The Transseptal Introducer is used for introducing various cardiovascular catheters into the left side of the heart through the interatrial septum. The Transseptal Introducer is intended for single use only.

Device Description

The Transseptal Introducer consists of a high-density polvethylene (HDPE) sheath, a dilator with a lubricious hydrophobic coating, and an uncoated introducer quidewire in a dispenser. The transseptal introducer comes in two French sizes, 8F and 8.5F, two lengths, 63cm and 81cm, and two curves, LO (50°) and L1 (40°, 51°). The components of the Transseptal Introducer include the transseptal sheath, transseptal dilator, introducer guidewire with dispenser, sterile packaging and labeling. There are eight model numbers: TSIL0863, TSIL1863, TSIL0881, TSIL1881, TSIL08563, TSIL18563, TSIL08581, and TSIL18581. The Transseptal Introducer is sterilized by 100% ethylene oxide cycle and is for single-use only. The Transseptal Introducer is used in a healthcare facility/hospital.

The Transseptal Introducer is used in transseptal procedures to introduce cardiovascular catheters into the left side of the heart after transseptal access was achieved with a transseptal needle and dilator. The device is used by inserting the device through the femoral vein in conjunction with a transseptal needle. The introducer quidewire is inserted through the femoral vein and guides the needle up to the fossa ovalis in the right atrium. The needle punctures the fossa ovalis and the dilator is used to insert and dilate the fossa further where the needle has punctured. This allows the sheath to cross and creates access to the left side of the heart. The introducer's duration in the body is less than 24 hours.

AI/ML Overview

Based on the provided text, the document describes a 510(k) premarket notification for a medical device (TSI Transseptal Introducer), which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo clinical effectiveness. Therefore, the information typically associated with acceptance criteria and a study proving a novel device's performance (such as an AI algorithm's performance) is not present in this document.

For a 510(k) submission like this, "acceptance criteria" are generally related to engineering and performance verification tests to show the device functions as intended and is equivalent to the predicate, not clinical accuracy or diagnostic performance in the way an AI often requires. The "study" here is primarily a series of bench and biocompatibility tests, not a clinical study involving human patients or ground truth established by experts for diagnostic purposes.

Here's a breakdown of why many of your requested points cannot be answered from this document, and what is provided instead:

Information NOT Applicable/Present for this Type of Device Submission:

Acceptance Criteria Table (Diagnostic Performance): This device is a catheter introducer, not a diagnostic tool or AI. Its "performance" is demonstrated through engineering and biocompatibility tests, not diagnostic metrics like sensitivity/specificity.
Sample size for the test set (Diagnostic): No diagnostic test set is mentioned. The sample sizes would apply to the quantities of devices tested in bench studies.
Data provenance (Diagnostic): Not applicable for bench tests.
Number of experts and qualifications (Diagnostic Ground Truth): Not applicable as there's no diagnostic ground truth to establish.
Adjudication method (Diagnostic): Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: This is typically for evaluating diagnostic tools where human readers interpret data, often with AI assistance. It's not relevant for a transseptal introducer.
Effect size of human reader improvement with AI assistance: Not applicable as there is no AI component.
Standalone (algorithm only) performance: Not applicable as there is no algorithm.
Type of ground truth (expert consensus, pathology, outcomes data): Not applicable, as the "ground truth" for a device like this is its physical properties meeting specifications and biocompatibility.
Sample size for the training set: There is no AI model or training set.
How the ground truth for the training set was established: Not applicable.

What the Document Does Provide (Related to "Acceptance Criteria" for a Device Submission of this Type):

The "acceptance criteria" for a 510(k) of a traditional medical device are met by demonstrating substantial equivalence to a predicate device through:

Direct Comparison of Characteristics: Showing the subject device has similar design, materials, and intended use as the predicate.
Performance Testing: Bench tests to confirm the device functions as expected and safely.
Biocompatibility Testing: Demonstrating the materials are safe for human contact.

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

As mentioned, a formal table of diagnostic acceptance criteria with specific performance metrics (like sensitivity, specificity, AUC) is not provided because this is a physical medical device, not a diagnostic algorithm.

Instead, the document lists "Performance Testing" and "Biocompatibility Data" as the studies performed to support substantial equivalence. The acceptance criterion for these tests is implicitly that the device performs equivalently or within acceptable limits to ensure safety and effectiveness, similar to the predicate.

Reported Device Performance (as stated in the document):
"The results of the testing demonstrated the subject device performed equivalently to the predicate device."
"The Transseptal Introducer met the requirements set forth in ISO-10993."

