(124 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on mechanical and electrical components for cardiopulmonary bypass.
Yes
The Stöckert S5 System, which the device is part of, is used for cardiopulmonary bypass, directly treating and supporting vital bodily functions during surgical procedures.
No
The device description indicates it is part of a system used for cardiopulmonary bypass, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it consists of an "Occluder Unit and Control Unit," which are hardware components. It is an accessory to a heart-lung machine console, further indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cardiopulmonary bypass," which is a procedure performed directly on a patient's body during surgery.
- Device Description: The device is described as an "Electrical Venous Occluder" and an accessory to a "heart lung machine console." These are devices used to support a patient's circulatory and respiratory functions during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is clearly intended for direct use on a patient during a medical procedure.
N/A
Intended Use / Indications for Use
The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Stöckert Electrical Venous Occluder is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the S5 heart lung machine console. It consists of an Occluder Unit and Control Unit to provide
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.
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
§ 870.4210 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).
0
KO8234/4
510(k) Summary Sorin Group Deutschland GmbH Stöckert S5 System with Electrical Venous Occluder (per 21 CFR 807.92)
1. SPONSOR
Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany
DEC 1 7 2008
| Contact Person: | Helmut Höfl |
|---|---|
| Telephone: | 011 49 89 323 010 |
Date Prepared: August 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), K071318 Terumo® Advanced Perfusion System 1, K022947
4. DEVICE DESCRIPTION
The Stöckert Electrical Venous Occluder is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the S5 heart lung machine console. It consists of an Occluder Unit and Control Unit to provide
1
5. INTENDED USE
The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Electrical Venous Occluder 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 Electrical Venous Occluder integrated 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 & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Principal consultant 49 Plain Street North Attleboro, CA 02760
DEC 1 7 2008
Re: K082344
Stöckert S5 System Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: December 1, 2008 Received: December 2, 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 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. 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 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 cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced 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,
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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510(k) Number (if known): K082344
Device Name: Stöckert S5 System
Indications for Use:
The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K082344
Sorin Group Deutschland GmbH August 14, 2008 Special 510(k): Device Modification Addition of the Stöckert Electrical Venous Occluder to the Stöckert S5 System