(384 days)
Not Found
No
The device description and performance studies focus on mechanical and functional aspects of a balloon occlusion system, with no mention of AI or ML.
No
The device is described as facilitating the infusion of therapeutic or diagnostic fluids, but it is not itself a therapeutic agent or treatment.
No
The "Intended Use / Indications for Use" states the device is for "facilitate the localized infusion of therapeutic or diagnostic fluids," indicating it facilitates the use of diagnostic fluids, but is not a diagnostic device itself.
No
The device description clearly outlines two physical components: a CO2 Inflation Device (a disposable syringe assembly) and a balloon Occlusion Guide Wire (a catheter with an inflatable balloon). This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion" within the peripheral vasculature. This describes a device used within the body for treatment or delivery of substances, not for testing samples outside the body.
- Device Description: The device components (inflation device and balloon occlusion guide wire) are designed for insertion into the peripheral vasculature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is mechanical (occlusion) and delivery-based (infusion).
Therefore, the GuardDOG™ Occlusion System is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The GuardDOG™ Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The GuardDOG System consists of two components: a carbon dioxide (CO2) Inflation Device and a balloon Occlusion Guide Wire. The GuardDOG Inflation Device is a disposable syringe assembly, which is prepackaged with carbon dioxide and is used to inflate the Occlusion Guide Wire. The GuardDOG Occlusion Guide Wire is a 200 or 300cm long by 0.014" outside diameter Catheter with an inflatable balloon on the distal end. The guide wire is inflated via a detachable hub, which is connected to the Inflation Device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Biocompatibility: Evaluated in compliance with Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, 21 CFR Part 58 and according to the recommendations in ISO 10993-1 Biological Evaluation of Medical Devices - Part One. Results demonstrated that the GuardDOG materials and manufacturing methods are appropriate and safe for the intended use.
- Sterilization and Packaging: Sterilized according to industry standard procedures and packaged appropriately to maintain a sterile barrier and device integrity.
- Vessel Safety Animal Study: Compared the incidence of acute vessel injury between the GuardDOG Occlusion System and the Equinox Occlusion Balloon Catheter in a canine model. The study concluded that the GuardDOG performed well with regard to vessel occlusion and does not cause any significant vessel injury compared to the predicate device, demonstrating appropriate safety and equivalence.
- Additional Animal Studies: Conducted to evaluate device integrity, track to a targeted vascular site, and deliver an infusion catheter device to the intended vascular territory. Results showed that the GuardDOG Occlusion System is compatible with standard interventional devices and is equivalent to predicate devices.
- Functional and Mechanical Integrity Testing: Performed to verify equivalency to predicate devices and appropriate safety and efficacy for the intended use.
- CO2 Inflation Medium Evaluation: A literature search was done to evaluate the effects of CO2 in the circulatory system. Results demonstrate that CO2 doses of 5-250cc are safe in the peripheral vasculature. The GuardDOG System limits potential exposure to CO2 to 5cc or less. The CO2 is maintained at high purity (greater than 95%). The rated burst diameter of the GuardDOG Occlusion Guide Wire balloon is 9.26 mm, providing an acceptable margin of error over the recommended 3-6 mm vessel occlusion range.
Key results: The data presented establish that the GuardDOG Occlusion System is equivalent to the predicate devices and demonstrate appropriate safety and efficacy for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
KO31354 11/4
GUARDDOG™ OCCLUSION SYSTEM MAY 1 8 2004 510(K) SUMMARY
| SUBMITTER'S
INFORMATION | Possis Medical, Inc.
9055 Evergreen Boulevard N.W.
Minneapolis, MN 55433 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| | Tel: (612) 780-4555
Fax: (612) 780-2227 |
| CONTACT | Mark D. Stenoien
Manager, Regulatory & Clinical Affairs |
| SUMMARY DATE | 29 April 2003 |
| DEVICE TRADE NAME | GuardDOG™ Occlusion System
GuardDOG Occlusion Guide Wire, 300 cm
GuardDOG Occlusion Guide Wire, 200 cm
GuardDOG Inflation Device |
| COMMON NAME | Temporary Occlusion Catheter |
| DEVICE CLASS | Catheter, Intravascular Occluding, Temporary
(MJN, 21 CFR 870.4450) Class II |
| LEGALLY MARKETED
PREDICATE DEVICES | PercuSurge Temporary Occlusion Balloon System
- K972777
Medtronic PercuSurge Inc.
