(43 days)
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.
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.
The provided document does not contain any data, tables, or studies that prove the device meets acceptance criteria.
The document is a 510(k) premarket notification for the Jostra HLM Tubing Sets with Safeline Coating. It describes the device, its intended use, and states that its performance data are comparable to the uncoated version. It also outlines a risk analysis (FMEA) performed to assess the impact of the Safeline coating. The conclusion is that the device is safe and effective for its intended use and substantially equivalent to predicate devices.
However, it does not provide quantitative acceptance criteria or detailed study results to demonstrate this. The key statement regarding performance is: "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."
Here's a breakdown of why I cannot answer your request based on the provided text:
- 1. A table of acceptance criteria and the reported device performance: This information is not present. The document states comparability but doesn't list criteria or specific performance metrics.
- 2. Sample size used for the test set and the data provenance: Not mentioned.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Adjudication method for the test set: Not mentioned.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device (tubing sets) and not an AI-assisted diagnostic tool involving human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used: Not explicitly stated, as there are no detailed studies presented. The "ground truth" here would likely be the established performance and safety profiles of the predicate, uncoated device.
- 8. The sample size for the training set: Not applicable and not mentioned, as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable and not mentioned.
The document focuses on substantiating that the addition of the "Safeline Coating" does not negatively impact the established safety and performance of the existing Jostra HLM Tubing Sets. The evidence provided is primarily through:
- Statement of Technical Comparison: The device has the same intended use, design, principles of operation, and performance as the predicate, with the only difference being the coating.
- Non-clinical Testing: All tests from the predicate 510(k) (K0503025) are deemed applicable. This implies that the new device would pass those same tests, but the results are not detailed here.
- Risk Analysis (FMEA): This identified potential hazards related to the coating (biological, functional, interaction with other coatings), and states that "Design verification tests were performed as a result of this risk analysis assessment" and that "The evaluation and test results do not show any kind of risk potential." Again, the specific tests and their quantitative results are not provided in this summary.
In summary, the document asserts comparability and safety through risk analysis and reliance on previous clearances, rather than presenting new, detailed performance study data against explicit acceptance criteria.
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Maquet Cardiopulmonary AG
Hechinger Strasse 38 72145 Hirrlingen
510(K) Summary
Submitter:
| K0618 | ( (24 |
|---|---|
| age11 | 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.
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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.
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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).
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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.
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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
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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
§ 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).