(60 days)
No
The device description and performance studies focus on mechanical components and changes to indications for use, with no mention of AI or ML.
Yes
The device is described as a "Fogarty Occlusion Catheter" intended for "temporary vessel occlusion" in various parts of the body (aorta, vena cava, internal jugular vein, peripheral vascular system). This function, while temporary, aims to treat or modify a physiological process (blood flow) within the body, which aligns with the definition of a therapeutic device.
No
The device is described as "Occlusion Catheters" and its intended use is "temporary vessel occlusion." This function is therapeutic (to block blood flow), not diagnostic (to identify or analyze 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, 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 "temporary vessel occlusion." This is a direct intervention on the patient's body to block blood flow, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a catheter with a balloon for inflation, designed to be inserted into blood vessels. This is a physical medical device used for a procedural purpose.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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
MJN
Device Description
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 juqular vein. The Small Occlusion catheters are intended to be used for temporary occlusion in the peripheral vascular system. The catheter consists of a single-lumen polyvinylchloride (PVC) 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 to maintain the straight catheter shape and to ensure that the lumen remains opened during storage or sterilization of the product. The device is supplied sterile and for single use only. This Traditional 510(k) is submitted to request clearance for changes to the indications for use statement. The proposed changes to the indications for use statement do not alter the intended use of the Fogarty Occlusion Catheter (i.e., temporary vessel occlusion).
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
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)
The only change made is a change to the indications for use statement, resulting in a revision to the Instructions for Use. An analysis was performed to evaluate these changes and it was determined that the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate. The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device, and as such no performance testing was conducted. The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911(SE 21 Jan 2010) for modifications of its packaging.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Fogarty Occlusion Catheter, K093911
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 23, 2015
Edwards Lifesciences, LLC. Naren Murugan Regulatory Affairs Associate II One Edwards Way Irvine, California 92614
Re: K152762
Trade/Device Name: Fogarty Occlusion Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: September 23, 2015 Received: September 24, 2015
Dear Naren Murugan:
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. 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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152762
Device Name Fogarty Occlusion Catheter
Indications for Use (Describe)
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Edwards Lifesciences, LLC. |
|---|---|
| Contact Person: | Naren Murugan |
| Edwards Lifesciences | |
| One Edwards Way | |
| Irvine, CA | |
| Direct Line: 949-250-2861 | |
| email: Naren murugan@edwards.com | |
| Date of Summary: | September 23, 2015 |
| Device Trade Name: | Fogarty Occlusion Catheter |
| Product Code: | MJN |
| Common or Usual Name: | Vascular Occlusion Balloon Catheter |
| Classification Name: | Vascular Clamp (21 CFR 870.4450) |
| Predicate Device(s): | Fogarty Occlusion Catheter, Pre-amendment device |
| Fogarty Occlusion Catheter, K093911 (SE, 21January 2010) | |
| Device Description: | 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 juqular vein. The Small Occlusion catheters are | |
| intended to be used for temporary occlusion in the peripheral | |
| vascular system. The catheter consists of a single-lumen | |
| polyvinylchloride (PVC) 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 to maintain the straight catheter shape and to | |
| ensure that the lumen remains opened during storage or | |
| sterilization of the product. The device is supplied sterile and for | |
| single use only. | |
| This Traditional 510(k) is submitted to request clearance for | |
| changes to the indications for use statement. The proposed | |
| changes to the indications for use statement do not alter the | |
| intended use of the Fogarty Occlusion Catheter (i.e., temporary | |
| Indication for Use: | 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. | |
| Technological Characteristics: | The technological characteristics of the Fogarty Occlusion Catheter are identical to those of the predicate (the current legally marketed version of the Fogarty Occlusion Catheter) in terms of the following: |
| Size and shape; Mode of Operation and Intended Use; Target population; Fundamental scientific technology; Patient-contacting materials; and, Method of delivery. | |
| Performance Testing Summary: | The only change made is a change to the indications for use statement, resulting in a revision to the Instructions for Use. An analysis was performed to evaluate these changes and it was determined that the specific vessels identified for each size catheter would be expected to have similar safety and effectiveness compared to the general indications for the predicate. |
| The device with the proposed change to the indication for use statement has the identical design, materials, technology, and operating principles as the current legally marketed version of the device, and as such no performance testing was conducted | |
| The current legally marketed version of the Fogarty Occlusion Catheter complies with all applicable design practices and regulations and was most recently cleared by FDA via K093911(SE 21 Jan 2010) for modifications of its packaging. | |
| Conclusion: | The technology of the Fogarty Occlusion Catheter is identical to the named predicate and the changes to the indications for use do not change the intended use or the adversely impact safety and effectiveness. Therefore, the Fogarty Occlusion Catheter is substantially equivalent to the predicate. |
vessel occlusion).
4