540 Oakmead Parkway
Sunnyvale, CA 94086 |
| | Equinox Occlusion Balloon - K990487
Micro Therapeutics, Inc.
2 Goodyear
Irvine, CA 92618 |
DEVICE DESCRIPTION
The GuardDOG System consists of two components: a carbon dioxide (CO2) Inflation Device and a balloon Occlusion Guide Wire. The GuardDOG Inflation Device is a disposable syringe assembly, which is prepackaged with carbon dioxide and is used to inflate the Occlusion Guide Wire. The GuardDOG Occlusion Guide Wire is a 200 or 300cm long by 0.014" outside diameter Catheter with an inflatable balloon on the distal end. The guide wire is inflated via a detachable hub, which is connected to the Inflation Device.
1
INTENDED USE
The GuardDOG™ Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.
COMPARISON TO PREDICATE DEVICE:
Table 1 summarizes key technical characteristics and physical properties of the Perma-Pass Graft and the predicate device. This information is provided for two graft sizes denoted as follows: thin wall 6mm internal diameter (6T), and standard wall 6mm internal diameter (6S).
| | GuardDOG™
Occlusion System | PercuSurge™
GuardWire Temporary
Occlusion Balloon
System - K972777 | MicroTherapeutics,
Inc. Equinox™
Occlusion Balloon –
K990487 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication / Intended
Use | The GuardDOG
Occlusion System is
indicated for use in
the peripheral
vasculature to
facilitate the localized
infusion of therapeutic
or diagnostic fluids,
with or without vessel
occlusion.
The safety and
effectiveness of this
device have not been
established in the
coronary, cerebral, or
carotid vasculature. | The PercuSurge
Temporary Occlusion
Balloon System is
indicated for use in
the peripheral
vasculature to
facilitate the localized
infusion of therapeutic
or diagnostic fluids,
with or without vessel
occlusion.
The safety and
effectiveness of this
device have not been
established in the
coronary, cerebral, or
carotid vasculature. | The
MicroTherapeutics,
Inc. Occlusion Balloon
Catheter is designed
for use in blood
vessels where
temporary occlusion is
desired. The MTI
Occlusion Balloon
Catheter offers a
vessel selective
technique of
temporary vascular
occlusion which is
useful in selectively
stopping or controlling
blood flow. |
| Major Components | GuardDOG Occlusion
Guide Wire, GuardDOG
Inflation Device | GuardWire Temporary
Occlusion Catheter,
MicroSeal® Adapter,
(optional: Export®
Catheter) | Equinox Occlusion
Balloon Catheter,
SilverSpeed 0.010"
Guidewire, and a
rotating hemostatic
valve |
| Accessories Included | Scissors, introducer | Fixed volume syringe,
introducer | |
| Balloon Catheter | | | |
| Number of lumens | Single lumen | Single lumen | Single lumen |
| Outer Diameter | 0.014 inch | 0.014 inch | 2.8-2.2 French
(0.037-0.029 inch) |
| Length | 200 or 300 cm | 175 cm | 150 cm |
| Inflated balloon | 3-6 mm | 4, 4.5, and 5 mm | 4 mm |
| Balloon Material | Compliant elastomer | Compliant elastomer | Compliant elastomer |
2
KC 3135 + T = 1 1-
| Inflation Medium | CO2 | 1:1 solution of 60%
contrast with saline | 1:1 solution of 60%
contrast with saline |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | Sterile, intended for
single use. | Sterile, intended for
single use. | Sterile, intended for
single use. |
| Biocompatibility | Biocompatible in
accordance with ISO
10993-1 Biological
Evaluation of Medical
Devices for external
communicating, blood
contact of short duration
device. | Biocompatible in
accordance with ISO
10993-1 Biological
Evaluation of Medical
Devices for external
communicating, blood
contact of short duration
device. | Biocompatible in
accordance with ISO
10993-1 Biological
Evaluation of Medical
Devices for external
communicating, blood
contact of short duration
device. |
The GuardDOG Occlusion System is equivalent to the predicate devices in technical characteristics.
