(231 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for the therapeutic aspiration of fluids from body cavities."
No
The device is indicated for the "therapeutic aspiration of fluids," which is a treatment, not a diagnostic process. While methods like ultrasound and fluoroscopy are mentioned for guidance during placement, their use is for ensuring the correct placement of the therapeutic device, not for diagnosing a condition.
No
The device description clearly details a physical catheter with various hardware components (needle, valve, hub, etc.) and mentions physical performance testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "therapeutic aspiration of fluids from body cavities." This describes a procedure performed on the patient's body to remove fluid.
- Device Description: The description details a physical catheter designed for insertion into the body for drainage. It mentions features like a needle, catheter, valve, and luer adapter for connecting to collection devices.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze the collected fluid for diagnostic purposes. The focus is solely on the removal of the fluid.
- No Mention of In Vitro Testing: The description and performance studies focus on the physical performance and safety of the device itself, not on its ability to perform tests on biological samples outside the body (which is the definition of in vitro).
IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. This device is used within the body for a therapeutic procedure.
N/A
Intended Use / Indications for Use
The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.
The Valved Safety Centesis Catheter is indicated for the therapeutic or diagnostic aspiration of fluids from body cavities.
Product codes
GCB
Device Description
The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound, fluoroscopy
Anatomical Site
body cavities
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 Valved Safety Centesis Catheter was subjected to functional and performance testing to demonstrate that the device performs as intended.
The following testing was performed:
- Visual Inspection .
- Radio-detectability
- Echogenicity ●
- Flow rate ●
- Occlusion
- Tensile strength
- Pressure testing ●
- Penetration force
- Safety feature verification ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4200 Introduction/drainage catheter and accessories.
(a)
Identification. An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
B. Braun Medical Incorporated Ms. Nancy Skocypec Regulatory Affairs Manager 901 Marcon Boulevard Allentown, Pennsylvania 18109
November 12, 2015
Re: K150800
Trade/Device Name: Valved Safety Centesis Catheter Regulation Number: 21 CFR 878.4200 Regulation Name: Introduction/drainage catheter and accessories Regulatory Class: Class I Product Code: GCB Dated: October 14, 2015 Received: October 20, 2015
Dear Ms. Skocypec:
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.
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
1
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 contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K150800
Device Name Valved Safety Centesis Catheter
Indications for Use (Describe)
The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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5. 510(k) SUMMARY
| Date: | November 10, 2015 |
|---|---|
| Submitter: | B. Braun Medical Inc. |
| Address: | 901 Marcon Boulevard |
| Allentown, PA 18109-9341 | |
| Phone number: | 610-266-0500 |
| Contact: | Nancy Skocypec |
| Phone: | (610) 596-2796 |
| Fax: | (610) 266-4962 |
| E-mail: | nancy.skocypec@bbraun.com |
| Trade name: | Valved Safety Centesis Catheter |
| Common name: | Centesis Catheter |
| Product Code: | GCB, Needle, Catheter |
| Regulation: | 21 CFR 878.4200, Drainage Catheter, Class II |
| Predicate Device: | Paracentesis Catheter, Allegiance Healthcare Corporation, |
| K974146 | |
| Reference device: | Introcan Safety 3. B. Braun Medical Inc., K111236 |
Description:
The Valved Safety Centesis Catheter is a drainage, centesis catheter with a self sealing valve and a passive safety needle-shielding feature. The catheter is designed with drainage holes located around the distal tip of the catheter to facilitate the drainage of fluid. The catheter surface and tapered end is designed for smooth transition through the tissue, while the inner surface is designed for easy retraction of the insertion needle. The insertion needle comes with a vent plug that allows air to exit and does not allow fluid to exit. The echogenic needle tip provides a guidance for proper catheter placement using ultrasound. The needle hub is clear and locks within the catheter hub. The catheter is radiopaque and can be visualized using fluoroscopy. The hub of the catheter contains a luer adapter to facilitate attachment of drainage collection devices and a bevel indicator for needle bevel orientation reference. The device is provided individually packaged sterile.
A drainage catheter under 21 CFR 878.4200 is normally classified as Class I exempt; however, this device has a sharps injury prevention feature. According to the FDA Guidance, "Medical Devices with Sharps Injury Prevention Features", devices with sharps injury prevention features are Class II devices subject to 21 CFR Part 820 Quality System Regulation. Therefore, under 21 CFR 878.9, a premarket notification is required before introducing this catheter into interstate commerce for commercial distribution.
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Indications for Use:
The Valved Safety Centesis Catheter is indicated for the therapeutic or diagnostic aspiration of fluids from body cavities.
Substantial Equivalence:
Technical Characteristics
The Valved Safety Centesis Catheter has the following similarities to the predicate device:
- Intended use
- Indications for use ●
- Catheter-over-the-needle design ●
- Principle of operation ●
- Self sealing valve .
- Radiopaque catheter ●
The differences between the predicate and subject device include a sharps injury prevention feature, catheter material composition and attached components.
Performance Testing
The proposed Valved Safety Centesis Catheter was subjected to functional and performance testing to demonstrate that the device performs as intended.
The following testing was performed:
- Visual Inspection .
- Radio-detectability
- Echogenicity ●
- Flow rate ●
- Occlusion
- Tensile strength
- Pressure testing ●
- Penetration force
- Safety feature verification ●
Biocompatibility Testing
Biocompatibility testing and chemical characterization was completed considering the recommendations defined in ISO 10993-1. The biocompatibility testing verified that no new issues of biocompatibility have been introduced with the proposed devices and therefore support the biological safety of the materials of composition.
Results of performance and biocompatibility testing demonstrate that the proposed device performs similarly to the predicate device and can be used safely and effectively 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.
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Conclusion:
Results of testing conducted on the proposed device demonstrate that the Valved Safety Centesis Catheter is safe and effective when used in accordance with its intended use. The differences, between subject device and predicate device, do not raise any new issues of safety and effectiveness. The Valved Safety Centesis Catheter is therefore substantially equivalent to the predicate device.