(70 days)
Not Found
No
The device description and performance studies focus on mechanical and fluid dynamics properties, with no mention of AI or ML.
No.
The device is an introducer used for percutaneous insertion of leads or catheters, not for treating a condition itself.
No
The device is an introducer for percutaneous insertion of pacing leads or catheters, which are therapeutic or interventional procedures, not diagnostic ones. Its function is to facilitate the delivery of other medical devices into the venous system.
No
The device description clearly outlines physical components like a needle, syringe, guidewire, sheath, dilator, and a valve constructed of silicon and molded components. The performance studies also focus on the physical properties and function of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous insertion of pacing leads or catheters in the venous system." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device components (needle, syringe, guidewire, introducer sheath, valve) are all tools used for accessing a blood vessel and introducing other medical devices. They are not designed to analyze biological samples.
- Performance Studies: The performance studies focus on the physical characteristics and functionality of the device during insertion and removal (flowrate, insertion/removal forces, peeling force). These are not studies related to the diagnostic analysis of biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
The Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Product codes (comma separated list FDA assigned to the subject device)
74 DYB
Device Description
The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed nouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.
The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
venous 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A Risk Analysis for the Valved Peelable Introducer was performed per MedAmicus' internal procedure, WI42020, Hazard Analysis, FMEA and Risk This document is modeled closely after European Standard Analysis. EN1441: 1998 Medical Devices - Risk Analysis.
The performance testing for this device included testing to verify that the valve portion functions per the design requirement. The remainder of the items (sheath, dilator, guidewire, syringe, and needle) have been tested under previously approved 510K's. The test results (see Figure 2 below) support the determination of substantial equivalence to the predicate device(s). This device will reduce the risk of blood loss and will minimize the risk of air intake.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test | Sample Size | Specification | Min | % Reduction In Air Flow compared to he Introducer with the valve not closed Mean | Max |
|---|---|---|---|---|---|
| Valve Pressure Flowrate | 30 | Valve must reduce flow | 90% | 95% reduction (before device insertion) | 99% |
| 78% | 86% reduction (after dilator/guidewire removal) | 94% | |||
| Valve Vacuum Flowrate | 29 | Valve must reduce flow | 93% | 96% reduction (before device insertion) | 99% |
| 80% | 88% reduction (after dilator/guidewire removal) | 99% | |||
| Force | Force | Force | |||
| Dilator Insertion Force | 29 | 2.0 lb. maximum | 0.47 lb. | 0.66 lb. | 1.03 lb. |
| Dilator Removal Force | 29 | 2.0 lb. maximum | 0.50 lb. | 0.74 lb. | 1.09 lb. |
| Catheter Insertion Force | 29 | 2.0 lb. maximum | 0.56 lb. | 0.88 lb. | 1.09 lb. |
| Valve Peeling Force | 29 | Valve must peel off catheter | Pass | Pass | Pass |
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
§ 870.1340 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
KOZ1004
P1/6
edamicus
INCORPORATED
V. 510(k) Summary
Submitter
MedAmicus, Incorporated
15301 Highway 55 West Minneapolis, MN 55447
Main: (763) 559-2613 Fax: (763) 559-0148
Submission Contact
Karyl Haskell Quality Assurance and Regulatory Affairs Manager (763) 577-2257 khaskell@medamicus.com
Date Prepared
February 28, 2002
Trade Name Valved Peelable Introducer
Common Name Catheter Introducer
Classification Name
Introducer, Percutaneous
Predicate Device
MedAmicus Percutaneous Introducer, K932323 MedAmicus Percutaneous Introducer, Material Change K000824
1
Device Description Information
Device Description
The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed nouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead.
The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.
Materials
The materials used in the manufacture of the Valved Peelable Introducer are identical to the materials used in the predicate device; with the exception of the valved portion of this introducer. All materials have been tested for biocompatibility.
The sheath body is constructed of PTFE and is filled with bismuth trioxide as a radiopacifier. The handles, made of TPX resin, are overmolded onto the PTFE sheath tubing. The dilator is made of HDPE resin filled with barium sulfate as a radiopacifier and has a HDPE hub overmolded onto the dilatory shaft.
The silicone part material is liquid silicone rubber. The permanent coating is parylene-N. The silicone lubricant, is a mixture of Dow 360 Medical Fluid and Hexanes.
The Valved Peelable Introducer will be packaged and EtO sterilized for one time use in a Tyvek pouch with a guidewire, needle and syringe. This configuration and specification remains the same as the configuration and specification that was previously cleared under K932323 and K000824.
The Polystyrene tray is commonplace in the medical industry as a packaging material for a number of medical devices. Biocompatability evaluations have
2
been conducted along with sterility testing which demonstrate that this material is suitable as a tray material.
Appendix A contains photographs and engineering drawings of the Valved Peelable Introducer.
Appendix B contains a kit certification statement as required by FDA.
This percutaneous introducer has been modified from the introducer cleared under K932323. The material for the sliding valve portion of the introducer has been modified from polypropylene to silicone. The purpose of this change is to add the functionality of allowing a device to pass through the valve. The originally cleared product included a sliding valve that had to be slid out of the way when a device was inserted.
