(78 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and function of a disposable introducer sheath and obturator, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates access into the ventricular system for other procedures but does not inherently treat a medical condition.
No
Explanation: The device is used to create and maintain a temporary pathway into the ventricular system for endoscope insertion, which is a procedural function, not a diagnostic one.
No
The device description explicitly states it consists of physical components (introducer sheath and ventricular obturator) and is used to obtain ventricular access, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain and maintain a temporary pathway into the ventricular system of the brain." This describes a surgical or procedural device used directly on a patient's body, not a device used to examine specimens (like blood, urine, or tissue) outside of the body to diagnose a condition.
- Device Description: The description of an introducer sheath and ventricular obturator further supports that this is a physical tool used for accessing an anatomical site.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
Therefore, the MINOP® Disposable Introducer is a surgical/procedural device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.
Product codes (comma separated list FDA assigned to the subject device)
GYK, GWG
Device Description
The MINOP® Disposable Introducer is a single used to obtain ventricular access and facilitate endoscope insertion. The MINOP® Disposable Introducer consists of an introducer sheath and a ventricular obturator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricular system of the brain
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)
Performance testing was performed on the peel force of the sheath for the Medcomp Vascu-Sheath® predicate device; the only sheath design change between this device and the proposed device is the addition of ink depth markings, which do not affect the peel force of the sheath. The rounding of the obturator tip on the proposed device also has no bearing on the peel force of the sheath. All other aspects of the obturator and sheath are identical to the legally marketed Medcomp device. Results of the peel force testing meet the requirements defined in Medcomp's internal standards for force at break.
Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.
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
A. Submitter Information:
| Submitter: | Aesculap, Inc.
3773 Corporate Parkway
Center Valley, PA 18034
Tel: (610) 984-9072
Fax: (610) 791-6882 | JUL 1 1 2006 |
|--------------------|-------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Matthew M. Hull
Regulatory Affairs Manager | |
| Date Prepared: | 11 April 2006 | |
| Trade Name: | MINOP® Disposable Introducer | |
| Common Name: | Endoscope Introducer | |
| Classification: | GYK | |
| C.F.R. Section: | 882.4545 | |
| Class: | II | |
| Predicate Devices: | K022513 Medcomp Vascu-Sheath®
Introducer Set
K990333 Medtronic PS Medical Endoscope
Introducer | |
D. Device Description:
The MINOP® Disposable Introducer is a single used to obtain ventricular access and facilitate endoscope insertion. The MINOP® Disposable Introducer consists of an introducer sheath and a ventricular obturator.
E. Intended Use:
B.
C.
The MINOP® Disposable Introducer is indicated to obtain and maintain a temporary pathway into the ventricular system of the brain.
F. Comparison to Predicate Device:
The technological characteristics of the MINOP® Disposable Introducer are substantially equivalent to the predicate devices. The proposed device is equivalent to the Medcomp Vascu-Sheath® Introducer Set in terms of design, materials, performance and sterilization; while the only differences are the indications for use, the obturator of the proposed device has a rounded tip, and its sheath has ink depth markings. The proposed device is equivalent to the Medtronic PS Medical Endoscope Introducer in regard to the indications for use.
G. Performance Data:
Performance testing was performed on the peel force of the sheath for the Medcomp Vascu-Sheath® predicate device; the only sheath design change between this device and the proposed device is the addition of ink depth markings, which do not affect the peel force of the sheath. The rounding of the obturator tip on the proposed device also has no bearing on the peel force of the sheath. All other aspects of the obturator and
1
sheath are identical to the legally marketed Medcomp device. Results of the peel force testing meet the requirements defined in Medcomp's internal standards for force at break.
Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized caduceus, a symbol often associated with medicine and healthcare. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the image. The caduceus is depicted with a staff entwined by two snakes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 1 2006
Aesculap, Inc. % Medcomp Ms. Lisa Weikert Regulatory Specialist 1499 Delp Drive Harleysville, Pennsylvania 19438
Re: K061135
Trade/Device Name: MINOP® Disposable Introducer Regulation Number: 21 CFR 882.1480 Regulation Name: Neurological endoscope Regulatory Class: II Product Code: GWG Dated: June 13, 2006 Received: June 14, 2006
Dear Ms. Weikert:
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
3
Page 2 - Ms. Lisa Weikert
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) 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 Office of Compliance at (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
J. Herbert Vennmo
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ 长いんしけろう
Device Name: MINOP® Disposable Introducer
Indications for Use:
THE MINOP® DISPOSABLE INTRODUCER IS INDICATED TO OBTAIN AND MAINTAIN A TEMPORARY PATHWAY INTO THE VENTRICULAR SYSTEM OF THE BRAIN.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Eyaluation (ODE)
Hulut Leun
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K061135