(205 days)
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood flow rate is defined from 0.5 - 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours. The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
This document is a 510(k) Pre-market Notification for a medical device called the "Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating." This notification aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices, rather than performing a traditional clinical study with acceptance criteria in the manner of a diagnostic AI device.
Therefore, many of the typical acceptance criteria and study design elements you've requested (like sample sizes for test sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable in this context. This is because the submission is focused on demonstrating substantial equivalence through non-clinical testing, rather than proving a specific performance metric against a defined ground truth for a diagnostic output.
However, I can extract information related to the device's performance based on the non-clinical testing presented to demonstrate this substantial equivalence.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of quantitative acceptance criteria in the sense of specific thresholds for metrics like sensitivity, specificity, or AUC as one would expect for an AI diagnostic device. Instead, it states that the device "met the requirements of" specific ISO standards. These standards themselves contain the "acceptance criteria" through their methodologies and required performance levels for device functionality.
| Acceptance Criteria (from Met Standards) | Reported Device Performance |
|---|---|
| ISO 10993-1: Biologic Evaluation of Medical Devices | The Quadrox-i Adult met the requirements of ISO 10993-1. (This implies it passed tests for biocompatibility, such as cytotoxicity, sensitization, irritation, acute systemic toxicity, etc.) |
| ISO 7199: 1996 "Cardiovascular implants and artificial organs – blood gas exchangers (oxygenators)" | The Quadrox-i Adult met the requirements of ISO 7199. (This implies it passed tests related to oxygenator performance, such as gas exchange efficiency, pressure drop, blood compatibility, and mechanical integrity relevant to its function as an oxygenator and heat exchanger.) |
| ISO 15675: 2001 "Cardiovascular implants and artificial organs – Cardiopulmonary Bypass – Arterial line blood filters" | The Quadrox-i Adult (version with integrated arterial filter) met the requirements of ISO 15675. (This implies it passed tests related to filter performance, such as particle removal efficiency, pressure drop, and blood compatibility relevant to its function in filtering air bubbles and particles.) |
| Integrity | Testing and evaluation demonstrated the device's integrity. (Specific metrics not provided, but implies structural soundness and absence of leaks/failures.) |
| Performance | Testing and evaluation demonstrated the device's performance. (Broad category, referring to its function as an oxygenator, heat exchanger, and filter as per the ISO standards.) |
| Biocompatibility | Testing and evaluation demonstrated the device's biocompatibility. (Refers to compliance with ISO 10993-1.) |
| Sterility | Testing and evaluation demonstrated the device's sterility. (Implies the device is manufactured and packaged to prevent microbial contamination.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for "test sets" or data provenance in the way one would for a clinical study on an AI diagnostic. The testing performed was non-clinical bench testing to evaluate the device against established international standards for medical devices. Therefore, these standards dictate the number of units or test replicates required for each specific test (e.g., how many devices are needed for a particular biocompatibility test or performance test). This is not a "data set" in the computational sense, but rather physical devices subjected to laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This concept is not applicable here. Ground truth, in the context of this 510(k) submission, is established by adherence to the methodologies and specifications within the referenced ISO standards. The "experts" involved are those who designed and conducted the tests according to these standards, and those who verified the results against the standard requirements. Their qualifications would be in biomedical engineering, materials science, toxicology, and other relevant fields required to perform and interpret the specified tests. There are no "experts" evaluating images or clinical data to establish a ground truth for a diagnostic outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study involving human readers or interpretation requiring adjudication.
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. This is not an AI diagnostic device and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission is adherence to the performance and safety specifications outlined in recognized international standards (ISO 10993-1, ISO 7199, ISO 15675) and demonstrated through non-clinical bench testing. This is a regulatory "ground truth" rather than a clinical one.
8. The sample size for the training set
Not applicable. No training set for an algorithm was used.
9. How the ground truth for the training set was established
Not applicable. No training set for an algorithm was used.
