The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.

Device Description

The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a medical device called the "Thinline Sheath Introducer." This document details the device's characteristics, indications for use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.

Crucially, this document is for a physical medical device (a catheter introducer) and contains no information about an AI/ML-driven device or its acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI/ML device, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance. The performance data presented in the document (Table 6.2) relates to physical and functional tests of the sheath introducer, such as tensile strength, burst pressure, and sterility, not AI algorithm performance.

If you can provide a document that discusses an AI/ML-driven medical device and its validation study, I would be able to answer your questions.

Summary

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September 27, 2023

Inneuroco Inc. Garry Koroshec Staff Design Quality Engineer / Regulatory Affairs 19700 Stirling Road, Suite 1 Pembroke Pines, Florida 33332

Re: K232260

Trade/Device Name: Thinline Sheath Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: July 28, 2023 Received: July 31, 2023

Dear Garry Koroshec:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation reguires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Finn E.
Donaldson -S

Digitally signed by Finn E.
Donaldson -S
Date: 2013.09.27 14:15:45
-04'00'

For Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality

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Enclosure

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Indications for Use

510(k) Number (if known) K232260

Device Name Thinline Sheath Introducer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Summary Prepared	September 27, 2023
Submitter	InNeuroCo Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332
Primary Submission Contact	Garry KoroshecStaff Design Quality Engineer / Regulatory Affairs
	InNeuroCo Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332
	Telephone: 1-954-254-5003Facsimile: 1-954-742-5989E-Mail: garry@inneuroco.com
Secondary Submission Contacts	Marianne GrunwaldtSenior Director of Regulatory Affairs and Quality Assurance
	InNeuroCo Inc.19700 Stirling Road, Suite 1Pembroke Pines, FL 33332
	Telephone: 1-954-703-5271Facsimile: 1-954-742-5989E-Mail: marianne@inneuroco.com
	Ming Cheng ChewRegulatory Consultant
	RQM+8401 73rd Avenue North, Suite 63Brooklyn Park, MN 55428
	Telephone: 763-232-3701E-Mail: mchew@rqmplus.com
Trade name	Thinline Sheath Introducer
Regulation Number	21 CFR 870.1340
Device Common or ClassificationName	Catheter Introducer
Product Class	Class II
Product Panel	Cardiovascular
Product Code	DYB
Predicate Device	Merit Prelude Ideal 9F Hydrophilic Sheath Introducer#K212152
Reference Device	Zenith (065 and 074)#K171672

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6.1 Device Description

6.2 Indications for Use

6.3 Technological Characteristics and Basis for Substantial Equivalence

Table 6.1 Technological Comparison between the Thinline Introducer Sheath and Prelude Ideal 9F Hydrophilic Sheath Introducer (K212152)

Parameter	Predicate DevicePrelude Ideal 9F Hydrophilic SheathIntroducer (K212152)	Subject DeviceThinline Introducer Sheath(K232260)
Indications forUse	The 9F Prelude Ideal Hydrophilic SheathIntroducer is intended to provide access andfacilitate the percutaneous introduction ofvarious devices into veins and/or arterieswhile maintaining hemostasis for a variety ofdiagnostic and therapeutic procedures.	The Thinline Sheath Introducer is intended toprovide access and facilitate thepercutaneous introduction of various devicesinto veins and/or arteries while maintaininghemostasis for a variety of diagnostic andtherapeutic procedures.
AnatomicalLocation	Cardiovascular	Cardiovascular
Product Code	DYB	DYB
Classification	Class II	Class II
RegulationNumber	870.1340	870.1340
Coating	Yes	Yes
Internalconstruction	Single Lumen	Single Lumen
Working Length	11 cm, 23 cm	11 cm, 23 cm
Max OuterDiameter	0.138 inches	0.142 inches
Shaft Innerdiameter	0.126 inches	0.126 inches
Accessoriessupplied	DilatorGuidewireMetal Access NeedleGuide Wire Insertion Device	DilatorGuidewire
Sterilization	Ethylene Oxide	Ethylene Oxide
Number of Uses	Single Use	Single Use

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6.4 Performance Data

Design verification and validation were performed to ensure that the Thinline Introducer Sheath meets its performance specifications and demonstrates substantial equivalence to the predicate device. A list of the performance testing conducted is presented below in Table 6.2. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All pre-determined acceptance criteria were met.

