(190 days)
Pre-amendment
Not Found
No
The device description and performance studies focus on the physical components and traditional testing methods, with no mention of AI or ML.
Yes
The devices are indicated for the removal of thrombi and stones from the body, which are direct treatments for medical conditions.
No
The devices described, the Fogarty Arterial Embolectomy Catheter and the Fogarty Biliary Balloon Probe, are indicated for the removal of thrombi, stones, and debris, and for exploration. These are therapeutic and interventional actions, not diagnostic ones. There is no mention of the devices being used to identify or determine a disease or condition.
No
The device description clearly details physical components such as catheter bodies, balloons, hubs, and stylets, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of both the Fogarty Arterial Embolectomy Catheter and the Fogarty Biliary Balloon Probe is for the physical removal of material (thrombi, stones, debris) from within the body (arterial system, biliary ducts). This is a therapeutic or interventional use, not a diagnostic one.
- Device Description: The description details a physical catheter with a balloon for mechanical manipulation within the body. It does not describe any components or functions related to analyzing samples of human origin in vitro (outside the body).
- Lack of IVD Indicators: There is no mention of:
- Analyzing biological samples (blood, tissue, etc.).
- Detecting or measuring substances in samples.
- Providing information for diagnosis, monitoring, or screening.
- Any form of in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. These devices are used in vitro. The devices described here are used in vivo (within the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
Fogarty Arterial Embolectomy Catheter:
The Fogarty Arterial Embolectomy Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.
Fogarty Biliary Balloon Probe:
The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.
Product codes (comma separated list FDA assigned to the subject device)
DXE, GCA
Device Description
Fogarty Arterial Embolectomy Catheter
The Fogarty Arterial Embolectomy Catheter consists of a catheter body tube made out of polyvinyl chloride (PVC) or nylon (3F only) of 40, 60, or 80 cm lengths.
The catheter contains a latex balloon at the distal end and a PVC hub at the proximal end for connection to a syringe for balloon inflation. They contain a soft, rounded tip, which promotes easy arterial insertion.
The model with an "S" has a stylet at the proximal end to support the inflation lumen during shipping and storage.
These devices are provided sterile and labeled for single use only.
Fogarty Biliary Balloon Probe
The Fogarty Biliary Balloon Probe consists of a single-lumen polyvinyl chloride (PVC) catheter body with a latex balloon at the distal end. A hub at the proximal end is used for balloon inflation. A flexible stylet is provided with Fogarty Biliary Balloon Probe. The stylet is of a designed stiffness intended to avoid perforation and yet maintain enough shape to facilitate introduction of the probe into areas of sharp angulation. These devices are provided sterile and labeled for single use only. The Fogarty Biliary Balloon Probe is not intended to be used with other devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vessels in the arterial system, biliary system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals and other appropriate clinical environments.
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)
Product Performance testing evaluation and Product Test/Balloon Inflation test to demonstrate final device is not affected.
Packaging testing in accordance to ISO 11607-1 – Packaging for Terminally Sterilized Medical Devices.
Sterilization testing in accordance to ISO 11135:2014 - Sterilization of health-care products- Ethylene oxide- Requirements for the development, validation and routing control of a sterilization process for medical devices.
EO/ ECH residuals evaluation in accordance to ISO10993-7:2008 - Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals.
The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe models have successfully passed performance, packaging, sterility assurance and EO/ECH residuals testing demonstrating that the subject devices are substantially equivalent to the predicate devices.
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.
Pre-amendment
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
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 12, 2020
Edwards Lifesciences, LLC Wendy Gonzalez Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K193379
Trade/Device Name: Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe Regulation Number: 21 CFR 870.5150 and 21 CFR 876.5010 Regulation Name: Embolectomy Catheter and Biliary Catheter and Accessories Regulatory Class: Class II Product Code: DXE, GCA Dated: May 18, 2020 Received: May 20, 2020
Dear Ms. Gonzalez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193379
Device Name
Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe
Indications for Use (Describe)
Fogarty Arterial Embolectomy Catheter:
The Fogarty Arterial Embolectorny Catheter is indicated for the removal and thrombi from vessels in the arterial system. To remove fibrous or adherent material, alternative devices such as the Fogarty Adherent Clot and Graft Thrombectomy Catheter are recommended.
