(232 days)
No
The 510(k) summary describes a purely mechanical introducer sheath with no mention of software, algorithms, or any features that would suggest the use of AI or ML.
No.
The device is an introducer sheath, which is an accessory device used to facilitate the introduction of another therapeutic device (EMBOL-X Intra-Aortic Filters) into the body, rather than providing direct therapy itself.
No
Explanation: The device is described as an introducer sheath used for the introduction of intra-aortic filters, which is an interventional/treatment purpose, not a diagnostic one. There is no mention of it collecting data or providing information about a patient's medical condition.
No
The device description clearly states it is made of flexible and non-flexible polymeric materials and includes physical components like a housing, obturator, valve, and suture loops, indicating it is a physical medical 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 is for introducing a filter into the aorta during a medical procedure. This is a therapeutic/interventional use, not a diagnostic one.
- Device Description: The description details a physical device used for accessing a blood vessel and introducing another device. It does not describe any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing any kind of diagnostic result.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The EMBOL-X Introducer Sheath does not fit this definition.
N/A
Intended Use / Indications for Use
Intended as a device access port to the vasculature during cardiovascular surgery.
The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.
Product codes
DYB
Device Description
Edwards Lifesciences' EMBOL-X Introducer Sheath is a sterile, non-pyrogenic, singleuse introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator.
The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding.
The device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vasculature
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 functional data indicate that the EMBOL-X Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed:
- Biocompatibility .
- Cytotoxicity o
- Haemocompatibility o
- Irritation/Intracutaneous Toxicity o
- Sensitization o
- Systemic Toxicity o
- Pyrogenicity o
- Genotoxicity o
- Thrombogenicity o
- . Sterility
- Performance Testing / Shelf Life .
- Tensile 0
- Leak 0
- Vent 0
- Latch Compression o
- Flange Flex O
- Insertion, Removal, and Retention Force o
- Functional/Compatibility testing with associated devices ਼
All data met acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
510(k) Summary
| Submitter: | Edwards Lifesciences LLC | |
|---|---|---|
| Submitter | ||
| Contact: | Luke Meidell, Regulatory Affairs Associate II | |
| 12050 Lone Peak Pkwy | ||
| Draper, UT 84020 | ||
| Ph - (801) 565-6212 | ||
| Fax - (801) 565-6108 | JUL 2 4 2013 | |
| Date Prepared: | July 19, 2013 | |
| Trade Name: | Edwards EMBOL-X™ Introducer Sheath | |
| Classification Name: | Introducer, Catheter, Cardiovascular Devices Panel; | |
| 21 CFR §870.1340 Product Code DYB, Class II | ||
| Predicate Device: | K002973, EMBOL-X Introducer |
Device Description:
Edwards Lifesciences' EMBOL-X Introducer Sheath is a sterile, non-pyrogenic, singleuse introducer made of flexible and non-flexible polymeric materials. It consists of a single lumen housing and a removable, snap-lock obturator.
The housing has a flexible suture flange for attachment to the vessel and orientation markings on the shaft and suture flange to assist in the placement of the EMBOL-X Introducer Sheath. Inside the housing is an internal valve to prevent backbleeding.
The device also has additional suture loops on the proximal end of the Introducer housing and a design that allows air to vent from the Introducer during insertion.
Intended Use:
Intended as a device access port to the vasculature during cardiovascular surgery.
1
Indications for Use:
The Indications for Use statement was revised from the predicate device (which allowed introduction of intravascular devices) to only allow introduction of EMBOL-X Intra-Aortic Filters. This revised Indication still falls within the old indication, although it limits the device to use with one intravascular device-the EMBOL-X Intra-Aortic Filter.
The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters.
Comparative Analysis:
The subject device has the same intended use and technological characteristics (i.e., design, material, chemical composition) as the predicate device. It has been demonstrated that the subject EMBOL-X Introducer Sheath is comparable to the predicate device in fundamental scientific technology, material types, principles of operation, and functional performance evaluations. No new issues of safety or efficacy have been raised.
Functional/Safety Testing:
The functional data indicate that the EMBOL-X Introducer Sheath performs in a substantially equivalent manner when compared to the predicate device. The following functional tests were performed:
- Biocompatibility .
- Cytotoxicity o
- Haemocompatibility o
- Irritation/Intracutaneous Toxicity o
- Sensitization o
- Systemic Toxicity o
- Pyrogenicity o
- Genotoxicity o
- Thrombogenicity o
- . Sterility
- Performance Testing / Shelf Life .
- Tensile 0
- Leak 0
2
- Vent 0
- Latch Compression o
- Flange Flex O
- Insertion, Removal, and Retention Force o
- Functional/Compatibility testing with associated devices ਼
All data met acceptance criteria.
Conclusion:
The Edwards EMBOL-X Introducer Sheath testing confirms that the subject EMBOL-X Introducer Sheath is substantially equivalent to the predicate EMBOL-X Introducer.
3
Public Health Service
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
July 24, 2013
Edwards Lifesciences LLC C/O Luke Meidell, Regulatory Affairs Associate II 12050 Lone Peak Pkwy Draper, UT 84020
Re: K123714
Trade/Device Name: Edwards EMBOL-X™M Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer. Catheter Regulatory Class: Class II Product Code: DYB Dated: July 12, 2013 Received: July 15, 2013
Dear Mr. Luke Meidell:
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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 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,
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
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Page 2 - Mr. Luke Meidell
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
M.A. Zillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
:
Indications for Use Statement 510(k) Number (if known): K123714 Device Name: EMBOL-X Introducer Sheath Indications for Use: The EMBOL-X Introducer Sheath is indicated for use in procedures requiring the introduction of EMBOL-X Intra-Aortic Filters. Prescription Use OR Over-The-Counter Use X (Per 21 CFR 801.109) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office Of Device Evaluation (ODE)
M. A. Hillman