Functional and mechanical integrity testing has been performed. The results verify equivalency to the predicate devices and appropriate safety and efficacy of the GuardDOG Occlusion System for the intended use.
One difference is that the GuardDOG Occlusion System uses CO2 gas as the inflation medium; both predicate devices use a 1:1 mixture of 60% contrast in saline. However, CO2 is an accepted contrast agent for use in the peripheral vasculature. A literature search was done to evaluate the effects of CO2 in the circulatory system. The results demonstrate that CO2 doses of 5-250cc are safe in the peripheral vasculature. The design of the GuardDOG System limits the potential exposure to CO2 to 5 cc or less. In addition, the GuardDOG is packaged such that CO2 is maintained at high purity (greater than 95%) and thus potential balloon failure will expose the patient to CO2 rather than to air embolism. Finally, the rated burst diameter of the GuardDOG Occlusion Guide Wire balloon is 9.26 mm and provides an acceptable margin of error over the recommended 3-6 mm vessel occlusion range. These results, individually and taken together, demonstrate equivalency to the predicate devices and appropriate safety and efficacy of the GuardDOG Occlusion System for the intended use.
NON-CLINICAL TESTS
Biocompatibility of the GuardDOG system was evaluated in compliance with Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies, 21 CFR Part 58 and according to the recommendations in ISO 10993-1 Biological Evaluation of Medical Devices - Part One. The results, reported in the Biocompatibility tab, demonstrate that the GuardDOG materials and manufacturing methods are appropriate and safe for the intended use. In addition, the GuardDOG System is sterilized according to industry standard procedures and is packaged appropriately in packaging that maintains a sterile barrier and device integrity as reported in the Packaging and Sterilization tab.
A Vesscl Safety Animal Study was performed to compared the incidence of acute vessel injury between the GuardDOG Occlusion System and the Equinox Occlusion Balloon Catheter in a canine model. The study concluded that the GuardDOG performed well with regard to vessel occlusion and does not cause any significant vessel injury compared
3
to the predicate device. These results demonstrate appropriate safety of the GuardDOG Occlusion System for the intended use and equivalence to the predicate device.
Additional animal studies were conducted to evaluate device integrity, track to a targeted vascular site and deliver an infusion catheter device the intended vascular territory. The GuardDOG Occlusion System is compatible with standard interventional devices such as introducers, guide catheters, and infusion catheters and is equivalent to the predicate devices based on acceptable results in these tests.
CONCLUSION
The data presented in this Premarket Notification establish that the GuardDOG Occlusion System is equivalent to the predicate devices and demonstrate appropriate safety and efficacy of the GuardDOG Occlusion System for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
4
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2004
Possis Medical, Inc. c/o Mr. Mark D. Stenoien Manager, Clinical and Regulatory Affairs 9055 Evergreen Boulevard NW Minneapolis, MN 55433-8003
Re: K031357
Trade Name: GuardDOG Occlusion System Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II (two) Product Code: MJN Dated: February 17, 2004 Received: February 18, 2004
Dear Mr. Stenoien:
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 classificd (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
5
Page 2 - Mr. Mark D. Stenoien
or any Federal statutes and regulations administered by other Federal agencies. You must or any 1 odetar bather and st requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. product radiation oonal of provesin marketing your device as described in your Section 510(k) I mis letter will and will be of substantial equivalence of your device to a legally premation of neation. "The 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), plcase 11 you deem e epecific and Compliance at (301) 594-4659. 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 other general mionmational 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,
Duna R. bo chines
G/\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
GUARDDOG™ OCCLUSION SYSTEM INDICATION FOR USE STATEMENT
APRIL 2003
The GuardDOG™ Occlusion System is indicated for use in the peripheral vasculature to The GualdDOO - Occalized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.
The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.
Prescription use _
Mark R. Vachner
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Ko 31357