The Long Sheath or LS is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal outer diameter of 0.109 inches. It is available with a nominal inner diameter of 0.088 inches. They are available in three working lengths: 70 cm, 80 cm, and 90 cm. The Long Sheath has a PTFE-lined lumen, which is braidreinforced, flexible, and has a hydrophilic coating. The LS are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provide a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve with an extension luer and a dilator. The LS is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the "Long Sheath" device (K152876). The "study" in this context refers to a series of non-clinical performance tests conducted to demonstrate that the Long Sheath is substantially equivalent to a legally marketed predicate device (NEURON MAX SYSTEM, K111380).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document provides a table summarizing the non-clinical tests, the test methods, and a general statement about the results. The specific acceptance criteria are not explicitly detailed for each test (e.g., a specific minimum tensile strength value). Instead, the results consistently state, "All units tested must meet the acceptance criteria. All samples met the acceptance criteria." This implies that predefined, quantifiable acceptance criteria were established for each test based on the relevant ISO or ASTM standards, and the device successfully met all of them.

Test	Test Method Summary	Reported Device Performance (Results)
Biocompatibility	Per ISO 10993-1	All units tested meet the acceptance criteria. All samples met the acceptance criteria. (Also noted as biocompatible and non-pyrogenic.)
Radiographic Detectability	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Visual Inspection	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Working Length	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Hub Compatibility	Per ISO 594-1 and ISO 594-2	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Outside Diameter	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Leak – Air	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Leak - Liquid	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Particulates	Per USP 788	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Catheter Burst	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Tensile	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Corrosion	Per ISO 10555-1	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Packaging - Dye Leak	Per ASTM F1929-12	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.
Packaging - Peel	Per ASTM F88-09	All units tested must meet the acceptance criteria. All samples met the acceptance criteria.

2. Sample size used for the test set and the data provenance

Sample Size: The document does not explicitly state the exact "sample size" (number of units) used for each individual test. It consistently uses the phrase "All units tested" and "All samples met the acceptance criteria," implying that a sufficient number of samples were tested to meet the statistical requirements of the respective ISO/ASTM standards for product verification. Specific quantities (e.g., n=3, n=5) are not provided in this summary.
Data Provenance: The document does not specify the country of origin of the data. It states that the studies were conducted "pursuant to 21CFR58, Good Laboratory Practices," which are U.S. federal regulations. This suggests the testing was likely performed in the U.S. or at facilities adhering to U.S. GLP standards. The data is retrospective in the sense that the testing was completed prior to the 510(k) submission.

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 to this type of submission. The "Long Sheath" is a physical medical device (catheter), and its performance is evaluated through objective, non-clinical engineering and biological tests (e.g., tensile strength, biocompatibility, leak tests) against established industry standards (ISO, ASTM, USP). Ground truth, in the sense of expert consensus on interpretations or diagnoses, is typically relevant for AI/software devices or diagnostic tools. Here, the "ground truth" is defined by the objective performance requirements set forth in the recognized standards.

4. Adjudication method for the test set

This section is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where human experts interpret data (e.g., medical images) and their agreement is resolved to establish a gold standard. For physical device testing, the results are objectively measured and compared against predefined pass/fail criteria from the standards.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the impact of AI on human performance in diagnostic tasks and is not relevant for the non-clinical evaluation of a physical catheter.

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

No, a standalone algorithm performance study was not done. This device is a physical catheter, not an algorithm or AI system. Its performance is inherent in its physical and material properties, not an algorithmic output.

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

The "ground truth" for the performance of the Long Sheath device is established by objective engineering and biological measurement criteria defined within recognized national and international standards. These standards (e.g., ISO 10993-1, ISO 10555-1, ISO 594-1/2, USP 788, ASTM F1929-12, ASTM F88-09) specify the methods and acceptable limits for various performance parameters (e.g., biocompatibility, physical dimensions, leak integrity, tensile strength, sterility characteristics). The device is deemed to meet the acceptance criteria if its measured performance falls within these predefined limits.

8. The sample size for the training set

This section is not applicable. This submission is for a physical medical device and does not involve AI or machine learning algorithms that require a "training set."

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

This section is not applicable for the same reasons as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 8, 2016

TNI Manufacturing, Inc. Ms. Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs 4635 NW 103td Avenue Sunrise. Florida 33351

Re: K152876

Trade/Device Name: Long Sheath Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 3, 2015 Received: December 7, 2015

Dear Ms. Grunwaldt:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena AS

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152876

Device Name Long Sheath

Indications for Use (Describe)

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasulature.

