(93 days)
The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.
The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
The document provided is a 510(k) summary for a medical device (Paragon Adult Maxi PMP Oxygenator with Tubing Pack) and does not contain information about an AI/ML powered device or study that determines acceptance criteria based on AI/ML performance.
The provided text details the regulatory review of a conventional medical device (oxygenator and tubing pack) and focuses on its substantial equivalence to predicate devices, in vitro and non-clinical test results. There is no mention of acceptance criteria related to a study proving an AI/ML device meets them. Therefore, I cannot extract the requested information from the provided document.
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September 18, 2020
Chalice Medical Ltd Stephen Horan Project Manager Manton Wood Enterprise Park Workson, Nottinghamshire S80 2RS United Kingdom
Re: K201642
Trade/Device Name: Paragon Adult Maxi PMP Oxygenator with Tubing Pack Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ, DTZ, DTR, DWF Dated: June 16, 2020 Received: June 17, 2020
Dear Stephen Horan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Fernando Aguel Assistant Director DHT2B: Division of Circulatory Support. Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201642
Device Name
Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Indications for Use (Describe)
The Paragon Adult Maxi PMP Oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to regulate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| DatePrepared: | 15th July 2020 |
|---|---|
| Submitter'sName andAddress | Chalice Medical LtdManton Wood Enterprise Park,Worksop, Nottinghamshire,S80 2RS,United Kingdom |
| ContactPerson: | Stephen HoranProject Manager, Chalice Medical LtdPhone: +44 1909 470 777Email: shoran@chalicemedical.com |
| ProprietaryName: | Paragon Adult Maxi PMP Oxygenator with Tubing Pack(Model: CME40004) |
| CommonName: | Hollow fiber membrane oxygenator with an integratedheat exchanger and Cardiopulmonary bypass tubingpack. |
| RegulationName: | Cardiopulmonary Bypass Oxygenator |
| RegulationNumber: | 870.4350 |
| Product Code: | DTZ, DTR, DWF |
| RegulatoryClass: | Class II |
| 510(k) ReviewPanel | Cardiovascular |
| PredicateDevice(s) | Sorin Group Italia Inspire 8M (K122254) - PrimaryCOBE Laboratories Tubing Sets (K771692) |
| FDAClearance | K201642 |
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5.1 Device Description
The Paragon Adult Maxi PMP oxygenator (Paragon Maxi) with Tubing Pack is a hollow fiber membrane oxygenator with an integrated heat exchanger pre-connected to blood line and gas line tubing. The Paragon Maxi facilitates the gas exchange into and out of the blood, and the requlation of blood temperature during cardiopulmonary bypass. The Paragon Maxi is supplied with a Rheopak surface coating that reduces platelet adhesion to coated surfaces.
The gas exchanger part of the Paragon Maxi is formed of plasma tight hollow fiber membranes. The gas flow takes place through the inner lumen of the fibers. Blood is in contact with the outer side of the membranes, so that oxygen can diffuse into the venous blood, while carbon dioxide diffuses out of the blood. The heat exchanging part of the Paragon Maxi is made of non-porous hollow fiber membranes. Water flows through the inner lumen of the fibers, so that blood temperature flowing outside is regulated.
The Tubing Pack is a component of a cardiopulmonary bypass procedure that facilitates extracorporeal circulatory support for a term of up to 6 hours.
5.2 Indications for Use
Paragon Adult Maxi PMP Oxvgenator with Tubing Pack (Model: CME40004)
The Paragon Adult Maxi PMP oxygenator is a hollow fiber membrane oxygenator intended for physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery. The integrated heat exchanger makes it possible to requlate the blood temperature. The Paragon Adult Maxi PMP Oxygenator is intended for clinical use for up to 6 hours. The Tubing Pack is intended for use in extracorporeal circulation during cardiopulmonary bypass procedures, lasting 6 hours or less.
