(280 days)
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.
The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypass support for up to six hours. The OXY-1 System includes; a disposable pump and oxygenator, a pump driver, blood tubing, and a console for powering and controlling the pump and managing gas flow. These components are designed to operate together to reduce the overall equipment footprint at the bedside.
The provided text is a 510(k) Summary for the Abiomed OXY-1 System, a cardiopulmonary bypass oxygenator. It outlines the device's characteristics, comparison to predicates, and performance data submitted to the FDA for substantial equivalence determination.
However, the document does not contain information related to a study involving acceptance criteria for an AI/ML medical device, human reader performance, ground truth establishment by experts, or MRMC studies. The performance data mentioned (Biocompatibility, Electrical Safety, Software V&V, and Performance Testing per FDA guidance) relates to the physical and functional aspects of the OXY-1 System hardware and software, typical for a Class II medical device of this type, not an AI/ML diagnostic or prognostic system.
Therefore, I cannot extract the information required by your request from the provided text, as the request is geared towards an AI/ML device study, which is not described herein.
To fulfill your request, I would need a document detailing the clinical validation or performance study of an AI/ML medical device.
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October 23, 2020
Abiomed Inc. % Ken Ryder Senior Director Global Regulatory Affairs 1500 John Ave Suite 190 Halethorpe, Maryland 21227
Re: K200109
Trade/Device Name: OXY-1 System Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary Bypass Oxygenator Regulatory Class: Class II Product Code: DTZ, KFM, DWA, DWF Dated: September 21, 2020 Received: September 22, 2020
Dear Ken Ryder:
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, and prohibitions 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 801); medical device 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
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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-devices/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) K200109
Device Name OXY-1 System
Indications for Use (Describe)
The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration
| 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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Product: Oxy-1 System Section: 5 – 510(k) Summary
510(k) Summary
I. SUBMITTER
Abiomed, Inc. 22 Cherry Hill Dr. Danvers, MA 01923 Phone: 978-646-1707
Contact Person: J. Kenneth Ryder Date Prepared: October 21, 2020
II. DEVICE
Name of Device: OXY-1 System Common or Usual Name: OXY-1 System Classification Name: Cardiopulmonary bypass oxygenator Regulatory Class: II Product Code: DTZ - Oxygenator, Cardiopulmonary Bypass KFM - Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type DWA - Control, Pump Speed, Cardiopulmonary Bypass DWF - Catheter, Cannula and Tubing, Vascular, Cardiopulmonary Bypass
III. PREDICATE DEVICE(S)
Medtronic Affinity NT (Model 511) Oxygenator (K191029) Maquet, Rotaflow Pump (K991864) Maquet, Rotaflow Console (K991864) Maquet, HLM Tubing Set with Bioline coating (K080592)
IV. DEVICE DESCRIPTION
The Breethe® OXY-1 System provides extracorporeal circulation for full or partial cardiopulmonary bypass support for up to six hours. The OXY-1 System includes; a disposable pump and oxygenator, a pump driver, blood tubing, and a console for powering and controlling the pump and managing gas flow. These components are designed to operate together to reduce the overall equipment footprint at the bedside.
V. INDICATION FOR USE
The OXY-1 System is indicated for:
- OXY-1 System The OXY-1 System is intended to be used for extracorporeal circulation. The OXY-1 System pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass up to 6 hours in duration.
The identified predicates are indicated for the following:
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| Product: Oxy-1 System | ||
|---|---|---|
| Section: 5 – 510(k) Summary Page 2 of 5 | ||
| Medtronic - Affinity NT511 (K191029) | The AFFINITY® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber is intended to beused in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxidefrom the blood and to cool or warm the blood during routine cardiopulmonary bypassprocedures up to 6 hours in duration. | |
| Maquet - RotaflowPump – RF 32(K991864) | The Rotaflow centrifugal pump system is intended for use in an extracorporeal perfusioncircuit to pump blood during short duration cardiopulmonary bypass procedures lasting6 hours or less. | |
| Maquet - RotaflowConsole (K991864) | The Rotaflow centrifugal pump system is intended for use in an extracorporeal perfusioncircuit to pump blood during short duration cardiopulmonary bypass procedures lasting6 hours or less. | |
| Maquet - HLM TubingSet with Bioline coating(K080592) | The HLM Tubing Sets with Bioline Coating are designed to be used in extracorporealcirculation during cardiopulmonary bypass procedures lasting six hours or less. |
