(176 days)
Not Found
No
The description focuses on the physical characteristics and function of a guide catheter, a standard medical device. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of these technologies. The performance studies described are standard device testing, not AI/ML model validation.
No
The device acts as a pathway for other diagnostic or therapeutic devices and agents, and is not inherently therapeutic itself.
No
The device is a guide catheter intended for introducing other devices or agents, whether diagnostic or therapeutic, into the vasculature. Its function is to facilitate access and delivery, not to diagnose a condition itself.
No
The device description clearly states it is a "small diameter tubular device" and describes its physical insertion and use within the vasculature, indicating it is a physical medical device, not software.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MMS Guide Catheter is a device used within the body (in vivo) to facilitate the introduction of other devices or substances into the peripheral vasculature. It is a tool for accessing and navigating the vascular system, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for "introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature." This describes an in-vivo procedure.
- Device Description: The description details a tubular device inserted into the vasculature, which is an in-vivo application.
The information provided about the device's function, intended use, and description all point to it being an in-vivo medical device, not an in-vitro diagnostic.
N/A
Intended Use / Indications for Use
The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
Product codes
KRA
Device Description
The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoro / Ultrasound
Anatomical Site
peripheral vasculature
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
Animal testing was conducted to assess the simulated clinical performance of the Guide Catheter. The product performed to specification.
Cadaver testing was conducted using the vasculature below the knee to assess the simulated clinical use of the product. The product performed to specification.
Product testing was completed and met all of the acceptance criteria. Testing was conducted on sterile final product. Testing was performed on baseline (non-aged) and aged products. Testing included:
- Dimensional verification
- Surface Review
- Leak
- Tracking
- Flow
- Flex/Kink
- Torque
- Tensile
- Packaging
Key Metrics
Not Found
Predicate Device(s)
Marksman Catheter (K111490)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human figure, with three faces in profile. The figure is stylized and appears to be in motion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 9, 2016
Micro Medical Solutions, Inc. Mr. Gregory Mathison Vice President, Regulatory, Clinical & Quality 790 Willard Street, #209 Quincy, MA 02169
Re: K152625 Trade/Device Name: MMS Guide Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: January 29, 2016 Received: February 3. 2016
Dear Mr. Mathison,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152625
Device Name MMS Guide Catheter
Indications for Use (Describe)
The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Applicant: | Micro Medical Solutions, Inc.
240 Andover Street
Wilmington, MA 01887
Tel: 978.909.3045 |
|------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name: | MMS Guide Catheter |
| Common Name: | Guide Catheter |
| Classification Name: | Catheter, continuous flush |
| 21CFR Number: | 870.1210 |
| Device Classification: | Class II |
| Product Code: | KRA |
| Predicate Devices: | Marksman Catheter (K111490) |
| Contact: | Greg Mathison
VP Regulatory, Clinical & Quality |
| DATE: | March 1, 2016 |
Substantially Equivalent to:
The MMS Guide Catheter is equivalent in intended use, principal of operation and technological characteristics to the Marksman Catheter (K111490).
Description of the device subject to premarket notification
The MMS Guide Catheter is a small diameter tubular device. It is inserted into the vasculature using standard access techniques and advanced over a guidewire to the physician desired location. The MMS Guide Catheter can be used as a pathway for other
5
diagnostic or therapeutic devices to enter the vasculature. The distal end has a standard luer fitting.
Indications for Use
The MMS Guide Catheter is intended for the introduction of interventional devices and infusion of diagnostic or therapeutic agents into the peripheral vasculature.
Materials
All materials used in the manufacture of the MMS Guide Catheter are suitable for this use and have been used in numerous previously cleared products. The MMS Guide Catheter materials were tested per ISO10993 and found to be biocompatible. Testing included the following:
- . Cytotoxicity
- Sensitization
- Acute Systemic Toxicity ●
- Hemolysis Extract ●
- Hemolysis Direct Contact
- Pyrogen
- Complement Activation ●
- Canine Thrombogenicity ●
Animal Testing
Animal testing was conducted to assess the simulated clinical performance of the Guide Catheter. The product performed to specification.