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Kor 2117
FEB 1 8 2009
MAQUET
. 510 (K) Summary [as required by 21 CFR 807.92(c) ]
| Submitter: | Maquet Cardiopulmonary AGHechinger Strasse 3872145 HirrlingenGermany |
|---|---|
| Contact Person: | Katrin SchwenkglenksPhone: +49 7478 921-151Fax: +49 7478 921-400E-mail: katrin.schwenkglenks@maquet-cp.com |
| Date Prepared: | July 18, 2008 |
| Device Trade Name: | Quadrox-i Adult Microporous MembraneOxygenator with and without Integrated ArterialFilter with Softline Coating |
| Common/Usual name: | Oxygenator with integrated heat exchanger andoptional integrated arterial filter |
| Classification names: | Oxygenator, cardiopulmonary bypassHeat Exchanger, cardiopulmonary bypassFilter, blood, cardiopulmonary bypass, arterial line |
| Predicate Devices: | Quadrox Hollow Fiber Membrane Oxygenator withSafeline Coating (art.code HMO 2030), K030264,Quart Arterial Filter (art.code HBF 140), K001787by Maquet Cardiopulmonary AG andSynthesis Ph.I.S.I.O. Adult Membrane OxygenatorWith Integrated Arterial Filter with Ph.I.S.I.O.Coating by Sorin Group Italia S.r.l., K073380. |
Device Description:
The Quadrox-i Adult is a blood-gas exchanger with integrated heat exchanger and optionally integrated arterial blood filter.
The Quadrox-i Adult may be marketed both as single product and premounted with the venous hardshell cardiotomy reservoir (K003551, K982136).
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MAQUET
Indications for Use:
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range. the device oxygenates the blood, eliminates carbon dioxide and requlates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 mm The device's utilization period is limited to six hours.
The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Statement of Technical Comparison:
The Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is well comparable to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating regarding the intended use. design, principals of operation, biocompatibility and performance as related to the oxygenator and heat exchanger part, as well as to the Quart Arterial Filter as related to the filter part. The Softline Coating is a biopassive coating comparable to other coatings on the market, as e.g. the Ph.I.S.I.O. Coating by the Sorin Group Italia S.r.I.
Non-clinical Testing
The Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating has been tested to and met the requirements of ISO 10993-1 Biologic Evaluation of Medical Devices as well as the requirements of ISO 7199: 1996 "Cardiovascular implants and artificial organs - blood gas exchangers (oxygenators) as well as the requirements of ાડવ 15675: 2001 "Cardiovascular implants and artificial organs -Cardiopulmonary Bypass - Arterial line blood filters".
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MAQUET
Determination of Substantial Equivalence
Testing and evaluation on safety and effectiveness was executed to demonstrate that the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating described in this submission is substantially equivalent to the Quadrox Hollow Fiber Membrane Oxygenator with Safeline Coating as well as to the Quart Arterial Filter with regards to the filter function.
The following areas have been tested:
- Integrity -
- Performance
- Biocompatibility
- Sterility
Conclusion
The data given demonstrate that the Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating is substantially equivalent to the named predicate devices which currently hold market clearance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the HHS emblem, which is a stylized depiction of an eagle. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2009
Maquet Cardiopulmonary AG c/o Ms. Katrin Schwenkglenks Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirrlingen, Germany
Re: K082117
Quadrox-i Adult Microporous Membrane Oxygenatotor with and without Integrated Arterial Filter with Softline Coating
Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator
Regulatory Class: Class II (two)
Product Code: DTZ
Dated: February 12, 2009
Received: February 17, 2009
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
Enclosure.
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 yours.
buna R. Laches
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices
Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): K082)17
Quadrox-i Adult Microporous Membrane Oxygenator with and without Integrated Arterial Filter with Softline Coating _
Indications for Use:
The membrane oxygenator Quadrox-i Adult is intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The blood المهابة is defined from 0.5 ~ 7 l/min. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The Quadrox-i Adult (HMO 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device's utilization period is limited to six hours.
The oxygenator is suitable for the delivery of the volatile anesthetics isoflurane and sevoflurane. The anesthetic gas is administered through the oxygenator's gas inlet by means of a suitable anesthetic gas vaporizer.
Responsibility for deciding whether to use an oxygenator rests solely with the attending physician.
Prescription Use Over-The-Counter Use X 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)
Duna R. Holmes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number: K082117
Page 1 of
(Posted November 13, 2003)
§ 870.4350 Cardiopulmonary bypass oxygenator.
(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”