AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH

K102460 · Summit Medical Products, Inc. · BSO · Jan 13, 2011 · Anesthesiology

Device Facts

• Record ID: K102460
• Device Name: AMBIT INTRODUCER, AMBIT NEEDLE, AMBIT SHEATH
• Applicant: Summit Medical Products, Inc.
• Product Code: BSO · Anesthesiology
• Decision Date: Jan 13, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 868.5120
• Device Class: Class 2

Intended Use

The amblT Introducer product line is intended to allow the percutancous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle. The amblT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.

Device Story

The ambIT Introducer is a sterile, single-use percutaneous catheter introducer system. It consists of a stainless steel shaft (11-17 GA, 3.25-12 inches) with a sharp or blunt tip, often paired with a plastic peelable sheath or internal plastic/metal insert. The device is used by physicians or trained personnel to create an access point for catheter placement near nerves or wound sites. The luer hub allows for fluid injection or aspiration at the site. After insertion, the stainless steel shaft is withdrawn, leaving the sheath in place for catheter introduction, or the catheter is inserted through the shaft after the insert is removed. The device facilitates regional anesthesia or wound site pain management by enabling precise catheter positioning.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified through adherence to ISO 594-2 (liquid/air leakage, separation force, unscrewing torque, ease of assembly, resistance to overriding, stress cracking) and ISO 10555-1 (force to break, strength of union) standards, alongside ISO 10993 biocompatibility testing.

Technological Characteristics

Materials: 304 stainless steel needle, polystyrene needle hub, HDPE sheath shaft with 10% BaSO4, HDPE tear-away hub. Principle: Mechanical percutaneous access. Dimensions: 11-17 GA, 3.25-12 inches. Connectivity: None. Sterilization: Sterile, single-use. Standards: ISO 594-2, ISO 10555-1, ISO 10993.

Indications for Use

Indicated for percutaneous placement of catheters near nerves or into surgical/non-surgical wound sites. For use by physicians or trained individuals under physician supervision.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• On-Q Introducers (K063234)

Submission Summary (Full Text)

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# 102460

## FINDING BETTER WAYS TO CARE FOR PEOPLE "

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SUMMIT MEDICAL PRODUCTS

JAN 1 3 2011

January 11, 2011 510(k) Summary

| Device<br>Sponsor: | Summit Medical Products, Inc.<br>2480 South Main Street Suite 212<br>Salt Lake City, UT 84115 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact<br>Information: | Marko Van Amen<br>Summit Medical Products, Inc<br>VP of Regulatory Affairs/Quality Assurance<br>2480 South Main Street Suite 212<br>Salt Lake City, UT 84115<br>Phone: [phone]<br>FAX: [phone] |
| Date<br>Submitted | January 11, 2011 |
| Trade Names: | ambIT Introducer, ambIT Sheath, ambIT Needle |
| Common<br>Name: | Catheter Introducer |
| Classification<br>Name: | Anesthesia, Conduction Catheter |
| Product Code: | BSO |
| Regulation<br>Number: | 868.5120 |
| Equivalent<br>To: | K063234 On-Q Introducers |
| Device<br>Description: | The ambIT™ Introducer is intended for the percutaneous<br>introduction of a catheter<br>1. A stainless steel shaft with a sharp tip.<br>a. Stainless steel shafts with sharp tips (various configurations such as<br>beveled or touhy) may or may not be solid (may be hollow).. The<br>diameter of the stainless steel shaft ranges from 11 to 17 GA and the<br>length is from 3.25 to 12 inches.<br>2. A plastic peelable sheath (split T-handle) on the outside of the stainless steel<br>shaft and/or a plastic/metal inserts inside hollow stainless steel shafts.<br>a. Introducers that have a plastic sheath will allow the catheter to be<br>inserted after the stainless steel shaft has been withdrawn. The tips of<br>the stainless steel shaft will be blunt or sharp.<br>b. Introducers that do not have a plastic sheath will allow the catheter to<br>be inserted through the stainless steel shaft, after the plastic/metal<br>insert has been withdrawn.<br>The ambiT Introducers may have a handle or luer hub connected to<br>the stainless steel shaft. |

Summit Medical Products, Inc. | 2480 South Main, Suite 212 | Salt Lake City, Utah 84115 Summit Medical Produces, Mor - | - 2158 Bear Han |Phone [phone] | | Fax [phone] | | Toll-Free 877-352-1888 | | www.summitmpi.com

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Image /page/1/Picture/1 description: The image shows a logo for Summit Medical Products. The logo features three mountain peaks, with the center peak being slightly taller and textured. Below the mountain graphic, the words "SUMMIT MEDICAL PRODUCTS" are printed in a simple, sans-serif font, with "SUMMIT MEDICAL" on the first line and "PRODUCTS" on the second line.