The subject device and the identified predicates have the same intended use for extracorporeal circulation during full or partial cardiopulmonary bypass. The Indications for Use for the OXY-1 System is substantially equivalent to the predicate devices. Differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Oxygenator TechnologicalCharacteristics /Performance Specifications | Subject DeviceOxy-1 System (PLU Disposable) | Predicate DeviceMedtronic - Affinity NT 511 (K191029) |
|---|---|---|
| Materials | ||
| Membrane | Polymethylpentene | Polypropylene |
| Housing | Polycarbonate | Polycarbonate |
| Potting | Urethane | Urethane |
| Design | ||
| Heat Exchanger | No | Yes |
| Membrane Type | Hollow Fiber | Hollow Fiber |
| Effective Membrane Surface Area | 2.4 m2 | 2.5 m2 |
| Gas Pathway | Two Gas Pathways | Single Gas Pathway |
| Oxygenator Geometry | Cylindrical | Cylindrical |
| Tubing Connectors | 3/8" | 3/8" |
| Priming Volume (Oxygenator Only) | 285 ml | 215 ml |
| Sterile | SAL 10^-6 | SAL 10^-6 |
| Sterilization method | Ethylene Oxide | Ethylene Oxide |
| Performance Specifications | ||
| Blood Flow Rate | 0.5-5.0 Lpm | 0.5 - 7.0 Lpm |
| Gas Transfer | Tested per "Guidance for Cardiopulmonary BypassOxygenators 510(k) Submissions" Dated November13, 2000 | Tested per "Guidance for CardiopulmonaryBypass Oxygenators 510(k) Submissions" DatedNovember 13, 2000 |
| Hemolysis | Average NIH of 0.0210 mg/100L | Average NIH of 0.0318 mg/100L |
| Pressure Drop (at 5 Lpm) | Average of 38 mmHg | Average of 52 mmHg |
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| Centrifugal PumpTechnologicalCharacteristics /Performance Specifications | Subject Device | Predicate Device |
|---|---|---|
| Oxy-1 System (PLU Disposable) | Maquet - Rotaflow Pump - RF 32 (K991864) | |
| Materials | ||
| Housing | Polycarbonate | Polycarbonate |
| Impeller | Polycarbonate | Polycarbonate |
| Bearing | Polyethylene, Sapphire | Polyethylene, Sapphire |
| Design | ||
| Pump Operation | Centrifugal pump | Centrifugal pump |
| Coupling | Magnetic | Magnetic |
| Bearing | Single pivot | Single pivot |
| Priming Volume (Pump Only) | 34ml | 32ml |
| Tubing Connectors | 3/8" | 3/8" |
| Sterile | SAL 10^-6 | SAL 10^-6 |
| Sterilization method | Ethylene Oxide | Ethylene Oxide |
| Performance Specifications | ||
| Blood Flow Rate | 0.5-5.0 Lpm | 0.5 - 9.0 Lpm |
| Hemolysis | Average NIH of 0.0210 mg/100L | Average NIH of 0.0318 mg/100L |
| Controller & DriverTechnologicalCharacteristics /Performance Specifications | Subject DeviceOxy-1 System (Console) | Predicate DeviceMaquet - Rotaflow Console (K991864) |
|---|---|---|
| Design | ||
| Coupling | Magnetic | Magnetic |
| Energy Source | Battery / Mains | Battery / Mains |
| Other features | ||
| Sweep Gas Source | Internal / External | External |
| Sighing Gas Source | Internal / External | External |
| Software | ||
| Constant RPM Mode | Yes | Yes |
| Constant Flow Mode | No | Yes |
| -Display | ||
| --Blood Flow | Yes | Yes |
| --Pump RPM Settings | Yes | Yes |
| --Internal Sweep Gas SourceSettings | Yes | N/A |
| --Alarm Limit Settings | Yes | Yes |
| -Alarms | ||
| --Blood Flow | Yes | Yes |
| --Bubble | Yes | Yes |
| --Low Battery | Yes | Yes |
| --System Failure Alarms | Yes | Yes |
| Hardware | ||
| -Bubble Sensor | Yes | Yes |
| -Flow Sensor | Yes | Yes |
| Emergency Drive Unit | Hand Crank | Hand Crank |
| Performance Specifications |
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| Controller & DriverTechnologicalCharacteristics /Performance Specifications | Subject Device | Predicate Device |
|---|---|---|
| RPM Range | 0-4500 RPM | 0-5000 RPM |
| Blood Tubing TechnologicalCharacteristics /Performance Specifications | Subject Device | Predicate Device |
|---|---|---|
| Oxy-1 System (PLU Disposable) | Maquet - HLM Tubing Set with Bioline coating(K080592) | |
| Materials | ||
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride |
| Surface Treatment | None | Bioline (albumin and heparin) |
| Design | ||
| Tubing Connectors | 3/8" | 3/8" |
VII. PERFORMANCE DATA
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility Testing:
Biocompatibility testing of the OXY-1 PLU Disposable was conducted for circulating blood for less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC):
The system complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing:
The software is classified as "major" level of concern. Testing and documentation for a "major" level of concern are provided in the submission.
Performance Testing:
The following testing was conducted as recommended in "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions; Final Guidance for Industry and FDA Staff" dated November 13, 2000.
- Gas Transfer Testing
- Blood and Gas Path Integrity
- Hemolysis
- Hydraulic Performance
- Volatile Organic Compounds
- Particulates evaluation
- ISO 80601-2-69
- Software V&V
- Reliability
- Shelf Life
No animal studies or clinical studies were required or conducted.
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Product: Oxy-1 System Section: 5 – 510(k) Summary
VIII. CONCLUSIONS
The OXY-1 System has the same intended use as the identified predicates, has been demonstrated to be substantially equivalent to the identified predicates through performance testing, and the differences do not raise different questions of safety and effectiveness.
§ 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.”