The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve.
The ambIT Tunnelers are intended for the perculaneous introduction of catheters.

Device Description

The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve. The ambIT® Tunneler is packaged and shipped non-sterile and must be cleaned and autoclaved by the purchaser/facility prior to use.

Summit Medical Products, Inc. is adding a tunneling device to the ambIT® Tunneler product line for use in the placement of catheters. This specification is specifically for a 16 gauge (GA), 12 inch shaft length, re-useable tunneler and single use sterilized peelable sheath.

The ambIT® Tunneler will consist of 2 components:

· The component is a stainless steel shaft (blunt end) with a handle. The diameter of the shaft is 16 GA (S French) and the length of the shaft will accommodate a 12 inch useable length sheath, The end of the shaft will have a rounded blunt tip.

AI/ML Overview

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

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Standard Met	Reported Device Performance
Design & Performance (General)	Requirements of FDA recognized consensus standards for device design and performance	"The ambIT® Tunneler design meets product specifications and intended uses."
-	ISO 10555-5:1996 (Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters)	Met the requirements of this standard.
-	ISO 9626:2001 (Stainless Steel Needle Tubing)	Met the requirements of this standard.
-	ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)	Met the requirements of this standard.
-	ISO 10993-1:2009 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing)	Met the requirements of this standard.
-	ISO 9626:1991/amd 1:2001 (Stainless steel needle tubing)	Met the requirements of this standard.
-	ISO 17664-2004 (Sterilization of Medical devices)	Met the requirements of this standard.
Material Equivalence	Medical grade malleable stainless steel per ASTM 304	"The overall device component material is substantially equivalent" to the predicate, both made from ASTM 304.
Tip Design	Blunt tip, free from feathered edges, burrs, and hooks.	"The proposed and predicate tunnelers are designed to have a blunt tip, as well as free from feathered edges, burts and hooks."
Size (Specific to this device)	16 GA shaft diameter, 12 inch shaft length	The device is explicitly designed to these specifications and is compared to a predicate device with a range of sizes.
Safety & Effectiveness	No adverse effect on safety and effectiveness due to minor technological differences from predicate.	"performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device."
Substantial Equivalence	Same indications for use and technological characteristics as the predicate device.	"The ambIT® Tunneler has the same indications for use and technological characteristics as the predicate device." "the proposed ambIT® Tunneler has been shown to be substantially equivalent to the cleared On-Q® Tunneler."

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

The provided text does not specify a sample size or data provenance (e.g., country of origin, retrospective/prospective) for any specific test set. The submission refers to "Non-Clinical Testing" which met various ISO standards and states "Results of testing demonstrate that the ambIT® Tunneler design meets product specifications and intended uses." This implies that the testing was likely laboratory-based and simulated, rather than involving human subjects or real-world data collection in a clinical setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the involvement of experts to establish ground truth. The evaluation criteria appear to be based on adherence to established international and national standards (ISO, ASTM) for medical device performance, materials, and sterilization. These standards themselves are developed by expert consensus within their respective fields, but the document doesn't detail specific experts involved in this particular device's ground truth establishment.

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

The document does not describe an adjudication method. Since the testing
primarily references adherence to engineering and material standards, it's unlikely that a human-based adjudication process (like 2+1, 3+1 for clinical endpoints) would be applicable or required. The "results demonstrate" implies meeting predefined thresholds within 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, an "ambIT® Tunneler" (a catheter tunneler), is a physical medical device, not an AI or imaging software. Therefore, there would be no MRMC study, human readers, or AI assistance involved.

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

This is not applicable. As mentioned above, the device is a physical medical tool, not an algorithm or software. Its performance is evaluated through non-clinical laboratory testing against physical and material standards.

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

The ground truth for this device's performance is primarily based on adherence to recognized engineering, material, and sterilization standards (e.g., ISO, ASTM). This represents a form of pre-defined technical and safety criteria established by expert consensus within the standards bodies themselves. It's not clinical "ground truth" like pathology or outcomes data, but rather a demonstration of inherent device properties and manufacturing processes meeting established benchmarks.

