(169 days)
No
The device description and performance studies focus on the physical construction and basic functionality of a balloon catheter, with no mention of AI or ML algorithms for analysis, control, or other functions.
No.
The device is indicated for temporary vessel occlusion, contrast media infusion, or therapeutic drug infusion, which are procedural uses rather than direct therapeutic treatments. While it can be used for drug infusion, the device itself does not act as a therapeutic agent.
No
The device is indicated for temporary vessel occlusion, chemotherapeutic drug infusion, and renal opacification procedures, which are therapeutic or interventional rather than diagnostic.
No
The device description clearly details a physical catheter with a balloon, lumens, and radiopaque markers, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Equalizer™ Occlusion Balloon Catheter is a medical device used within the body (in vivo) to temporarily block blood vessels. It is a therapeutic and interventional device, not a diagnostic one that analyzes samples outside the body.
- Intended Use: The intended uses listed (temporary vessel occlusion, arteriography, hemorrhage control, drug infusion, renal opacification) are all procedures performed directly on the patient's vascular system.
Therefore, based on the provided information, the Equalizer™ Occlusion Balloon Catheter is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Equalizer™ Occlusion Balloon Catheter 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.
Any use for procedures other than those indicated in the instructions is not recommended.
Product codes
MJN
Device Description
The Equalizer™ Occlusion Balloon Catheter is constructed of a soft compliant latex balloon mounted near the tip of a dual-lumen nylon catheter shaft. Radiopaque markers are placed adjacent to the balloon to provide visual reference points for balloon positioning within the vessel. The catheter shaft is radiopaque, maximizing fluoroscopic visibility. Proximal to the bifurcation, the two lumens of the catheter are marked to differentiate their use. 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 the infusion of contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub for attachment to ancillary devices.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing and, therefore, these devices may be considered substantially equivalent to the predicate devices.
The following biocompatibility and bench testing were completed on the Equalizer Occlusion Balloon Catheter:
Biocompatibility
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
Hemocompatibility: Direct Hemolysis, Partial Thromboplastin Time (PTT), Complement Activation, In Vitro Hemocompatibility
USP Physicochemical Tests for Plastics
The following in-vitro performance tests were completed on the Equalizer Occlusion Balloon Catheter:
Bench
Deflated Balloon Profile
Proximal Bond Tensile
Inflated Balloon O.D.
Balloon Deflation Time
Multiple Inflation, Challenge
Balloon Burst, Challenge
Sheath Compatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary
per 21 CFR §807.92
JUL 2 2 2014
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and
Information | Diane Nelson
Regulatory Affairs Specialist
Phone: 763-255-0813
Fax: 763-494-2222
e-mail: diane.nelson@bsci.com |
| | Date Prepared |
| Proprietary
Name | Equalizer™ Occlusion Balloon Catheter |
| Common Name | Vascular Clamp |
| Product Code | MJN – Catheter, Intravascular Occluding, Temporary |
| Classification | Class II, 21 CFR Part 870.4450 – Vascular Clamp |
| Predicate
Device(s) | Equalizer™ Occlusion Balloon Catheter K021721
20 June 2002 |
| Device
Description | The Equalizer™ Occlusion Balloon Catheter is constructed of a soft
compliant latex balloon mounted near the tip of a dual-lumen nylon catheter
shaft. Radiopaque markers are placed adjacent to the balloon to provide
visual reference points for balloon positioning within the vessel.
The catheter shaft is radiopaque, maximizing fluoroscopic visibility.
Proximal to the bifurcation, the two lumens of the catheter are marked to
differentiate their use. 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 the infusion of
contrast media or therapeutic drugs. Each lumen ends in a luer fitting hub
for attachment to ancillary devices. |
| | Intended Use/
Indications for
Use of Device |
| Comparison of
Technological
Characteristics | The Equalizer™ Occlusion Balloon Catheter will incorporate a substantially
equivalent design, packaging, fundamental technology, manufacturing,
sterilization and intended use as those featured in the predicate Occlusion
Balloon Catheter. |
| Performance
Data | Bench testing and biocompatibility testing were performed to support a
determination of substantial equivalence. The results of these tests provide
reasonable assurance that the proposed device has been designed and
tested to assure conformance to the requirements for its intended use. No
new safety or performance issues were raised during the testing and,
therefore, these devices may be considered substantially equivalent to the
predicate devices. |
| | The following biocompatibility and bench testing were completed on the
Equalizer Occlusion Balloon Catheter: |
| | Biocompatibility
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Materials Mediated Pyrogenicity
Hemocompatibility: Direct Hemolysis, Partial Thromboplastin Time (PTT),
Complement Activation, In Vitro Hemocompatibility
USP Physicochemical Tests for Plastics |
| | The following in-vitro performance tests were completed on the Equalizer
Occlusion Balloon Catheter: |
| | Bench
Deflated Balloon Profile
Proximal Bond Tensile
Inflated Balloon O.D.
Balloon Deflation Time
Multiple Inflation, Challenge
Balloon Burst, Challenge
Sheath Compatibility |
| Conclusion | Based on the Indications for Use, technological characteristics, safety and
performance testing, the Equalizer™ Occlusion Balloon Catheter has been
shown to be appropriate for its intended use and is considered to be
substantially equivalent to the Equalizer™ Occlusion Balloon Catheter
(K021721 cleared 20 June 2002). |
1
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.
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2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
DEPARTMENT OF HEALTH & HUMAN SERVICES - USA
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 22, 2014
Boston Scientific Corp. Diane Nelson Regulatory Affairs Specialist One Scimed Place Maple Grove, Minnesota 55311-1566
Re: K140273
Trade/Device Name: Equalizer Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: June 13, 2014 Received: June 16, 2014
Dear Ms. Nelson:
We have reviewed vour 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. Ilsting 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
3
Page 2 - Diane Nelson
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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
4
Indications for Use
510(k) Number (if known): K140273
Device Name: Equalizer™ Occlusion Balloon Catheter
Indications for Use:
Equalizer™ Occlusion Balloon Catheter 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.
Any use for procedures other than those indicated in the instructions is not recommended.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/4/Picture/11 description: The image shows the name "Kenneth J. Cavanaugh-S" in a bold, sans-serif font. The letters "J" and "." are partially obscured by a faded, geometric design, possibly a logo or watermark. The name is written in black against a white background, creating a high contrast.
Boston Scientific Corporation
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