Cadaver Experience
Cadaver testing was conducted using the vasculature below the knee to assess the simulated clinical use of the product. The product performed to specification.
Non-Clinical Testing
Product testing was completed and met all of the acceptance criteria. Testing was conducted on sterile final product. Testing was performed on baseline (non-aged) and aged products. Testing included:
- Dimensional verification
- Surface Review ●
- Leak
- Tracking ●
- Flow ●
- Flex/Kink ●
- Torque ●
- Tensile ●
- Packaging ●
6
Performance Data
All necessary verification and validation testing has been performed for the MMS Guide Catheter to assure substantial equivalence to the predicate devices.
Basis for Determination of Substantial Equivalence
Upon reviewing the safety information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the MMS Guide Catheter is determined to be substantially equivalent to existing legally marketed devices.
| Trade name | MMS Guide Catheter | Marksman Catheter | SE Discussion |
|---|---|---|---|
| Product code | KRA | KRA | Same product code |
| 510(k) number | K152625 | K111490 | |
| 21CFR | 870.1210 | 870.1210 | Same CFR number |
| Device | |||
| Classification | II | II | Same - Class II |
| Device | |||
| description | The MMS Guide Catheter is a | ||
| small diameter tubular device. | |||
| It is inserted into the | |||
| vasculature using standard | |||
| access techniques and | |||
| advanced over a guidewire to | |||
| the physician desired location. | |||
| The MMS Guide Catheter can | |||
| be used as a pathway for other | |||
| diagnostic or therapeutic | |||
| devices to enter the | |||
| vasculature. The distal end | |||
| has a standard luer fitting. | The Marksman Catheter is a | ||
| variable stiffness, single | |||
| lumen catheter designed to | |||
| access small, tortuous vascular | |||
| areas. The outer surface of the | |||
| catheter's distal segment is | |||
| coated with a hydrophilic | |||
| material to provide lubricity | |||
| during use. The catheter also | |||
| incorporates a PTFE liner to | |||
| facilitate movement of | |||
| introduction devices passed | |||
| through its lumen. The | |||
| Marksman Catheter has a | |||
| radiopaque marker at the | |||
| distal tip to facilitate | |||
| fluoroscopic visualization. | |||
| The distal tip of the catheter is | |||
| shapeable. | |||
| The Marksman Catheter is | |||
| provided with various working | |||
| lengths. The Marksman | |||
| Catheter is for single use only. | The device description is the | ||
| same. |
Comparison of Product Features
7
| Intended Use | The MMS Guide Catheter is
intended for the introduction
of interventional devices and
infusion of diagnostic or
therapeutic agents into the
peripheral vasculature. | The Marksman Catheter is
indicated for the introduction
of interventional devices and
infusion of diagnostic or
therapeutic agents into the
neuro, peripheral and coronary
vasculature. | Same Indications for Use |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Length | 40 cm working length | 105cm | Equivalent |
| Diameter | 3.2 Fr | 0.027" | Equivalent |
| Method of
visualization | Fluoro / Ultrasound | Fluoro | Equivalent |
| Sterilization | Yes - ETO | Yes - ETO | Both devices are supplied
sterile. |
| Single use | Y | Y | Same |
| Shelf life | 22 months after production | Not indicated on submission | This will be on the product
label |
| Packaging | Tyvek / Poly pouch | Unknown | Tyvek / Poly heat sealed
pouches are common
packaging for sterile products |
| Materials | Biocompatible | Biocompatible | Biocompatible |
Conclusion
The products are substantially equivalent as the indications for use are the same, the clinical application is the same, the materials are equivalent, the dimensions are equivalent and the tested product performance attributes are equivalent.