Summary of "Performance Tests" (acting as the "study" for this type of device):

Acceptance Criteria Category / Test Type	Specific Tests Conducted	Reported Device Performance (General Statement)
Physical/Mechanical Performance	- Visual and dimensional inspection- Particulate testing (USP <788>, Light Obscuration Method)- Liquid leakage from sheath introducers under pressure- Air pressure leak test- Sideport-stopcock-hub tug test- Sheath joint pull tests- Guidewire restriction- Curve template inspection- Dilator flexibility testing- Corrosion resistance- Guidewire tensile strength- Fracture and flex testing- Curve integrity testing- Packaging testing- In vitro simulated use- Surface morphology assessment	The results of the testing demonstrated the subject device performed equivalently to the predicate device.
Sterilization Validation	- Validated in accordance with ANSI/AAMI/ISO 11135-1 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices).	Sterilized to a SAL of 10^-6^.
Biocompatibility	- ISO 10993-5 Cytotoxicity- 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- ASTM F2382-17 Partial Thromboplastin Time (PTT) testing- Platelet/Leukocyte Count (Guideline: ASTM F2888-13)	The Transseptal Introducer met the requirements set forth in ISO-10993. (Considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours)).

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

Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for engineering validation. (e.g., "The results of the testing demonstrated...") This is typical for bench testing where the focus is on meeting specifications rather than generalizability to a patient population.
Data Provenance: Not applicable. These are laboratory-based engineering and biological tests, not patient data from specific countries.

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. There is no ground truth established by medical experts in the context of diagnostic accuracy for this device. The "ground truth" is that the device physically meets its engineering specifications and is biocompatible.

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

Not applicable. Adjudication methods are relevant for subjective interpretations, typically in diagnostic studies. Bench tests follow objective 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

No, this type of study was not done. It is not relevant for a catheter introducer.

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

Not applicable, as this is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is adherence to established engineering specifications, safety standards, and biocompatibility requirements (e.g., ISO 10993 standards) which are objectively measured.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI model.

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

Not applicable.

Summary

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October 26, 2018

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

Re: K181031

Trade/Device Name: TSI Transseptal Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 13, 2018 Received: April 18, 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. 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.

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

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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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K181031

Device Name TSI Transseptal Introducer

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Page 6.1

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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: October 24, 2018

Identification of the Device

Proprietary-Trade Name: TSI Transseptal Introducer Device Class: Class II Classification Name: Catheter Introducer (CFR 870.1340) Common/Usual Name: Transseptal Introducer Product Code: DYB

Equivalent Legally Marketed Devices

Daig Corp. (St. Jude Medical, now Abbott), Fast-Cath Transseptal Guiding Introducer, K964518

Reference Devices

Oscor Inc., Adelante-S Lite (SafeSheath Ultra Lite), K122084 Oscor Inc., Adelante-SII (SafeSheath II), K122084

Description of the Devices

Indications for Use

The Indications for Use statement for the Transseptal Introducer device is identical to the predicate device. Both devices have the same intended use and are used for the introduction of catheters into the heart. The devices are used in conjunction with a transseptal needle. Both

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devices are used to create a port to the left side of the heart from the right side so that cardiovascular catheters can be introduced.

Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of this device are similar to the predicate device. The subject and predicate device are based on the follow technological elements:

Similar materials for the introduction of catheters into the heart ●
. Marker band tip used by the physician to locate the sheath across the fossa
Sideholes to allow for fluids to pass through at a sufficient rate ●
Device used in conjunction with other transseptal devices such as a transseptal needle or ● quidewire
Introducer quidewire used to quide the introducer into the right atrium
Needle extends past the transseptal dilator to puncture the fossa
. Dilator tip used to dilate fossa ovalis up to the sheath inner diameter
Dilator shaft to sheath tip transition allows the sheath to pass through the fossa after ● dilator insertion

Performance Testing

The following performance tests were performed in support of the substantial equivalence to the predicate:

. Visual and dimensional inspection
Particulate testing (USP <788>, Light Obscuration Method) ●
Liquid leakage from sheath introducers under pressure ●
Air pressure leak test
Sideport-stopcock-hub tug test ●
Sheath joint pull tests ●
. Guidewire restriction
Curve template inspection
. Dilator flexibility testing
Corrosion resistance ●
Guidewire tensile strength ●
Fracture and flex testing
Curve integrity testing
Packaging testing ●
. In vitro simulated use
. Surface morphology assessment

In addition, the sterilization conditions have been validated in accordance with ANSI/AAMI//SO 11135- 1, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of sterilization process for medical devices. The device is sterilized to a SAL of 106. The results of the testing demonstrated the subject device performed equivalently to the predicate device.

Biocompatibility Data

The biocompatibility evaluation for the Transseptal Introducer 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- "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 ●
ISO 10993-10 Sensitization ●
ISO 10993-10 Irritation/Intracutaneous Reactivity ●
. ISO 10993-11 Acute Systemic Toxicity

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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
ASTM F2382-17 Partial Thromboplastin Time (PTT) testing .
. Platelet/Leukocyte Count (Guideline: ASTM F2888-13)

The Transseptal Introducer is considered an external communicating device with circulating blood contact and limited exposure (less than 24 hours). The Transseptal Introducer met the requirements set forth in ISO-10993.

Conclusion

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

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).