(141 days)
Not Found
No
The summary describes a physical medical device (balloon catheter) and its performance testing, with no mention of AI or ML capabilities.
Yes
The device is used to temporarily stop or control blood flow and for balloon-assisted embolization of intracranial aneurysms, which are therapeutic interventions aimed at treating a medical condition.
No
The device is described as an "Occlusion Balloon Catheter" used to "temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms." Its function is therapeutic (to block blood flow or assist in embolization) rather than diagnostic (to identify or characterize a disease).
No
The device description clearly details a physical catheter with a balloon, radiopaque markers, and a luer fitting. The performance studies also focus on physical characteristics and material properties, not software functionality.
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, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Stryker Neurovascular TransForm™ Occlusion Balloon Catheters are used inside the body (in the neuro and peripheral vasculature) to physically manipulate blood flow and assist in embolization. They are a surgical/interventional device, not a diagnostic one.
- Intended Use: The intended use clearly describes a therapeutic intervention (temporarily stopping or controlling blood flow, balloon assisted embolization), not a diagnostic test.
- Device Description: The description focuses on the physical characteristics and function of a catheter used within the body.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the device during the procedure, not to analyze a specimen.
Therefore, based on the provided information, this device is a therapeutic medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MJN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro and peripheral vasculature
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)
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.
- Biocompatibility Testing
- Conducted in accordance with EN ISO 10993-1.
Specific tests developed for the TransForm™ Occlusion Balloon Catheter:
- 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 Compliant Balloons 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 Visual Standard: 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 Pullback Force): 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
(K122576) 510(k) Summary Section 5 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| Summary Date: | 11 January 2013
JAN 1 1 2013 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Name and
Address: | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA. 94538 |
| Contact: | Jim Leathley
Regulatory Affairs Manager
Phone: 510 413-2663
Fax: 510 413-2558
Email: 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 Marketed
Predicate Devices: | HyperGlide™ and HyperForm™ Occlusion Balloon Systems
(K101570), cleared 13 July 2010 |
| 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. |
:
·
:
.
1
510(k) Summary Of Safety And Effectiveness (cont.)
Indications for Use / Intended Use:
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.
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.
2
510(k) Summary Of Safety And Effectiveness (con
Comparison to Predicate Devices
| Point of Comparison | Predicate ev3 HyperGlide™ and
HyperForm™ Occlusion Balloon Systems
(K101570) | TransForm™ Occlusion Balloon Catheters
(Subject device) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use in the blood vessels of the peripheral and neurovasculature
where temporary occlusion is desired. These catheters offer a
vessel selective technique of temporary vascular occlusion which is
useful in selectively stopping or controlling blood flow and for
balloon assisted embolization of intracranial aneurysms. | 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. |
| 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 F
Proximal: 2.8 F | Distal: 2.8 F
Proximal: 2.8 F |
| Distal Tip Length | 2 mm / 4mm | 3.25 mm |
| Point of Comparison | | |
| | Predicate ev3 HyperGlide™ and
HyperForm™ Occlusion Balloon Systems
(K101570) | TransForm™ Occlusion Balloon Catheters
(Subject device) |
| Balloon Diameter / Length | Diameter: 3, 4, 5, 7 mm
Length: 7, 10, 15, 20, 30 mm | Diameter: 3, 4, 5, 7 mm
Length: 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
3
510(k) Summary Of Safety And Effectiveness (cont
Comparison to Predicate Devices (cont.
Page 5-4
4
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.
5
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 Compliant | |
| Balloons 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 Visual | |
| Standard | 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 Pullback | |
| Force) | 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. |
6
t
.
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.
7
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.
8
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
9
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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