K Number
K080832
Device Name
STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
Date Cleared
2008-07-30

(127 days)

Regulation Number
870.4220
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Device Description
The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.
More Information

Not Found

No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on a gas blender accessory for a heart-lung machine.

No
The device is an accessory to a heart-lung machine used during cardiopulmonary bypass, which supports life functions during surgery rather than directly treating a disease or condition.

No

Explanation: The device, the Stöckert Gas Blender as part of the Stöckert S5 System, is described as being used "during cardiopulmonary bypass for procedures lasting six (6) hours or less." This indicates a therapeutic or life-support function, not a diagnostic one. There is no mention of it being used to detect, diagnose, or monitor a disease or condition.

No

The device description explicitly states it is an "optional accessory" to the Stöckert S5 System and "cannot be operated independently from the heart lung machine console," indicating it is a hardware component integrated with a larger hardware system, not a standalone software device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states it's for use during cardiopulmonary bypass for procedures. This is a procedure performed on a patient, not a test performed on a sample taken from a patient.
  • Device Description: The device is described as an accessory to a heart-lung machine console, which is used for supporting a patient's circulation and oxygenation during surgery. This further reinforces its use in a clinical procedure setting, not a laboratory diagnostic setting.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on sample analysis.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to support a physiological process during surgery.

N/A

Intended Use / Indications for Use

The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Product codes (comma separated list FDA assigned to the subject device)

DTQ, DWB, DTR, KRI, DTW, DXS, DWA, KRL, DTX

Device Description

The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications.

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.

Terumo® Advanced Perfusion System 1, K022947

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

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).

0

108832

JUL 30 2008

510(k) Summary Sorin Group Deutschland GmbH Stöckert S5 System Gas Blender (per 21 CFR 807.92)

SPONSOR 1.

Sorin Group Deutschland GmbH
Lindberghstrasse 25
80939 Munich
Germany
Contact Person:Helmut Höfl
Telephone:011 49 89 323 010

Date Prepared: May 14, 2008

2. DEVICE NAME

Proprietary Names:Stöckert S5 System
Common/Usual Names:Heart Lung Machine
Classification Names:Cardiopulmonary bypass heart lung machine console and accessories
Proprietary Name:Stöckert S5 System

3. PREDICATE DEVICES

Stöckert S5 System (Parent Device) Terumo® Advanced Perfusion System 1, K022947

DEVICE DESCRIPTION 4.

The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.

เก่ INTENDED USE

The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

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6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Gas Blender to the cited predicate devices based on equivalence in intended use, fundamental technological and operational characteristics. Information and testing submitted in this Special 510(k): Device Modification demonstrates that the Stöckert Gas Blender integrated with the S5 System Stöckert Gas Blender with the S5 System do not raise new issues of safety or effectiveness.

7. PERFORMANCE INFORMATION

Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications.

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 2008

Sorin Group Deutscland c/o Ms. Rosina Robinson, RN, Med, RAC Principal Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K080832

Stockert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ, DWB, DTR, KRI, DTW, DXS, DWA, KRL, DTX Dated: June 13, 2008 Received: June 19, 2008

Dear Ms. Robinson:

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 vour 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.

3

Page 2 - Ms. Rosina Robinson

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 sct 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 cquivalence 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 (240) 276-0120. 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 Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Dmen R. hohner

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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Indication for Use

510(k) Number (if known): K080832

Stöckert S5 System Device Name:

Indications for Use:

The modified Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dina R. Vollmer

ivision Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K080832