Catheters (MassTransit®, Prowler® Plus, and the Prowler® 14) |
| Intended Use | The VasCon Roamer Microcatheters are indicated for the selectiveinfusion of various diagnostic, therapeutic, and embolic agents into theperipheral, coronary, and neurovasculature. |
| DeviceDescription andSummary ofTechnologicalCharacteristics | The VasCon Roamer Microcatheters are single lumen catheters,incorporating a Pebax body reinforced with stainless steel andplatinum wire, a PTFE lubricious inner lumen, and a soft radiopaquetip to reduce potential vessel injury. They are available in French sizesof 2.3/1.9, 2.8/2.3, 3.0/2.8, 2.4/2.0, and 2.8/2.7 and in lengths of 105cm, 135 cm, and 150 cm. The inside diameters are 0.017, 0.019,0.021, and 0.027 inches. They have a hydrophilic coating to providelubricity during use. The technological characteristics are equivalent tothe predicate device. |
| TestingSummary | Laboratory testing has been performed on the VasCon RoamerMicrocatheter to assure compliance to the specifications.In addition, laboratory testing has been performed on the materials toassure biocompatibility. |
| Conclusions | The testing as discussed above demonstrates that, like the predicatedevices, the VasCon Roamer Microcatheters are safe and effective forits intended use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
VasCon LLC c/o Stephen F. Vadas, PhD Vice President 9344 NW 13th Street Miami, FL 33172
Re: K053310
Trade/Device Name: VasCon Roamer Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: catheter, continuous flush Regulatory Class: Class II Product Code: KRA Dated: March 12, 2008 Received: April 7, 2008
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 he 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 - Dr. Stephen F. Vadas
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0210. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Anrley B. Boan
for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Usc
510(k) Number (if known):
VasCon Roamer Microcatheter Device Name:
Indications For Use:
The VasCon Roamer Microcatheters are indicated for the selective infusion of various diagnostic, therapeutic, and embolic agents into the peripheral, coronary, and neurovasculature.
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)
Andree Brown for BDZ
§ 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).