(43 days)
Not Found
No
The summary describes a tubing set for a heart-lung machine and its coating, with no mention of AI or ML capabilities.
Yes
The device is used in combination with a heart-lung machine for oxygenation of blood and removal of carbon dioxide, directly supporting vital physiological function during surgical procedures.
No
The device description clearly states its purpose is to connect the patient to a heart-lung machine for oxygenation of blood and removal of carbon dioxide, making it a component in a life support system, not a diagnostic one.
No
The device description clearly states it is a tubing set used in combination with a heart-lung machine, indicating it is a physical hardware component, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical procedures requiring extracorporeal support for up to six hours." This describes a device used during a surgical procedure to support bodily functions, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description clearly states the tubing sets are used to "connect the patient to the heartlung machine and it's components" for "oxygenation of blood and removal of carbon dioxide." This is a life support function, not a diagnostic test.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
The device is a component of an extracorporeal perfusion system used for physiological support during surgery.
N/A
Intended Use / Indications for Use
The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
The Safeline coating is used to reduce the surface tension on blood contact surfaces.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The Jostra HLM Tubing Sets with Safeline 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 Jostra HLM Tubing Sets with Safeline Coating are used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the Jostra HLM Tubing Sets with Safeline Coating is to connect the patient to the heartlung machine and it's components. The Jostra HLM Tubing Sets with Safeline Coating are therefore a component in the extracorporeal perfusion circulation system, for the oxygenation of blood and the removal of carbon dioxide. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data of the Jostra HLM Tubing Sets with Safeline Coating are comparable with the performance data of the Jostra HLM Tubing Sets without the Safeline Coating.
All of the Jostra HLM Tubing Set tests in 510(k) number K0503025 are applicable to the Jostra HLM Tubing Set - Safeline Coated product.
The risk analysis method used to assess the impact of the modification was done according to the logic of a Failure Modes and Effects Analysis (FMEA). Design verification tests were performed as a result of this risk analysis assessment.
All possible risks for the user and the patient related to the design change (combination of the existing Jostra HLM Tubing Set with the existing Safeline Coating) have been assessed by evaluation or testing acc. to the risk analysis for the Jostra HLM Tubing Set with Safeline Coating. As a result of this analysis the following hazards were addressed:
Biological Hazards related to
- pyrogenicity
- ETO-degassing
- Biocompatibility
Functional Hazards related to - device integrity
Hazards due to wrong application - interaction between Safeline and other coatings
The evaluation and test results do not show any kind of risk potential for the user and/or the patient. The modification does not alter the fundamental scientific technologies of the Jostra HLM Tubing Set. Based on the test results and the evaluation the Jostra HLM Tubing Set with Safeline Coating are safe and effective for their intended use and are substantially equivalent to the named predicate devices, the uncoated Jostra HLM Tubing Set and the RotaFlow Centrifugal Pump with Safeline Coating (regarding the Safeline Coating).
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
Maquet Cardiopulmonary AG
Hechinger Strasse 38 72145 Hirrlingen
510(K) Summary
Submitter:
| K0618 | ( (
24 |
|-----------|-----------|
| age
11 | 1-
Of |
AUG 1 1 2006
-
Contact Person: James Collie Phone: 215-491-5245 Or Katrin Schwenkglenks Phone: 011-49-7478-921-151
Germany -
Date Prepared: June 30, 2006
-
Device Trade Name: Jostra HLM Tubing Sets with Safeline Coating
-
Common/Usual name: Custom Tubing Pack
-
Classification names: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing
Cardiopulmonary Bypass Adaptor, Stopcock, Manifold, or Fitting
Cardiopulmonary Bypass Pump Tubing
Jostra HLM Tubing Sets - 510(k) number Predicate Devices: K053025
RotaFlow Centrifugal Pump with Safeline Coating. K061072, (with regards to the Safeline Coating only)
Device Description:
The Jostra HLM Tubing Sets with Safeline 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.
1
In open heart surgery the Jostra HLM Tubing Sets with Safeline Coating are used in combination with the heartlung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the Jostra HLM Tubing Sets with Safeline Coating is to connect the patient to the heartlung machine and it's components. The Jostra HLM Tubing Sets with Safeline Coating are therefore a component in the extracorporeal perfusion circulation system, for the oxygenation of blood and the removal of carbon dioxide. The utilization period of the use of the tubing sets is restricted to six hours.
The performance data of the Jostra HLM Tubing Sets with Safeline Coating are comparable with the performance data of the Jostra HLM Tubing Sets without the Safeline Coating.
Indications for Use:
Jostra HLM Tubing Set - Safeline coated
The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
Indications for use Jostra Safeline Coating
To reduce the surface tension on blood contact surfaces.
The above tubing set indications for use has been cleared with the Jostra HLM Tubing Set 510(k) number K0503025. The intended use of the modified devices, as described in its labeling, has not changed as a result of the modification.
Statement of Technical Comparison:
The Jostra HLM Tubing Set - Safeline Coated has the same intended use, design, principals of operation, and performance as the Jostra HLM Tubing Set without the Safeline Coating, The only difference is the application of the Safeline Coating to the tubing and connectors.
Non-clinical Testing:
All of the Jostra HLM Tubing Set tests in 510(k) number K0503025 are applicable to the Jostra HLM Tubing Set - Safeline Coated product.
2
K061832
Page 3 of 3
Risk analysis
The risk analysis method used to assess the impact of the modification was done according to the logic of a Failure Modes and Effects Analysis (FMEA). Design verification tests were performed as a result of this risk analysis assessment.
All possible risks for the user and the patient related to the design change (combination of the existing Jostra HLM Tubing Set with the existing Safeline Coating) have been assessed by evaluation or testing acc. to the risk analysis for the Jostra HLM Tubing Set with Safeline Coating. As a result of this analysis the following hazards were addressed:
Biological Hazards related to
- pyrogenicity .
- ETO-degassing �
- Biocompatibility ●
Functional Hazards related to
-
. device integrity
Hazards due to wrong application -
interaction between Safeline and other coatings .
The evaluation and test results do not show any kind of risk potential for the user and/or the patient. The modification does not alter the fundamental scientific technologies of the Jostra HLM Tubing Set.Based on the test results and the evaluation the Jostra HLM Tubing Set with Safeline Coating are safe and effective for their intended use and are substantially equivalent to the named predicate devices, the uncoated Jostra HLM Tubing Set and the RotaFlow Centrifugal Pump with Safeline Coating (regarding the Safeline Coating).
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 1 2006
Maquet Cardiopulmonary AG c/o Mr. James Collie President 414 Maryjoe Way Warrington, PA 18976
Re: K061832
Jostra HLM Tubing Sets with Safeline Coating Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing, Vascular Regulatory Class: Class II (two) Product Code: DWF Dated: June 30, 2006 Received: June 29, 2006
Dear Mr. Collie:
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.
4
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Duna R. Vicines
Image /page/4/Picture/4 description: The image shows a black and white drawing of a squiggly line. The line is thick and appears to be drawn with a marker or pen. The line is not straight and has several curves and bends. The drawing is simple and abstract.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K06 1832
Device Name: Jostra HLM Tubing Set with Safeline Coating
Indications For Use:
The Jostra HLM Tubing Set with Safeline Coating is indicated for use in surgical procedures requiring extracorporeal support for up to six hours
The Safeline coating is used to reduce the surface tension on blood contact surfaces.
Prescription Use _ x (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Diana R. V. Innes
(Division Sign-Off) Division of Cardiovascular Devices
Page 1 of 1
510(k) Number k06183d