(74 days)
No
The document describes a physical medical device (cannula and accessories) and its functional testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is used for extracorporeal circulatory support, which is a therapeutic intervention to assist the body's circulation.
No
Explanation: The device is a cannula used for venous drainage in an extracorporeal bypass circuit. Its function is to facilitate blood flow, not to diagnose a medical condition. Performance studies listed are functional tests, not diagnostic accuracy studies.
No
The device description explicitly lists physical components made of Poly Vinyl Chloride (PVC) and various accessories, 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 "venous drainage cannula with an extracorporeal bypass circuit for extracorporeal circulatory support". This describes a device used in vivo (within the body) to assist with blood circulation, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a physical cannula and accessories for surgical use, not reagents, instruments, or software for analyzing biological samples.
- Performance Studies: The performance studies focus on functional aspects like physical testing, sterilization, biocompatibility, and flow characteristics, which are typical for surgical devices, not diagnostic accuracy metrics like sensitivity or specificity.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic results, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the CentriMag Drainage Cannula is a medical device used for surgical support, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
DWF
Device Description
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
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
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.
Clinical testing was not performed for the CentriMag Drainage Cannula Kit.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 LLC | |||||||||
| 45 First Avenue | |||||||||
| Waltham, MA 02451Contact Person:Lydia Sakakeeny, Ph.D. | |||||||||
| Regulatory Affairs Specialist | |||||||||
| Ph: (781) 466-6553 | |||||||||
| Fax: (781) 622-5090 | |||||||||
| e-mail: Isakakeeny@levitronix-us.com | 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 | |||||||||
| 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 | |||||||||
| B. | Device Information | ||||||||
| Trade or Proprietary Name:CentriMag Drainage Cannula KitCommon or Usual Name:CentriMag Drainage Cannula KitClassification Name:Catheter, cannula and tubing, vascular, cardiopulmonary | |||||||||
| bypass (DWF, 870.4210), Class IIPerformance Standard:Performance standards do not currently exist for | |||||||||
| these devices. None are established under section | |||||||||
| 514 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, 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. | |||||||||
| Trade or Proprietary Name: | CentriMag Drainage Cannula Kit | ||||||||
| Common or Usual Name: | CentriMag Drainage 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. |
C. Legally Marketed Predicate Device
| Levitronix Device | Predicate | Predicate 510(k) |
|---|---|---|
| CentriMag Drainage Cannula Kit | Edwards Lifesciences | |
| Venous Drainage Cannula | K8701091 |
1 510k originally issued to Research Medical, Inc.
1
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).
2
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.
3
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
4
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