(74 days)
Not Found
No
The summary describes a physical medical device (cannula and accessories) and its functional testing, with no mention of software, algorithms, or AI/ML terms.
No
The device is an arterial return cannula used in an extracorporeal bypass circuit, which is a component of a life-support system rather than a device that provides therapy itself. It facilitates blood flow but does not treat a condition.
No
Explanation: The device is an arterial return cannula used in an extracorporeal bypass circuit for circulatory support, and its function involves physical support and flow, not diagnostics. The studies listed are performance and safety tests, not diagnostic accuracy validations.
No
The device description explicitly lists multiple physical components made of materials like PVC, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "extracorporeal circulatory support" as an "arterial return cannula with an extracorporeal bypass circuit." This describes a device used in vivo (within the body) to support circulation, not a device used in vitro (outside the body) to examine specimens from the body for diagnostic purposes.
- Device Description: The description details a cannula and accessories for insertion into the arterial system. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the CentriMag Return Cannula is an in vivo medical device, not an IVD.
N/A
Intended Use / Indications for Use
The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:
- A) One Obturator (or Introducer)
- B) One Hemostasis Seal
- C) One Cap
- D) One Porous Plug
- E) One Needle with Sheath
- F) One Guidewire Assembly
- G) Two Stabilizer Rings Medium
- H) Two Stabilizer Rings Small
- I) Two Tip Stabilizers
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)
The CentriMag Return 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUN 2 0 2011
510(k) Summary - Levitronix CentriMag Return Cannula Kit
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
B.
Date Prepared: April 6, 2011 Submitter's Name & Address: Levitronix LLC 45 First Avenue Waltham, MA 02451 Contact Person: Lydia Sakakeeny, Ph.D. Regulatory Affairs Specialist Ph: (781) 466-6553 Fax: (781) 622-5090 e-mail: Isakakeeny@levitronix-us.com Device Information Trade or Proprietary Name: CentriMag Return Cannula Kit Common or Usual Name: CentriMag Return Cannula Kit Classification Name: Catheter, cannula and tubing, vascular, cardiopulmonary bypass (DWF, 870.4210), Class II Performance Standard: Performance standards do not currently exist for these devices. None are established under section 514 of the Food, Drug and Cosmetic Act.
். Legally Marketed Predicate Device
| Levitronix Device | Predicate | Predicate 510(k) |
|---|---|---|
| CentriMag Return Cannula Kit | Medtronic EOPA™ Elongate | |
| one-piece Arterial Cannula | ||
| and Guidewire (Medtronic | ||
| EOPA 77722) | K031037 |
1
D. Device Description
CentriMag Return Cannula Kit
The CentriMag Return Cannula Kit consists of a sterile, single-use, disposable, noncoated, Polyvinyl Chloride (PVC) Cannula and the following accessories:
- A) One Obturator (or Introducer)
- в) One Hemostasis Seal
- c) One Cap
- D) One Porous Plug
- E) One Needle with Sheath
- F) One Guidewire Assembly
- G) Two Stabilizer Rings Medium
- H) Two Stabilizer Rings Small
-
- Two Tip Stabilizers
E. Intended Use
The CentriMag Return Cannula is indicated for use as an arterial return cannula with an extracorporeal bypass circuit for extracorporeal circulatory support for periods up to six hours.
F. Comparison to Predicate Device
The CentriMag Return Cannula Kit has an indication 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 Return 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
H. Clinical Performance
Clinical testing was not performed for the CentriMag Return Cannula Kit.
l. Conclusion
The Levitronix CentriMag Return Cannula Kit is substantially equivalent to the Medtronic EOPA™ Elongate one-piece Arterial Cannula and Guidewire (K031037).
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract image of an eagle.
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
K110980 Re: CENTRIMAG® Return 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 10 eommer of the ride 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 your 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.
3
Page 2 - Lydia Sakakeeny, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be davised that I Dri 3 losaanes or our device complies with other requirements of the Act that I DA has made a colorminations administered by other Federal agencies. You must of any I cucral statutes and regulations and limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sense and CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality systems (22) regions 531-542 of the Act); 21 CFR 1000-1050. production control provisions (Setians (Seting your device as described in your Section 510(k) I mis icher with anow you to begin maniening of substantial equivalence of your device to a legally premarket notification: "The PDF Internation 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 If you desire specific at not to: 700 - 0200 276-0120. Also, please note the regulation entitled, Conact the Office of Compilance in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your respended 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.
Sincerely yours,
Brian D. Zuckerman, M.D.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
Applicant:
Levitronix LLC
KITO980
510(k) Number (if known):
Device Name:
CentriMag Return Cannula Kit
Indications for Use:
The CentriMag Return Cannula is indicated for use as an arterial return 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 Sign-Off) Division of Cardiov 510(k) Number