(89 days)
Not Found
Not Found
No
The 510(k) summary describes a mechanical introducer set and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an "Introducer Set" intended for the "introduction and placement of guidewires and/or catheters," which are tools for accessing the body, not for treating a disease or condition itself.
No
Explanation: The device is an introducer set designed for placing guidewires and catheters. Its intended use is purely for introduction and placement, not for diagnosing any condition.
No
The device description clearly states it is comprised of physical components like a guidewire, needle, and introducer tubing made from polyurethane, indicating it is a hardware medical device.
Based on the provided information, the MicroCruiser® Plus Introducer Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "introduction and placement of guidewires and/or catheters." This describes a medical device used in vivo (within the body) for a procedural purpose.
- Device Description: The description details components like guidewires, needles, and introducers made of biocompatible materials, designed for insertion into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed for testing biological samples in vitro (outside the body). The MicroCruiser® Plus Introducer Set is clearly designed for direct use within the patient's body during a medical procedure.
N/A
Intended Use / Indications for Use
The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
MicroPuncture
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
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a logo for MD Tech Medical Device Technologies Inc. The logo is black and white and features the letters "MD TECH" in a bold, sans-serif font. The words "MEDICAL DEVICE TECHNOLOGIES INC" are written in a smaller font below the letters "MD TECH". The logo is simple and modern.
SEP = 5 2001
600 SW 47th Aven iainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
| 510(k) SUMMARY | ||
|---|---|---|
| ---------------- | -- | -- |
| APPLICANT: | Medical Device Technologies, Inc.
3600 SW 47th Avenue
Gainesville, FL 32608 | |
|----------------------|-----------------------------------------------------------------------------------|--|
| CONTACT: | Karl Swartz
Quality Assurance Manager | |
| TELEPHONE: | (352)338-0440
fax (352)338-0662 | |
| TRADE NAMES: | MicroCruiser® Plus Introducer Set | |
| COMMON NAME: | Catheter introducers | |
| CLASSIFICATION NAME: | §870.1340-Introducer, Catheter | |
SUBSTANTIAL EQUIVALENCE:
| Company Name | Product Name | 510(k) No. |
|---|---|---|
| Cook, Inc. | MicroPuncture | Pre-Amendment |
DESCRIPTION OF DEVICE:
The MicroCruiser® Plus Introducer Set is comprised of an .018" diameter guidewire, a guidewire introducer needle, and a coaxial introducer that has a diameter suitable for catheter introduction and placement. The introducer tubing is made from biocompatible polyurethane that has been used extensively in both short and long term catheters. The introducers are provided in the following French sizes: 3 (Inner)/4 (Outer), 3 (Inner)/5 (Outer), and 4 (Inner)/6 (Outer), and in lengths of 10 cm.
INDICATIONS FOR USE:
The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 5 2001
Mr. Karl Swartz Medical Device Technologies, Inc. 3600 SW 47th Avenue Gainesville, FL 32608
Re: K011790
MicroCruiser® Plus Introducer Set Regulation Number: 870.1340 Regulatory Class: II (two) Product Code: DYB Dated: June 7, 2001 Received: June 8. 2001
Dear Mr. Swartz:
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 Regulations, 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might
2
Page 2 - Mr. Karl Swartz
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 diagnostic 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 International and Consumer 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,
James E. Dillard III
mes E. Dillard Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Image /page/3/Picture/0 description: The image is a logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is black and white and features the letters "MDTECH" in a bold, sans-serif font. The letters are stacked on top of each other, with the "MD" on top and the "TECH" on the bottom. Below the letters is the text "MEDICAL DEVICE TECHNOLOGIES INC" in a smaller font. The logo is surrounded by a black border.
3600 SW 47th Avenue iainesville, Florida 32608 TEL: 352/338-0440 FAX: 352/338-0662
Page_1_of_1_
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MicroCruiser® Plus Introducer Set
Indications for Use:
The MicroCruiser® Plus Introducer Set is intended for use in the introduction and placement of guidewires and/or catheters..
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of Cardiovascular & Respiratory Devices
510(k) Number K011790
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Image /page/3/Picture/13 description: The image shows the logo for Marmon Group. The logo consists of three vertical bars with the word "MARMON" in between the bars. Below the logo is the text "A member of The Marmon Group of companies". The text is in a smaller font size than the logo.