The Scepter XC Occlusion Balloon Catheter is intended for use in the peripheral and neurovasculature where temporary occlusion is desired. The balloon catheter provides temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The balloon catheter also offers balloon assisted embolization of intracranial aneurysms.

Device Description

The Scepter XC Occlusion Batheter is a dual coaxial lumen catheter with a nondetachable low inflation pressure compliant balloon attached to the distal end of the catheter. The catheter is designed to track over a steerable guidewire. Radiopaque marker bands are located at ends of the balloon and distal tip of the catheter to facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the microcatheter hub is used for the attachment of accessories. The catheters are packaged sterile for single use only.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Scepter XC Occlusion Balloon Catheter, seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical trials to establish efficacy and safety from scratch. Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) is not present in this document.

Instead, the submission focuses on non-clinical performance testing to demonstrate that the new device performs comparably to the predicate and meets design specifications.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not applicable or not provided in a 510(k) summary of this nature:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a table of "Pre-clinical Testing" with "Pass" as the result for each test. This indicates that the device met the internal acceptance criteria for these engineering and performance tests, which are typically designed to ensure safety and functionality. However, the specific quantitative acceptance criteria for each test (e.g., "Tensile strength must be > X Newtons") are not explicitly stated in this summary, only the outcome "Pass."

Pre-clinical Testing	Acceptance Criteria (Implicit - met design specs)	Reported Device Performance
Surface and physical attributes	Met internal design specifications	Pass
Tensile strength	Met internal design specifications	Pass
Leakage (liquid and air)	Met internal design specifications	Pass
Static and dynamic burst pressure	Met internal design specifications	Pass
Simulated use	Met internal design specifications	Pass
Compatibility with devices	Met internal design specifications	Pass
Kink resistance	Met internal design specifications	Pass
Catheter flexural fatigue	Met internal design specifications	Pass
Hydrophilic coating	Met internal design specifications	Pass
Hub testing	Met internal design specifications	Pass
Torque testing	Met internal design specifications	Pass
Balloon testing - burst, compliance, deflation time, fatigue	Met internal design specifications	Pass
Biocompatibility testing (ISO 10993-1)	Met ISO 10993-1 standards	Pass

2. Sample Size Used for the Test Set and the Data Provenance:

Test Set Sample Size: Not applicable in the context of clinical performance testing for this 510(k) submission. The "test set" here refers to physical devices undergoing pre-clinical engineering tests. The sample sizes for these specific tests are not provided in this summary.
Data Provenance: The device is submitted by MicroVention, Inc., based in Tustin, California, U.S.A. The pre-clinical testing would have been conducted by or for MicroVention.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

This information is not applicable as this submission focuses on pre-clinical engineering and performance testing, not a clinical study involving expert interpretation of data or images to establish a diagnostic ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reason as point 3. Adjudication methods are relevant for clinical studies where multiple reviewers assess outcomes or diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically conducted for diagnostic imaging devices to compare human reader performance with and without AI assistance, which is outside the scope of this device (an occlusion balloon catheter).
Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable as no MRMC study or AI component is described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

No, this information is not applicable. The Scepter XC Occlusion Balloon Catheter is a physical medical device, not a diagnostic algorithm or AI system. Therefore, "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used:

For the pre-clinical tests, the "ground truth" equates to pre-defined engineering specifications and international standards (e.g., ISO 10993-1 for biocompatibility). The device either met these specifications ("Pass") or it did not. This is not clinical ground truth (like pathology or outcomes data).

8. The Sample Size for the Training Set:

This information is not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not an AI or machine learning system that requires data for training.

9. How the Ground Truth for the Training Set was Established:

This information is not applicable for the same reason as point 8.

In summary:

This 510(k) submission for the Scepter XC Occlusion Balloon Catheter primarily relies on demonstrating substantial equivalence to a predicate device (Scepter C Occlusion Balloon Catheter, K110741) through pre-clinical engineering and performance testing. The "acceptance criteria" were internal design specifications and relevant international standards for medical devices, which the new device "passed." The submission does not involve clinical studies with human participants, expert ground truth establishment, or AI algorithm performance evaluations, which are typically associated with the other questions.

Summary

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510(k) Summary

JAN 1 3 2012

Trade Name:	Scepter XC Occlusion Balloon Catheter
Generic Name:	Occlusion Balloon Catheter
Classification:	Class II, 21 CFR 870.4450
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.
Contact:	Naomi Gong
Date Prepared:	December 15, 2011
Predicate Device:

Number	Description	Clearance Date
K110741	MicroVention Scepter C OcclusionBalloon Catheter	September 29, 2011

Device Description:

Indication For Use:

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Verification and Test Summary:

: .

Pre-clinical Testing	Result
Surface and physical attributes	Pass
Tensile strength	Pass
Leakage (liquid and air)	Pass
Static and dynamic burst pressure	Pass
Simulated use	Pass
Compatibility with devices	Pass
Kink resistance	Pass
Catheter flexural fatigue	Pass
Hydrophilic coating	Pass
Hub testing	Pass
Torque testing	Pass
Balloon testing - burst, compliance, deflation time, fatigue	Pass
Bicompatibility testing (ISO 10993-1)	Pass

Technological Comparison:

	Predicate Device	510(k) Subject Device
Lumen configuration	Dual coaxial lumen	Same
Inner Diameter	0.0165"	Same
Outer Diameter	2.6 - 2.8 F	Same
Balloon Diameter/Length	4 mm/ 10-20 mm	4 mm/10 mm
Material	Polyether block amide, polyolefin,stainless steel, PTFE, polyurethaneelastomeric alloy, Pt/Ir, nylon,polyimide	Same
No. of Markers	3	Same
Coating	Hydrophilic coating	Same
Guidewire compatibility	0.014" or smaller wire	Same
Method of supply	Sterile and single use	Same

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Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the Scepter XC Occlusion Balloon Catheter when compared with the predicate device, Scepter C Occlusion Balloon Catheter (K110741).

The devices,

Have the same intended use, .
Use the same operating principle, .
Incorporate the same basic design, 트
Use similar construction and material,
트 Are sterilized using same methods and processes.

In summary, the Scepter XC Occlusion Balloon Catheter described in this submission is in our opinion, substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird.

-Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room --WO66-G609 Silver Spring, MD 20993-0002

JAN 1 3 2012

MicroVention, Inc. c/o Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780

Re: K113698

Trade/Device Name: Scepter XC Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: December 15, 2011 Received: December 16, 2011

Dear Ms. Gong:

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.

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Page 2 - Ms. Naomi Gong

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 that I DA has made a determinations administered by other Federal agencies. You must of ally I-cuttal statutes and regulations, including, but not limited to: registration and listing (21 Comply with an the Her of required 801); medical device reporting (reporting of medical CFK Fatt 607), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic form in the quality systems (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 If you desire specific advice for your device on our accessor offices/ucm115809.htm for go to into.//www.idd.gov.itRadiological Health's (CDRH's) Office of Compliance. Also, please the Center for Devices and Radioneground by reference to premarket notification (21 CFR Pattigen (1 note the regulation childred. "Misoranans 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 You may other general mionnations one Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

(800) 036-2041 01 (501) 721 (2017) 721 Devices for You/Industry/default.htm.

Sincerely yours,

M. A. Hilliker

Bram D. Zuckerman, M.D. Ser 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): K1136 98

Device Name: Scepter XC Occlusion Balloon Catheter

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. S. Hilleben

(Division Sign-Off) Division of Cardiovascular Devices

K113698 510(k) Number

Page 1 of 1

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).