(185 days)
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tube body having a curved J-tip end and a flange for suture attachment. Attached to the side of the J-tip end is an Introducer port having a single lumen housing and a removable self-venting keyed snap-lock Obturator. The outer portion of the J-tip includes a radiused groove that accepts the complimentary radiused distal end of the provided Obturator. With the Obturator inserted, the Obturator provides a smooth, minimally disruptive fit along the J-tip's radiused groove. Removal of the Obturator from the Introducer port reveals a channel through which a physically compatible device may be introduced through the Introducer's hemostatic valve and along the groove of the J-tip. The Introducer port acts as an intravascular hemostasis conduit that can accommodate the introduction of intravascular devices with an exit diameter ranging from 12 FR to 14 FR in size. The Obturator is removed only when intravascular access with a device is necessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24 FR. All models are a J-tip configuration whose tips are made from metal or plastic. The device is packaged sterile and non-pyrogenic, is single use only, and come with a separate optional use porous vent plug for cannula venting.
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
Here's an analysis of the provided text regarding the device's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | All materials must be biocompatible. | "All materials used in the EMBOL-X Aortic Cannula are shown to be biocompatible." |
| Functional Performance | Joint strength, gasket seal integrity, and flow rate should be substantially equivalent or better than the predicate device(s). | "In-vitro bench test results for joint strength, gasket seal integrity, and flow rate PERFORMANCE characteristics was substantially equivalent or better than in performance to the TESTS: predicate device(s)." This statement implies that the device met this criterion by demonstrating performance either equal to or superior to the predicate devices in these specific areas. |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics. | The FDA letter (K020693) explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications of use stated in the enclosure) to legally marketed predicate devices..." The submission also states: "The EMBOL-X Aortic Cannula is technologically and substantially equivalent to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly mentions in-vitro bench tests. These tests are typically conducted on a controlled number of manufactured units of the device, rather than on patient data.
- Sample Size for Test Set: Not specified. The document states "bench test results" which implies testing was performed on a sample of the manufactured device. The exact number of units tested for joint strength, gasket seal integrity, and flow rate is not provided.
- Data Provenance: In-vitro bench testing. This means the data was generated in a laboratory setting, not from human or animal subjects. Therefore, there is no country of origin or retrospective/prospective distinction in the typical sense for clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The study described is in-vitro bench testing, not a clinical study involving diagnosis or interpretation by experts. Therefore, there's no "ground truth" to be established by clinical experts for these specific performance metrics. The ground truth for bench tests is typically defined by engineering specifications and physical measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies when multiple human readers interpret data to resolve discrepancies. For in-vitro bench testing, measurements are taken according to predefined protocols, and results are compared against engineering specifications, eliminating the need for reader adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The studies mentioned are in-vitro bench tests comparing the device's physical performance characteristics (joint strength, seal integrity, flow rate) to predicate devices. These are not studies involving human readers and AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The device described is a medical instrument (Aortic Cannula), not a software algorithm or AI. Therefore, there are no "standalone" algorithm performance studies relevant to this submission.
7. Type of Ground Truth Used
The ground truth for the in-vitro bench tests was based on engineering specifications and physical measurements of the device's performance characteristics (joint strength, gasket seal integrity, and flow rate). The performance was then compared to the same metrics for predicate devices.
8. Sample Size for the Training Set
This information is not applicable. As this is an in-vitro bench test for a physical medical device, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. There is no training set for a physical device's in-vitro bench testing, so no ground truth was established for it in this context.
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SEP 5 2002
Image /page/0/Picture/1 description: The image shows a sequence of alphanumeric characters, specifically "K020693". The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized. The numbers are clearly distinguishable, and the overall image is simple and straightforward.
