(294 days)
Not Found
No
The description focuses on the physical properties and function of tubing sets for extracorporeal circulation, with no mention of AI or ML.
Yes
The device is used in cardiopulmonary bypass procedures, which are therapeutic interventions.
No
The device is described as tubing used to connect a patient to a heart-lung machine during cardiopulmonary bypass procedures, facilitating blood oxygenation and carbon dioxide removal. This is a therapeutic or support device, not a diagnostic one.
No
The device is described as physical tubing sets with a coating, used in combination with a heart-lung machine. There is no mention of software as the primary or sole 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 to oxygenate it and remove carbon dioxide, which is a therapeutic procedure, not a diagnostic one.
- Device Description: The description clearly states the tubing sets are used to connect the patient to the heart-lung machine and its components for oxygenation and carbon dioxide removal. This is a life-support function, not a diagnostic test.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, tissue, etc.) to provide information about a patient's health status, disease, or condition.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (within the extracorporeal circulation system connected to the patient) and serves a therapeutic function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
DWF
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.
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)
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
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.
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
Special 510(k) Device Modification HLM Tubing Set with Softline Coating
| 510(k) SUMMARY | DEC 1 8 2009 |
|---|---|
| SUBMITTER: | Maquet Cardiopulmonary AG |
| Hechinger Strasse 38 | |
| 72145 Hirrlingen, Germany | |
| CONTACT PERSON: | Dr. Ingrid Richter |
| Phone: (011) 49 7478 921- 337 | |
| Fax: (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 Vascular |
| Catheter, 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
1
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.
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 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.
3
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
4
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) |
|---|
| -------------------------------------------------------- |
| Sign-Off |
|---|
| ---------- |
| Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | K090533 |
Page __ of ___
(Posted November 13, 2003)