(139 days)
The ambIT™ Introducer products are intended allow for the percutaneous 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 ambIT Introducer product line is intended for use by a physician or by a trained individual under direct supervision of a physician.
The ambIT™ Introducer is intended for the percutaneous introduction of a catheter
- A stainless steel shaft with a sharp tip.
a. Stainless steel shafts with sharp tips (various configurations such as beveled or touhy) may or may not be solid (may be hollow).. The diameter of the stainless steel shaft ranges from 11 to 17 GA and the length is from 3.25 to 12 inches. - A plastic peelable sheath (split T-handle) on the outside of the stainless steel shaft and/or a plastic/metal inserts inside hollow stainless steel shafts.
a. Introducers that have a plastic sheath will allow the catheter to be inserted after the stainless steel shaft has been withdrawn. The tips of the stainless steel shaft will be blunt or sharp.
b. Introducers that do not have a plastic sheath will allow the catheter to be inserted through the stainless steel shaft, after the plastic/metal insert has been withdrawn.
The ambiT Introducers may have a handle or luer hub connected to the stainless steel shaft.
The following are the configurations and names for the amblT Introducers:
- amblT Introducer Sheath
a. Sterile single use product
b. Made for use with ambIT Tunneler (without sheath) reusable product. - amblT Introducer Needle
a. Sterile single use product
b. Stainless steel shaft with sharp tip and insert inside stainless steel shaft.
The provided document is a 510(k) summary for the ambIT Introducer, seeking substantial equivalence to a predicate device, the On-Q Introducer.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the ambIT Introducers meet the requirements of several FDA-recognized consensus standards. It also claims substantial equivalence to the predicate device based on material, intended use, and similar testing to applicable ISO standards. The "reported device performance" is implicitly that the device passed all applicable testing requirements of these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ISO 594-2 Liquid Leakage test | Passed |
| ISO 594-2 Air Leakage test | Passed | |
| ISO 594-2 Separation Force test | Passed | |
| ISO 594-2 Unscrewing Torque | Passed | |
| ISO 594-2 Ease of Assembly | Passed | |
| ISO 594-2 Resistance to Overriding | Passed | |
| ISO 594-2 Stress Cracking | Passed | |
| ISO 10555-1 Force to Break | Passed | |
| ISO 10555-1 Strength of Union | Passed | |
| Biocompatibility | ISO 10993 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing | Passed |
| Overall Assessment | Substantial Equivalence to Predicate Device (On-Q Introducer) based on materials, intended use, and applicable standards. | Achieved |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for the testing conducted against the ISO standards. It generally states that "The product passed all applicable testing requirements."
The data provenance is from testing conducted by Summit Medical Products, Inc. as part of their 510(k) submission. It refers to a "comparison of the proposed and predicate device is provided" in Section 2, but this detailed comparison is not fully contained within the provided excerpts regarding the actual results of the testing. The nature of these tests (e.g., bench testing, animal studies) suggests they are prospective in the sense that they were performed specifically for this submission. The origin of any specific data (e.g., patient data) if applicable for performance claims, is not mentioned, as this device primarily relies on engineering and biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in the context of this 510(k) submission. The "ground truth" for this device revolves around meeting established engineering and biocompatibility standards (e.g., ISO standards) and demonstrating substantial equivalence to a legally marketed predicate device. The assessment relies on technical testing and regulatory review rather than expert consensus on diagnostic or clinical outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable. As mentioned above, the evaluation is based on objective testing against established standards, not on human interpretation or adjudication of outputs.
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 information is not applicable. This document describes a medical device (catheter introducer) for which an MRMC study for AI assistance would not be relevant. AI is not mentioned as part of the device's function.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. This device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
The "ground truth" for this device is based on:
- Predetermined engineering and performance specifications defined by recognized international standards (ISO 594-2, ISO 10555-1).
- Biocompatibility requirements as outlined in ISO 10993-1.
- The characteristics and performance of a legally marketed predicate device (On-Q Introducer K063234) for demonstrating substantial equivalence.
8. The Sample Size for the Training Set:
This information is not applicable. There is no mention of a "training set" as this device is not an AI/ML product. The submission refers to a comparison with a predicate device and testing against established standards, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for an AI/ML algorithm.
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102460
FINDING BETTER WAYS TO CARE FOR PEOPLE "
Image /page/0/Picture/2 description: The image shows three triangles of different shades. The triangle on the left is a dark shade, the triangle in the middle is a lighter shade, and the triangle on the right is a dark shade. The triangles are arranged in a row, with the middle triangle slightly taller than the other two.