510(k) SUMMARY
| SUBMITTER'S NAME: | EMBOL-X®, INC. |
|---|---|
| ADDRESS: | 645 Clyde Ave, Mountain View, CA |
| PHONE NUMBER: | (650) 390-0280 |
| FAX NUMBER: | (650) 390-0282 |
| CONTACT PERSON: | Edwin Lee |
| DATE PREPARED: | July 3, 2002 |
| TRADE NAME: | Aortic Cannula |
| COMMON NAME: | Aortic Cannula |
| CLASSIFICATIONNAME: | Cardiopulmonary Bypass Vascular Cannula |
| PREDICATEDEVICE(S): | a) EMBOL-X® Introducerb) DLP® Curved Metal Tip Arterial Cannula |
| DEVICEDESCRIPTION: | The EMBOL-X® Aortic Cannula consist of a standard 3/8" ID wire reinforced tubebody having a curved J-tip end and a flange for suture attachment. Attached to theside of the J-tip end is an Introducer port having a single lumen housing and aremovable self-venting keyed snap-lock Obturator. The outer portion of the J-tipincludes a radiused groove that accepts the complimentary radiused distal end ofthe provided Obturator. With the Obturator inserted, the Obturator provides asmooth, minimally disruptive fit along the J-tip's radiused groove. Removal ofthe Obturator from the Introducer port reveals a channel through which aphysically compatible device may be introduced through the Introducer'shemostatic valve and along the groove of the J-tip. The Introducer port acts as anintravascular hemostasis conduit that can accommodate the introduction ofintravascular devices with an exit diameter ranging from 12 FR to 14 FR in size.The Obturator is removed only when intravascular access with a device isnecessary. The EMBOL-X Aortic Cannulas have an insertion diameter size of 24FR. All models are a J-tip configuration whose tips are made from metal orplastic. The device is packaged sterile and non-pyrogenic, is single use only, andcome with a separate optional use porous vent plug for cannula venting. |
| INTENDED USE: | The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascendingaorta during cardiopulmonary bypass (CPB) surgery where procedures mayrequire the hemostatic introduction and removal of compatible intravasculardevices into the vascular system.The intended use is substantially equivalent to that of the predicates. |
| TECHNOLOGICALCHARACTERISTICSCOMPARISON: | The EMBOL-X Aortic Cannula is technologically and substantially equivalent tothe predicate devices. The EMBOL-X Aortic Cannula combines the predicatearterial cannula design with the predicate EMBOL-X Introducer design into onedevice. The device's principle operating functions and technologicalcharacteristics have remained unchanged. |
| BIOCOMPATIBILITY: | All materials used in the EMBOL-X Aortic Cannula are shown to bebiocompatible. |
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biocompatible.
In-vitro bench test results for joint strength, gasket seal integrity, and flow rate PERFORMANCE characteristics was substantially equivalent or better than in performance to the TESTS: predicate device(s).
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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 2002 SEP
Embol-X c/o Mr. Edwin Lee 645 Clyde Avenue Mountain View, CA 94043-2208
Re: K020693
Aortic Cannula Regulation Number: 870.4210 Regulation Name: CPB Catheter, cannula, tubing Regulatory Class: Class II (two) Product Code: DWF Dated: June 28, 2002 Received: July 1, 2002
Dear Mr. Lee:
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.
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.
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Page 2 - Mr. Edwin Lee
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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), 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.
Dalk Telle
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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Ver/ 3 - 4/24/96
EMBOL-X®, Inc. Applicant:
K020693 510(K) NUMBER (IF KNOWN):
Device Name: Aortic Cannula
Indications For Use:
The EMBOL-X Aortic Cannula is indicated for the perfusion of the ascending aorta during cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system.
| ਾ ਦੇ1 1 | קחר | ాగా/ YO |
|---|---|---|
| ្រី | 8 | C |
| 1774218518 - 144 | ਹੈ | H U Gy |
| aller | 50 | 0ું મુંદિવ |
| 1":"7 | 11 | / |
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K020693
Prescription Use X
(Per 21 CFR 801.109)
OR
.
Over-The-Counter Use ____________
(Optional Format 1-2-96)
§ 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).