(122 days)
The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.
CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.
Several types of performance testing were conducted to demonstrate the substantial equivalence of the CentriMag Pre-connected Pack. Unfortunately, the provided document does not contain all the information requested. Here's a breakdown of what information is available and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Gas Exchange (oxygen and carbon dioxide transfer) | Not specified in the document | Not specified in the document |
| Blood Pathway Pressure Drop | Not specified in the document | Not specified in the document |
| In vitro Hemolysis | Not specified in the document | Not specified in the document |
| Blood, Gas, and Water Pathway Integrity | Not specified in the document | Not specified in the document |
| Heat Exchange Efficiency and Water Pathway Pressure Drop | Not specified in the document | Not specified in the document |
| Usable Life (Reliability) | Not specified in the document | Not specified in the document |
| Functionality and Integrity of Accessories | Not specified in the document | Not specified in the document |
| Shelf Life Testing | Not specified in the document | Not specified in the document |
| Validation of EtO Sterilization | Not specified in the document | Not specified in the document |
| Packaging Testing | Not specified in the document | Not specified in the document |
| Biocompatibility (Genotoxicity, Hemocompatibility, Cytotoxicity, Implantation, Sensitization, Irritation, Systemic Toxicity, Particulate Matter, Volatile Organic Compounds) | Meets requirements for external communicating medical device with limited (≤ 24 hour) circulating blood contact per ISO 10993-1. | Results meet the requirements for external communicating medical device with limited (≤ 24 hour) circulating blood contact. (Specific performance details not provided) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the performance tests. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). All tests appear to be laboratory-based performance tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the tests described are performance tests of a medical device's physical and functional characteristics, not studies that require expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted. This document describes the performance testing of a physical medical device (CentriMag Pre-connected Pack), not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable as an algorithm or AI system is not the subject of this 510(k) submission.
7. The type of ground truth used
For the performance tests, the "ground truth" would be the established engineering and medical standards for device performance, as referenced by the "Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions Final Guidance for Industry and FDA Staff" and ISO 10993-1 for biocompatibility. The tests aim to demonstrate that the device meets these pre-defined physical, chemical, and biological requirements.
8. The sample size for the training set
This information is not applicable as this is not an AI or machine learning device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is not an AI or machine learning device that requires a training set.
Summary of the Study:
The studies conducted for the CentriMag Pre-connected Pack were a series of performance tests in accordance with FDA guidance and international standards for cardiopulmonary bypass oxygenators and biocompatibility. These tests aimed to demonstrate the device's integrity, durability, and functionality, as well as its biological safety. The document explicitly states that "No animal studies or clinical studies are required." The performance testing and comparative testing with reference devices (Rotaflow Centrifugal Pump, Quadrox-iD Adult Oxygenator, HLM Tubing Set, CentriMag Acute Circulatory Support System, Eurosets PMP Sterile Oxygenator) were used to demonstrate substantial equivalence to the predicate device, the OXY-1 System (K200109). The conclusion is that the CentriMag Pre-connected Pack is substantially equivalent as the technological characteristics and performance testing do not raise different questions of safety and effectiveness compared to the predicate device.
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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
December 1, 2022
Abbott Kim Bondarenko Manager, Regulatory Affairs 6035 Stoneridge Drive Pleasanton, California 94588
Re: K222297
Trade/Device Name: CentriMag Pre-connected Pack Regulation Number: 21 CFR 870.4350 Regulation Name: Cardiopulmonary bypass oxygenator Regulatory Class: Class II Product Code: DTZ, KFM, DTQ, DTR, DWA, DWF, KRI Dated: November 17, 2022 Received: November 18, 2022
Dear Kim Bondarenko:
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 medical devices and radiation-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) K22297
Device Name CentriMag™ Pre-connected Pack
Indications for Use (Describe)
The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than six (6) hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory necessary for open surgical procedures on the aorta or vena cava.
| 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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Image /page/3/Picture/1 description: The image shows the Abbott logo, which is a blue stylized letter 'A'. Below the logo, the word "Abbott" is written in bold, followed by the text "CentriMag Pre-connected Pack" in a smaller font size. The text indicates that the image is related to Abbott's CentriMag Pre-connected Pack product.
