(205 days)
Not Found
No
The device description and performance studies indicate a purely mechanical, manually operated device with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The device facilitates the placement of a catheter but does not directly treat a disease or condition itself.
No
This device is an introducer needle used for the percutaneous placement of catheters, which is a therapeutic or interventional function, not a diagnostic one. It facilitates the delivery of other instruments or substances, rather than gathering information or diagnosing a condition.
No
The device description clearly outlines physical components (Stainless Steel Needle Hub, Tear-Away Sheath Hub, Tear-Away Sheath Shaft, Protective Guard) and describes a manual insertion procedure, indicating it is a hardware device.
Based on the provided information, the B. Braun Tear-Away Introducer Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the percutaneous placement of catheters in close proximity to nerves and around or into surgical/non-surgical wound sites. This is a procedure performed on the patient's body, not on a sample taken from the patient.
- Device Description: The device is described as a sterile, single-use, disposable device consisting of a needle, sheath, and protective guard. It is manually operated and inserted into the patient's skin. This aligns with a surgical/interventional tool, not a diagnostic test performed on a sample.
- Mechanism of Action: The device facilitates the placement of a catheter within the patient's body. It does not analyze or test any biological sample.
- 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 diagnostic, monitoring, or compatibility purposes.
In summary, the B. Braun Tear-Away Introducer Needle is a medical device used for a procedural purpose (catheter placement) within the patient's body, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.
Product codes (comma separated list FDA assigned to the subject device)
BSO
Device Description
The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.
The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.
The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.
The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon in a clinical hospital setting
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)
Nonclinical tests for determination of substantial equivalence:
- Visual Dimensional Inspection
- Luer Compatibility-Gauging
- Needle Removal Force
- Occlusion
- Pressure
- Cannula Deflection
- Cannula Breakage
- Tensile Strength
- Associated Device
- Stress Cracking
- Fluid Leakage by Pressure Decay
- Subatmospheric Pressure Air Leakage
- Resistance to Separation from Unscrewing
- Resistance to Separation from Axial Load
- Resistance to Overriding
Results of the testing demonstrate that the proposed device performs similarly to the predicate device and can be used according to its intended use. No clinical testing was performed, as this device does not require clinical studies to demonstrate substantial equivalence with the predicate device.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 22, 2017
B. Braun Medical Inc. Kimberly Smith Sr. Regulatory Affairs Specialist 901 Marcon Blvd. Allentown, Pennsylvania 18109
Re: K171584
Trade/Device Name: B. Braun Tear-Away Introducer Needle Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: Class II Product Code: BSO Dated: November 21, 2017 Received: November 21, 2017
Dear Kimberly Smith:
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.
1
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K171584
Device Name
B. Braun Tear-Away Introducer Needle
Indications for Use (Describe)
The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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4
510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
610-266-0500
Contact: Kimberly Smith, Sr. Regulatory Affairs Specialist |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: (610) 596-2326
Fax: (610) 266-4962
E-mail: Kim.smith@bbraun.com |
| DATE: | December 22, 2017 |
| DEVICE NAME: | B. Braun Tear-Away Introducer Needle |
| COMMON NAME: | Catheter Introducer |
| CLASSIFICATION: | Class II per 21 CFR 868.5120, Anesthesia conduction catheter
Product Code: BSO
Panel: Anesthesiology |
| PREDICATE DEVICE: | Summit Medical Products, ambIT® Introducer
K102460, Class II, BSO, 868.5120 |
Description
The B. Braun Tear-Away Introducer Needle is a sterile, single-use, disposable device, that consists of a Stainless Steel Needle Hub. Tear-Away Sheath Hub. Tear-Away Sheath Shaft (tube) and a Protective Guard over the needle.
The B. Braun Tear-Away Introducer Needle is a manually operated device inserted into a patients skin by a surgeon in a clinical hospital setting for the percutaneous introduction of a catheter.
