(192 days)
Not Found
No
The summary describes a tubing set for cardiopulmonary bypass and does not mention any AI or ML components or functionalities.
No.
The device is a component that connects the patient to a heart-lung machine; the heart-lung machine performs the therapeutic action of oxygenating blood and removing carbon dioxide.
No
The device is a tubing set used for connecting a patient to a heart-lung machine during cardiopulmonary bypass procedures, facilitating blood oxygenation and carbon dioxide removal. It is a component in the extracorporeal perfusion circulation system, not a device that diagnoses a condition or disease.
No
The device description clearly states it is a physical tubing set used in extracorporeal circulation, connecting a patient to a heart-lung machine. It is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for extracorporeal circulation during cardiopulmonary bypass procedures. This involves circulating blood outside the body for oxygenation and carbon dioxide removal, which is a therapeutic procedure, not a diagnostic test performed on samples.
- Device Description: The description clearly states the tubing sets are used to connect the patient to the heart-lung machine and its components, acting as a component in the extracorporeal perfusion circulation system. This is a functional component of a life support system, not a device used to analyze biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to facilitate a therapeutic procedure.
N/A
Intended Use / Indications for Use
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
Product codes
DWE, DWF, DTL
Device Description
The HLM Tubing Sets with Bioline 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 Bioline 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 Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline 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.
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
Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Bioline Coating described in this submission is substantially equivalent to the Jostra HLM-Tubing Set as a custom tubing pack and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the Bioline Coating. The following areas have been evaluated: Integrity, Performance, Biocompatibility, Sterility. The data given demonstrate that the HLM-Tubing Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4390 Cardiopulmonary bypass pump tubing.
(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).
0
SEP 1 2008
Maquet Cardiopulmonary AG
Phone: (011) 49 7478 921- 151
(011) 49 7478 921- 400
Hechinger Strasse 38 72145 Hirrlingen, Germany
Katrin Schwenkglenks
February 22, 2008
510(k) SUMMARY
SUBMITTER:
CONTACT PERSON:
DATE PREPARED:
HLM Tubing Sets with Bioline Coating DEVICE TRADE NAME:
Fax:
COMMON/USUAL NAME Custom Tubing Pack
CLASSIFICATION NAME
Bypass Cardiopulmonary Vascular Catheter, Cannula, or Tubing; Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting; Cardiopulmonary Bypass Pump Tubing.
PREDICATE DEVICES OR LEGALLY MARKETED DEVICES
Jostra HLM Tubing Sets (K053025)
Quadrox D Diffusion Membrane Oxygenator with Bioline Coating (K071774)
DEVICE DESCRIPTION / INDICATONS FOR USE STATEMENT
The HLM Tubing Sets with Bioline 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 Bioline 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 Bioline Coating is to connect the patient to the heart-lung machine and it's components. The HLM Tubing Sets with Bioline 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.
· Maquet Cardiopulmonary AG, Hirrlingen, Germany
1
Special 510(k) Device Modification HLM Tubing Set with Bioline Coating
The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON
The HLM Tubing Set - Bioline Coated has the same intended use, design, principals of operation, and performance as the uncoated Jostra HLM Tubing Set. The only difference is the application of the Bioline Coating to the tubing and connectors.
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
Evaluation on safety and effectiveness was executed to demonstrate that the HLM-Tubing Set with Bioline Coating described in this submission is substantially equivalent to the Jostra HLM-Tubing Set as a custom tubing pack and to the Quadrox D Diffusion Membrane Oxygenator with Bioline Coating with regards to the Bioline Coating.
The following areas have been evaluated:
- Integrity
- Performance
- Biocompatibility
- Sterility
CONCLUSION
The data given demonstrate that the HLM-Tubing Set with Bioline Coating is substantially equivalent to the named predicate devices which hold currently market clearance.
Maquet Cardiopulmonary AG, Hirrlingen, Germany
2
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.
SEP 1 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K080592
HLM Tubing Set with Bioline Coating Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II (two) Product Code: DWE, DWF, DTL Dated: August 29, 2008 Received: September 4, 2008
Dear Ms. Schwenkglenks:
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.
3
Page 2 - Ms. Katrin Schwenkglenks
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 (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 vours.
er R. Vo. Amer
o Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ KO80592 Device Name: HLM Tubing Set with Bioline Coating
Indications for Use:
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
Prescription Use × (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR
(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)
Donna R. Wehner
(Division Sign-Off)
Division of Cardiovascular Devices
Page _ of _
10(k) Number_K080592 (Posted November 13, 2003)