SUMMIT MEDICAL PRODUCTS
JAN 1 3 2011
January 11, 2011 510(k) Summary
| DeviceSponsor: | Summit Medical Products, Inc.2480 South Main Street Suite 212Salt Lake City, UT 84115 |
|---|---|
| ContactInformation: | Marko Van AmenSummit Medical Products, IncVP of Regulatory Affairs/Quality Assurance2480 South Main Street Suite 212Salt Lake City, UT 84115Phone: 801-352-1888FAX: 801-352-1818 |
| DateSubmitted | January 11, 2011 |
| Trade Names: | ambIT Introducer, ambIT Sheath, ambIT Needle |
| CommonName: | Catheter Introducer |
| ClassificationName: | Anesthesia, Conduction Catheter |
| Product Code: | BSO |
| RegulationNumber: | 868.5120 |
| EquivalentTo: | K063234 On-Q Introducers |
| DeviceDescription: | The ambIT™ Introducer is intended for the percutaneousintroduction of a catheter1. A stainless steel shaft with a sharp tip.a. Stainless steel shafts with sharp tips (various configurations such asbeveled or touhy) may or may not be solid (may be hollow).. Thediameter of the stainless steel shaft ranges from 11 to 17 GA and thelength is from 3.25 to 12 inches.2. A plastic peelable sheath (split T-handle) on the outside of the stainless steelshaft and/or a plastic/metal inserts inside hollow stainless steel shafts.a. Introducers that have a plastic sheath will allow the catheter to beinserted after the stainless steel shaft has been withdrawn. The tips ofthe stainless steel shaft will be blunt or sharp.b. Introducers that do not have a plastic sheath will allow the catheter tobe inserted through the stainless steel shaft, after the plastic/metalinsert has been withdrawn.The ambiT Introducers may have a handle or luer hub connected tothe 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 801-352-1888 | | Fax 801-352-1818 | | Toll-Free 877-352-1888 | | www.summitmpi.com
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FINDING BETTER WAYS TO CARE FOR PEOPLE™
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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.
:
| 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. | |||
| Indicationsfor Use: | The ambIT™ Introducer products are intended allow for thepercutaneous placement of catheters in close proximity tonerves and around or into surgical wound or non-surgicalwound sites. It may be used to inject or aspirate theintroduction area via the luer hub of the needle. | ||
| SubstantialEquivalence(SE)Rational: | The ambIT™ Introducer product is considered substantiallyequivalent based on the materials that are used, the intendeduse, and both devices were tested to the same applicable ISOstandards. The product passed all applicable testingrequirements. The ambIT™ Introducer is intended for thepercutaneous introduction of a catheter. | ||
| In Section 2 of the 510(k) application for the ambIT Introducerdevice (K102460) a comparison of the proposed and predicatedevice is provided. A comparison of the proposed medicaldevice, ambIT™ Introducer to the predicate medical device,the On-Q Introducer products (510K# K063234) is summarizedbelow in Table 1. Both products have common features, suchas they both use the similar materials of construction, similarintended use, and similar consensus standards for the designand performance for both devices | |||
| Table 1: Substantially Equivalence Comparison Table ofproposed device -ambIT™ Introducer to the predicatedevice – ON-Q Introducer™. | |||
| Device | Proposed DeviceambIT™ Introducer(510(k) #K102460) | Predicate DeviceOn-Q Introducer(510(k) #K063234) | |
| Intended Use | The ambIT™Introducer products areintended allow for thepercutaneous placementof catheters in closeproximity to nerves and | The On-QIntroducers™ areintended for thepercutaneousintroduction andplacement of | |
| around or into surgicalwound or non-surgicalwound sites. It may beused to inject oraspirate theintroduction area viathe luer hub of theneedle. | catheters into oraround surgicalwound sites and/orclose proximity tonerves. Introducerswith a luer hub maybe used to aspirateor inject a bolus offluid or medicationprior to placing thecatheters. | ||
| Trade Names | ambIT Introducer,ambIT Needle, ambITSheath | ON-Q Needle,ON-Q Tunneler,ON-Q Sheath | |
| Materials ofConstruction | Needle | Needle | |
| • Stainless steel (304)needle 18 GA• Needle Hub-Polystyrene (clear) | • Stainless steel(304) needle 18GA• Needle Hub-Polystyrene(clear) | ||
| Sheath | Sheath | ||
| • Tear away hub- Highdensity Polyethylene(HDPE)• Sheath Shaft (tube)-High densityPolyethylene (HDPE)with 10%BaSO4 | • Tear away hub-High densityPolyethylene(HDPE)• Sheath Shaft(tube)- HighdensityPolyethylene(HDPE) with10% BaSO4 | ||
| Tunneler Sheath | Tunneler Sheath | ||
| • Sterile, single use product• Plastic peelable sheath | • Sterile, single useproduct• Plastic peelablesheath | ||
| 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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Image /page/2/Picture/1 description: The image shows a logo for Summit Medical Products. The logo features three mountain peaks, with the center peak being a lighter shade than the other two. Below the mountain peaks, the text "SUMMIT MEDICAL PRODUCTS" is written in a simple, sans-serif font.
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 (800) 638-2041 or (301) 796-7100 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:
Page 16 of 27
Summit Medical Products, Inc.
§ 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).