(204 days)
The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
The Plegiox is a product, which is delivered to the end user in a pyrogen-free and sterile way. The product is determined for single use only. Re-sterilization and re-use are forbidden. The Plegiox is a cardioplegia heat exchanger with integrated bubble trap.
The provided text describes a 510(k) submission for the "Plegiox Cardioplegia Heat Exchanger with and without Safeline Coating" by Maquet Cardiopulmonary AG. The submission asserts substantial equivalence to predicate devices based on in-vitro testing.
However, the document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and a comprehensive "study" in the way one might expect for a novel device's performance evaluation. The information provided is primarily focused on the device description, indications for use, and a general statement about in-vitro testing for substantial equivalence.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this type of regulatory submission document.
Here's the information that can be extracted or inferred from the provided text, along with a clear indication of what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance |
|---|---|
| Ability to set and maintain temperature of blood and crystalloid cardioplegic solutions during ECC. | "The Plegiox Cardioplegia Heat Exchanger has shown to be as effective as the predicate device." (Based on in-vitro testing). |
| Single-use only, for an application period of no longer than 6 hours. | Consistent with predicate device's recommended use period. |
| (For Safeline Coating) Reduction of surface tension on blood contact surfaces. | Functions with the same intended use as the predicate's Safeline Coating. |
| Compliance with general safety and effectiveness requirements for cardioplegia heat exchangers. | Demonstrated through in-vitro testing to be substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document only mentions "in-vitro testing" without detailing the number of units or test runs conducted.
- Data Provenance: The device is manufactured by Maquet Cardiopulmonary AG, Germany. The testing was conducted "in-vitro." Specific details on the lab location or origin of data are not provided beyond the company's location. The testing is assumed to be prospective in the sense that it was conducted specifically to support this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/not specified. For this type of in-vitro performance test for a physical device, "ground truth" is typically established by engineering standards, validated measurement equipment, and specified test protocols, not by expert consensus on clinical data.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication method for the test set
- Adjudication Method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typical for clinical studies involving human interpretation (e.g., imaging reads). For in-vitro engineering tests of a heat exchanger, performance is objectively measured against predefined technical specifications.
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
- MRMC Study: No. This is a medical device (heat exchanger), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human readers or AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. The "standalone performance" would refer to its in-vitro functional capabilities, which were tested.
7. The type of ground truth used
- Ground Truth Type: For "in-vitro testing on safety and effectiveness," the "ground truth" would be established by predefined engineering specifications, validated measurement methods, and compliance with industry standards for heat exchange efficiency and material biocompatibility. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This refers to a physical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set for a physical device, this question is not relevant.
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MAQUET
510 (K) Summary [as required by 21 CFR 807.92(c) ]
Maquet Cardiopulmonary AG Submitter: Hechinger Strasse 38 72145 Hirrlingen APR - 4 2008 Germany Katrin Schwenkglenks Contact Person:
Phone: +49 7478 921-151 Fax: +49 7478 921-400 E-mail: katrin.schwenkglenks@maquet-cp.com
September 07, 2007
Plegiox Cardioplegia Heat Exchanger with and Device Trade Name: without Safeline Coating
Cardioplegia Heat Exchanger Common/Usual Name:
Classification Names:
Predicate Devices:
Date Prepared:
Cardiopulmonary Bypass Heat Exchanger (21 CFR 870.4240, product code: DTR)
CSC 14 Blood Cardioplegia System, Cobe Cardiovascular Inc. (K012898) and Jostra RotaFlow Centrifugal Pump with Safeline Coating (K061072), Maquet Cardiopulmonary AG.
030(v2)
Device Description
The Plegiox is a product, which is delivered to the end user in a pyrogen-free and sterile way. The product is determined for single use only. Re-sterilization and re-use are forbidden. The Plegiox is a cardioplegia heat exchanger with integrated bubble trap.
Statement of Indications for Use
The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
Statement of Technical Characteristics Comparison
Maquet Cardiopulmonary AG has compared indications for use, design, specifications, performance characteristics and safety of the Plegiox Heat Exchanger with and without Safeline Coating and of the predicate devices.
In-vitro testing on safety and effectiveness was executed to demonstrate that the Plegiox with and without Safeline Coating described in this submission is substantially equivalent to the named predicate devices.
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Indications for use for the Plegiox Cardioplegia Heat Exchanger, Maquet Cardiopulmonary AG:
"The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
CSC 14 Cardioplegia Heat Exchanger, Cobe Cardiovascular Inc.:
"CSC14 is recommended for use as a heating/cooling device and bubble trap for cardioplegia and clear fluid perfusion in extracorporeal circulation associated with cardiopulmonary bypass. It is suggested not to use CSC 14 for more than 6 hours.
CSC 14 can be used in combination with the devices listed in paragraph 1. Devices which can be used with CSC 14."
Safeline Coating:
The Safeline Coating applied to the Plegiox Cardioplegia Heat Exchanger has the same intended use as the predicate RotaFlow Centrifugal Pump with Safeline Coating from Maquet Cardiopulmonary. The indications for use of the Safeline Coating is "To reduce the surface tension on blood contact surfaces." for both devices.
Comparison of the performance
The substantial equivalence in performance of the Plegiox Cardioplegia Heat Exchanger with the predicate device has been shown by in-vitro testing. The Plegiox Cardioplegia Heat Exchanger has shown to be as effective as the predicate device.
Prepared by Maquet Cardiopulmonary AG, Hirrlingen, Germany
Confidential
040(v2)
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 4 2008
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K072583
Plegiox Cardioplegia Heat exchanger with and without Safeline Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger Regulatory Class: Class II (two) Product Code: DTR Dated: March 14, 2008 Received: March 19, 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/cdrf/industry/support/index.html.
Sincerely yours,
Dmna R. bchmer
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): __ Ko72583 Device Name: Plegiox Cardiplegia Heat Exchanger with and without Safeline Coating
Indications for Use:
The Plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation.
The product is designed for single use only, for an application period of no longer than 6 hours.
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. Seidel
ivision of Cardiovascular Devices
510(k) Number K072583
Page 1 of
029(v2
(Posted November 13, 2003)
§ 870.4240 Cardiopulmonary bypass heat exchanger.
(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).