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 pouch. 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MedAmicus Valved Peelable Introducer based on the provided text:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria	Reported Device Performance
Valve Pressure Flowrate	Valve must reduce flow (Min 90% reduction before insertion, Min 78% reduction after dilator/guidewire removal)	95% reduction (before device insertion) to 99% reduction (after dilator/guidewire removal)
Valve Vacuum Flowrate	Valve must reduce flow (Min 93% reduction before insertion, Min 80% reduction after dilator/guidewire removal)	96% reduction (before device insertion) to 99% reduction (after dilator/guidewire removal)
Dilator Insertion Force	2.0 lb. maximum	Mean: 0.66 lb. (Range: 0.47 lb. - 1.03 lb.)
Dilator Removal Force	2.0 lb. maximum	Mean: 0.74 lb. (Range: 0.50 lb. - 1.09 lb.)
Catheter Insertion Force	2.0 lb. maximum	Mean: 0.88 lb. (Range: 0.56 lb. - 1.09 lb.)
Valve Peeling Force	Valve must peel off catheter	Pass (Test results indicated "Pass")

Study Information

2. Sample size used for the test set and the data provenance:

Test set sample sizes:
- Valve Pressure Flowrate: 30 units
- Valve Vacuum Flowrate: 29 units
- Dilator Insertion Force: 29 units
- Dilator Removal Force: 29 units
- Catheter Insertion Force: 29 units
- Valve Peeling Force: 29 units
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies internal testing by MedAmicus.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The study appears to be engineering/performance testing against specifications, rather than a clinical study requiring expert ground truth for interpretation of observational data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. The tests are focused on quantifiable physical properties and performance against predefined engineering specifications, not on subjective interpretations requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical introducer, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical medical device, not an algorithm. The testing described is "standalone" in the sense that it evaluates the device's physical performance independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth consists of predefined engineering specifications and performance benchmarks (e.g., maximum force, minimum reduction percentage). These are derived from design requirements and potentially industry standards, not from clinical expert consensus, pathology, or outcomes data in the typical sense.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. As there is no AI model or training set, this question is not relevant.

Summary

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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

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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

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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.

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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.

SubjectDevice	PredicateDevice	PredicateDevice
MedAmicus ValvedPeelable Introducer	MedAmicusIntroducer,Percutaneous, ValvedK932323	MedAmicus MaterialChange, PercutaneousIntroducer K000824
Intended Use	The MedAmicus ValvedPeelable Introducer isintended for use in thepercutaneous insertion ofpacing leads or cathetersin the venous system.	TheMedAmicusPercutaneous Introduceris indicatedfor use inthe insertionof pacingleads orcatheters inthe venoussystem.	The MedAmicusPercutaneousIntroducer is indicatedfor use in the insertionof pacing leads orcatheters in the venoussystem.
DesignFeatures	PTFEIntroducersheath withsliding valveto reduce therisk of bloodloss andminimize therisk of airintake.Devices maybe insertedthrough thevalve.	Introducersheath witha slidingvalve toreduce therisk ofblood lossand airaspiration	Introducer Sheath andDilator only

Device Comparison Chart

Figure 1

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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	% ReductionIn Air Flowcompared tohe Introducerwith the valvenot closedMean	Max
ValvePressureFlowrate	30	Valve mustreduce flow	90%	95% reduction(before deviceinsertion)	99%
			78%	86% reduction(afterdilator/guidewire removal)	94%
ValveVacuumFlowrate	29	Valve mustreduce flow	93%	96% reduction(before deviceinsertion)	99%
			80%	88% reduction(after dilator/guidewireremoval)	99%
			Force	Force	Force
DilatorInsertionForce	29	2.0 lb.maximum	0.47 lb.	0.66 lb.	1.03 lb.
DilatorRemovalForce	29	2.0 lb.maximum	0.50 lb.	0.74 lb.	1.09 lb.
CatheterInsertionForce	29	2.0 lb.maximum	0.56 lb.	0.88 lb.	1.09 lb.
ValvePeelingForce	29	Valve mustpeel offcatheter	Pass	Pass	Pass

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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.

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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.

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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

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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______________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use______________

(Per 21 CFR 801.109)

Page 9 of 15

Regulation Number and Section

§ 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).