The Intermediate Catheter is a variable stiffness catheter and has a catheter shaft reinforced with a stainless steel braid, a stainless steel coil, a Nitinol coil, and has a radiopaque Platinum/Iridium marker band on the distal end. The catheter has a nominal distal outer diameter of 0.072" and a nominal proximal outer diameter of 0.078". It is available with a nominal inner diameter of 0.060". They are available in three working lengths, 105 cm, 115 cm. and 125 cm. The Intermediate Catheters have a PTFE-lined lumen, which is braid and coil reinforced, flexible, and has a hydrophilic coating. The Intermediate Catheters are inserted through a guide catheter or vascular sheath, provide access to the target site and once in place, provides a reinforcing conduit for other intravascular devices. Accessories included with the device are a Tuohy-Borst hemostasis valve and a split introducer sheath. The Intermediate Catheter is supplied sterile, non-pyrogenic, and intended for single use only.

AI/ML Overview

The document describes the non-clinical testing of an Intermediate Catheter for submission K152202 to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not an AI/ML device submission, and therefore the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" are interpreted in the context of typical FDA 510(k) submissions for non-AI devices.

Here's the breakdown of the information as requested, adapted for a non-AI medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Test Method Summary	Acceptance Criteria (Implicit from Results)	Reported Device Performance
Biocompatibility	Per ISO 10993-1	All units tested must meet the acceptance criteria.	All samples met the acceptance criteria. (Found biocompatible and non-pyrogenic)
Sterilization Validation	Per ISO 11135	All units tested must meet the acceptance criteria.	All samples met the acceptance criteria.
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 Data Provenance

The document states, "All units tested must meet the acceptance criteria. All samples met the acceptance criteria." This implies that a sufficient number of samples were tested for each specific test according to the requirements of the referenced ISO and ASTM standards. However, the exact sample sizes for each test are not explicitly stated in this summary.

The data provenance is from non-clinical bench testing and laboratory studies conducted by TNI Manufacturing, Inc. (the submitter). These are prospective tests designed to evaluate the physical, mechanical, and biological properties of the device. The country of origin of the data is implicit to be the USA, where TNI Manufacturing, Inc. is located. The biocompatibility testing explicitly states it was conducted "pursuant to 21CFR58, Good Laboratory Practices," which are U.S. regulations for nonclinical laboratory studies.

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

This section is not applicable as this submission is for a physical medical device (catheter) and involves non-clinical bench testing, not an AI/ML device that generates diagnoses or interpretations requiring expert consensus as ground truth. The "ground truth" for these tests is established by the objective physical, chemical, and biological properties measured according to the specified international standards.

4. Adjudication Method for the Test Set

This is not applicable as there is no human interpretation or decision-making process for the "ground truth" in these non-clinical tests that would require adjudication. The tests involve objective measurements and adherence to 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

This is not applicable. The device is a physical catheter, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study, human reader improvement with AI, or effect size related to AI assistance would be conducted or relevant for this type of submission.

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

This is not applicable. As stated above, this is a physical medical device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on the objective measurements and pass/fail criteria defined by internationally recognized standards (e.g., ISO, ASTM, USP). For example:

Biocompatibility: Adherence to ISO 10993-1 guidelines, meaning the material does not elicit adverse biological responses.
Sterilization Validation: Demonstrated sterility according to ISO 11135.
Physical/Mechanical properties (e.g., Working Length, OD, Catheter Burst, Tensile): Conformance to specified dimensions, mechanical strengths, and absence of leaks or defects as defined by ISO 10555-1 and other relevant standards.
Particulates: Conformance to USP 788 limits.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/ML device.

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

This is not applicable. There is no "training set" for a physical medical device.

Summary

{0}------------------------------------------------

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 words "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

December 14, 2015

TNI Manufacturing, Inc. % Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K152202

Trade/Device Name: Intermediate Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, DYB, DTL Dated: November 19, 2015 Received: November 23, 2015

Dear Mr. Job:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 -S/^

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K152202

Device Name Intermediate Catheter

Indications for Use (Describe)

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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 complete 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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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

Daniel Sablyak President 4635 NW 103rd Avenue Sunrise, Florida 33351 Telephone: 1-954-742-5988 Facsimile: 1-954-742-5989 E-Mail: Dan@tnimfg.com

Date Prepared

November 16, 2015

Device Trade or Proprietary Name

Intermediate Catheter Hemostasis Valve Split Sheath Introducer

Device Common or Classification Name:

Catheter, Percutaneous, 21CFR870.1250, Class II Hemostasis Valve, 21CFR870.4290, Class II Catheter Introducer, 21CFR870.1340, Class II

Product Code:

{4}------------------------------------------------

DQY (Catheter)

DTL (Hemostasis Valve)

DYB (Catheter Dilator)

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

Name of Predicate Device	Name of Manufacturer	510(k) Number
5MAXTM DDCDistal Delivery Catheters	Penumbra, Inc.Alameda, California	K122772
	Predicate DevicePenumbra 5MAXTMDDC	Intermediate Catheter
510(k) Number	K122772	K152202
Classification	21CFR870.1250, Class II	Same
Product Code	DQY	Same
Indication For Use	The DDC Catheters areindicated for theintroduction ofinterventional devices intothe peripheral and neurovasculature.	The Intermediate Catheter isindicated for theintroduction ofinterventional devices intothe peripheral and neurovasculature.
Inner Lumen	PTFE	PTFE
Catheter ShaftMaterial	Nylon, PTFE,polyurethane,hydrophilic coating	Nylon, PTFE, polyimide,polyether block amide, PET,polycarbonate/urethanehydrophilic coating
Hub Material	Polycarbonate	Same
Catheter ShaftReinforcement	Stainless Steel/Nitinol	Same
Marker Band	Platinum/Iridium	Same
Packaging	Tyvek Pouch,polyethylene supporthoop, packaging card,SBS Carton	Same
Sterilization	Ethylene Oxide	Same
Pyrogenicity	Nonpyrogenic	Same
Inside Diameter (ID)	0.062"	Same
Outside Diameter(OD)	6 Fr	Same
Working Lengths (cm)	115 and 125 cm	105, 115, and 125 cm
	Predicate DevicePenumbra 5MAX™DDC	Intermediate Catheter
Compatible Guidewire	0.038"	Same

Device Description

Indications For Use

The Intermediate Catheter is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

Comparison to Predicate Device

{5}------------------------------------------------

{6}------------------------------------------------

Summary of Non Clinical Data

Biocompatibility tests conducted with the Intermediate Catheters 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 Intermediate Catheters to be biocompatible non-pyrogenic. and

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

Test	Test MethodSummary	Results
Biocompatibility	Testing completedper ISO 10993-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
SterilizationValidation	Testing completedper ISO 11135	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
RadiographicDetectability	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Visual Inspection	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Test	Test MethodSummary	Results
Working Length	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Hub compatibility	Testing completedper ISO 594-1 andISO 594-2	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Outside diameter	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Leak — Air	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Leak — Liquid	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Particulates	Testing completedper USP 788	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Catheter Burst	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Tensile	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Corrosion	Testing completedper ISO 10555-1	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Packaging - DyeLeak	Testing completedper ASTM F1929-12	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.
Packaging - Peel	Testing completedper ASTM F88-09	All units tested must meet the acceptancecriteria. All samples met the acceptancecriteria.

Intermediate Catheter Performance Testing

{7}------------------------------------------------

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).