(15 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and sterilization of a physical tunneling device, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a tool for the percutaneous introduction of catheters, not as a device that delivers a therapeutic effect itself.
No
Explanation: The device is described as a "tunneler" intended for the "percutaneous introduction of catheters." Its purpose is to facilitate the placement of other medical devices (catheters), not to diagnose a medical condition.
No
The device description clearly outlines physical components made of stainless steel and a peelable sheath, indicating it is a hardware device used for percutaneous introduction of catheters. There is no mention of software as a component or function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "percutaneous introduction of catheters." This is a procedure performed directly on a patient's body.
- Device Description: The device is a "reusable device indicated for use in the percutaneous introduction of catheters into and around the surgical wound site or close to the nerve." This describes a surgical or procedural tool used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze biological samples. This device is clearly intended for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
BSO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
into and around the surgical wound site or close to the nerve.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 #212 |
| Salt Lake City, UT 84115 | |
| Contact Person: | Marko Van Amen |
| VP of Regulatory Affairs/Quality Assurance | |
| Tel: 801.214.3464 | |
| Fax: 801.352.1888 | |
| Email 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.
1
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.
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.
2
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.
3
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.
4
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
5
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