The HLM Tubing Sets with Softline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

Device Description

The HLM Tubing Sets with Softline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Softline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Softline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Softline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours. The Softline Coating improves the physical surface properties of products for the extracorporeal circulation system.

AI/ML Overview

The provided document, K090533, describes a Special 510(k) Device Modification for HLM Tubing Sets with Softline Coating. The document confirms that the device is substantially equivalent to predicate devices based on evaluations in integrity, performance, biocompatibility, and sterility. However, it does not provide detailed acceptance criteria or study results in the format requested. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to already marketed devices.

Therefore, I cannot fulfill most of the requested information (points 1-9) as the detailed study data regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness with human readers are not present in the provided text.

Specifically:

A table of acceptance criteria and the reported device performance: Not provided. The document states "The following areas have been evaluated: Integrity, Performance, Biocompatibility, Sterility" but does not list specific acceptance criteria or performance metrics.
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This device is a medical accessory, not an AI/diagnostic device that would require expert-established ground truth in the way described.
Adjudication method for the test set: Not applicable/provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI diagnostic device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI diagnostic device.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI diagnostic device.
How the ground truth for the training set was established: Not applicable. This is not an AI diagnostic device.

The document states:
"Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Softline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating (K080592) as a custom tubing pack and to the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117) with regards to the Softline Coating."

This implies that standard evaluations for medical device safety and effectiveness in the areas of integrity, performance, biocompatibility, and sterility were conducted to show equivalence to predicate devices, but the specific details of these evaluations are not included in the provided text.

Summary

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K090533

Special 510(k) Device Modification HLM Tubing Set with Softline Coating

510(k) SUMMARY	DEC 1 8 2009
SUBMITTER:	Maquet Cardiopulmonary AGHechinger Strasse 3872145 Hirrlingen, Germany
CONTACT PERSON:	Dr. Ingrid RichterPhone: (011) 49 7478 921- 337Fax: (011) 49 7478 921- 400
DATE PREPARED:	February 24, 2009
DEVICE TRADE NAME:	HLM Tubing Sets with Softline Coating
COMMON/USUAL NAME	Custom Tubing Pack
CLASSIFICATION NAME	Cardiopulmonary Bypass VascularCatheter, Cannula, or Tubing;Cardiopulmonary Bypass Adaptor,Stopcock, Manifold, or Fitting;Cardiopulmonary Bypass Pump Tubing.

PREDICATE DEVICES OR LEGALLY MARKETED DEVICES

HLM Tubing Set with Bioline coating (K080592)

Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117)

DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT

The HLM Tubing Sets with Softline Coating are for single use only. They may be sold sterile, non-sterile, and bulk packed. Tubing sets that are sold sterile are not to be re-sterilized by the user.

In open heart surgery the HLM Tubing Sets with Softline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Softline Coating is to connect the patient to the heart-lung machine and its components. The HLM Tubing Sets with Softline Coating are therefore a

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component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours.

The Softline Coating improves the physical surface properties of products for the extracorporeal circulation system.

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The HLM Tubing Set - Softline Coated has the same intended use, design, principals of operation, and performance as the HLM Tubing Set with Bioline Coating. The only difference is the application of the Softline Coating instead of the Bioline coating to the set components.

DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Softline Coating described in this submission is substantially equivalent to the HLM-Tubing Set with Bioline Coating (K080592) as a custom tubing pack and to the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating (K082117) with regards to the Softline Coating.

The following areas have been evaluated:

Integrity
Performance
Biocompatibility
Sterility

CONCLUSION

The data given demonstrate that the HLM-Tubing Set with Softline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Maquet Cardiopulmonary AG c/o Dr. Ingrid Richter Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany

DEC 1 8 2009

Re: K090533

HLM Tubing Set with Softline Coating Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: November 23, 2009 Received: November 25, 2009

Dear Dr. Richter:

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 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 - Dr. Ingrid Richter

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 device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

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

510(k) Number (if known): Ko905333

Device Name: HLM Tubing Set with Softline Coating

Indications for Use:

. .

The HLM Tubing Sets with Softline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Sign-Off
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Division of Cardiovascular Devices
510(k) Number	K090533

Page __ of ___

(Posted November 13, 2003)

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).