Valved Safety Centesis Catheter

K150800 · B.Braun Medical, Inc. · GCB · Nov 12, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K150800
• Device Name: Valved Safety Centesis Catheter
• Applicant: B.Braun Medical, Inc.
• Product Code: GCB · General, Plastic Surgery
• Decision Date: Nov 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Valved Safety Centesis Catheter is indicated for the therapeutic aspiration of fluids from body cavities.

Device Story

Valved Safety Centesis Catheter is a drainage catheter featuring a self-sealing valve and passive needle-shielding mechanism. Device inputs include manual insertion into body cavities; echogenic needle tip facilitates ultrasound-guided placement. Catheter includes distal drainage holes, radiopaque material for fluoroscopic visualization, and a luer adapter for connection to drainage collection devices. Insertion needle includes a vent plug allowing air exit while preventing fluid leakage. Device is used by clinicians in clinical settings for fluid aspiration. Passive safety feature shields needle after use to prevent sharps injury. Output is the successful drainage of body cavity fluids, aiding in therapeutic or diagnostic management. Benefits include reduced risk of sharps injury to healthcare providers and efficient fluid removal.

Clinical Evidence

No clinical testing was performed. Substantial equivalence supported by bench testing, including visual inspection, radio-detectability, echogenicity, flow rate, occlusion, tensile strength, pressure testing, penetration force, and safety feature verification. Biocompatibility testing conducted per ISO 10993-1.

Technological Characteristics

Catheter-over-needle design; radiopaque; echogenic needle tip; self-sealing valve; luer adapter; passive needle-shielding safety feature. Materials evaluated per ISO 10993-1. Sterile, single-use.

Indications for Use

Indicated for therapeutic or diagnostic aspiration of fluids from body cavities in patients requiring centesis procedures.

Regulatory Classification

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.

Predicate Devices

• Paracentesis Catheter, Allegiance Healthcare Corporation (K974146)

Reference Devices

• Introcan Safety 3, B. Braun Medical Inc. (K111236)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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<br>Allentown, PA 18109-9341 |
| Phone number: | 610-266-0500 |
| Contact: | Nancy Skocypec |
| Phone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| 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,<br>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.