EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE by MILLIMED A/S

The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.
The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.
The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.

Device Description

The EasyPass™ US Y-connector Hemostatic Valve consists of a y-connector body with a rotating luer lock, a sidearm and a hemostasis valve. To open the hemostasis valve, a valve opener cap with a center passage tube is pushed distally. The hemostasis valve is closed by pulling the valve opener cap proximally. The passage tube on the valve opener provides a completely opened and smooth lumen for the insertion of interventional devices.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "EasyPass™ US Y-connector Hemostatic Valve." This type of document is filed with the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, thereby allowing it to be marketed without a full Pre-Market Approval (PMA) process.

Critically, a 510(k) summary does not typically contain detailed information about specific acceptance criteria or the comprehensive results of a device performance study as one would expect for an AI/ML medical device. The performance section found in a 510(k) often only states that testing was done and demonstrated safety and effectiveness, usually by comparing it to the predicate device.

Therefore, many of the requested items related to an AI/ML study (e.g., sample size for test set, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this document because it describes a hardware medical device (a hemostatic valve), not an AI/ML algorithm.

Based on the provided text, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically used for AI/ML device studies. Instead, it states general findings related to the device's functionality compared to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Device design is substantially equivalent to predicate device.	Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device (Guidant Corporation's Copilot Bleedback Control Valve K991102).
Principle of operation is substantially equivalent.	Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device (Guidant Corporation's Copilot Bleedback Control Valve K991102).
Device is safe and effective for its intended use.	The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve. (Intended use: maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller. The guidewire insertion tool facilitates introduction, and the torquer provides a handle for manipulation.)

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

Not Applicable (N/A). This document refers to a physical medical device (hemostatic valve), not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "performance testing" mentioned would typically involve bench testing (e.g., flow rates, leak testing, material compatibility), not analysis of patient data.

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

N/A. As this is not an AI/ML device, there are no "experts" establishing ground truth in this context. The evaluation would be engineering/performance-based against specifications, potentially with clinical input on usability, but not for "ground truth" labeling.

4. Adjudication method for the test set

N/A. No test set or adjudication method as described for AI/ML devices is mentioned or applicable.

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

N/A. This device is a passive hardware component, not an AI system. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

N/A. This is a hardware device, not an algorithm.

7. The type of ground truth used

N/A. For this physical device, "ground truth" would relate to its physical and functional performance against established engineering standards and specifications (e.g., no leaks, smooth passage of devices, consistent hemostasis), rather than clinical "ground truth" from pathology or outcomes data. The document focuses on demonstrating substantial equivalence to a predicate device based on design and principle of operation, supported by general performance testing findings.

8. The sample size for the training set

N/A. This is not an AI/ML device, so there is no training set.

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

N/A. This is not an AI/ML device, so there is no training set or ground truth in that context.

Summary

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OCT 2004

10-2

510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

Submitter's Name:	Millimed A/S
Submitter's Address:	Langebjerg 2DK-4000 RoskildeDenmark
Telephone:	+45 4676 1420
Fax:	+45 4676 1970
Contact Person:	Jannie Funch, Quality Manager
Date Prepared:	July 30, 2004
Device Trade Name:	EasyPass™ US Y-connector Hemostatic Valve
Device Common Name:	Hemostasis Device
Device Classification Name:	Cardiovascular Surgical Devices

Device Classification: Class II

Summary of Substantial Equivalence:

The EasyPass Y-connector Hemostatic Valve is substantially equivalent to Guidant Corporation's Copilot Bleedback Control Valve (K991102)

Device Description:

Intended Use:

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The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.

K042060

20f2

The torquer, inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.

Technological Characteristics:

Comparisons of the new and predicate device show that technological characteristics such as device design and principle of operation are substantially equivalent to the currently marketed predicate device.

Performance Data:

The results of the performance testing demonstrated the safety and effectiveness of the EasyPass™ US Y-connector Hemostatic Valve.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

OCT 6 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Millimed A/S c/o Ms. Jannie Funch Quality Manager Langebjerg 2 DK-4000 Roskilde Denmark

K042060 Re:

EasyPass™ US Y-connector hemostatic Valve Regulation Number: 21 CFR 870.4290 Regulation Name: Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting Regulatory Class: Class II (two) Product Code: DTL Dated: July 30, 2004 Received: July 30, 2004

Dear Ms. Funch:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosule) to regars comment date of the Medical Device Amendments, or to commerce proof to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have been receised in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercerore, market the Act include requirements for annual registration, listing of general controls provisions of the 110 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 II your device is classified (Socure) ins. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations FRA Inay be subject to sable additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

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Page 2 - Ms. Jannie Funch

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 (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. 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), please contact the Office of Compliance at (301) 594-4646. 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) you may obtain. 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,

Ввиташов

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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Indications for Use Statement

510(k) Number (if known)
Device Name	EasyPass™ US Y-connector Hemostatic Valve
Indications for Use	The EasyPass™ US Y-connector Hemostatic Valve is intended to maintain hemostasis during the introduction, use and withdrawal of diagnostic and interventional devices that have an outer diameter of 7 French or smaller.The guide wire insertion tool facilitates introduction of the guide wire through the hemostasis valve and into the guiding catheter.The torquer, when inserted over the proximal end of the guide wire, provides a handle for easier manipulation of the guide wire.
Prescription Use	X
OR Over-The-Counter Use
	(Per 21 CFR 801.109)
	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K042060

Regulation Number and Section

§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.

(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.