Fogarty Occlusion Catheter

K152762 · Edwards Lifesciences, LLC · MJN · Nov 23, 2015 · Cardiovascular

Device Facts

• Record ID: K152762
• Device Name: Fogarty Occlusion Catheter
• Applicant: Edwards Lifesciences, LLC
• Product Code: MJN · Cardiovascular
• Decision Date: Nov 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Fogarty Occlusion Catheter is a single-lumen PVC catheter with a distal latex balloon and proximal gate valve; used for temporary vessel occlusion. Operated by clinicians in vascular procedures. Inflation of balloon achieved via syringe connected to gate valve; removable stainless-steel stylet maintains catheter shape and lumen patency during storage. Device is sterile, single-use. Output is physical occlusion of target vessel; assists in hemorrhage control or flow management during surgery. Benefits include temporary cessation of blood flow to facilitate vascular interventions.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence established via comparative analysis of design, materials, and technological characteristics against the predicate.

Technological Characteristics

Single-lumen polyvinylchloride (PVC) catheter body; latex balloon; stainless-steel stylet. Manual inflation via syringe. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for temporary vessel occlusion in patients requiring temporary occlusion of the aorta, vena cava, and internal jugular vein (Large Occlusion catheters) or the peripheral vascular system (Small Occlusion catheters).

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Fogarty Occlusion Catheter (Pre-amendment device)
• Fogarty Occlusion Catheter (K093911)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) | |
|--------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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#### TRADITIONAL 510(K) SUMMARY 5.0

| Submitted by: | Edwards Lifesciences, LLC. |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Naren Murugan<br>Edwards Lifesciences<br>One Edwards Way<br>Irvine, CA<br>Direct Line: 949-250-2861<br>email: Naren [e-mail] |
| 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<br>Fogarty Occlusion Catheter, K093911 (SE, 21January 2010) |
| Device Description: | The Fogarty Occlusion Catheters are indicated for temporary<br>vessel occlusion. The Large Occlusion catheters are intended to<br>be used for temporary occlusion in the aorta, vena cava and<br>internal juqular vein. The Small Occlusion catheters are<br>intended to be used for temporary occlusion in the peripheral<br>vascular system. The catheter consists of a single-lumen<br>polyvinylchloride (PVC) catheter body with a latex balloon at the<br>distal end and a gate valve at the proximal end. The catheter<br>lumen is used for inflation of the balloon via a syringe connected<br>to the gate valve. A removable stainless-steel stylet is provided<br>with each catheter to maintain the straight catheter shape and to<br>ensure that the lumen remains opened during storage or<br>sterilization of the product. The device is supplied sterile and for<br>single use only.<br>This Traditional 510(k) is submitted to request clearance for<br>changes to the indications for use statement. The proposed<br>changes to the indications for use statement do not alter the<br>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).

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