(84 days)
Not Found
No
The device description and intended use are purely mechanical, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML devices.
No
The device is described as an "Introducer Sheath" used to create a channel for accessing the ventricular system, which is an accessory function for a procedure, not a direct therapeutic action itself.
No
The device description states its use is to "make a channel through the brain into the ventricular system" and provide "atraumatic passage," indicating it is an interventional or surgical tool for accessing an anatomical site, not for diagnosing conditions.
No
The device description clearly states it includes a peelaway sheath and a blunt ended obturator, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is used to "make a channel through the brain into the ventricular system." This is a surgical or interventional procedure performed on the body, not a test performed on a sample taken from the body.
- Lack of IVD Indicators: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting analytes (substances in the body).
- Providing diagnostic information based on laboratory testing.
This device is a surgical instrument used for accessing a specific anatomical site within the brain.
N/A
Intended Use / Indications for Use
The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain, ventricular system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1480 Neurological endoscope.
(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).
0
4/28/99
X. Safety and Effectiveness Summary
This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 882.4545
| Establishment Registration Number: | 2021898 |
|---|---|
| Address of Manufacturer: | Medtronic PS Medical Corporation |
| 125 Cremona Drive | |
| Goleta CA, 93117 | |
| (805) 968-1546 ext. 1776 | |
| Fax: (805) 968-5038 | |
| Contact Person: | Jeffrey Henderson |
| Date: | January 29, 1998 |
| Trade or Proprietary Name: | Medtronic PS Medical Endoscope Introducer |
| Common usual or Classification Name: | Instrument, Shunt System |
| (882.4545) |
Navigational F Sheath (K931973) Codman Peel Away Sheath (K883607)
Description:
The Introducer Sheath includes two parts, a peelaway sheath and a blunt ended obturator, which fits inside the sheath. The Introducer Sheath provides an atraumatic passage into the ventricular system.
The Introducer Sheath is a device used to Intended Use: make a channel through the brain into the ventricular system
Intended Use predicate device: The Disposable Neuroview Endoscope is intended for use in direct visualization, diagnosis of disease and therapeutic applications for intracranial procedures (e.g., biopsy, tumor resection, coagulation of choroid plexus, cyst fenestration, shunt placement, etc.),
Technological comparison: Medtronic PS Medical submits that the materials of fabrication, intended uses, performance characteristics and design specifications of the Endoscope Introducer 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 Endoscope Introducer based upon the predicate and currently marketed devices.
1
| Feature | Medtronic PS Medical
Endoscope Introducer | Neuro Navigational Peel Away
Introducer Sheath | Codman Peel Away Sheath |
|--------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Device
configuration/
contents | • Peel Away Sheath
• Obturator | • Peel Away Sheath
• Obturator | • Peel Away Sheath
• Obturator |
| Sterility Method | EtO | not specified | not specified |
| Sterile | Sterile single use device | Sterile device single use | Sterile single use device |
| Intended Use | The Introducer Sheath is a device used to make a
channel through the brain into the ventricular system. | The Disposable Neuroview Endoscope is intended
for use in direct visualization, diagnosis of disease
and therapeutic applications for intracranial
procedures (e.g., biopsy, tumor resection,
coagulation of choroid plexus, cyst fenestration,
shunt placement, etc.). | not specified |
1
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, stylized with thick, curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 8 1999
Mr. Jeffrey Henderson Vice President, Quality Medtronic PS Medical 125 Cremona Drive Goleta, California 93117
Re: K990333 Trade Name: Endoscope Introducer Regulatory Class: II Product Code: GWG Dated: January 29, 1999 Received: February 3, 1999
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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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.
3
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,
Colin M. Wittwer, Ph.D., MD
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
4
Device Name: Endoscope Introducer
Indications for Use:
The Introducer Sheath is a device used to make a channel through the brain into the ventricular system.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
colla
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number L990373
Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)
(optional format 1-2-96)
Prescription Use __
(Per 21 CFR 801.109)