(191 days)
No
The description focuses on mechanical components and their function for vascular access, with no mention of AI or ML.
No
This device is for introducing guidewires or catheters into the vascular system, acting as an access tool rather than directly treating a medical condition or disease.
No
The device is described as being used for percutaneous introduction of a guidewire or catheter into the vascular system, providing a channel for attaining vascular access, which are interventional or access functions, not diagnostic.
No
The device description clearly outlines physical components such as needles, guidewires, and coaxial introducers, indicating it is a hardware medical device kit.
Based on the provided information, the Micro-Stick® Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the percutaneous introduction of a guidewire or catheter into the vascular system. This is a procedure performed on the patient's body, not on a sample taken from the patient's body.
- Device Description: The device components (needle, guidewire, introducer) are all designed for accessing and navigating within the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening. The Micro-Stick® Set does not fit this description.
N/A
Intended Use / Indications for Use
The Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.
Product codes
DYB
Device Description
The Micro-Stick® Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath.
The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version.
The Micro-Stick® Set is packaged sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular 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
The following in-vitro testing was performed on the Micro-Stick® Set to assure reliable design and performance in accordance with ISO standards and/or internal procedures.
- Guidewire Passage .
- Air Leakage o
- Liquid Leakage o
- Force at Break o
- o Simulated Use
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) SUMMARY
19195
A. Submitter Information:
| Submitter: | MEDCOMP®
1499 Delp Drive
Harleysville, PA-19438- |
|----------------|--------------------------------------------------------|
| | JAN - 8 2010 |
| | (215) 256-4201 Telephone |
| | (215) 256-9191 Fax |
| Contact: | Susan Pileggi |
| Date Prepared: | June 26, 2009 |
B. Device Name: Micro-Stick® Set
| Common Name: | Introducer Set |
|---|---|
| Classification Name: | Catheter Introducer (74 DYB) |
| C.F.R. Section: | 880.1340 |
| Class: | II |
C. Predicate Devices:
| | K071574: Enpath Medical Inc, Stiffer Coaxial
Micro-Introducer Set |
|--|----------------------------------------------------------------------|
| | K990705: MedAmicus Inc, MedAmicus Coaxial
Introducer |
D. Device Description:
The Micro-Stick® Set is designed to provide dilation of the initial entry point and provide a channel for attaining vascular access. The coaxial introducer consists of an inner dilator within a slightly shorter outer sheath.
The kit contains a 21 gauge introducer needle, a .018" diameter guidewire, and a 4F or 5F coaxial introducer. The coaxial introducer is offered in a standard and stiff version.
The Micro-Stick® Set is packaged sterile.
E. Intended Use:
The Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.
Page 1 of 2 Medcomp Micro-Stick® Set Summary
1
r. Comparison to Predicate Devices:
The Micro-Stick® Set is substantially equivalent to the predicate devices in terms of intended use, anatomical location, general design, and method of sterilization.
Bench / Performance Data: G.
The following in-vitro testing was performed on the Micro-Stick® Set to assure reliable design and performance in accordance with ISO standards and/or internal procedures.
- Guidewire Passage .
- Air Leakage o
- Liquid Leakage o
- Force at Break o
- o Simulated Use
H. Biocompatibility:
Results for all biocompatibility testing demonstrate the materials used meet the requirements of ISO 10993.
Conclusion: l.
The proposed devices meet the performance criteria of design verification as specified by ISO standards and test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed devices are substantially equivalent to the legally marketed predicate devices.
Medcomp Micro-Stick® Set Summary
Page 2 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a three-lined sphere, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MedComp c/o Ms. Susan Pileggi 1499 Delp Drive Harleysville, PA 19438
JAN - 8 2010
Re: K091954
Micro-Stick Set Regulation Number: 21 CFR 880.1340 Regulation Name: Introducer Catheter Regulatory Class: Class H Product Code: DYB Dated: November 24, 2009 Received: November 24, 2009
Dear Ms. Pileggi:
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 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. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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.
3
Page 2 - Ms. Susan Pileggi
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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. .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
R. h. hmer
Bram D. Zuckerman, M.D. Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Indications for Use
510(k) Number (if known): K091954
Device Name: Micro-Stick® Set
Indications for Use:
The Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature.
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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dma D. V. Lussa
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K091954
4-1
Page 1 of 1