The Transseptal Cannula is used in conjunction with a transseptal guidewire to puncture the interatival septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.

Device Description

The Transseptal Cannula is a stainless steel device that comes in three lengths equivalent to the body of a transseptal needle, 69.7cm for the 71cm cannula, 87.7cm for the 89cm cannula, and 96.7cm for the 98cm cannula, and two distal curves, Curve0 and Curve1. The size is 18 gauge with an inner diameter of .033" at the tip. The components of the Transseptal Cannula include the transseptal cannula, sterile packaging and labeling. There are six model numbers for the cannula: TSC071, TSC089, TSC171, TSC189, and TSC198. The Transseptal Cannula is sterilized by 100% ethylene oxide cycle and is for single use-only. The Transseptal Cannula is used in a healthcare facility/hospital.

The Transseptal Cannula is used in transseptal procedures to provide structural support to a transseptal guidewire to gain access to the left atrium through the right side of the heart. The device is used by a physician by inserting the device through a transseptal dilator and sheath assembly. The devices are inserted in the femoral vein. The transseptal quidewire is then advanced to the fossa ovalis with the support of the Transseptal Cannula and dilator. This allows physicians to use a transseptal guidewire in difficult cases where there is a particularly tough septum as the Transseptal Cannula provides the extra support needed. The cannula's duration in the body is less than 24 hours.

AI/ML Overview

This FDA 510(k) summary is for a medical device called the "Needle Free Transseptal Cannula." It details the device's characteristics and compares it to a legally marketed predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like a cut-off value for a pull test. Instead, it lists the types of performance tests conducted, implying that the device was deemed acceptable if it passed these tests, meaning it met internal specifications or comparative standards.

Since quantitative acceptance criteria and specific reported numerical performance values are not given, the table below will list the tests performed and indicate that the device "met requirements" or "passed" as implied by the "Conclusion" section stating the device is substantially equivalent based on performance testing.

Acceptance Criteria Category	Reported Device Performance (as implied)
Visual and dimensional inspection	Met requirements (Passed)
Particulate testing (USP<788>, Light Obscuration Method)	Met requirements (Passed)
Mating Joint Pull test (Handle to Hub)	Met requirements (Passed)
Guidewire Restriction Inspection	Met requirements (Passed)
Strength of Union Cannula Hub and Cannula	Met requirements (Passed)
Needle Point Inspection	Met requirements (Passed)
Hub Female Luer Taper	Met requirements (Passed)
Water Leak Testing	Met requirements (Passed)
Air Leak Testing	Met requirements (Passed)
Packaging Testing	Met requirements (Passed)
Biocompatibility (ISO 10993-5 Cytotoxicity)	Met requirements (Passed)
Biocompatibility (ISO 10993-10 Sensitization)	Met requirements (Passed)
Biocompatibility (ISO 10993-10 Irritation/Intracutaneous Reactivity)	Met requirements (Passed)
Biocompatibility (ISO 10993-11 Acute Systemic Toxicity)	Met requirements (Passed)
Biocompatibility (ISO 10993-11 Pyrogenicity)	Met requirements (Passed)
Biocompatibility (ISO 10993-3 Genotoxicity)	Met requirements (Passed)
Biocompatibility (ISO 10993-4 Hemocompatibility – ASTM Hemolysis)	Met requirements (Passed)
Biocompatibility (ISO 10993-4 Hemocompatibility Complement Activation)	Met requirements (Passed)

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

The document does not provide details on the sample size used for specific performance tests (e.g., number of units tested for pull strength, a specific number of animals or human subjects for biocompatibility). The provenance of the data is not explicitly stated in terms of country of origin, but all tests were conducted according to recognized international standards (e.g., USP <788>, ISO 10993 series). The nature of the tests indicates that these are laboratory/bench tests rather than clinical studies with human patient data; therefore, the terms "retrospective or prospective" do not directly apply in the usual sense.

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

This section is not applicable (N/A) as the device is a mechanical instrument and the tests described are primarily material, mechanical, and biocompatibility evaluations, not diagnostic image or data interpretation that typically requires expert "ground truth" establishment.

4. Adjudication Method for the Test Set

This section is not applicable (N/A) for the same reasons as point 3. Adjudication methods (like 2+1 or 3+1) are typically used for disagreements in human expert assessments of data, which is not relevant here.

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 section is not applicable (N/A). The device is a physical medical instrument (a cannula), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or AI-related effectiveness is irrelevant.

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

This section is not applicable (N/A) as the device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be defined by the specifications and standards that the device had to meet (e.g., a certain pull strength, absence of particulates beyond a threshold, non-toxicity). For biocompatibility, the ground truth is established by the normative criteria outlined in the ISO 10993 standards. It is based on objective measurements and established scientific/engineering criteria rather than expert consensus on complex data or patient outcomes.

8. The Sample Size for the Training Set

This section is not applicable (N/A). As a physical medical device, there is no "training set" in the context of machine learning. The device design and manufacturing processes are validated through design verification and validation testing, not through data training.

