(212 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a physical catheter, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as a "Septostomy Catheter" intended to "enlarge interatrial openings" and perform a procedure that can correct a condition where "balloon atrial septostomy is insufficient or unsuccessful." These phrases clearly indicate a medical intervention to treat a medical condition.
No
The device is intended to enlarge interatrial openings and is a catheter used in a surgical procedure, not for diagnosing a condition.
No
The device description clearly details physical components such as a catheter, stainless-steel cannula, blade, pin vise, gasket, and Y sidearm adapter, indicating it is a hardware device. The performance studies also focus on physical properties like biocompatibility, radiopacity, tensile strength, and corrosion.
Based on the provided information, the Park Blade Septostomy Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to enlarge interatrial openings and perform septostomy procedures. This is a surgical/interventional procedure performed directly on the patient's anatomy.
- Device Description: The device is a catheter with a blade designed for mechanical action within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples from the body. This device is used inside the body to perform a physical modification.
N/A
Intended Use / Indications for Use
The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.
Product codes (comma separated list FDA assigned to the subject device)
DXF
Device Description
The Park Blade Septostomy Catheter is a radiopaque polyethylene catheter with a distal tip section made of a stainless-steel cannula and a proximal end section consisting of a pin vise, a gasket, and a Y sidearm adapter. The distal stainless-steel cannula contains a stainless-steel blade that is linked to a lever, which allows the distal end to form a triangle. The Park Blade Septostomy Catheter is manufactured in 5.7 or 7.3 French sizes. The catheter working length measures either 65 or 85 centimeters from the distal tip to the distal end of the shrink tube. The blade lengths for the 5.7 French catheters are either 9.4 or 13.4 millimeters; for the 7.3 French size catheter, the blade measures 20.0 millimeters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
interatrial openings
Indicated Patient Age Range
older infants and children
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)
The following tests were performed to demonstrate that the Park Blade Septostomy Catheter met applicable design and performance requirements and support a determination of substantial equivalence.
- Biocompatibility Testing - Testing was performed in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- Radiopacity Testing - Radiopacity testing was performed in accordance with the qualitative evaluation described in ASTM F640-12 and BS EN ISO 10555-1. The predetermined acceptance criteria were met.
- Tensile Testing - Testing was performed in accordance with BS EN ISO 10555-1. The pre-determined acceptance criteria were met.
- Corrosion Testing - Testing demonstrated, when tested in accordance with BS EN ISO 10555-1, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- Dimensional and Blade Activation Verification - Testing was performed in accordance with design input specifications. The pre-determined acceptance criteria were met.
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
§ 870.5175 Septostomy catheter.
(a)
Identification. A septostomy catheter is a special balloon catheter that is used to create or enlarge the atrial septal defect found in the heart of certain infants.(b)
Classification. Class II (performance standards).
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April 4, 2019
Cook Incorporated Rebecca Odulio Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K182399
Trade/Device Name: Park Blade Septostomy Catheter Regulation Number: 21 CFR 870.5175 Regulation Name: Septostomy Catheter Regulatory Class: Class II Product Code: DXF Dated: October 19, 2018 Received: October 22, 2018
Dear Rebecca Odulio:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Rachel E. Neubrander -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)
Device Name Park Blade Septostomy Catheter
Indications for Use (Describe)
The Park Blade Septostomy Catheter is interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. if the interatial septum is intact, the procedure can be performed in conjunction with a transseptal technique.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary: K182399
Submitted Bv:
Rebecca Odulio (Li-chun Liu) Cook Incorporated 750 Daniels Way Bloomington, IN 47404 Phone: (812) 335-3575 x104673 Fax: (812) 332-0281 Date Prepared: August 31, 2018
Device:
| Trade Name: | Park Blade Septostomy Catheter |
|---|---|
| Common Name: | Septostomy Catheter |
| Classification Name: | Catheter, Septostomy |
| DXF (21 CFR §870.5175) | |
| Product classification: | Class II |
| Review Panel: | Cardiovascular |
Indications for Use:
The Park Blade Septostomy Catheter is intended to enlarge interatrial openings. The device can also be used when balloon atrial septostomy is insufficient or unsuccessful, particularly in older infants and children with a thickened atrial septum. Normally, the existing interatrial opening is used for this procedure. However, if the interatrial septum is intact, the procedure can be performed in conjunction with a transseptal technique.
Predicate Device:
The predicate device, the Blade Septostomy Catheter, was cleared for commercial distribution under 510(k) number K801031, on July 28, 1980.
Comparison to Predicate Device:
It has been demonstrated that the Park Blade Septostomy Catheter is identical to the predicate device (K801031) in terms of intended use, principles of operation, basic technological characteristics, and similar in materials of construction to the predicate device. Additional device dimensions and material changes have been included for the subject device as compared to the
4
predicate device. The safety and effectiveness of the subject device modifications are supported by performance and biocompatibility testing.
Device Description:
The Park Blade Septostomy Catheter is a radiopaque polyethylene catheter with a distal tip section made of a stainless-steel cannula and a proximal end section consisting of a pin vise, a gasket, and a Y sidearm adapter. The distal stainless-steel cannula contains a stainless-steel blade that is linked to a lever, which allows the distal end to form a triangle. The Park Blade Septostomy Catheter is manufactured in 5.7 or 7.3 French sizes. The catheter working length measures either 65 or 85 centimeters from the distal tip to the distal end of the shrink tube. The blade lengths for the 5.7 French catheters are either 9.4 or 13.4 millimeters; for the 7.3 French size catheter, the blade measures 20.0 millimeters.
Test Data:
The following tests were performed to demonstrate that the Park Blade Septostomy Catheter met applicable design and performance requirements and support a determination of substantial equivalence.
- . Biocompatibility Testing - Testing was performed in accordance with ISO 10993-1:2009. The pre-determined acceptance criteria were met.
- Radiopacity Testing Radiopacity testing was performed in accordance with the . qualitative evaluation described in ASTM F640-12 and BS EN ISO 10555-1. The predetermined acceptance criteria were met.
- Tensile Testing Testing was performed in accordance with BS EN ISO 10555-1. The . pre-determined acceptance criteria were met.
- Corrosion Testing Testing demonstrated, when tested in accordance with BS EN ISO . 10555-1, the device revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
- Dimensional and Blade Activation Verification Testing was performed in . accordance with design input specifications. The pre-determined acceptance criteria were met.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.