The plastic guard is removed and the B. Braun Tear-Away Introducer Needle is placed through the patient's skin with the bevel tip up. The needle is then withdrawn from the Tear-Away Introducer Sheath and discarded.
The Tear-Away Introducer Needle Sheath remains in the patient to facilitate the placement of an introduction catheter. An introduction catheter is inserted thru the Tear-Away Introducer Needle Sheath and into the patient. Once the introduction catheter is placed to the desired location, the Tear-Away Introducer Needle Sheath is withdrawn by sliding the sheath back towards the hub of the catheter. The Tear-Away Introducer Needle Sheath is then split apart and peeled away from the catheter while holding the hub of the sheath at the T-handle. The Tear-Away Introducer Needle Sheath is then discarded.
5
Intended Use
The B. Braun Tear-Away Introducer Needle is intended for the percutaneous placement of a catheter.
Indications for Use
The B. Braun Tear-Away Introducer Needle is intended to allow for the percutaneous placement of catheters in close proximity to nerves and around or into surgical wound or non-surgical wound sites.
Substantial Equivalence
Predicate Device - Summit Medical Products, ambIT Introducer (K102460)
The B. Braun Tear-Away Introducer Needle presented in this submission has the identical intended use, similar indications for use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of the same components and similar materials and meet performance specifications similar to the predicate device.
| Characteristic | Proposed | Predicate Device – K102460 |
|---|---|---|
| B. Braun Tear-Away Introducer Needle | ambIT Introducer | |
| Intended Use | Percutaneous placement of a catheter. | Percutaneous placement of a catheter. |
| Indications for Use | The B. Braun Tear-Away Introducer Needle | |
| is intended to allow for the percutaneous | ||
| placement of catheters in close proximity to | ||
| nerves and around or into surgical wound or | ||
| non-surgical wound sites. | The amibIT Introducer products line is | |
| intended to 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. | ||
| Materials of | ||
| construction | Needle - Stainless steel (304) | |
| Needle hub - polystyrene (clear) | ||
| Tear-away sheath hub – HDPE with | ||
| Masterbatch light blue | ||
| Tear-away sheath tube - HDPE with 10% | ||
| BaSO4, 1% TiO2 | ||
| Protective Needle Guard – LDPE | Needle - Stainless steel (304), 18 Ga | |
| Needle hub - polystyrene (clear) | ||
| Tear-away sheath hub – HDPE | ||
| Sheath shaft (tube) - HDPE with 10% BaSO4 | ||
| Summary of | ||
| nonclinical tests for | ||
| determination of | ||
| substantial | Visual | |
| • Dimensional Inspection | ||
| • Luer Compatibility-Gauging | ||
| • Needle Removal Force | ||
| • Occlusion | ||
| • Pressure | ||
| • Cannula Deflection | ||
| • Cannula Breakage | ||
| • Tensile Strength | ||
| • Associated Device | ||
| • Stress Cracking | ||
| • Fluid Leakage by Pressure Decay | ||
| • Subatmospheric Pressure Air Leakage | ||
| • Resistance to Separation from Unscrewing | ||
| • Resistance to Separation from Axial Load | ||
| • Resistance to Overriding | • Liquid Leakage test | |
| • Air Leakage test | ||
| • Separation Force test | ||
| • Unscrewing Torque | ||
| • Ease of assembly | ||
| • Resistance to Overriding | ||
| • Stress Cracking | ||
| • Force to Break | ||
| • Strength of Union |
6
| Characteristic | Proposed | Predicate Device – K102460 |
|---|---|---|
| B. Braun Tear-Away Introducer Needle | ambIT Introducer | |
| Principle of | ||
| operation | Manual | Manual |
| Environment of use | For use by a surgeon in hospital environments | Unknown |
| Sterilization Method | Ethylene Oxide, SAL 10-6 | Unknown |
| Biocompatibility | ||
| and Contact | ||
| Duration | External Communicating Device – | |
| Tissue/Bone/Dentin, Limited ( |