Fogarty Biliary Balloon Probe:
The Fogarty Biliary Balloon Probe is indicated for the removal of stones and ductal debris and exploration.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) SUMMARY
| Fogarty Arterial Embolectomy Catheter and Fogarty Biliary Balloon Probe | ||
|---|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC | |
| Contact Person | Wendy Vera González | |
| Associate Manager, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| (949) 250- 2500 | ||
| Date Prepared | June 9, 2020 | |
| Trade Name | Fogarty Arterial Embolectomy | |
| Catheter | Fogarty Biliary Balloon Probe | |
| Regulation | ||
| Description | Embolectomy Catheter | Biliary catheter and accessories |
| Regulation Class / | ||
| Product Code | Class II | |
| DXE | Class II | |
| GCA | ||
| Predicate | ||
| Device(s) | Pre-amendment | Pre-amendment |
| Regulation | ||
| Number | 21 CFR 870.5150 | 21 CFR 876.5010 |
| Device | ||
| Description | Fogarty Arterial Embolectomy Catheter | |
| The Fogarty Arterial Embolectomy Catheter consists of a catheter | ||
| body tube made out of polyvinyl chloride (PVC) or nylon (3F only) | ||
| of 40, 60, or 80 cm lengths. |
The catheter contains a latex balloon at the distal end and a PVC
hub at the proximal end for connection to a syringe for balloon
inflation. They contain a soft, rounded tip, which promotes easy
arterial insertion.
The model with an “S” has a stylet at the proximal end to support
the inflation lumen during shipping and storage.
These devices are provided sterile and labeled for single use only. | |
| Fogarty Biliary Balloon Probe | | |
| The Fogarty Biliary Balloon Probe consists of a single-lumen
polyvinyl chloride (PVC) catheter body with a latex balloon at the
distal end. A hub at the proximal end is used for balloon inflation. | | |
| A flexible stylet is provided with Fogarty Biliary Balloon Probe.
The stylet is of a designed stiffness intended to avoid perforation
and yet maintain enough shape to facilitate introduction of the
probe into areas of sharp angulation. These devices are provided
sterile and labeled for single use only. The Fogarty Biliary Balloon
Probe is not intended to be used with other devices. | | |
| Indications for
Use/Intended Use | The Fogarty Arterial Embolectomy Catheter is indicated for the
removal of fresh, soft emboli and thrombi from vessels in the
arterial system. To remove fibrous or adherent material, alternative
devices such as the Fogarty Adherent Clot and Graft
Thrombectomy Catheter are recommended. | |
| | The Fogarty Biliary Balloon Probe is indicated for the removal of
stones and ductal debris and exploration. | |
| Comparative
Analysis | The subject device is identical to the predicate devices in terms of
intended use, indications for use, and technology. The proposed
changes involve the creation of new model numbers for the existing
legally marketed device with a new packaging configuration, new
labels and updates to the IFU as a result of the new model numbers. | |
| | Packaging design verification, sterilization (EO resistance and
residuals), product performance and biocompatibility evaluations
were conducted to ensure that the change in final packaging did not
alter the performance of the subject devices. | |
| | The subject Fogarty Arterial Embolectomy Catheter and Fogarty
Biliary Balloon Probe, have been shown to be substantially
equivalent to the predicate devices for its intended use in hospitals
and other appropriate clinical environments. | |
| Functional/ Safety
Testing | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary
Balloon Probe with new packaging configuration are identical to the
predicate device in terms of final device and indications for use. To
ensure that the Fogarty Arterial Embolectomy Catheter and Fogarty
Biliary Balloon Probe with new packaging configuration did not
raise any new concerns of safety and effectiveness, and are
substantially equivalent to the predicate devices, the following
evaluation and testing were performed:
Product Performance testing evaluation and Product Test
/Balloon Inflation test to demonstrate final device is not
affected. | |
| | > Packaging testing in accordance to ISO 11607-1 – Packaging
for Terminally Sterilized Medical Devices.
Sterilization testing in accordance to ISO 11135:2014 -
Sterilization of health-care products- Ethylene oxide-
Requirements for the development, validation and routing
control of a sterilization process for medical devices.
EO/ ECH residuals evaluation in accordance to ISO10993-
7:2008 - Biological evaluation of medical devices – Part 7:
Ethylene oxide sterilization residuals. | |
| | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary
Balloon Probe models have successfully passed performance,
packaging, sterility assurance and EO/ECH residuals testing
demonstrating that the subject devices are substantially equivalent to
the predicate devices. | |
| Conclusion | The Fogarty Arterial Embolectomy Catheter and Fogarty Biliary
Balloon Probe are substantially equivalent to the predicate device. | |
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