(93 days)
No
The summary describes a mechanical device for gas exchange and temperature regulation during cardiopulmonary bypass. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is used for physiologic gas exchange and temperature regulation of blood during cardiopulmonary bypass, which are therapeutic interventions.
No
The device is an oxygenator and heat exchanger used for physiological gas exchange and blood temperature regulation during cardiopulmonary bypass surgery. It facilitates physical processes (gas and heat exchange) rather than identifying or analyzing a medical condition or disease.
No
The device description clearly details a physical medical device (hollow fiber membrane oxygenator with integrated heat exchanger and tubing pack) used for gas exchange and temperature regulation during cardiopulmonary bypass surgery. The performance studies focus on in vitro testing of the physical components. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "physiologic gas exchange in adults and small adults undergoing cardiopulmonary bypass surgery." This describes a device used during a medical procedure to support a patient's physiological functions, not a device used to test samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "hollow fiber membrane oxygenator with an integrated heat exchanger" that facilitates "gas exchange into and out of the blood" and "regulation of blood temperature." This is consistent with a device used in extracorporeal circulation during surgery, not a diagnostic test.
- Mechanism of Action: The description explains how oxygen and carbon dioxide diffuse across membranes and how blood temperature is regulated. This is a physical process supporting blood function, not a chemical or biological test performed on a sample.
- Lack of Diagnostic Language: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
In summary, the Paragon Adult Maxi PMP Oxygenator is a medical device used for therapeutic support during surgery, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
DTZ, DTR, DWF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and small adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 Pathway Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Heat Exchanger Fluid Pathway Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Gas Pathway Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Connector security | Non-comparative | Acceptance criteria met by the devices. |
| Oxygen Transfer Rates | Comparative | No statistically significant difference in the O2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Carbon Dioxide Transfer Rates | Comparative | No statistically significant difference in the CO2 transfer rates of the Paragon Maxi oxygenator and the predicate. |
| Blood Side Pressure Drop | Comparative | The Paragon Maxi has a lower and more clinically favourable blood side pressure drop than the predicate oxygenator as a consequence of slight differences in the oxygenator design. |
| Heat Exchanger Performance Factor | Comparative | No statistically significant difference in the heat exchanger performance of the Paragon Maxi oxygenator and the predicate. |
| Blood cell damage | Comparative | No statistically significant difference in the blood cell damage test results (e.g. hemolysis, white blood cell count, platelet count) of the Paragon Maxi oxygenator and the predicate. |
| Tubing kink resistance | Comparative | No statistically significant difference in the kink resistance of the Adult Tubing Pack and the predicate tubing. |
| Tubing clamp resilience | Comparative | No statistically significant difference in clamp resilience of the Adult Tubing Pack and the predicate tubing. |
| Pressure decay of tubing | Comparative | No statistically significant difference in the pressure decay of the Adult Tubing Pack and the predicate tubing. |
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
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
510(k) Summary
| Date
| Prepared: | 15th July 2020 |
|---|---|
| Submitter's | |
| Name and | |
| Address | Chalice Medical Ltd |
| Manton Wood Enterprise Park, | |
| Worksop, Nottinghamshire, | |
| S80 2RS, | |
| United Kingdom | |
| Contact | |
| Person: | Stephen Horan |
| Project Manager, Chalice Medical Ltd | |
| Phone: +44 1909 470 777 | |
| Email: shoran@chalicemedical.com | |
| Proprietary | |
| Name: | Paragon Adult Maxi PMP Oxygenator with Tubing Pack |
| (Model: CME40004) | |
| Common | |
| Name: | Hollow fiber membrane oxygenator with an integrated |
| heat exchanger and Cardiopulmonary bypass tubing | |
| pack. | |
| Regulation | |
| Name: | Cardiopulmonary Bypass Oxygenator |
| Regulation | |
| Number: | 870.4350 |
| Product Code: | DTZ, DTR, DWF |
| Regulatory | |
| Class: | Class II |
| 510(k) Review | |
| Panel | Cardiovascular |
| Predicate | |
| Device(s) | Sorin Group Italia Inspire 8M (K122254) - Primary |
| COBE Laboratories Tubing Sets (K771692) | |
| FDA | |
| Clearance | K201642 |
4
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, .
5
- 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 Pathway | ||
| Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Heat Exchanger | ||
| Fluid Pathway | ||
| Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Gas Pathway | ||
| Integrity | Non-comparative | Acceptance criteria met by the devices. |
| Connector security | Non-comparative | Acceptance criteria met by the devices. |
| Oxygen Transfer | ||
| Rates | Comparative | No statistically significant difference in the O2 |
| transfer rates of the Paragon Maxi | ||
| oxygenator and the predicate. | ||
| Carbon Dioxide | ||
| Transfer Rates | Comparative | No statistically significant difference in the |
| CO2 transfer rates of the Paragon Maxi | ||
| oxygenator and the predicate. | ||
| Blood Side | ||
| Pressure Drop | Comparative | The Paragon Maxi has a lower and more |
| clinically favourable blood side pressure drop | ||
| than the predicate oxygenator as a | ||
| consequence of slight differences in the | ||
| oxygenator design. |
6
| Heat Exchanger
Performance
Factor | Comparative | No statistically significant difference in the
heat exchanger performance of the Paragon
Maxi oxygenator and the predicate. |
|-----------------------------------------|-------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Blood cell damage | Comparative | No statistically significant difference in the
blood cell damage test results (e.g.
hemolysis, white blood cell count, platelet
count) of the Paragon Maxi oxygenator and
the predicate. |
| Tubing kink
resistance | Comparative | No statistically significant difference in the
kink resistance of the Adult Tubing Pack and
the predicate tubing. |
| Tubing clamp
resilience | Comparative | No statistically significant difference in clamp
resilience of the Adult Tubing Pack and the
predicate tubing. |
| Pressure decay of
tubing | Comparative | No statistically significant difference in the
pressure decay of the Adult Tubing Pack and
the 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