OXY-1 System

K223161 · Abiomed, Inc. · DTZ · Feb 23, 2023 · Cardiovascular

Device Facts

• Record ID: K223161
• Device Name: OXY-1 System
• Applicant: Abiomed, Inc.
• Product Code: DTZ · Cardiovascular
• Decision Date: Feb 23, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support. The system comprises a disposable pump and oxygenator, a pump driver, blood tubing, and a console for pump control and gas flow management. It operates by pumping blood through a hollow fiber oxygenator (polymethylpentene membrane) to facilitate gas exchange (oxygenation and CO2 removal). The device is used in clinical settings; operated by trained healthcare professionals. The console provides real-time monitoring of blood flow, pump RPM, and alarm status (bubble, low battery, system failure). An emergency hand crank is provided for manual drive. The system simplifies bedside operation and reduces equipment footprint. Clinical benefit is derived from maintaining patient oxygenation and CO2 removal during short-term bypass procedures.

Clinical Evidence

Bench testing only. Performance data includes hemolysis testing (average NIH 0.0210 mg/100L), pressure drop (average 38 mmHg at 5 Lpm), and gas transfer testing conducted per FDA guidance for cardiopulmonary bypass oxygenators.

Technological Characteristics

Oxygenator: Polymethylpentene hollow fiber membrane, polycarbonate housing, urethane potting. Effective surface area: 2.3 m². Blood flow rate: 0.5-5.0 Lpm. Coupling: Magnetic. Energy: Battery/Mains. Sterilization: Ethylene Oxide (SAL 10^-6). Connectivity: Internal/External gas sources. Pump Driver: 0-4500 RPM range, flow sensor, LED indicator, emergency hand crank. Tubing: Polyvinyl Chloride.

Indications for Use

Indicated for patients requiring extracorporeal circulation, oxygenation, and carbon dioxide removal during cardiopulmonary bypass procedures for up to 6 hours.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• OXY-1 System (K200109)

Submission Summary (Full Text)

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February 23, 2023

Abiomed Inc. Ken Ryder Sr. Director, Regulatory Affairs 22 Cherry Hill Drive Danvers, Massachusetts 01923

Re: K223161

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: January 25, 2023 Received: January 27, 2023

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

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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Nicole M. Gillette -S

Nicole Gillette 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) K223261

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)

| <div> <span></span>Prescription Use (Part 21 CFR 201 Subpart D) </div> | <div> <span></span>Over-The-Counter Use (21 CFR 300) </div> |
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X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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#### Abiomed OXY-1 System 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807.92.

## A. Application Information:

| Date Prepared: | October 06, 2022 |
|-----------------------------|--------------------------------------------|
| Submitter's Name & Address: | ABIOMED, Inc. |
| | 22 Cherry Hill Drive |
| | Danvers, MA 01923 |
| Contact Person: | J. Kenneth Ryder |
| | Senior Director, Global Regulatory Affairs |
| | Ph: 978-646-1707 |
| | E-mail: [e-mail] |

#### B. Device Information:

| Trade or Proprietary Name: | OXY-1 System |
|----------------------------|-------------------------------------------------------------------------|
| Common or Usual Name: | OXY-1 System |
| FDA Classification: | Class II, 21 CFR 870.4350 |
| Regulation Description: | Cardiopulmonary bypass oxygenator |
| Product Code: | DTZ - Oxygenator, Cardiopulmonary Bypass |
| | KFM - Pump, Blood, Cardiopulmonary Bypass, Non-Roller<br>Type |
| | DWA - Control, Pump Speed, Cardiopulmonary Bypass |
| | DWF - Catheter, Cannula and Tubing, Vascular,<br>Cardiopulmonary Bypass |

#### C. Predicate Device:

The primary predicate device was the OXY-1 System, which is cleared under K200109.

#### D. Device Description:

The Abiomed OXY-1 System provides extracorporeal circulation for cardiopulmonary bypass support for up to six hours in duration. The OXY-1 System includes:

- A Disposable pump and oxygenator .
- A Pump Driver (blood pump) ●
- Blood tubing .
- A Console for controlling the pump and managing gas flow .

These components are designed to operate together, simplify operation, and reduce the overall equipment footprint at the bedside.

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#### E. Indications for Use:

#### INDICATIONS FOR USE:

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.

## F. Technological Characteristics Comparison of Subject and Predicate Devices:

The subject device, the OXY-1 System (Configuration 2) is identical to the predicate device Intended Use/Indications for Use, general system components, sterilization, and mechanism of action. Differences between the subject device and the predicate device were all determined to be minor, have no adverse impact on safety or effectiveness, and raise no different questions of safety or effectiveness compared to the predicate device. The minor differences include the oxygenator effective surface area and the presence of a green indicator light on the pump driver.

| | Subject Device | Predicate Device |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics | OXY-1 System (Configuration 2) | OXY-1 System (Configuration 1) |
| Oxygenator | | |
| Membrane | Polymethylpentene | Polymethylpentene |
| Housing | Polycarbonate | Polycarbonate |
| Potting | Urethane | Urethane |
| Heat Exchanger | No | No |
| Membrane Type | Hollow Fiber | Hollow Fiber |
| Effective Membrane<br>Surface Area | 2.3 m² | 2.4 m² |
| Gas Pathway | Two Gas Pathways | Two Gas Pathways |
| Oxygenator Geometry | Cylindrical | Cylindrical |
| Tubing Connectors | 3/8" | 3/8" |
| Priming Volume<br>(Oxygenator Only) | 285 ml | 285 ml |
| Sterile | SAL 10^-6 | SAL 10^-6 |
| Sterilization method | Ethylene Oxide | Ethylene Oxide |
| Performance Specifications (Oxygenator) | | |
| Blood Flow Rate | 0.5-5.0 Lpm | 0.5-5.0 Lpm |
| Gas Transfer | Tested per "Guidance for<br>Cardiopulmonary Bypass<br>Oxygenators 510(k) Submissions"<br>Dated November 13, 2000 | Tested per "Guidance for<br>Cardiopulmonary Bypass<br>Oxygenators 510(k) Submissions"<br>Dated November 13, 2000 |
| Hemolysis | Average NIH of 0.0210 mg/100L | Average NIH of 0.0210 mg/100L |
| Pressure Drop (at 5 Lpm) | Average of 38 mmHg | Average of 38 mmHg |
| Coupling | Magnetic | Magnetic |
| Energy Source | Battery / Mains | Battery / Mains |
| <b>Other Features</b> | | |
| Sweep Gas Source | Internal / External | Internal / External |
| Sighing Gas Source | Internal / External | Internal / External |
| <b>Software</b> | | |
| Constant RPM Mode | Yes | Yes |
| Constant Flow Mode | No | No |
| <b>User Interface/ Display</b> | | |
| Blood Flow | Yes | Yes |
| Pump RPM Settings | Yes | Yes |
| Internal Sweep Gas | Yes | Yes |
| Alarm Limit Settings | Yes | Yes |
| Blood Flow | Yes | Yes |
| Bubble | Yes | Yes |
| Low Battery | Yes | Yes |
| System Failure Alarms | Yes | Yes |
| Bubble Sensor | Yes | Yes |
| <b>Pump Driver</b> | | |
| LED Indicator Light | Yes | No |
| <b>Controller &amp; Driver</b> | | |
| Flow Sensor | Yes | Yes |
| Emergency Drive Unit | Hand Crank | Hand Crank |
| RPM Range | 0-4500 RPM | 0-4500 RPM |
| <b>Blood Tubing</b> | | |
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride |

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