The Stryker Neurovascular TransForm™ Occlusion Balloon Catheters (Compliant and Super Compliant) are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.

Device Description

Stryker Neurovascular's TransForm Occlusion Balloon Catheters (Compliant and Super Compliant) are compliant, variable stiffness reinforced balloon catheters. The outer surface of the catheter's distal segment is coated with a lubricious hydrophilic coating designed to reduce friction. Each balloon catheter has two radiopaque markers to facilitate fluoroscopic visualization. The proximal end of the balloon catheter incorporates a strain relief and a standard luer fitting to facilitate the attachment of accessories.

AI/ML Overview

Here's an analysis of the provided 510(k) summary for the TransForm™ Occlusion Balloon Catheter, detailing acceptance criteria and proof of their fulfillment.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, shelf life, packaging, and biocompatibility). The "acceptance criteria" for this type of submission are typically that the new device meets the performance requirements for its intended use and is proven safe and effective for that use, typically demonstrated by showing it performs comparably or better than the predicate for relevant attributes.

Since specific numerical acceptance criteria (e.g., "Deflation time must be < X seconds") are not explicitly stated as pass/fail thresholds in the summary, the table below will list the types of performance characteristics assessed and imply the acceptance was demonstrated by achieving satisfactory results for these tests, thereby showing equivalency and fitness for purpose.

Acceptance Criterion (Implicit)	Reported Device Performance (as demonstrated by testing)
Functional Performance:
Tip Flexibility	Tested (Method: Rotational Cantilever Stiffness Test Method) - Satisfactory results implied, demonstrating comparable flexibility to predicate device.
Stiffness	Tested (Method: Rotational Cantilever Stiffness Test Method) - Satisfactory results implied, demonstrating comparable stiffness to predicate device.
Balloon Compliance	Measured and confirmed (Compliance of Compliant & Super Compliant Balloons and Balloon Nominal Diameter test) - Demonstrated appropriate compliance for intended use.
Max Inflation Volume/Burst Mode	Measured (Maximum Inflated Volume / Burst Mode test) - Demonstrated safe and effective inflation volumes and burst characteristics.
Balloon Fatigue	Performed (Balloon Fatigue test) - Demonstrated durability over multiple inflation/deflation cycles.
Deflation Time	Measured (Deflation Time test) - Demonstrated acceptable deflation time for clinical use.
Friction Force	Measured as "Occlusion Balloon Wire Movement" (friction force produced as guidewire tracks) - Demonstrated acceptable frictional properties for guidewire compatibility.
Surface Defects	Inspected per visual standards (Occlusion Balloon Catheter Visual Standard, Polyimide Hybrid Catheter Shaft Visual Standard) - Confirmed absence of critical surface defects.
Kink Radius of Curvature	Tested - Satisfactory results implied, demonstrating resistance to kinking during typical use.
Tensile Strength	Tested - Satisfactory results implied, demonstrating mechanical integrity.
Balloon Shape Retention	Performed (Balloon Shape Retention test) - Demonstrated the balloon maintains its shape post-inflation/deflation.
Particulate	Tested - Satisfactory results implied, ensuring cleanliness and patient safety.
Corrosion Resistance	Tested - Satisfactory results implied, ensuring material compatibility within the body.
Chemical Compatibility	Performed (Chemical Pre-Conditioning Procedure), followed by chemical compatibility tests - Demonstrated material integrity with recommended liquid chemicals.
Guide Catheter Compatibility	Measured as "Balloon Deflation Profile (Peak Pullback Force)" through a 5F (0.053") ID guide catheter - Demonstrated compatibility and ease of withdrawal after cycling.
Sterility & Packaging Integrity:
Shelf Life (Product and Packaging)	Tested - Demonstrated stability and sterility maintenance over time.
Distribution / Shipping Challenge Conditioning and Testing	Performed - Demonstrated ability of packaging to withstand shipping hazards.
Packaging Verification (Sterile Barrier Integrity)	Performed (complies with EN ISO 11607-1 and -2) - Demonstrated packaging maintains sterility.
Biocompatibility:
Biocompatibility	Performed (in accordance with EN ISO 10993-1) - Demonstrated materials are biocompatible for patient contact.

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

Sample Size for Test Set: The document does not specify the exact sample sizes (N) for each individual test (e.g., how many catheters were tested for balloon fatigue, how many were submitted for biocompatibility). It only lists the types of tests performed.
Data Provenance: All tests described are non-clinical bench and lab tests, as well as packaging and shelf life testing. This data is generated in a controlled laboratory environment, not from human or animal subjects. Therefore, concerns about country of origin, retrospective/prospective studies, and ground truth establishment from patient data are not applicable to the non-clinical testing described.