8. The sample size for the training set:

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against standards.

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

This is not applicable for the same reasons as above.

Summary

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K110814

APR - 8 2011

510(k) SUMMARY

This 510(k) Summary is provided per the requirements of section 807.92(c).

510(k) Number:	TBD
Owner Name:	Summit Medical Products, Inc.
Address:	2480 South Main Street #212Salt Lake City, UT 84115
Contact Person:	Marko Van AmenVP of Regulatory Affairs/Quality AssuranceTel: 801.214.3464Fax: 801.352.1888Email address: mvanamen@summitmpi.com
Date Prepared:	January 23, 2011
Device Trade Name:	ambIT® Tunneler

Device Trade Name:	ambIT® Tunneler
Device Common Name:	Catheter Tunneler
Class:	Class II, 21 CFR 868.5120, Product Code BSO

Predicate Device(s):

On-Q® Tunneler (K063234) .

Device Description:

The ambIT® Tunneler is a non-sterile, reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve. The ambIT® Tunneler is packaged and shipped non-sterile and must be cleaned and autoclaved by the purchaser/facility prior to use.

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The ambIT® Tunneler will consist of 2 components:

Indication for Use:

The intended use is for the percutaneous introduction of catheters.

Comparison to Predicate Devices:

The proposed device, ambIT® Tunneler, covered under this 510(k) is similar to the predicate device, On-Q® Tunneler, with the exception of the predicate, On-Q® Tunneler, product's size offering. The On-Q® Tunneler shaft diameter ranges from 11 to 17 gauge and the length ranges from 3.25 to 12 inches. The amblT® Tunneler has a shaft diameter of 16 GA and a length of 12 inches. The overall device component material is substantially equivalent; the tunnelers are made from a medical grade malleable stainless steel certified per ASTM 304. The proposed and predicate tunnelers are designed to have a blunt tip, as well as free from feathered edges, burts and hooks.

Where minor technological differences exist between the proposed device and the predicate device, performance testing demonstrates that these differences do not adversely affect the safety and effectiveness of the proposed device.

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Summary of Non-Clinical Testing:

The proposed device, the ambIT® Tunneler, and the predicate device, the On-O® Tunneler, met the requirements of the following FDA recognized consensus for the device design and performance requirements:

. ISO 10555-5:1996, Sterile, Single-Use Intravascular Catheters - Over Needle Peripheral Catheters
ISO 9626:2001. Stainless Steel Needle Tubing .
. ISO 17665-1:2006, Sterilization of health care products - Moist heat- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 10993-1:2009, Biological Evaluation of Medical Devices Part 1: Evaluation and t Testing
ISO 9626:1991/amd 1:2001 Stainless steel needle tubing .
ISO 17664-2004 Sterilization of Medical devices .

Results of testing demonstrate that the ambIT® Tunneler design meets product specifications and intended uses.

Statement of Equivalence:

The ambIT® Tunneler has the same indications for use and technological characteristics as the predicate device. Based on this and the design and engineering data provided in the Premarket Notification, the proposed ambIT® Tunneler has been shown to be substantially equivalent to the cleared On-Q® Tunneler.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling a bird or a person reaching upwards, composed of three curved lines. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the symbol.

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

Summit Medical Products, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

APR - 8 2011

Re: K110814

Trade/Device Name: ambIT Tunneler Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: March 22, 2011 Received: March 24, 2011

Dear Mr. Devine:

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.

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Page 2- Mr. Devine

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm 1.1.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

th for

Anthony D. Watson, B.S., M.S., M.B.A. Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): TBD

Device Name: ambIT Tunneler

Indications For Use:

The ambIT Tunnelers are intended for the perculaneous introduction of catheters.

FDA CDRH DMC

ﺴﻴﺴﺎ

MAR 2 4 2011

Haooview

Prescription Use ਮ (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultheis

(Division Sign-Off) Division of Anesthesiology; General Hospital Infection Control, Dental Devices

510(k) Number: K110814

Abbreviated 510(k) Submission for the Summit Medical Products, Inc ambIT® Tunneler Page 9

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).