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| | | The following are the configurations and names for the amblT Introducers: | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | | 1. amblT Introducer Sheath | |
| | | a. Sterile single use product | |
| | | b. Made for use with ambIT Tunneler (without sheath) reusable product. | |
| | | 2. amblT Introducer Needle | |
| | | a. Sterile single use product | |
| | | b. Stainless steel shaft with sharp tip and insert inside stainless steel shaft. | |
| Indications<br>for Use: | The ambIT™ Introducer products are intended allow for the<br>percutaneous placement of catheters in close proximity to<br>nerves and around or into surgical wound or non-surgical<br>wound sites. It may be used to inject or aspirate the<br>introduction area via the luer hub of the needle. | | |
| Substantial<br>Equivalence<br>(SE)<br>Rational: | The ambIT™ Introducer product is considered substantially<br>equivalent based on the materials that are used, the intended<br>use, and both devices were tested to the same applicable ISO<br>standards. The product passed all applicable testing<br>requirements. The ambIT™ Introducer is intended for the<br>percutaneous introduction of a catheter. | | |
| In Section 2 of the 510(k) application for the ambIT Introducer<br>device (K102460) a comparison of the proposed and predicate<br>device is provided. A comparison of the proposed medical<br>device, ambIT™ Introducer to the predicate medical device,<br>the On-Q Introducer products (510K# K063234) is summarized<br>below in Table 1. Both products have common features, such<br>as they both use the similar materials of construction, similar<br>intended use, and similar consensus standards for the design<br>and performance for both devices | | | |
| Table 1: Substantially Equivalence Comparison Table of<br>proposed device -ambIT™ Introducer to the predicate<br>device – ON-Q Introducer™. | | | |
| | Device | Proposed Device<br>ambIT™ Introducer<br>(510(k) #K102460) | Predicate Device<br>On-Q Introducer<br>(510(k) #K063234) |
| | Intended Use | The ambIT™<br>Introducer products are<br>intended allow for the<br>percutaneous placement<br>of catheters in close<br>proximity to nerves and | The On-Q<br>Introducers™ are<br>intended for the<br>percutaneous<br>introduction and<br>placement of |
| | | | |
| | around or into surgical<br>wound or non-surgical<br>wound sites. It may be<br>used to inject or<br>aspirate the<br>introduction area via<br>the luer hub of the<br>needle. | catheters into or<br>around surgical<br>wound sites and/or<br>close proximity to<br>nerves. Introducers<br>with a luer hub may<br>be used to aspirate<br>or inject a bolus of<br>fluid or medication<br>prior to placing the<br>catheters. | |
| Trade Names | ambIT Introducer,<br>ambIT Needle, ambIT<br>Sheath | ON-Q Needle,<br>ON-Q Tunneler,<br>ON-Q Sheath | |
| Materials of<br>Construction | Needle | Needle | |
| | • Stainless steel (304)<br>needle 18 GA<br>• Needle Hub-<br>Polystyrene (clear) | • Stainless steel<br>(304) needle 18<br>GA<br>• Needle Hub-<br>Polystyrene<br>(clear) | |
| | Sheath | Sheath | |
| | • Tear away hub- High<br>density Polyethylene<br>(HDPE)<br>• Sheath Shaft (tube)-<br>High density<br>Polyethylene (HDPE)<br>with 10%BaSO4 | • Tear away hub-<br>High density<br>Polyethylene<br>(HDPE)<br>• Sheath Shaft<br>(tube)- High<br>density<br>Polyethylene<br>(HDPE) with<br>10% BaSO4 | |
| | Tunneler Sheath | Tunneler Sheath | |
| | • Sterile, single use product<br>• Plastic peelable sheath | • Sterile, single use<br>product<br>• Plastic peelable<br>sheath | |
| | | | |
| | | | |
| | Introducers Sterile, single use product Stainless steel shaft with a sharp end Plastic peelable sheath | Introducers Sterile, single use product Stainless steel shaft with a sharp end Plastic peelable sheath | |
| Standards: | The ambiT Introducers meet the requirements as set forth in the following FDA recognized consensus standards for device design and performance requirements: ISO 594-2 Liquid Leakage test ISO 594-2 Air Leakage test ISO 594-2 Separation Force test ISO 594-2 Unscrewing Torque ISO 594-2 Ease of Assembly ISO 594-2 Resistance to Overriding ISO 594-2 Stress Cracking ISO 10555-1 Force to Break ISO 10555-1 Strength of Union ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing | | |
| Safety and Effectiveness: | Based on the comparison to the predicate device and the conformance to the recognized standards, the ambiT Introducers are safe and effective and substantially equivalent to legally marketed devices. | | |

Summit Medical Products, Inc. | 2480 South Main, Suite 212 | Salt Lake City, Utah 84115 Summit Medical Products, Inc.

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Summit Medical Products. Inc. | 2480 South Main, Suite 212 | | Salt Lake City, Utah 84115 Summit Medical Products: nel:

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# FINDING BETTER WAYS TO CARE FOR PEOPLE"

Image /page/3/Picture/1 description: The image shows the logo for Summit Medical Products. The logo consists of three triangles of varying shades, arranged to resemble mountain peaks. Below the triangles, the text "SUMMIT MEDICAL PRODUCTS" is printed in a bold, sans-serif font, with "SUMMIT MEDICAL" on the first line and "PRODUCTS" on the second line.

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

Mr. Marko Van Amen Vice President of Regulatory Affairs and Quality Assurance Summit Medical Products, Incorporated 2480 South Main Street Salt Lake City, Utah 84115

JAN 1 3 201

Re: K102460

Trade/Device Name: amblT Introducers Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: August 28, 2010 Received: January 7, 2011

Dear Mr. Amen:

. .

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. Amen

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 115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

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Image /page/6/Picture/0 description: The image shows the logo for Summit Medical Products. The logo consists of three triangles of varying shades, arranged to look like mountain peaks. Below the triangles, the words "SUMMIT MEDICAL" are stacked on top of "PRODUCTS" in a sans-serif font.

Abbreviated 510(k) - ambIT Introducer

510(k) Number K 102460:

JAN 1 3 2011

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Device Name: ambIT Introducers

Indications for Use:

The amblT Introducer product line is intended to allow the percutancous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites. It may be used to inject or aspirate the introduction area via the luer hub of the needle

The amblT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.

Prescription Use l (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)

Richard C. Chapman 1/13/11
(Division Sign-Off)

02460

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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Summit Medical Products, Inc.