(265 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter with a balloon, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for temporary vessel occlusion, not for treating a disease or condition.
No
The device is described as an "Occlusion Catheter" used for "temporary vessel occlusion." Its function is to block blood flow, not to gather information or diagnose a condition.
No
The device description clearly outlines physical components such as a catheter body, balloon, gate valve, and stylet, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary vessel occlusion" within the human body (aorta, vena cava, internal jugular vein, peripheral vascular system). This is a direct intervention on the patient.
- Device Description: The description details a physical catheter with a balloon for inflation, designed to be inserted into blood vessels.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is used inside the body for a therapeutic or procedural purpose (occlusion).
N/A
Intended Use / Indications for Use
The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein.
The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
Models: 620403F, 620404F, and 620405F
The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter to maintain the straight catheter shape and to ensure that the lumen remains opened during storage of the product.
Models: 62080814F and 62080822F
The Fogarty 8F Large Occlusion Catheters consist of a single-lumen polyvinylchloride catheter body with a latex balloon at the distal end and a gate valve at the proximal end. The catheter lumen is used for inflation of the balloon via a syringe connected to the gate valve. A removable stainless-steel stylet is provided with each catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, vena cava, internal jugular vein, peripheral vascular 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 testing. 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 Occlusion Catheters 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.
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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
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February 14, 2022
Edwards Lifesciences, LLC Anisha Butala Regulatory Affairs Specialist One Edwards Way Irvine, California 92614
Re: K211610
Trade/Device Name: Fogarty Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: January 13, 2022 Received: January 14, 2022
Dear Anisha Butala:
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
1
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 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 (OS) 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,
for Carmen Gacchina Johnson, PhD Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211610
Device Name Fogarty Occlusion Catheters
Indications for Use (Describe)
The Fogarty Occlusion Catheters are indicated for temporary vessel occlusion.
The Large Occlusion Catheters are intended to be used for temporary occlusion in the aorta, vena cava and internal jugular vein.
The Small Occlusion Catheters are intended to be used for temporary occlusion in the peripheral vascular system.
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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SECTION 5. 510(K) SUMMARY
| Fogarty Occlusion Catheters | ||
|---|---|---|
| 510(k) Submitter | Edwards Lifesciences, LLC | |
| One Edwards Way Irvine, CA, USA 92617 | ||
| Contact Person | Primary Contact | |
| Anisha Butala | ||
| Specialist, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 250-1004 | ||
| Fax: (949) 809-2954 | ||
| Email: | ||
| Anisha_Butala@edwards.com | Secondary Contact | |
| Karen O'Leary | ||
| Director, Regulatory Affairs | ||
| Edwards Lifesciences | ||
| One Edwards Way | ||
| Irvine, CA 92614 | ||
| Telephone: (949) 250-0715 | ||
| Fax: (949) 809-2954 | ||
| Email: Karen_OLeary@edwards.com | ||
| Date Prepared | February 14, 2022 | |
| Trade Name | Fogarty Occlusion Catheters | |
| Common Name | Vascular Occlusion Balloon Catheter | |
| Classification | ||
| Name | MJN - Catheter, Intravascular Occluding, Temporary | |
| Regulation | ||
| Class/Product | ||
| Code | 21 CFR 870.4450/MJN | |
| Predicate Device(s) | Fogarty Occlusion Catheter, K152762, (SE November 23, 2015) | |
| Device Description | Models: 620403F, 620404F, and 620405F | |
| The Fogarty Small Occlusion Catheters (4F, 5F) consist of a single-lumen | ||
| polyvinylchloride catheter body with a latex balloon at the distal end and a gate | ||
| valve at the proximal end. The 3F Fogarty Occlusion Catheter is made of Nylon. | ||
| The catheter lumen is used for inflation of the balloon via a syringe connected to | ||
| the gate valve. A removable stainless-steel stylet is provided with each catheter | ||
| to maintain the straight catheter shape and to ensure that the lumen remains | ||
| opened during storage of the product. | ||
| Models: 62080814F and 62080822F | ||
| The Fogarty 8F Large Occlusion Catheters consist of a single-lumen | ||
| polyvinylchloride catheter body with a latex balloon at the distal end and a gate | ||
| valve at the proximal end. The catheter lumen is used for inflation of the balloon | ||
| via a syringe connected to the gate valve. A removable stainless-steel stylet is | ||
| provided with each catheter. | ||
| Indications for | ||
| Use/Intended Use | Fogarty Occlusion Catheters are intended for temporary vessel occlusion. | |
| Models: 620403F, 620404F, and 620405F | ||
| The Small Occlusion catheters are intended to be used for temporary occlusion | ||
| in the peripheral vascular system. | ||
| Models: 62080814F and 62080822F | ||
| The Large Occlusion catheters are intended to be used for temporary occlusion | ||
| in the aorta, vena cava and internal jugular vein. | ||
| Comparative | ||
| Analysis | The subject device is identical to the predicate device, K152762 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 devices with | ||
| a new alternative 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 testing evaluations were conducted to ensure
that the change in the new alternative final packaging did not alter the
performance of the subject devices. The subject Fogarty Occlusion Catheters
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 Occlusion Catheters with new alternative packaging configuration
are identical to the predicate device in terms of the final device and indications
for use. To ensure that the Fogarty Occlusion Catheters with new alternative
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 testing. 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 Occlusion Catheters 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 Occlusion Catheters are substantially equivalent to the predicate
devices, K152762. | |
Table 5-1: Summary Table
4