(196 days)
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.
The Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.
The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.
The provided text describes a 510(k) premarket notification for the EndoSonics Visions 8.2F PV Intravascular Imaging Catheter. The submission aims to establish substantial equivalence to predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.
Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information, are not applicable and not found within this document. This is because the device being reviewed is a physical medical device (an ultrasonic imaging catheter), not an AI/ML software.
However, I can extract information related to the device's technical specifications and the testing performed to demonstrate its safety and performance based on the provided text.
Here's a summary of the available information structured to best fit your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Meets/Exceeds Specification: "All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed." (Implies meeting the standard criteria for biocompatibility, though specific thresholds are not listed) |
| Radiopacity | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include radiopacity... These tests demonstrated the devices meet or exceed specification..." (Specific values not provided, but indicated as satisfactory) |
| Tensile Strength (Catheter Shaft) | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include... tensile strength of the catheter shaft... These tests demonstrated the devices meet or exceed specification..." and "Tensile strength of the catheter shaft... show that the catheter tip met design specifications." (Specific values not provided, but indicated as satisfactory) |
| Tensile Strength (Catheter Distal End) | Meets/Exceeds Specification: "Testing of the EndoSonics Visions catheters include... catheter distal end tensile strength... These tests demonstrated the devices meet or exceed specification..." and "Tensile strength of the... catheter tip show that the catheter tip met design specifications." (Specific values not provided, but indicated as satisfactory) |
| Profile Measurements (Catheter Tip) | Within Specification Tolerances: "Testing of the EndoSonics Visions catheters include... profile measurements... as well as catheter tip profiles were within specification tolerances." (Specific values not provided, but indicated as satisfactory) |
| Acoustic Output (Thermal Index) | Reported Value: TI = 0.012 MI (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for TI are not stated in the document directly) |
| Acoustic Output (Spatial-Peak Temporal-Average Intensity) | Reported Value: ISPTA = 0.0158 mW/cm^2 (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for ISPTA are not stated in the document directly) |
| Acoustic Output (Spatial-Peak Pulse-Average Intensity) | Reported Value: ISPPA = 0.044 W/cm^2 (This is a measured value; implied to be within acceptable safety limits, though specific acceptance criteria for ISPPA are not stated in the document directly) |
| Substantial Equivalence | Achieved: The FDA letter explicitly states, "We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the ultimate "acceptance criterion" for a 510(k) submission. |
Regarding the other requested points (relevant for AI/ML studies):
- 2. Sample size used for the test set and the data provenance: Not applicable. This is a physical device submission, not an AI/ML study. The testing mentioned (radiopacity, tensile strength, etc.) would be performed on a sample of manufactured devices, not on a "test set" of patients or data in the AI sense.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for diagnostic accuracy in the AI/ML context is being established here. Performance is based on engineering and safety specifications.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is not an AI-assisted device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device type would relate to objective engineering measurements rather than clinical interpretations/diagnoses.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
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JAN 1 4 1999
EndoSonics Corporation
Visions 8.2F PV Models 88900
510(k) Premarket Notification
June 30, 1998
510(k) Summary
| Submitted By: | EndoSonics Corporation2870 Kilgore RoadRancho Cordova, CA 95670916-638-8008Contact: Adam Savakus |
|---|---|
| Summary Preparation: | June 30, 1998 |
| Device: | EndoSonics Visions 8.2F PV Intravascular Imaging Catheter |
| Common or Usual Name: | Ultrasonic Imaging Catheter |
| Predicate Devices: | EndoSonics Visions 3.5F model 84700 Intravascular Imaging Catheter |
| EndoSonics Cathscanner Model 302 Intravascular Imaging Catheter | |
| Millar Mikro-Tip Doppler Catheter Model DC-101Millar Instruments IncorporatedHouston, TX | |
| Small Vessel Balloon Angioplasty CatheterCook IncorporatedBloomington, IN 47402 | |
| ATL Ultramark 8 Ultrasound Imaging SystemAdva...l Techno'ogy LabsBothell WA | |
| CVIS Insight SystemCardiovascular Imaging SystemsSunnyvale, CA |
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510(k) Summary
The EndoSonics Visions 8.2F PV catheter is a diagnostic device intended for use in diagnostic ultrasound imaging of the peripheral vasculature.
The Visions 8.2F PV is available in an over-the-wire design. The catheter has a 7.0F shaft with a maximum distal diameter of 8.2F.
The EndoSonics Visions 8.2F PV catheter is substantially equivalent to existing devices such as the EndoSonics Cathscanner Model 302 and Visions Model 84700 catheters with the Oracle (Cathscanner III) Imaging System, the Cook Small Vessel Balloon Angioplasty catheter, the ATL Ultramark 8 imaging system, the Millar Mikro Tip Doppler catheter, and the CVIS Insight imaging system and catheters
All catheters are manufactured from similar biocompatible materials. Biocompatability testing has been performed.
Testing of the EndoSonics Visions catheters include radiopacity, tensile strength of the catheter shaft, catheter distal end tensile strength, profile measurements, and biocompatibility. These tests demonstrated the devices meet or exceed specification as well as catheter tip profiles were within specification tolerances. Tensile strength of the catheter shaft and catheter tip show that the catheter tip met design specifications.
The acoustic outputs for the Visions 8.2F PV catheter were found to be:
= 0.0158 mW/cm-= 0.044 W/cm2 = 0.012 MI
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping, curved lines, possibly representing a stylized human form or a symbol of health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 4 1999
Mr. Adam Savakus Vice President, Clinical and Regulatory Affairs EndoSonics Corporation 2870 Kigore Road Rancho Cordova, CA 95670
Re: K982329 Trade Name: Visions 8.2F PV Ultrasoinic Imaging Catheter (Model 88900) Regulatory Class: II Product Code: ITX Dated: October 16, 1998 Received: October 19, 1998
Dear Mr. Savakus:
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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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 Reqister. Please note: this
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Page 2 - Mr. Adam Savakus
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.
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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4586. 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" (21CFR 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/dsma/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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Page 1 of 1
510(k) Number:
K98 2329
Visions 8.2F PV Ultrasoinic Imaing Catheter (Model 88900) Device Name:
Indications for Use:
The Visions catheters are designed for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels.
The Visions ultrasound imaging catheter is designed for use as an adjunct to conventional angiographic procedures to provide:
- An image of the vessel lumen and wall structures. (1)
- (2) Dimensional measurements from the image.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chrityl-mytten
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological De 510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.