(27 days)
The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.
The Equalizer Balloon Catheter is designed for temporary occlusion of vessels up to 40mm in diameter. To allow for large inflation diameters, the balloons are mounted on a non-tapered catheter shaft. All Equalizer Balloon Catheters have two lumens that are marked. The tubing, marked BALLOON, is the balloon inflation lumen. The tubing marked DISTAL is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for infusion of contrast medium. The Equalizer Balloon Catheter is constructed of a soft compliant latex balloon mounted on the tip of a multi-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon segment of the catheter to provide visual reference points for balloon positioning within the vessel. Catheter shafts are radiopaque, maximizing fluoroscopic visibility.
The provided document is a 510(k) premarket notification for a medical device (Equalizer Occlusion Balloon Catheter). It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, discussing:
- General Provisions: Trade Name, Classification Name, Predicate Devices, Classification, Performance Standards (not established by FDA), Intended Use and Device Description.
- Biocompatibility: Stating no new materials were introduced and predicate devices were tested.
- Summary of Substantial Equivalence: Concluding that the device is substantially equivalent based on gathered data without raising new safety or efficacy issues.
- FDA Correspondence: Confirming substantial equivalence.
- Indications for Use: Listing the medical applications for the device.
There is no data, study design, acceptance criteria, or performance metrics described in this document that would allow for the completion of the requested table and information about a clinical or performance study. This type of regulatory submission typically relies on substantial equivalence to existing devices rather than new performance studies with specific acceptance criteria.
{0}------------------------------------------------
JUN 2 0 2002
16021721
Special 510(k) - Device Modification
Equalizer Occlusion Balloon Catheter
May 23, 2002
Summary of Safety and Effectiveness
| General Provisions | Trade Name: Equalizer Balloon CatheterClassification Name: Catheter, Angioplasty, Peripheral, Transluminal |
|---|---|
| Name of Predicate Devices | Large Occlusion Balloon CatheterBlue Max Balloon Catheter |
| Classification | Class II |
| Performance Standards | Performance Standards have not been established by FDA under Section 514 of the Food, Drug and Cosmetic Act |
| Intended Use and Device Description | The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures.The Equalizer Balloon Catheter is designed for temporary occlusion of vessels up to 40mm in diameter. To allow for large inflation diameters, the balloons are mounted on a non-tapered catheter shaft. All Equalizer Balloon Catheters have two lumens that are marked. The tubing, marked BALLOON, is the balloon inflation lumen. The tubing marked DISTAL is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire. The lumen can also be used for infusion of contrast medium. The Equalizer Balloon Catheter is constructed of a soft compliant latex balloon mounted on the tip of a multi-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon segment of the catheter to provide visual reference points for balloon positioning within the vessel. Catheter shafts are radiopaque, maximizing fluoroscopic visibility. |
| Biocompatibility | No new materials have been introduced during this modification as compared to the predicate devices. The predicate devices have been tested for biocompatibility. All data demonstrate this device is biocompatible for its intended use. |
| Summary of Substantial Equivalence | The Equalizer Occlusion Balloon Catheter has been tested and compared to the predicate devices. All data gathered demonstrate this device as substantially equivalent. No new issues of safety or efficacy have been raised. |
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus is depicted in a simple, black and white design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation c/o Jennifer Bolton, RAC Senior Regulatory Affairs Specialist One Boston Scientific Place Natick, MA 01760-1537
JUN 2 0 2002
Re: K021721
Device Name: Equalizer Occlusion Balloon Catheter Regulation Number: 21 CFR 1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: May 23, 2002 Received: May 24, 2002
Dear Ms. Bolton:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set
{2}------------------------------------------------
Page 2 - Jennifer Bolton, RAC
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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Dala Tule
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Special 510(k) -- Device Modification Equalizer Occlusion Balloon Catheter May 23, 2002
Indications For Use
| 510(k)Number(if known) | Unknown |
|---|---|
| DeviceName: | Equalizer Balloon Catheter |
| Indicationsfor Use | The Equalizer Balloon is indicated for use for temporary vessel occlusion in applications including arteriography, preoperative occlusion, emergency control of hemorrhage, chemotherapeutic drug infusion and renal opacification procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021721
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).