Device Sizes
Sizes of the sheath and dilator range from 7FR to 16FR. The materials and construction are the same for all French sizes.
| French | Sheath Length |
|---|---|
| ±.50 | |
| 7 | 5.93 |
| 7L | 5.86 |
| 8 | 5.93 |
| 9 | 5.93 |
| 10 | 5.93 |
| 11 | 5.93 |
| 12 | 5.93 |
| 13 | 5.93 |
| 14 | 5.53 |
| 15 | 5.53 |
| 16 | 5.53 |
Intended Use
The Valved Peelable Introducer is indicated for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Technological Characteristics
The device is technologically equivalent to other introducers, including the valve mechanism to reduce blood loss and the risk of air intake.
3
KO21004
4/6
Comparison to Predicate Device(s)
The Device Comparison Chart, Figure 1 below, shows that the Subject Device is equivalent to the two Predicate Devices. The Intended Use statements are identical and the design features are similar. The MedAmicus Valved Peelable Introducer is substantially equivalent to the MedAmicus Introducer Percutaneous, Valved, K932323, cleared November 9, 1993 in combination with the Material Change, Percutaneous Introducer K000824, cleared April 13, 2000.
| Subject
Device | Predicate
Device | Predicate
Device | |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| MedAmicus Valved
Peelable Introducer | MedAmicus
Introducer,
Percutaneous, Valved
K932323 | MedAmicus Material
Change, Percutaneous
Introducer K000824 | |
| Intended Use | The MedAmicus Valved
Peelable Introducer is
intended for use in the
percutaneous insertion of
pacing leads or catheters
in the venous system. | The
MedAmicus
Percutaneou
s Introducer
is indicated
for use in
the insertion
of pacing
leads or
catheters in
the venous
system. | The MedAmicus
Percutaneous
Introducer is indicated
for use in the insertion
of pacing leads or
catheters in the venous
system. |
| Design
Features | PTFE
Introducer
sheath with
sliding valve
to reduce the
risk of blood
loss and
minimize the
risk of air
intake.
Devices may
be inserted
through the
valve. | Introducer
sheath with
a sliding
valve to
reduce the
risk of
blood loss
and air
aspiration | Introducer Sheath and
Dilator only |
Device Comparison Chart
Figure 1
4
Summary of Studies
A Risk Analysis for the Valved Peelable Introducer was performed per MedAmicus' internal procedure, WI42020, Hazard Analysis, FMEA and Risk This document is modeled closely after European Standard Analysis. EN1441: 1998 Medical Devices - Risk Analysis.
The performance testing for this device included testing to verify that the valve portion functions per the design requirement. The remainder of the items (sheath, dilator, guidewire, syringe, and needle) have been tested under previously approved 510K's. The test results (see Figure 2 below) support the determination of substantial equivalence to the predicate device(s). This device will reduce the risk of blood loss and will minimize the risk of air intake. The following table includes the tests that have been conducted, the specifications of the tests and the results of each test:
| Test | Sample Size | Specification | Min | % Reduction
In Air Flow
compared to
he Introducer
with the valve
not closed
Mean | Max |
|--------------------------------|-------------|------------------------------------|----------|----------------------------------------------------------------------------------------------------|----------|
| Valve
Pressure
Flowrate | 30 | Valve must
reduce flow | 90% | 95% reduction
(before device
insertion) | 99% |
| | | | 78% | 86% reduction
(after
dilator/guidew
ire removal) | 94% |
| Valve
Vacuum
Flowrate | 29 | Valve must
reduce flow | 93% | 96% reduction
(before device
insertion) | 99% |
| | | | 80% | 88% reduction
(after dilator
/guidewire
removal) | 99% |
| | | | Force | Force | Force |
| Dilator
Insertion
Force | 29 | 2.0 lb.
maximum | 0.47 lb. | 0.66 lb. | 1.03 lb. |
| Dilator
Removal
Force | 29 | 2.0 lb.
maximum | 0.50 lb. | 0.74 lb. | 1.09 lb. |
| Catheter
Insertion
Force | 29 | 2.0 lb.
maximum | 0.56 lb. | 0.88 lb. | 1.09 lb. |
| Valve
Peeling
Force | 29 | Valve must
peel off
catheter | Pass | Pass | Pass |
5
K621004 1.616
510(k) Summary Conclusion
Medamicus belives that the MedAmicus Valved Peelable Introducer is substantially equivalent to the predicate MedAmicus Percutaneous Introducer kits. The intended use, materials, sterilization, packaging, labeling, method of operation and manufacturing methods have been proven to be identical.
6
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 6 2002
MedAmicus, Incorporated c/o Ms. Karyl D. Haskell Ouality Assurance and Regulatory Affairs Manager 15301 Highway 55 West Minneapolis, MN 55447
Re: K021004 Trade Name: Valved Peelable Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: 74 DYB Dated: March 27, 2002 Received: March 28, 2002
Dear Ms. Haskell:
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.
7
Page 2 - Ms. Karyl D. Haskell
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 forth in 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. 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 and additionally 21 CFR Part 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 Part 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.
Elia Mallia
for
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
VII. Indications for Use
510(k) Number (if known): Not Assigned
Device Name: MedAmicus Valved Peelable Introducer
The MedAmicus Valved Peelable Introducer is Indications for Use: intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
Olia Mallia
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K021004 1:0(k) Number _
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use______________
(Per 21 CFR 801.109)
Page 9 of 15