(60 days)
Not Found
No
The summary describes a simple cannula for fluid transfer and drug admixture, with no mention of AI, ML, image processing, or any computational analysis of data.
No.
The "Intended Use" states that the cannula is for "aspiration of fluids for fluid transfer" and "drug admixture only," which are procedural functions rather than therapeutic interventions directly treating a disease or condition.
No
The device is a cannula intended for fluid transfer and drug admixture, not for identifying a disease or condition.
No
The device description clearly describes a physical cannula, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aspiration of fluids for fluid transfer" and "drug admixture only." This describes a device used for handling and preparing medications or other fluids, not for testing biological samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description of a cannula for fluid transfer aligns with the intended use and does not suggest any diagnostic function.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information about a patient's health status.
The device is a tool for fluid handling, which is a common medical procedure, but it does not perform a diagnostic test itself.
N/A
Intended Use / Indications for Use
The Sterican™ Cannula is intended for the aspiration of fluids for fluid transfer and may be used with a syringe for transferring fluids from stoppered vials, glass or plastic ampoules. The Sterican™ Cannula is intended for drug admixture only.
Product codes (comma separated list FDA assigned to the subject device)
FMI
Device Description
The Sterican™ Cannula is a semi blunt, 18G (1.20mm) x 1½ inch (40 mm) cannula configuration with a single cut bevel (40°). The hub can be used to establish either slip fit or locking type connections to male 6% (Luer) taper slip fit or locking type adapters.
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
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)
Biocompatibility and performance testing was performed with Sterican™ Cannula to support substantial equivalence to the predicate device. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing was performed to demonstrate safety and effectiveness.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Ki31842
5. 510(k) SUMMARY
AUG 2 0 2013
| DATE: | August 16, 2013 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| 610-266-0500 | |
| Contact: Kimberly Smith, Regulatory Affairs Specialist | |
| Phone: (610) 596-2326 | |
| Fax: (610) 266-4962 | |
| E-mail: kim.smith@bbraun.com | |
| DEVICE NAME: | Sterican™ Cannula |
| COMMON NAME: | Cannula |
| DEVICE | |
| CLASSIFICATION: | 21 CFR §880.5570, Class II |
| Hypodermic single lumen needle | |
| Classification Product Code: FMI | |
| PREDICATE DEVICE: | 510(k) Number: K944931 |
| Device Name: Becton Dickinson Blunt Steel Cannula | |
| Classification Product Code: FMI | |
| Regulation Number: §880.5570, Class II | |
| Applicant: BD Becton Dickinson Vacutainer Systems Preanalytic |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION
The Sterican™ Cannula is a semi blunt, 18G (1.20mm) x 1½ inch (40 mm) cannula configuration with a single cut bevel (40°). The hub can be used to establish either slip fit or locking type connections to male 6% (Luer) taper slip fit or locking type adapters.
INDICATIONS FOR USE
The Sterican™ Cannula is intended for the aspiration of fluids for fluid transfer and may be used with a syringe for transferring fluids from stoppered vials, glass or plastic ampoules. The Sterican™ Cannula is intended for drug admixture only.
SUBSTANTIAL EQUIVALENCE
B. Braun Medical Inc's. Sterican™ Cannula is substantially equivalent to the predicate device having similar indications for use, technological properties and performance.
Technical Characteristics
Sterican™ Cannula has similar physical and technical characteristics to the predicate device. Both the Sterican™ Cannula and the predicate device are comprised of a protective cap,
1
stainless steel cannula and a hub. Both devices are comprised of similar materials and components.
Performance Data
Biocompatibility and performance testing was performed with Sterican™ Cannula to support substantial equivalence to the predicate device. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing was performed to demonstrate safety and effectiveness.
CONCLUSION
Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Sterican™ Cannula is considered substantially equivalent to the predicate device and is safe and effective for its intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 20, 2013
B. Braun Medical, Incorporated Ms. Kimberly Smith Regulatory Affairs Specialist 901 Marcon Boulevard ALLENTOWN PA 18109-9341
Re: K131842
Trade/Device Name: Sterican™ Cannula Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: II Product Code: FMI Dated: June 17, 2013 Received: June 21, 2013
Dear Ms. 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 I ou may, dietelo, mannot 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 - Ms. Smith
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Page _________________________________________________________________________________________________________________________________________________________________________
K131842 510(k) Number (if known): __
Device Name: Sterican™ Cannula
Indications For Use:
The Sterican™ Cannula is intended for the aspiration of fluids for fluid transfer and may be used with a syringe for transferring fluids from stoppered vials, glass or plastic ampoules. The Sterican™ Cannula is intended for drug admixture only.
Prescription Use X (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Richard C. Chapman 2013.09.16 10:27:02 -04'00'