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

This question is not applicable to this 510(k) summary. The "ground truth" for non-clinical performance testing is established by engineering specifications, validated test methods (e.g., EN ISO standards), and internal performance requirements, not by expert consensus on clinical data. The tests measure objective physical and chemical properties of the device.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data or images. For non-clinical bench testing, results are typically objective measurements with defined pass/fail criteria.

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:

This is not applicable. The TransForm™ Occlusion Balloon Catheter is a medical device (a physical catheter), not an AI/software as a medical device (SaMD) that assists human readers in interpreting medical images. Therefore, an MRMC study related to AI assistance is irrelevant to this submission.

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

This is not applicable for the same reason as point 5. This is a physical medical device, not an algorithm.

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

The "ground truth" for this submission's non-clinical testing is based on:

Established engineering specifications and design requirements: These define the target performance characteristics of the device.
Industry standards (e.g., EN ISO 10555-1, EN ISO 10555-4, EN ISO 11607-1 and -2, EN ISO 10993-1): These provide standardized test methods and accepted performance benchmarks for medical devices.
Comparison to the predicate device: The predicate device's established performance serves as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set:

This is not applicable. This is a physical medical device, not an AI/machine learning model that requires a "training set."

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

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

Summary

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(K122576) 510(k) Summary Section 5 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Summary Date:	11 January 2013JAN 1 1 2013
Submitter Name andAddress:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA. 94538
Contact:	Jim LeathleyRegulatory Affairs ManagerPhone: 510 413-2663Fax: 510 413-2558Email: jim.leathley@stryker.com
Trade Name:	TransForm™ Occlusion Balloon Catheter(Compliant and Super Compliant)
Common Name:	Intravascular Occluding Catheter, Temporary
Classification Name:	Vascular Clamp (21 CFR 870.4450, Product Code: MJN)
Legally MarketedPredicate Devices:	HyperGlide™ and HyperForm™ Occlusion Balloon Systems(K101570), cleared 13 July 2010
Device Description:	Stryker Neurovascular's TransForm Occlusion BalloonCatheters (Compliant and Super Compliant) are compliant,variable stiffness reinforced balloon catheters. The outer surfaceof the catheter's distal segment is coated with a lubricioushydrophilic coating designed to reduce friction. Each ballooncatheter has two radiopaque markers to facilitate fluoroscopicvisualization. The proximal end of the balloon catheterincorporates a strain relief and a standard luer fitting to facilitatethe attachment of accessories.

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510(k) Summary Of Safety And Effectiveness (cont.)

Indications for Use / Intended Use:

Accessories:

There are no accessories to the TransForm™ Occlusion Balloon Catheters.

Comparison to Predicate Device:

Intended Use / Indications for Use

Intended Use / Indications for Use are the same as for the predicate device.

Design and Materials

TransForm™ Occlusion Balloon Catheters and predicate ev3 HyperGlide™ and HyperForm™ Occlusion Balloon Systems are similar in design as follows:

. both devices comprise a single lumen catheter with a non-detachable, open-ended balloon attached at the distal end
both devices are designed to track over a guidewire .
. for both devices, inflation of the balloon is accomplished by inserting a guidewire into the distal seal (tip)
. both devices utilize two platinum radiopaque markers to facilitate radiographic visualization
both catheters utilize a hydrophilic coating to assist in catheter . advancement
. both devices are supplied as sterile, single-use devices
. both devices use similar materials (i.e., polymers and metals)

The table on the following page compares the TransForm Occlusion Balloon Catheters to the predicate devices.

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510(k) Summary Of Safety And Effectiveness (con

Comparison to Predicate Devices

Point of Comparison	Predicate ev3 HyperGlide™ andHyperForm™ Occlusion Balloon Systems(K101570)	TransForm™ Occlusion Balloon Catheters(Subject device)
Intended Use	For use in the blood vessels of the peripheral and neurovasculaturewhere temporary occlusion is desired. These catheters offer avessel selective technique of temporary vascular occlusion which isuseful in selectively stopping or controlling blood flow and forballoon assisted embolization of intracranial aneurysms.	The Stryker Neurovascular TransForm Occlusion BalloonCatheters are indicated for use in the neuro and peripheralvasculature to temporarily stop or control blood flow andfor balloon assisted embolization of intracranialaneurysms.
Lumen Configuration	Single lumen	Single lumen
Effective Length	150 cm	150 cm
Inner Diameter	0.010 inch	0.014 inch
Distal OD/ Prox OD	Distal: 2.2, 2.5 and 3.0 FProximal: 2.8 F	Distal: 2.8 FProximal: 2.8 F
Distal Tip Length	2 mm / 4mm	3.25 mm
Point of Comparison
	Predicate ev3 HyperGlide™ andHyperForm™ Occlusion Balloon Systems(K101570)	TransForm™ Occlusion Balloon Catheters(Subject device)
Balloon Diameter / Length	Diameter: 3, 4, 5, 7 mmLength: 7, 10, 15, 20, 30 mm	Diameter: 3, 4, 5, 7 mmLength: 5, 7, 10, 15, 20, 30 mm
Materials	Polymers and metals	Polymers and metals
Radiopaque Markers	2 ea.	2 ea.
Coating	Hydrophilic	Hydrophilic
Guidewire Compatibility	0.010 inch	0.014 inch
How supplied	Sterile, single-use	Sterile, single-use

Page 5-3

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510(k) Summary Of Safety And Effectiveness (cont

Comparison to Predicate Devices (cont.

