(271 days)
(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.
The ERMI Pediatric Arterial Cannulae are used to access the aorta or femoral artery during cardiopulmonary bypass.
Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and the study that proves the device meets those criteria:
Device: Edwards Lifesciences Research Medical Inc. Pediatric Arterial Cannulae
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional testing | Successfully undergone |
| Biocompatibility testing | Successfully undergone |
| Dimensions (smaller diameter & length than predicate) | Confirmed. This is the only difference noted between the subject and predicate devices. |
2. Sample size used for the test set and the data provenance
The 510(k) summary does not provide details on the sample size used for functional or biocompatibility testing, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). It simply states the tests were "successfully undergone."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the 510(k) summary. The summary focuses on engineering and biocompatibility testing, which generally do not involve clinical experts in establishing ground truth in the same way as, for example, diagnostic imaging devices.
4. Adjudication method for the test set
This information is not provided in the 510(k) summary. Given the nature of functional and biocompatibility testing, a traditional adjudication method for establishing ground truth from multiple expert readings is typically not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was performed or is relevant for this medical device. This device is a physical medical instrument (cannula) used during cardiopulmonary bypass, not an AI or diagnostic imaging tool. Therefore, there is no human-in-the-loop AI assistance aspect to evaluate.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done or is relevant for this medical device. This is a physical medical device, not a software algorithm.
7. The type of ground truth used
The ground truth used for this device would be based on engineering specifications and established regulatory standards for functional performance and biocompatibility of medical devices.
- Functional Testing: Ground truth would be defined by the pre-established performance specifications (e.g., flow rates, resistance, integrity under pressure, connection security).
- Biocompatibility Testing: Ground truth would be defined by the biological response observed in accordance with ISO 10993 standards and relevant regulatory guidelines.
8. The sample size for the training set
This information is not provided and not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are validated through engineering principles and quality systems, not machine learning training.
9. How the ground truth for the training set was established
This information is not provided and not applicable. As explained above, there is no training set for this type of device. The "ground truth" for its design and manufacturing is established through adherence to quality management systems (e.g., ISO 13485, 21 CFR Part 820) and compliance with industry standards for materials and performance.
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510(k) Summary
| Submitter: | Edwards Lifesciences LLCOne Edwards WayIrvine, California 92614 USA |
|---|---|
| Contact: | Jason Smith, Senior Regulatory Affairs SpecialistPhone: 949-250-2662Fax: 949-250-3579E-mail: jason_smith@edwards.com |
| Date Prepared: | October 29, 2003 |
| Trade Name: | Edwards Lifesciences Research Medical Inc. PediatricArterial Cannulae (abbreviated to ERMI Pediatric ArterialCannulae) |
| Common Name: | Cardiopulmonary Bypass Vascular Catheter, Cannula, orTubing (21 CFR 870.4210) |
| PredicateDevices: | Research Industries' Various Cardiovascular DevicesResearch Medical, Inc. Fem-Flex Femoral AccessCannulation KitTerumo L-Series 1964 Type Pediatric Aortic Cannulae |
| DeviceDescription: | The ERMI Pediatric Arterial Cannulae are used to accessthe aorta or femoral artery during cardiopulmonarybypass. |
| Indications forUse: | The ERMI Pediatric Aortic Perfusion Cannulae areindicated for perfusion of the aorta so that perfusion of thearteries via a heart-lung machine may take place.The ERMI Pediatric Arterial Perfusion Cannulae areindicated for perfusion of the femoral artery duringprocedures requiring cardiopulmonary bypass wherefemoral artery cannulation is deemed appropriate.The ERMI Pediatric Femoral Arterial Cannulae areindicated for use in situations which require rapid femoralarterial access for short term cardiopulmonary bypass. |
| ComparativeAnalysis: | Extracorporeal circuit components with a DurafloTreatment are indicated for use in cardiopulmonarysurgery when a heparin-treated blood path is desired.The only difference between the subject catheters and thepredicate Research Medical catheters is the subjectcatheters are smaller in diameter and length. Aside fromthe smaller sizes, there is no difference between the ERMIPediatric Arterial Cannulae and the predicate devices. |
| Functional/SafetyTesting: | The ERMI Pediatric Arterial Cannulae have successfullyundergone functional and biocompatibility testing. |
| Conclusion: | The ERMI Pediatric Arterial Cannulae are substantiallyequivalent to the predicate devices. |
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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
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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.
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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
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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
Page 1 of 1
§ 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).