(85 days)
The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.
The Medtronic PS Medical Innervision Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter incorporates a BioGlide surface modification on the interior and exterior of the catheter. The catheter incorporates a slit tip.
This document is a 510(k) summary for the Medtronic PS Medical Innervision Ventricular Catheter with BioGlide. It is a premarket notification for a medical device seeking clearance from the U.S. Food and Drug Administration (FDA) based on substantial equivalence to predicate devices. As such, it does not describe a clinical study in the way a traditional clinical effectiveness study would for a novel device or drug.
Therefore, many of the typical acceptance criteria and study details (like sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance with metrics like AUC or sensitivity/specificity, and training set details) are not applicable in this context.
Here's a breakdown of the available information in relation to your request:
1. A table of acceptance criteria and the reported device performance:
The document describes the device's characteristics and compares them to predicate devices to establish "substantial equivalence." The "acceptance criteria" for a 510(k) submission are primarily about demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through a comparison of:
| Acceptance Criteria (Demonstrated Substantial Equivalence to Predicate Devices) | Reported Device Performance (Summary of the Innervision Ventricular Catheter with BioGlide) |
|---|---|
| Materials of Fabrication | Manufactured of translucent silicone elastomer w/barium impregnated stripe. Incorporates a BioGlide surface modification on the interior and exterior. |
| Intended Uses | Proximal component of a CSF-Flow Control Shunt for shunting cerebrospinal fluid from brain ventricles to the right atrium or peritoneal cavity. Designed for use with Medtronic PS Medical endoscopes (e.g., Neuropen) for direct visual placement. |
| Performance Characteristics | Incorporates a slit tip. (Implied performance is similar to predicate devices due to similar design and materials). |
| Design Specifications | Similar to predicate devices: Ventricular Catheter (882.4100). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a 510(k) submission based on substantial equivalence to existing predicate devices, not a clinical trial with a "test set" of patients in the traditional sense. The "test" here is the comparison of the device's characteristics to those of already approved devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. "Ground truth" in this context is the safety and effectiveness of the predicate devices, which have already been established by the FDA. The submission relies on the existing regulatory clearance of those devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. There is no "test set" requiring adjudication in a clinical trial sense. The FDA's review process involves evaluation by regulatory 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. This device is a physical catheter, not an AI or imaging diagnostic tool. Therefore, MRMC studies or AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of submission is the established safety and efficacy profiles of the predicate devices as previously determined by the FDA. The new device is asserted to be "substantially equivalent" to these already cleared devices, meaning it does not raise new questions of safety and effectiveness.
8. The sample size for the training set:
- Not Applicable. There is no "training set" for a device like this in the context of a 510(k). The device's design and materials are based on established engineering principles and prior device experience, not machine learning training data.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
In summary:
This document is a regulatory submission for device clearance, not a report of a clinical efficacy study. The "study" proving the device met acceptance criteria is the comparison presented in the document itself, demonstrating that the Innervision Ventricular Catheter with BioGlide shares the same technological characteristics, intended use, and therefore the same safety and effectiveness as its predicate devices, which were already cleared by the FDA.
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DEC I 6 998
983331
Safety and Effectiveness Summary X.
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic PS Medical Corporation125 Cremona DriveGoleta CA, 93117(805) 968-1546 ext. 1770Fax: (805) 968-5038 |
| Contact Person: | Jeffrey Henderson: |
| Date: | August 17, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Innervision VentricularCatheter w/BioGlide |
| Common usual or Classification Name: | Ventricular Catheter (882.4100) |
Medtronic PS Medical Innervision Ventricular Predicate Device Identification: Catheter submitted under the Premarket Notification for the Catheter Placement Kit (K940096), Medtronic PS Medical Ventricular Catheter with BioGlide submitted under the Premarket Notification for the BioGlide Shunt Kit (K951258)
The Medtronic PS Medical Innervision Description: Ventricular Catheter with BioGlide is manufactured of translucent silicone elastomer w/barium impregnated stripe. The catheter incorporates a BioGlide surface modification on the interior and exterior of the catheter. The catheter incorporates a slit tip.
Intended Use: The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity.
Intended Use predicate device: The Innervision Ventricular Catheter is designed to be used with the Innervision endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the right atrium of the heart or to the peritoneal cavity.
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Medtronic PS Medical submits that the Technological comparison: materials of fabrication, intended uses, performance characteristics and design specifications of the Innervision Ventricular Catheter with BioGlide are substantially equivalent to those of the predicate devices. Based upon the summary above, Medtronic PS Medical determines substantial equivalence, safety, and efficacy of the Innervision Ventricular Catheter with BioGlide based upon the predicate and currently marketed devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 16 1000
Mr. Jeffrey Henderson Vice-President. Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117-5500
Re: K983331
Trade Name: Medtronic PS Medical Innervision Ventricular Catheter With Bioglide Regulatory Class: II Product Code: HCA Dated: September 18, 1998 Received: September 22, 1998
Dear Mr. Henderson:
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 (OS) 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 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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Page 2 - Mr. Jeffrey Henderson
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) 594-4595. 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,
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
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Device Name: Innervision Ventricular Catheter with BioGlide 510(k) Number (if known): 《♀♀3333
Indications for Use:
"The Innervision Ventricular Catheter with BioGlide is designed to be used with the Neuropen endoscope or other compatible Medtronic PS Medical endoscope when the physician desires direct vision from the tip of a ventricular catheter during its placement. Direct vision facilitates placement of the catheter tip at a specific intraventricular location. The catheter is designed to be used as the proximal component of a CSF-Flow Control Shunt for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: ` or Prescription Use: (Per 21 CFR 801.109)
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(Division Sign-Off) Division of General Restorative Devices 298333 510(k) Number
(optional format 1-2-96)
§ 882.4100 Ventricular catheter.
(a)
Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.(b)
Classification. Class II (performance standards).