5.3 Technological Characteristics
The Paragon Maxi and the Tubing Pack have been compared with the predicate devices and found to be substantially equivalent. The devices have thefollowing similarities:
- Same intended use, ●
- Same operating principle, ●
- Same fundamental technological characteristics, ●
- Same biological status (i.e. sterile, non-pyrogenic), ●
- Similar base materials, .
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- Similar packaging materials and configurations, .
- Same methods of sterilisation. .
The Paragon Maxi and the Tubing Pack are both single use disposable products, supplied sterile, sterilised by ethylene oxide, non-toxic and non-pyrogenic. The shelf life of the Paragon Adult Maxi PMP Oxygenator and Tubing Pack have been substantiated using products that have been subjected to simulated distribution conditions and aged prior to performance testing.
5.4 In Vitro Test Results
Performance testing has been planned and conducted in accordance with the requirements of the following:
- . FDA's Guidance for Cardiopulmonary Bypass Oxygenators (2000),
- . ISO 7199:2016 Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators),
- . ISO 15676:2016 Cardiovascular implants and artificial organs -- Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO),
The following performance characteristics were evaluated for the Paragon Maxi oxygenator and the Tubing Pack:
| Test | Method | Conclusion |
|---|---|---|
| Blood PathwayIntegrity | Non-comparative | Acceptance criteria met by the devices. |
| Heat ExchangerFluid PathwayIntegrity | Non-comparative | Acceptance criteria met by the devices. |
| Gas PathwayIntegrity | Non-comparative | Acceptance criteria met by the devices. |
| Connector security | Non-comparative | Acceptance criteria met by the devices. |
| Oxygen TransferRates | Comparative | No statistically significant difference in the O2transfer rates of the Paragon Maxioxygenator and the predicate. |
| Carbon DioxideTransfer Rates | Comparative | No statistically significant difference in theCO2 transfer rates of the Paragon Maxioxygenator and the predicate. |
| Blood SidePressure Drop | Comparative | The Paragon Maxi has a lower and moreclinically favourable blood side pressure dropthan the predicate oxygenator as aconsequence of slight differences in theoxygenator design. |
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| Heat ExchangerPerformanceFactor | Comparative | No statistically significant difference in theheat exchanger performance of the ParagonMaxi oxygenator and the predicate. |
|---|---|---|
| Blood cell damage | Comparative | No statistically significant difference in theblood cell damage test results (e.g.hemolysis, white blood cell count, plateletcount) of the Paragon Maxi oxygenator andthe predicate. |
| Tubing kinkresistance | Comparative | No statistically significant difference in thekink resistance of the Adult Tubing Pack andthe predicate tubing. |
| Tubing clampresilience | Comparative | No statistically significant difference in clampresilience of the Adult Tubing Pack and thepredicate tubing. |
| Pressure decay oftubing | Comparative | No statistically significant difference in thepressure decay of the Adult Tubing Pack andthe predicate tubing. |
5.5 Non-Clinical Test Results
The biological safety of the Paragon Adult Maxi PMP Oxygenator with Tubing Pack have been evaluated in accordance with the process defined in ISO 10993-1:2009. Biological risk assessments and the applicable biocompatibility testing demonstrate the biocompatibility and biological safety of these devices.
The Paragon Adult Maxi PMP Oxygenator with Tubing Pack is sterilised by ethylene oxide gas to achieve a SAL of 10-6. The pyrogen levels of the devices were determined following ANSI/AAMI ST72:2011 – Bacterial Endotoxins Test Methods, Routine Monitoring and Alternatives to Batch Testing. The Bacterial Endotoxin Testing validation confirmed that the endotoxin recoveries were all below the 'Endotoxin Release Limit' of <20 EU/device.
5.6 Conclusion
The information provided within this submission demonstrates that the Paragon Adult Maxi PMP Oxygenator with Tubing Pack are substantially equivalent to the identified predicate devices.
§ 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.”