(192 days)
The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporeal circulation during cardiopulmonary bypass procedures lasting six hours or less.
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. The Bioline Coating improves the physical surface properties of products for the extracorporeal circulation system.
This document is a 510(k) summary for a medical device called "HLM Tubing Sets with Bioline Coating." It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, many of the requested categories for a study proving device meets acceptance criteria are not directly applicable or explicitly detailed in this type of submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The submission states that "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 areas evaluated were: Integrity, Performance, Biocompatibility, and Sterility.
The document does not provide a specific table of numerical acceptance criteria or detailed reported performance values. Instead, it concludes that the device is "substantially equivalent" to predicate devices, implying it meets the same implicit performance and safety standards as those already cleared.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Integrity | Deemed substantially equivalent to predicate devices. |
| Performance | Deemed substantially equivalent to predicate devices. |
| Biocompatibility | Deemed substantially equivalent to predicate devices. |
| Sterility | Deemed substantially equivalent to predicate devices. |
| Intended Use | Same as predicate devices: for oxygenation of blood and removal of carbon dioxide in open heart surgery with a heart-lung machine; utilization period restricted to six hours. |
| Design/Principles of Operation | Same as uncoated Jostra HLM Tubing Set; only difference is the Bioline Coating application. |
Missing Information: Numerical performance metrics, specific pass/fail thresholds, and detailed results of the evaluations are not included in this summary.
Study Details
Given this is a 510(k) summary for substantial equivalence, a traditional "study" in the sense of a large-scale clinical trial with specific acceptance criteria and detailed statistical analysis is not typically presented in this format. The evaluations are likely bench tests and material science assessments.
- Sample size used for the test set and the data provenance: Not specified in the summary. The studies would likely involve multiple tubing sets and connectors for integrity, performance (e.g., flow rates, pressure resistance), biocompatibility (e.g., in vitro or in vivo tests), and sterility tests. Data provenance is not mentioned, but given the manufacturer is in Germany, a portion of the testing might have occurred in Germany.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For this type of device and submission, ground truth would be established by scientific and engineering standards (e.g., ISO, ASTM, internal specifications) for material properties and device function, rather than expert consensus on diagnostic imaging.
- Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., medical imaging). For device integrity and performance, results are typically determined by measurement against predefined specifications.
- 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. This device is not an AI-powered diagnostic tool, so MRMC studies or AI assistance are irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device (tubing set), not an algorithm or software.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device would be based on established engineering principles, material science specifications, validated test methods (e.g., for biocompatibility and sterility), and performance standards relevant to cardiopulmonary bypass equipment. For example, sterility would be confirmed by validated sterilization processes and sterility testing, biocompatibility by cytotoxicity, sensitization, and irritation tests according to ISO 10993.
- The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion from the document:
The submission concludes that "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." This means the conducted evaluations confirmed that the modified device (with Bioline coating) performs as safely and effectively as the existing, legally marketed predicate devices, with no new questions of safety or effectiveness raised.
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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
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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
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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.
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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
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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)
§ 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).