(147 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and biocompatibility of a mechanical cannula, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
This device is an arterial return or venous drainage cannula used for extracorporeal circulation during cardiopulmonary bypass, which assists with surgical procedures but does not therapeutically treat a disease or condition itself.
No
The description states that the device is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula, providing extracorporeal circulation of the blood. There is no mention of it being used to collect or analyze data for diagnostic purposes; its function is interventional, managing blood flow during surgery.
No
The device description clearly outlines a physical, sterile, single-use medical device made of polymer tubing with a guidewire, obturator, stylet, dilators, needle, and scalpel. It is intended for use in cardiopulmonary bypass, which is a hardware-dependent procedure. There is no mention of any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for use with cardiopulmonary bypass as an arterial return or venous drainage cannula. This is a device used in vivo (within the body) to facilitate a medical procedure (cardiopulmonary bypass).
- Device Description: The description details a physical device (cannula, guidewire, dilators, needle, scalpel) used for accessing and managing blood flow during surgery. It does not describe a test or assay performed on biological samples in vitro (outside the body).
- 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.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool used to manage blood flow during a procedure, not to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.
Product codes (comma separated list FDA assigned to the subject device)
DWF
Device Description
The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction
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)
Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993
Bench testing has demonstrated that the device meets the proposed product specifications.
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.
K060101, K000274, K974259, K070749
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
KC091542
ESTECH EasyFlow Cannula with Guidewire Premarket Notification
Section 5: 510(k) Summary of Safety and Effectiveness
Device Information:
OCT 20 2009
| Category | Comments |
|---|---|
| Sponsor: | ESTECH, Inc. |
| 2603 Camino Ramon | |
| Suite 100 | |
| San Ramon, CA 94583 | |
| Tel: 925-543-2110 | |
| Correspondent: | Tamer Ibrahim |
| Vice President, R&D, QA/RA | |
| 2603 Camino Ramon | |
| San Ramon, CA 94523 | |
| Contact Information: | Tel: 925-543-2110 |
| Fax: 925-866-7117 | |
| Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Device Classification & Code: | Class II, DWF (21 CFR 870.4210) |
| Device Classification Name: | Cardiopulmonary bypass vascular catheter, |
| cannula or tubing | |
| Device Proprietary Name: | ESTECH EasyFlow Cannula with |
| Guidewire |
Predicate Device Information:
:
| Predicate Device: | ESTECH Aortic EasyFlow Cannula |
|---|---|
| (K060101) | |
| Predicate Device Manufacturer: | ESTECH, Inc. |
| Predicate Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |
| Predicate Device: | Medtronic EOPA Elongated One-Piece |
| Arterial Cannula with Guidewire (K000274) | |
| Predicate Device Manufacturer: | Medtronic, Inc. |
| Predicate Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Predicate Device Classification: | 21 CFR 870.4210 |
| Predicate Device Classification & Code: | Class II, DWF |
| Predicate Device: | Edwards Lifesciences Venous Flex II
Peripheral And Intra-Operative Access
Venous Return Cannulae (K974259) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | Edwards Lifesciences, Inc. |
| Predicate Device Common Name: | Cardiopulmonary bypass vascular cannula |
| Predicate Device Classification: | 21 CFR 870.4210 |
1
Endoscopic Technologies, Inc.
ESTECH EasyFlow Cannula with Guidewire Premarket Notification
| Predicate Device Classification & Code: | Class II, DWF |
|---|---|
| ----------------------------------------- | --------------- |
| Predicate Device: | ESTECH Percutaneous Insertion Dilator Kit
(K070749) |
|-----------------------------------------|--------------------------------------------------------|
| Predicate Device Manufacturer: | ESTECH, Inc |
| Predicate Device Common Name: | Vessel dilator for percutaneous
catheterization |
| Predicate Device Classification: | 21 CFR 870.1310 |
| Predicate Device Classification & Code: | Class II, DRE |
b. Date Summary Prepared
19May09
c. Description of Device
The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates multiple perforations at the distal end to provide a diffuse flow pattern. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction
d. Intended Use
The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.
e. Comparison to Predicate Device
The ESTECH EasyFlow Cannula with Guidewire is identical in technology, design, materials, manufacture, and packaging to the ESTECH Aortic EasyFlow Cannula (K060101) with the addition that it is packaged with a guidewire and accessory introduction components including scalpel, needle, and dilators. A small hole has been added to the cannula and obturator tips to facilitate pass through of the guidewire. The ESTECH EasyFlow Cannula with Guidewire is similar in intended use to the Medtronic EOPA Elongated One-Piece Arterial Cannula with Guidewire that it is intended for use with cardiopulomonary bypass as an arterial return cannula. The ESTECH EasyFlow Cannula with Guidewire is similar in intended use to the Edwards Lifesciences Venous Flex II Peripheral
Section 5, Page 2
2
Endoscopic Technologies, Inc.
And Intra-Operative Access Venous Return Cannulae which are intended for use in situations in which short term cardiopulmonary bypass peripheral access venous return procedures, i.e., internal jugular vein, right innominate vein, and femoral vein access, as well as the standard intra-operative access venous return procedures, i.e right atrial appendage and right atriotomy access is desired.
ESTECH concludes that the ESTECH EasyFlow Cannula with Guidewire is substantially equivalent to the predicate devices.
f. Summary of Supporting Data
Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993
Bench testing has demonstrated that the device meets the proposed product specifications.
CONFIDENTIAL
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a stylized image of an eagle. The eagle is depicted with its wings spread, and its body is formed by three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
1
OCT 20 2009
Endoscopic Technologies, Inc. c/o Mr. Tamer Ibrahim Vice President 2603 Camino Ramon, Suite 100 San Ramon, CA 94583
K091542 Re:
ESTECH EasyFlow Cannula with Guidewire Regulation Number: 21 CFR 870.4210 Regulation Name: Catheter, Cannula and Tubing Vascular, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWF Dated: September 21, 2009 Received: September 23, 2009
Dear Mr. Ibrahim:
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 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
4
Page 2 -- Mr. Tamer Ibrahim
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Dovices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Section 4: Indications for Use
510(k) Number (if known): Ke99542
Device Name: ESTECH EasyFlow Cannula with Guidewire
Indications For Use:
The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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) | |
|---|---|
| Page 1 of 1 | |
| Cardiovascular Devices | |
| 510(k) number | K091542 |
CONFIDENTIAL