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 (particularly §807.92).
l. SUBMITTER
II.
| Date Prepared: | July 29, 2022 |
|---|---|
| Submitter's Name & Address: | Abbott6035 Stoneridge DrivePleasanton, CA 94588 |
| Establishment Registration No. | 2916596 |
| Contact Person: | Kim BondarenkoPhone: (925) 460-7361 |
| DEVICE | |
| Trade or Proprietary Name: | CentriMag™ Pre-connected Pack |
| Common or Usual Name: | Pre-connected blood pump and oxygenatorcomponents for cardiopulmonary bypass |
| Classification Name: | Cardiopulmonary bypass oxygenator |
| Classification Regulation: | 21 CFR 870.4350 Cardiopulmonary bypassoxygenator |
| Product Code: | DTZ, KFM, DWA, DTQ, DTR, DWF, and KRI |
| Regulatory Class: | Class II |
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III. LEGALLY MARKETED PREDICATE DEVICE
Predicate Device:
- . OXY-1 System (K200109)
Reference Devices:
- Rotaflow Centrifugal Pump with Softline Coating (K090515)
- . Quadrox-iD Adult Oxygenator (K150267)
- HLM Tubing Set with Softline Coating (K090533)
- CentriMag Acute Circulatory Support System (K200306)
- Eurosets PMP Sterile Oxygenator (K141492)
DEVICE DESCRIPTION IV.
CentriMag Pre-connected Pack is to be used with the CentriMag™ Acute Circulatory Support System components (console, motor, flow probe and monitor) to provide extracorporeal circulation for full or partial cardiopulmonary bypass support for less than 6 hours. The CentriMag™ Pre-connected Pack contains sterile disposable components: a blood pump, oxygenator, and priming bag pre-connected by tubing. The pack also includes disposable accessories commonly used in the setup of pump and oxygenator connections to the cardiopulmonary bypass extracorporeal circuit.
V. INDICATIONS FOR USE
The CentriMag™ Pre-connected Pack is indicated for use with the CentriMag™ Acute Circulatory Support System to provide physiologic gas exchange of the blood and to pump a patient's blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:
(i) Full or partial cardiopulmonary bypass during open surgical procedures on the heart or great vessels; or
(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Substantial equivalence of the CentriMag Pre-connected Pack to be used with the CentriMag Acute Circulatory Support System was demonstrated through technological characteristics with the identified predicate device; performance testing, and comparative testing using reference devices. CentriMag Pre-connected Pack and Abiomed's OXY-1 System (K200109) have the same intended use, clinical setting, target user, tubing connections and principle of operation. The minor technological differences do
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Image /page/5/Picture/0 description: The image shows the logo for Abbott Laboratories. The logo is a stylized letter 'A' in blue. The 'A' is formed by thick, rounded lines, giving it a modern and clean appearance. Below the logo, the company name 'Abbott' is written in a bold, sans-serif font.
CentriMag Pre-connected Pack
not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicates.
- VII. PERFORMANCE DATA
Performance tests were conducted on the CentriMag Pre-connected Pack to support the determination of substantial equivalence and demonstrate the integrity, durability of the devices over the intended shelf life.
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 Exchange (oxygen and carbon dioxide transfer) O
- O Blood Pathway Pressure drop
- In vitro Hemolysis O
- Blood, Gas, and Water Pathway Integrity O
- Heat Exchange Efficiency and Water Pathway Pressure Drop O
- Usable Life (Reliability) Testing
- . Functionality and Integrity Testing of Accessories
- Shelf Life Testing
- Validation of EtO Sterilization
- Packaging Testing
No animal studies or clinical studies are required.
Biocompatibility Testing
Biocompatibility testing of the CentriMag Pre-connected Pack was conducted in accordance with FDA biocompatibility guidance Use of International Standard ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process per ISO 10993-1. The results meet the requirements for external communicating medical device with limited (≤ 24 hour) circulating blood contact.
- Genotoxicity
- . Hemocompatibility
- Cytotoxicity
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Abbo
CentriMag Pre-connected Pack
- Implantation
- Sensitization, Irritation
- Systemic Toxicity
- Particulate Matter
- . Volatile Organic Compounds
CONCLUSION VIII.
CentriMag Pre-connected Pack to be used with CentriMag Acute Circulatory Support System has the same intended use as the identified predicate device OXY-1 System. The comparison of technological characteristics between subject and predicate device, and performance testing conducted on the subject device including comparator testing with identified reference devices do not raise different questions of safety and effectiveness. The subject device and the predicate device are substantially equivalent.
§ 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.”