(271 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (cannulae) used for perfusion during cardiopulmonary bypass. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on functional and biocompatibility testing, not algorithmic performance.
No
The device is described as an "Extracorporeal circuit component" used for access during cardiopulmonary bypass procedures, and its indications for use focus on facilitating perfusion rather than treating a disease or condition itself.
No
These devices are cannulae used for perfusion during cardiopulmonary bypass procedures, not for diagnosing conditions. Their function is to facilitate the flow of blood, not to identify or characterize diseases or conditions.
No
The device description and intended use clearly describe physical cannulae (tubes) used for surgical procedures, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for perfusion of arteries during cardiopulmonary bypass procedures. This involves direct interaction with the patient's circulatory system to deliver blood or other fluids.
- Device Description: The description reinforces this by stating the cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a therapeutic/supportive purpose during surgery.
N/A
Intended Use / Indications for Use
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.
(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.
(Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.
Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
Product codes (comma separated list FDA assigned to the subject device)
DWF~
Device Description
The ERMI Pediatric Arterial Cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, femoral artery
Indicated Patient Age Range
Pediatric
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 ERMI Pediatric Arterial Cannulae have successfully undergone functional and biocompatibility testing.
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.
Research Industries' Various Cardiovascular Devices, Research Medical, Inc. Fem-Flex Femoral Access Cannulation Kit, Terumo L-Series 1964 Type Pediatric Aortic Cannulae
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
510(k) Summary
| Submitter: | Edwards Lifesciences LLC
One Edwards Way
Irvine, California 92614 USA |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jason Smith, Senior Regulatory Affairs Specialist
Phone: 949-250-2662
Fax: 949-250-3579
E-mail: jason_smith@edwards.com |
| Date Prepared: | October 29, 2003 |
| Trade Name: | Edwards Lifesciences Research Medical Inc. Pediatric
Arterial Cannulae (abbreviated to ERMI Pediatric Arterial
Cannulae) |
| Common Name: | Cardiopulmonary Bypass Vascular Catheter, Cannula, or
Tubing (21 CFR 870.4210) |
| Predicate
Devices: | Research Industries' Various Cardiovascular Devices
Research Medical, Inc. Fem-Flex Femoral Access
Cannulation Kit
Terumo L-Series 1964 Type Pediatric Aortic Cannulae |
| Device
Description: | The ERMI Pediatric Arterial Cannulae are used to access
the aorta or femoral artery during cardiopulmonary
bypass. |
| Indications for
Use: | The ERMI Pediatric Aortic Perfusion Cannulae are
indicated for perfusion of the aorta so that perfusion of the
arteries via a heart-lung machine may take place.
The ERMI Pediatric Arterial Perfusion Cannulae are
indicated for perfusion of the femoral artery during
procedures requiring cardiopulmonary bypass where
femoral artery cannulation is deemed appropriate.
The ERMI Pediatric Femoral Arterial Cannulae are
indicated for use in situations which require rapid femoral
arterial access for short term cardiopulmonary bypass. |
| Comparative
Analysis: | Extracorporeal circuit components with a Duraflo
Treatment are indicated for use in cardiopulmonary
surgery when a heparin-treated blood path is desired.
The only difference between the subject catheters and the
predicate Research Medical catheters is the subject
catheters are smaller in diameter and length. Aside from
the smaller sizes, there is no difference between the ERMI
Pediatric Arterial Cannulae and the predicate devices. |
| Functional/Safety
Testing: | The ERMI Pediatric Arterial Cannulae have successfully
undergone functional and biocompatibility testing. |
| Conclusion: | The ERMI Pediatric Arterial Cannulae are substantially
equivalent to the predicate devices. |
t
1
Aron Shultz 11/26/03
Jason Smith Senior Regulatory Affairs Specialist Edwards Lifesciences LLC
Date
Edwards Lifesciences Research Medical Inc. - Confidential Edwards Lifesciences Research Medical Inc. - Connidential
Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 8 2004
Edwards Lifesciences LLC c/o Mr. Jason Smith Senior Regulatory Affairs Specialist One Edwards Way Irvine, CA 92614
Re: K033463
Edwards Lifesciences Research Medical Pediatric Arterial Cannulae Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Catheter, Cannula and Tubing Regulatory Class: Class II (two) Product Code: DWF~ Dated: May 25, 2004 Received: May 26, 2004
Dear Mr. Smith:
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 - Jason Smith.
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 (OS) 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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Duma R. Vidanel
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
510(k) Number (if known): K033463
Device Name: Edwards Lifesciences Research Medical Pediatric Arterial Cannulae
Indications For Use:
(Models PEDA008SB, PEDA010SB, PEDA012SB, PEDA014SB, PEDA016SB, PAA010CB, PAA012CB, PAA014CB, PAA016CB, AA018S, AA018C): The Edwards Lifesciences Research Medical Pediatric Aortic Perfusion Cannulae are indicated for perfusion of the aorta so that perfusion of the arteries via a heart-lung machine may take place.
(Models APC018, APC018B) The Edwards Lifesciences Research Medical Pediatric Arterial Perfusion Cannulae are indicated for perfusion of the femoral artery during procedures requiring cardiopulmonary bypass where femoral artery cannulation is deemed appropriate.
(Models FEMII010A, FEMII014A, FEMII014A, FEMII008AT, FEMII010AT, FEMII012AT, FEMII014AT): The Edwards Lifesciences Research Medical Pediatric Femoral Arterial Cannulae are indicated for use in situations which require rapid femoral arterial access for short term cardiopulmonary bypass.
Extracorporeal circuit components with a Duraflo Treatment are indicated for use in cardiopulmonary surgery when a heparin-coated blood path is desired.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
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)
Deanna P. Richter
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K0 3346
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