Page 5-4

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510(k) Summary Of Safety And Effectiveness (cont.)

Testing and Non-Clinical Performance Data:

Design verification of the TransForm™ Occlusion Balloon Catheters consisted of:

· Functional Testing (bench) to assess:

Tip Flexibility
Stiffness
Balloon Compliance
Max Inflation Volume/Burst Mode
Balloon Fatigue
Deflation Time
Friction Force
Surface Defects

Kink Radius of Curvature Tensile Strength Balloon Shape Retention Particulate Corrosion Resistance Chemical Compatibility Guide Catheter Compatibility

Testing was conducted in accordance with EN ISO 10555-1 and EN ISO 10555-4

· Shelf Life Testing (Product and Packaging)
· Distribution / Shipping Challenge Conditioning and Testing

· Packaging Verification Testing

Assessing the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics

Assessing the ability of packaging to protect the device and to maintain sterility (sterile barrier testing).

Packaging complies with EN ISO 11607-1 and -2.

· Biocompability Testing

Conducted in accordance with EN ISO 10993-1.

Those tests developed specifically for the TransForm Occlusion Catheter are listed in the table on the following page.

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510(k) Summary Of Safety And Effectiveness (cont

Fests Developed for the TransForm™ Occlusion Balloon Cathete

Title	Purpose
Rotational Cantilever Stiffness Test Method	To describe the method of testing the flexibility of NEMO and predicate catheter shafts by means of a cantilever bending test.
Compliance of Compliant & Super CompliantBalloons and Balloon Nominal Diameter	To measure balloon compliance and balloon nominal diameter on NEMO occlusion balloon catheter.
Maximum Inflated Volume / Burst Mode	To measure maximum inflated volume and document the burst mode for NEMO occlusion balloon catheter.
Balloon Fatigue	To perform balloon fatigue (multiple inflation/deflation cycles) testing of NEMO occlusion balloon catheter.
Deflation Time	To measure deflation time on NEMO occlusion balloon catheter when balloon is deflated from its maximum volume using recommended contrast/saline solution.
Occlusion Balloon Catheter Visual Standard	To provide definition of visual defects specified in the Occlusion Balloon Catheter Finished Good drawings.
Polyimide Hybrid Catheter Shaft VisualStandard	To provide definition of visual defects specified in the Taper, PI Hybrid Shaft Sub Assy drawings.
Balloon Shape Retention	To perform balloon shape retention test on NEMO occlusion balloon catheter.
Chemical Pre-Conditioning Procedure	To pre-condition NEMO test units with recommended liquid chemicals prior to conducting chemical compatibility tests as detailed in NEMO occlusion balloon catheters product specification document, 90635788.
Occlusion Balloon Wire Movement	To measure the friction force produced as the guidewire tracks through the distal tip seal of the balloon catheter.
Balloon Deflation Profile (Peak PullbackForce)	To measure withdrawal force of the deflated balloon through a 5F (0.053") ID guide catheter after 30 balloon inflation/deflation cycles.
Product Removal From Hoop	This STM tests to determine if the NEMO Occlusion Balloon Catheter is sufficiently protected by the dispenser hoop during transit and that it will not be kinked or damaged during removal from the hoop.

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Conclusion:

Based on the comparision information for the indications for use, the technical comparison table above, and the verification/validation testing, the TransForm™ Occlusion Balloon Catheter (Compliant and Super Compliant) was shown to be substantially equivalent to the predicate devices to which equivalence was claimed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, with flowing lines suggesting movement or care.

January 11, 2013

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

Stryker Neurovascular c/o Mr. James Leathley Regulatory Affairs Manager 47900 Bayside Parkway Fremont, California 94538

Re: K122576

Transform Occlusion Balloon Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (Two) Product Code: MJN (Temporary Intravascular Occluding Catheter) Dated: December 22, 2012 Received: December 27, 2012

Dear Mr. Leathley:

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

Joyce M. Whang

for

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122576

Device Name: _TransForm™ Occlusion Balloon Catheter (Compliant and Super Compliant)

Indications For Use:

The Stryker Neurovascular TransForm Occlusion Balloon Catheters are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.

Prescription Use x (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joyce M. Whang

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K122576

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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).