EQUALIZER OCCLUSION BALLOON CATHETER by BOSTON SCIENTIFIC CORP.

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.

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.

AI/ML Overview

The provided K140273 510(k) Summary describes a medical device, the Equalizer™ Occlusion Balloon Catheter, and its performance evaluation. However, it does not involve an AI/ML device, and therefore several of the requested categories are not applicable. The study primarily relies on bench testing and biocompatibility testing rather than clinical performance data related to diagnostic accuracy or AI model performance.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility
Cytotoxicity	Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce cell toxicity.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Sensitization	Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce sensitization.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Intracutaneous Reactivity	Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce intracutaneous reactivity.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Acute Systemic Toxicity	Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce acute systemic toxicity.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Materials Mediated Pyrogenicity	Not explicitly stated but implied to meet ISO 10993 standards for medical devices to not induce pyrogenicity.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Hemocompatibility (Direct Hemolysis, PTT, Complement Activation, In Vitro Hemocompatibility)	Not explicitly stated but implied to meet ISO 10993 standards for medical devices for blood-contacting applications.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
USP Physicochemical Tests for Plastics	Not explicitly stated but implied to meet USP standards for plastics used in medical devices.	"Biocompatibility testing were performed to support a determination of substantial equivalence." (Implied to meet standards)
Bench Performance
Deflated Balloon Profile	Not explicitly stated but implied to be comparable to or within acceptable limits of the predicate device for proper insertion and navigation.	"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." (Implied to meet criteria)
Proximal Bond Tensile	Not explicitly stated but implied to be sufficient for the intended use and comparable to the predicate device to prevent detachment.	"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." (Implied to meet criteria)
Inflated Balloon O.D.	Not explicitly stated but implied to be within specified dimensions for effective vessel occlusion and comparable to the predicate device.	"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." (Implied to meet criteria)
Balloon Deflation Time	Not explicitly stated but implied to be rapid enough for safe and effective use, comparable to the predicate device.	"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." (Implied to meet criteria)
Multiple Inflation, Challenge	Not explicitly stated but implied to withstand multiple inflations without loss of integrity or function, comparable to the predicate device.	"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." (Implied to meet criteria)
Balloon Burst, Challenge	Not explicitly stated but implied to withstand pressures beyond normal operating conditions without premature burst, comparable to the predicate device.	"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." (Implied to meet criteria)
Sheath Compatibility	Not explicitly stated but implied to be compatible with intended sheaths, allowing for smooth insertion and removal.	"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." (Implied to meet criteria)

Notes on Acceptance Criteria: The document primarily states that testing was performed to "support a determination of substantial equivalence" and provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." Specific quantitative acceptance criteria are not detailed in this summary for each test, but they would typically reference established industry standards (e.g., ISO for biocompatibility) or internal specifications benchmarked against the predicate device (Equalizer™ Occlusion Balloon Catheter K021721).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The study described is bench testing and biocompatibility testing, not a clinical study involving human data. Therefore:

Sample Size for Test Set: Not specified in terms of human subjects or clinical cases. For bench tests, it would refer to the number of devices or components tested. For biocompatibility, it refers to the samples tested in vitro or in animal models (though details are not provided).
Data Provenance: Not applicable as it's not clinical data. The tests were performed in a laboratory setting, likely at the manufacturer's facilities or a contract research organization.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a physical medical device (catheter), and its performance evaluation involves engineering and biocompatibility testing, not interpretation of medical images or diagnostic outputs for which ground truth would be established by medical experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies or studies involving human readers/interpreters to resolve discrepancies in ground truth, which is not relevant for bench and biocompatibility testing of a physical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML device and no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic AI/ML devices is not directly applicable here. Instead, the "ground truth" for this device's performance can be considered:

Biocompatibility Standards: Established international standards (e.g., ISO 10993 series) define acceptable biological responses.
Engineering Specifications: Predetermined design specifications and performance requirements (e.g., burst pressure, inflation time, tensile strength) established by the manufacturer and benchmarked against the predicate device.
Predicate Device Performance: The performance characteristics of the legally marketed predicate device (Equalizer™ Occlusion Balloon Catheter K021721) served as the reference for establishing substantial equivalence.

8. The sample size for the training set

Not applicable. There is no AI/ML component; therefore, no training set is relevant.

9. How the ground truth for the training set was established

Not applicable. There is no AI/ML component; therefore, no ground truth for a training set was established.

Summary

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K140273

510(k) Summary

per 21 CFR §807.92

JUL 2 2 2014

Submitter'sName andAddress	Boston Scientific CorporationOne Scimed PlaceMaple Grove, MN 55311
Contact NameandInformation	Diane NelsonRegulatory Affairs SpecialistPhone: 763-255-0813Fax: 763-494-2222e-mail: diane.nelson@bsci.com
	Date Prepared
ProprietaryName	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
PredicateDevice(s)	Equalizer™ Occlusion Balloon Catheter K02172120 June 2002
DeviceDescription	The Equalizer™ Occlusion Balloon Catheter is constructed of a softcompliant latex balloon mounted near the tip of a dual-lumen nylon cathetershaft. Radiopaque markers are placed adjacent to the balloon to providevisual 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 todifferentiate their use. The tubing marked 'BALLOON' is the ballooninflation lumen. The tubing marked 'DISTAL' is the central lumen of thecatheter, which terminates at the distal tip. This lumen is used to pass thecatheter over a guidewire. The lumen can also be used for the infusion ofcontrast media or therapeutic drugs. Each lumen ends in a luer fitting hubfor attachment to ancillary devices.
	Intended Use/Indications forUse of Device
Comparison ofTechnologicalCharacteristics	The Equalizer™ Occlusion Balloon Catheter will incorporate a substantiallyequivalent design, packaging, fundamental technology, manufacturing,sterilization and intended use as those featured in the predicate OcclusionBalloon Catheter.
PerformanceData	Bench testing and biocompatibility testing were performed to support adetermination of substantial equivalence. The results of these tests providereasonable assurance that the proposed device has been designed andtested to assure conformance to the requirements for its intended use. Nonew safety or performance issues were raised during the testing and,therefore, these devices may be considered substantially equivalent to thepredicate devices.
	The following biocompatibility and bench testing were completed on theEqualizer Occlusion Balloon Catheter:
	BiocompatibilityCytotoxicitySensitizationIntracutaneous ReactivityAcute Systemic ToxicityMaterials Mediated PyrogenicityHemocompatibility: Direct Hemolysis, Partial Thromboplastin Time (PTT),Complement Activation, In Vitro HemocompatibilityUSP Physicochemical Tests for Plastics
	The following in-vitro performance tests were completed on the EqualizerOcclusion Balloon Catheter:
	BenchDeflated Balloon ProfileProximal Bond TensileInflated Balloon O.D.Balloon Deflation TimeMultiple Inflation, ChallengeBalloon Burst, ChallengeSheath Compatibility
Conclusion	Based on the Indications for Use, technological characteristics, safety andperformance testing, the Equalizer™ Occlusion Balloon Catheter has beenshown to be appropriate for its intended use and is considered to besubstantially equivalent to the Equalizer™ Occlusion Balloon Catheter(K021721 cleared 20 June 2002).

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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

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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

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Indications for Use

510(k) Number (if known): K140273

Device Name: Equalizer™ Occlusion Balloon Catheter

Indications for Use:

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)

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Boston Scientific Corporation

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Regulation Number and Section

§ 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).