(139 days)
Not Found
No
The summary describes a mechanical system for extracorporeal circulation with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as supporting "cardiopulmonary bypass," which is a medical procedure used to temporarily take over the function of the heart and lungs during surgery, thus directly treating a physiological process to support life.
No
The stated intended use of the OXY-1 System is for extracorporeal circulation to pump, oxygenate, and remove carbon dioxide from blood during cardiopulmonary bypass. This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly lists multiple hardware components including a disposable pump and oxygenator, a pump driver, blood tubing, and a console. This indicates it is a system with significant hardware components, not a software-only device.
Based on the provided information, the OXY-1 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "extracorporeal circulation" and "pumps, oxygenates and removes carbon dioxide from blood during cardiopulmonary bypass." This describes a device that directly interacts with and supports the patient's circulatory system, not a device used to test samples of blood or other bodily fluids outside the body to diagnose or monitor a condition.
- Device Description: The components listed (pump, oxygenator, tubing, console) are all consistent with a system used for extracorporeal circulation, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the OXY-1 System falls under the category of a therapeutic or life support device, not an in vitro diagnostic device.
N/A
Intended 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.
Product codes
DTZ, KFM, DWA, DWF
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.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 300) |
|---|---|
| --------------------------------------------------------------------------- | ---------------------------------------------------------------- |
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: kryder@abiomed.com |
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 | |
| Type | |
| DWA - Control, Pump Speed, Cardiopulmonary Bypass | |
| DWF - Catheter, Cannula and Tubing, Vascular, | |
| 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 | ||
| 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 | ||
| 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 | ||
| (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 | |
| Cardiopulmonary Bypass | ||
| Oxygenators 510(k) Submissions" | ||
| Dated November 13, 2000 | Tested per "Guidance for | |
| Cardiopulmonary Bypass | ||
| Oxygenators 510(k) Submissions" | ||
| 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 |
| Other Features | ||
| Sweep Gas Source | Internal / External | Internal / External |
| Sighing Gas Source | Internal / External | Internal / External |
| Software | ||
| Constant RPM Mode | Yes | Yes |
| Constant Flow Mode | No | No |
| User Interface/ Display | ||
| 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 |
| Pump Driver | ||
| LED Indicator Light | Yes | No |
| Controller & Driver | ||
| Flow Sensor | Yes | Yes |
| Emergency Drive Unit | Hand Crank | Hand Crank |
| RPM Range | 0-4500 RPM | 0-4500 RPM |
| Blood Tubing | ||
| Tubing | Polyvinyl Chloride | Polyvinyl Chloride |
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