In some cases, verification test data were leveraged from data that had been generated from testing done on previously cleared devices.

Test performed	Test Summary	Results
Design Verification Testing
Tensile Strength	Testing was completed per ISO 10555-1, Section 4.6 andAnnex B.	Pass
PTFE delamination	PTFE liner was visually inspected to ensure thatdelamination of the liner was not present.	Pass
Torque Strength	The device must withstand one turn of the hub	Pass
Catheter Burst	Testing was completed per ISO10555-1, Section 4.10and Annex F.	Pass
Visual Inspection	Samples were visually inspected under 2.5X magnificationto ensure acceptance criteria were met.	Pass
Particulates	Testing was completed per USP <788>. Testing was alsoperformed in comparison to the predicate.	Pass
Liquid Leak Test (sheath andhemostasis valve)	Testing was conducted per ISO 10555-1, Section 4.7 andAnnex C.	Pass
Air Leak Test	Testing was conducted per ISO 10555-1 section 4.7.2 andAnnex D.	Pass
Dimensional Verification	The catheter and introducer must meet specifications	Pass
Coating Length	The sheath length with hydrophilic coating must meetspecifications	Pass
Chemical Compatibility	The device shall withstand exposure to saline, dextrose,heparin, and contrast	Pass
Tip Flexibility/Stiffness	Units will be held at 5 mm, 10 mm, and 20 mm from thedistal tip, and a tensile test stand will be used to record theforce required to displace the tip by 1 mm. Testingconducted per FDA Guidance Document #1600,Coronary, Peripheral, and Neurovascular Guidewires -Performance Tests and Recommended Labeling.	Pass
Hub Compatibility	Catheter luers shall be tested per ISO 594-1:1986 andISO 594-2:1998	Pass
Kink Resistance	After conditioning, two points on each test sample werewrapped around progressively smaller diameter pegsand/or mandrels until a kink was observed.	Pass
Packaging - Pouch Leak Test	Testing was conducted per ASTM F-1929.	Pass
Packaging - Pouch Peel Test	Testing was conducted per ASTM F88/F88M.	Pass
Packaging - Visual Inspection	Packaging was visually inspected to determine if anyperforations, nicks, cuts, or punctures on the pouch werepresent. All pouch seals were also visually inspected toverify that seals were not damaged or peeled, and that allseals were intact.	Pass
Label Legibility	Labeling will be inspected visually to ensure text remainslegible after transportation and environmentalconditioning.	Pass
Packaging - Seal Width	The seals will meet the specified width	Pass
Design Validation Testing
In-vitro Simulated Use Study –Benchtop	The Thinline Sheath Introducer was prepared per the IFU.A simulated interventional procedure was performed byphysicians in order to verify the product's performance.	Pass
Test performed	Test Summary	Results
In-vitro Simulated Use Study -Useability	Participating physicians were asked to rate variousaspects of the Thinline Sheath Introducer includingperformance and IFU	Pass

Table 6.2 – Performance Bench Tests Performed on the Thinline Introducer Sheath

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6.5 Biocompatibility testing

Biocompatibility of the Thinline Introducer Sheath was leveraged from the reference device (K171672) based on the similarities in design, materials, suppliers, and processing. The following biocompatibility endpoints were leveraged to support the substantial equivalence of the subject device:

Biological Effect	Test
Cytotoxicity	MEM elution, 48 hr. inc., triplicate L929, 24 hr. ext. (nonimplant)
Sensitization	Magnusson-Kligman Method, 2 extracts
Irritation	Intracutaneous Toxicity (ISO), 2 extracts
Material mediated pyrogenicity	Material Mediated Pyrogen
Acute Systemic Toxicity	Systemic Injection (ISO), 2 extracts
Hemocompatibility	Hemolysis, ASTM Method, indirect (human blood)
	Hemolysis, ASTM Method, direct contact (human blood)
	Complement Activation, SC5b-9
	Dog Thrombogenicity

Table 6.3 Summary of Biocompatibility Testing Leveraged from the Reference Device (K171672)

6.6 Sterilization Validation

A confirmatory sterilization study was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide sterilization cycle. The device passed all sterility, EO residual, LAL, and bioburden testing.

6.7 Conclusion

Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the Thinline Introducer Sheath, is substantially equivalent to the predicate Merit Prelude Ideal 9F Hydrophilic Sheath Introducer #K212152.

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).