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.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Park Blade Septostomy Catheter. It outlines the device description, indications for use, comparison to a predicate device, and test data conducted to demonstrate substantial equivalence.

However, this submission is for a traditional medical device (catheter) and does not involve Artificial Intelligence (AI) or machine learning (ML). Therefore, many of the requested categories related to AI/ML device performance, ground truth, expert review, training sets, and MRMC studies are not applicable.

Below, I will answer the relevant questions based on the provided text, and explicitly state "Not Applicable" for questions related to AI/ML.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This submission is for a medical catheter (Park Blade Septostomy Catheter), which is a physical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the "acceptance criteria" discussed are related to the physical and material properties of the catheter, and the "study" refers to the engineering and biocompatibility tests conducted on the device.

1. A table of acceptance criteria and the reported device performance

The document states that pre-determined acceptance criteria were met for all tests. However, the specific quantitative acceptance criteria for each test are not detailed in this summary. The summary only reports the outcome that the criteria were satisfied.

Test Performed	Reported Device Performance
Biocompatibility Testing	The pre-determined acceptance criteria were met.
Radiopacity Testing	The pre-determined acceptance criteria were met.
Tensile Testing	The pre-determined acceptance criteria were met.
Corrosion Testing	Revealed no signs of corrosion that would affect functional performance. The pre-determined acceptance criteria were met.
Dimensional and Blade Activation Verification	The pre-determined acceptance criteria were met.

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

The document does not specify the sample sizes used for each of the physical and material tests (Biocompatibility, Radiopacity, Tensile, Corrosion, Dimensional, and Blade Activation Verification). It also does not mention data provenance in terms of country of origin or retrospective/prospective nature, as these tests are typically conducted in a laboratory setting.

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 is a physical device; "ground truth" and "experts" in the context of diagnostic interpretation are not relevant here. The tests are based on engineering standards and measurements.

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

Not Applicable. This concept is relevant for interpreting ambiguous results, usually in diagnostic imaging or clinical trials with subjective endpoints. The tests performed are objective physical and material property evaluations.

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 a physical medical device, not an AI-assisted diagnostic tool.

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

Not Applicable. This is a physical medical device, not an AI algorithm.

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

The "ground truth" for these types of tests are the specifications and requirements defined by the relevant ISO, ASTM, and BS EN standards (e.g., ISO 10993-1:2009 for biocompatibility, ASTM F640-12 and BS EN ISO 10555-1 for radiopacity, BS EN ISO 10555-1 for tensile and corrosion, and design input specifications for dimensional/blade activation). These are established engineering benchmarks.

8. The sample size for the training set

Not Applicable. This is a physical device; there is no "training set" in the context of machine learning.

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

Not Applicable. This is a physical device; there is no "training set" or "ground truth" establishment in the context of machine learning.

Summary

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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)

K182399

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, SeptostomyDXF (21 CFR §870.5175)
Product classification:	Class II
Review Panel:	Cardiovascular

Indications for Use:

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

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predicate device. The safety and effectiveness of the subject device modifications are supported by performance and biocompatibility testing.

Device Description:

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.

Regulation Number and Section

§ 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).