Type of Use (Select one or both, as applicable)

X 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's Name and Address

TNI Manufacturing, Inc. 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989

Contact Information

Marianne Grunwaldt Director, Quality Assurance & Regulatory Affairs InNeuroCo, Inc 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-305-495-3883 Facsimile: 1-954-742-5989 E-Mail: Marianne@InNeuroCo.com

Date Prepared

September 25, 2015

Device Trade or Proprietary Name

Long Sheath or LS

Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II

Product Code:

DQY

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Identification of the Legally Marketed Devices to which Equivalence is Being Claimed

Name of Predicate Device	Name of Manufacturer	510(k) Number
NEURON MAX SYSTEM	Penumbra, Inc.Alameda, California	K111380

Device Description

Indications for Use

The Long Sheath is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

	Predicate DevicePenumbra NEURONMAX SYSTEM	TNI Manufacturing, Inc.Long Sheath
510(k) Number	K111380	K152876
Classification	21CFR870.1250, Class II	21CFR870.1250, Class II
Product Code	DQY	DQY

Comparison to Predicate Device

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Review Panel	Cardiovascular	Cardiovascular
Indication For Use	The Neuron™ MAXSystem is indicated for theintroduction ofinterventional devices intothe peripheral, coronary,and neuro vasculature.	The Long Sheath isindicated for theintroduction ofinterventional devices intothe peripheral, coronary,and neuro vasculature.
Components Supplied	Sheath, Vessel Dilator,Hemostasis Valve,	Sheath, Vessel Dilator,Hemostasis Valve
Catheter ShaftMaterial	Nylon, Polyurethane	Polyether Block Amide,(PEBAX)
Inner Liner	PTFE	PTFE
Hub Material	Polycarbonate	Polycarbonate
Strain Relief	Polyolefin	Polyolefin
Catheter ShaftReinforcement	Stainless Steel Braid	Stainless Steel Braid
Lubricious Coating	Hydrophilic Coating	Hydrophilic Coating
Radiopaque MarkerBand	Platinum/ Iridium	Platinum/ Iridium
Packaging	Tyvek Pouch,polyethylene support tube,packaging card, SBScarton	Tyvek/Nylon Pouch,polyethylene support tube,packaging card, SBS carton
Sterilization	Ethylene Oxide	Ethylene Oxide
Pyrogenicity	Nonpyrogenic	Nonpyrogenic
Working Lengths	70, 80, 90, and 100 cm	70, 80, 90 cm
Internal Diameter	0.088 inches	0.088 inches
Outer Diameter	0.108 inches	0.109 inches
Shelf Life	3 years	3 years
Vessel Dilator	Aid in sheath introductionduring procedure	Aid in sheath introductionduring procedure
Hemostasis Valve	Minimizes blood loss	Minimizes blood loss
Luer Tapered Hub	Yes	Yes

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Summary of Non Clinical Data

Biocompatibility tests conducted with the Long Sheath and accessories were selected in accordance with ISO 10993-1 guidelines (Biological Evaluation of Medical Devices) for limited duration (<24 hours), external communicating devices, contacting circulating blood. Studies were conducted pursuant to 21CFR58, Good Laboratory Practices. Biocompatibility testing found the Long Sheath to be biocompatible and non-pyrogenic.

The conclusions drawn from the physical, mechanical, and performance testing of the subject LS and accessories demonstrates that the product is Substantially Equivalent to the legally marketed predicate device for its labeled indications.

Test	Test MethodSummary	Results
Biocompatibility	Testing completedper ISO 10993-1	All units tested meet the acceptancecriteria. All samples met the acceptancecriteria
RadiographicDetectability	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Visual Inspection	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Working Length	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Hub compatibility	Testing completedper ISO 594-1 andISO 594-2	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Test	Test MethodSummary	Results
Outside diameter	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Leak – Air	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Leak - Liquid	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Particulates	Testing completedper USP 788	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Catheter Burst	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Tensile	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Corrosion	Testing completedper ISO 10555-1	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Packaging - Dye Leak	Testing completedper ASTM F1929-12	All units tested must meet theacceptance criteria. All samples met theacceptance criteria
Packaging - Peel	Testing completedper ASTM F88-09	All units tested must meet theacceptance criteria. All samples met theacceptance criteria

Long Sheath Performance Testing

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Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).