(74 days)
The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
The CentriMag Drainage Cannula Kit consists of a sterile, single-use, disposable, noncoated, Poly Vinyl Chloride (PVC) Cannula and the following accessories:
- A) One Cap with Tape
B) One Apical Sewing Ring Handle
C) One Apical Sewing Ring
D) One Apical Support Cuff
E) Two Stabilizer Rings - Large
F) Two Stabilizer Rings - Medium
Here's an analysis of the provided 510(k) summary regarding the Levitronix CentriMag Drainage Cannula Kit, focusing on the acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|---|
| Physical Testing | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Sterilization Validation | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Biocompatibility | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Shelf Life Studies | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Transportation | Pre-established acceptance criteria (details not provided) | Met pre-established acceptance criteria |
| Hemolysis (in vitro) | Pre-established acceptance criteria (details not provided for specific thresholds of hemolysis) | Met pre-established acceptance criteria |
| Flow versus Pressure Drop | Pre-established acceptance criteria (details not provided for specific flow rates and pressure drops) | Met pre-established acceptance criteria |
| Overall Goal | Substantial equivalence to the predicate device (Edwards Lifesciences Venous Drainage Cannula, K870109) | Demonstrated substantial equivalence through functional testing |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample sizes used for any of the functional tests (Physical Testing, Sterilization Validation, Biocompatibility, etc.).
It also does not mention data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that no clinical testing was performed, the data is likely derived from bench or in-vitro tests conducted internally by Levitronix LLC or its contractors.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this submission. The studies described are functional (bench/in-vitro) tests, not studies requiring expert interpretation of clinical data or images to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable as there are no expert interpretations or clinical data requiring adjudication mentioned in the summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed for the CentriMag Drainage Cannula Kit. The summary explicitly states: "Clinical testing was not performed for the CentriMag Drainage Cannula Kit." This type of study would involve human readers (e.g., clinicians) evaluating cases with and without AI assistance, which is irrelevant for this type of medical device submission (a cannula).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable in the context of this device. A "standalone algorithm" refers primarily to AI/ML software devices. The CentriMag Drainage Cannula Kit is a physical medical device (a catheter/cannula) used in an extracorporeal bypass circuit, not an algorithm. The performance detailed is the physical and functional performance of the device itself.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI/ML medical devices (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. For this physical cannula device, the "ground truth" for the functional tests would be established by:
- Engineering specifications and design requirements: For physical properties, flow dynamics, and material characteristics.
- Established standards and regulations: For sterilization, biocompatibility, and transportation integrity.
- Predicate device performance data: The performance of the predicate device (Edwards Lifesciences Venous Drainage Cannula) would serve as a benchmark for comparison to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This information is not applicable. The CentriMag Drainage Cannula Kit is a physical medical device and does not involve an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above (no AI/ML algorithm or training set).
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K110983
510(k) Summary – Levitronix CentriMag Drainage Cannula Kit
JUN 2 0 2011
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, and in particular §807.92.
| A. | Application Information | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Date Prepared:April 6, 2011Submitter's Name & Address:Levitronix LLC45 First AvenueWaltham, MA 02451Contact Person:Lydia Sakakeeny, Ph.D.Regulatory Affairs SpecialistPh: (781) 466-6553Fax: (781) 622-5090e-mail: Isakakeeny@levitronix-us.com | Date Prepared: | April 6, 2011 | Submitter's Name & Address: | Levitronix LLC45 First AvenueWaltham, MA 02451 | Contact Person: | Lydia Sakakeeny, Ph.D.Regulatory Affairs SpecialistPh: (781) 466-6553Fax: (781) 622-5090e-mail: Isakakeeny@levitronix-us.com | |||
| Date Prepared: | April 6, 2011 | ||||||||
| Submitter's Name & Address: | Levitronix LLC45 First AvenueWaltham, MA 02451 | ||||||||
| Contact Person: | Lydia Sakakeeny, Ph.D.Regulatory Affairs SpecialistPh: (781) 466-6553Fax: (781) 622-5090e-mail: Isakakeeny@levitronix-us.com | ||||||||
| B. | Device Information | ||||||||
| Trade or Proprietary Name:CentriMag Drainage Cannula KitCommon or Usual Name:CentriMag Drainage Cannula KitClassification Name:Catheter, cannula and tubing, vascular, cardiopulmonarybypass (DWF, 870.4210), Class IIPerformance Standard:Performance standards do not currently exist forthese devices. None are established under section514 of the Food, Drug and Cosmetic Act. | Trade or Proprietary Name: | CentriMag Drainage Cannula Kit | Common or Usual Name: | CentriMag Drainage Cannula Kit | Classification Name: | Catheter, cannula and tubing, vascular, cardiopulmonarybypass (DWF, 870.4210), Class II | Performance Standard: | Performance standards do not currently exist forthese devices. None are established under section514 of the Food, Drug and Cosmetic Act. | |
| Trade or Proprietary Name: | CentriMag Drainage Cannula Kit | ||||||||
| Common or Usual Name: | CentriMag Drainage Cannula Kit | ||||||||
| Classification Name: | Catheter, cannula and tubing, vascular, cardiopulmonarybypass (DWF, 870.4210), Class II | ||||||||
| Performance Standard: | Performance standards do not currently exist forthese devices. None are established under section514 of the Food, Drug and Cosmetic Act. |
C. Legally Marketed Predicate Device
| Levitronix Device | Predicate | Predicate 510(k) |
|---|---|---|
| CentriMag Drainage Cannula Kit | Edwards LifesciencesVenous Drainage Cannula | K8701091 |
1 510k originally issued to Research Medical, Inc.
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D. Device Description
CentriMag Drainage Cannula Kit
The CentriMag Drainage Cannula Kit consists of a sterile, single-use, disposable, noncoated, Poly Vinyl Chloride (PVC) Cannula and the following accessories:
- A) One Cap with Tape
B) One Apical Sewing Ring Handle
C) One Apical Sewing Ring
D) One Apical Support Cuff
E) Two Stabilizer Rings - Large
F) Two Stabilizer Rings - Medium
ய் Intended Use
The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
F. Comparison to Predicate Device
The CentriMag Drainage Cannula Kit has indications for use, design features, and functional characteristics which are substantially equivalent to the predicate device. The device raises no new safety or effectiveness issues.
G. Summary of Performance Data
The CentriMag Drainage Cannula Kit has successfully undergone functional testing demonstrating substantial equivalence to the predicate device. The following functional testing was performed. All met pre-established acceptance criteria.
- Physical Testing .
- . Sterilization Validation
- Biocompatibility .
- Shelf Life Studies .
- Transportation .
- . Hemolysis (in vitro)
- Flow versus Pressure Drop .
ાન. Clinical Performance
Clinical testing was not performed for the CentriMag Drainage Cannula Kit.
l. Conclusion
The Levitronix CentriMag Drainage Cannula Kit is substantially equivalent to the Edwards Lifesciences Venous Drainage Cannula (K870109).
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.
Food and-Drug Administration-10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Levitronix LLC c/o Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist 45 First Avenue Waltham, MA 02451
JUN 2 0 2011
Re: K110983
CENTRIMAG® Drainage.Cannula Kit Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheters, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: April 6, 2011 Received: April 7, 2011
Dear Dr. Sakakeeny:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 -- Lydia Sakakeeny, Ph.D.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincefely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Applicant:
Levitronix LLC
510(k) Number (if known):
Device Name:
CentriMag Drainage Cannula Kit
110983
Indications for Use:
The CentriMag Drainage Cannula is intended to be used as a venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sidn-Off
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).