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

This section is not applicable (N/A) for the same reasons as point 8.

Summary

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February 16, 2018

Pressure Products Medical Device Manufacturing LLC Andrew Armour Managing Director 1 School Street Morton, Pennsylvania 19070

Re: K172934

Trade/Device Name: Needle Free Transseptal Cannula Regulation Number: 21 CFR 870.1390 Regulation Name: Trocar Regulatory Class: Class II Product Code: DRC Dated: January 16, 2018 Received: January 17, 2018

Dear Mr. Armour:

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 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);

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Page 2 - Andrew Armour

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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,

Nicole G. Ibrahim -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) K172934

Device Name Needle Free Transseptal Cannula

Indications for Use (Describe)

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

Submitter

Pressure Products Medical Device Manufacturing LLC. 1 School Street Morton, PA 19070 Phone: 610-285-9858 Fax: 610-285-9859

Contact Person: Andrew Armour Prepared: February 14, 2018

Identification of the Device

Proprietary-Trade Name: Needle Free™ Transseptal Cannula Device Class: Class II Classification Name: Trocar (CFR 870.1390) Common/Usual Name: Transseptal Cannula Product Code: DRC

Equivalent Legally Marketed Devices

St. Jude Medical, BRK Transseptal Needle, K122587

Description of the Devices

Indications for Use

The Transseptal Cannula is used in conjunction with a transseptal quidewire to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access. The Transseptal Cannula is intended for single use only.

The BRK Transseptal Needle is used to puncture the interatrial septum during a transseptal catheterization procedure to gain left heart access.

Both the Transseptal Cannula and the transseptal needle are used in transseptal catheterization procedures to gain left heart access. The difference between the two indications for use is that the Transseptal Cannula is used with a transseptal guidewire to puncture the septum, while the

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transseptal needle has a needle point and it is used on its own to puncture the septum. Because the two devices are made of stainless steel, the Transseptal Cannula, when used in conjunction with a transseptal guidewire, mimics the same structural support as a procedure with the transseptal needle. Because of these similarities, the BRK transseptal needle is the predicate device for the Transseptal Cannula.

Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of this device are similar to the predicate device. The difference between the two indications for use is that the Transseptal Cannula is used with a transseptal guidewire to puncture the septum, while the transseptal needle point and it is used on its own to puncture the septum. The subject and predicate device are based on the follow technological elements:

Stainless steel that provides structural support in the transseptal procedure ●
Smooth inner diameter so devices can pass through the body of the devices smoothly .
Devices are inserted through the transseptal dilator and sheath assembly so that it can . be used in the transseptal procedure
. Devices come in 71, 89, and 98cm lengths (actual lengths: 69.7cm, 87.7cm, and 96.7cm)
Devices come in two curves. Curve0 and Curve1 ●
Devices assembled through the transseptal introducer system match curve shapes .
. Cannula used with transseptal guidewire in the introducer assembly feels equivalent to the transseptal needle with the introducer assembly

The following are technological modifications to the predicate device:

Needle point on predicate device to create the primary puncture of the fossa while ● Transseptal Cannula is used with a transseptal guidewire to create the primary puncture of the fossa
The tip of the cannula is a blunt radius edge so it is stopped in the transseptal dilator . while transseptal needle has a needle point
. Hub is clear instead of metal so that it is lighter and allows visualization of the introduction of devices
. Transseptal Cannula is a non-skiving device when inserted into the transseptal dilator

Performance Testing

The following performance data were provided in support of the substantial equivalence to the predicate:

Visual and dimensional inspection ●
Particulate testing (USP<788>, Light Obscuration Method) ●
Mating Joint Pull test (Handle to Hub) ●
Guidewire Restriction Inspection
Strength of Union Cannula Hub and Cannula ●
Needle Point Inspection ●
Hub Female Luer Taper ●
Water Leak Testing
Air Leak Testing ●
Packaging Testing ●

Biocompatibility Data

The biocompatibility evaluation for the Transseptal Cannula was conducted in accordance with FDA 510/k) Memorandum- #G95-1 "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," June 16, 2016, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by the FDA. The following tests were performed:

ISO 10993-5 Cytotoxicity

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ISO 10993-10 Sensitization .
ISO 10993-10 Irritation/Intracutaneous Reactivity ●
ISO 10993-11 Acute Systemic Toxicity ●
ISO 10993-11 Pyrogenicity .
ISO 10993-3 Genotoxicity .
. ISO 10993-4 Hemocompatibility – ASTM Hemolysis Complete
ISO 10993-4 Hemocompatibility Complement Activation Complete with C3a & SC5b-9 .

The Needle Free™ Transseptal Cannula is considered an external communicating device with an indirect blood path, and limited exposure (less than 24 hours). The Transseptal Cannula met the requirements set forth in ISO-10993.

Conclusion

When compared to the predicate device, the Transseptal Cannula is substantially equivalent in design, technological characteristics, materials and performance testing.

Regulation Number and Section

§ 870.1390 Trocar.

(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.