(123 days)
The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative, perioperative and postoperative periods associated with general and orthopedic surgery.
The B. Braun Nerve Block Catheter consists of polyamide tubing with an open or closed rounded tip, and will be available in sizes ranging from 18 G to 24 G, with a length ranging from 400 mm to 1010 mm. A soft tip version of the catheter (with a Pebax soft tip welded to the catheter body) will also be available in a closed tip configuration.
The provided 510(k) summary for the "B. Braun Nerve Block Catheter" does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. This type of document, a 510(k) summary, primarily focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance study results against pre-defined acceptance criteria.
The information provided describes:
- Device Name: B. Braun Nerve Block Catheter
- Intended Use: To provide continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management.
- Predicate Devices: B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233), B. Braun Medical Inc. Perifix® Set for Epidural Anesthesia with Tuohy Needle and Catheter (K813186), I-Flow Corporation Nerve Block Infusion Kit (K984502), I-Flow Corporation Intra Op Catheter (K991543).
- Substantial Equivalence Argument: The device has similar materials, construction, design, and intended use as the predicate devices. Differences mentioned are in the location of catheter markings and size range compared to the B. Braun predicate, and similar indications for use to the I-Flow predicates.
Therefore, I cannot fulfill your request for the table of acceptance criteria and associated study details because this information is not present in the provided text.
To reiterate, a 510(k) submission generally focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics and intended use, and may involve bench testing to ensure safety and effectiveness, but it rarely includes detailed clinical or performance studies with pre-defined acceptance criteria and statistical analysis as would be found for a novel device or a PMA submission.
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JUL 15 2003 8.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2280Contact: Patricia D. Wilson, Regulatory Affairs Specialist |
|---|---|
| DEVICE NAME: | B. Braun Nerve Block Catheter |
| COMMON OR USUALNAME: | Nerve Block Catheter / Elastomeric Infusion Pump Accessory |
| DEVICECLASSIFICATION: | Class II, 21 CFR 868.5120 (Anesthetic Conduction Catheter) and21 CFR § 880.5725 (Elastomeric Infusion Pump) |
| PREDICATE DEVICE: | B. Braun Medical Inc. Soft Tip Epidural Catheter Kit (K971233)B. Braun Medical Inc. Perifix® Set for Epidural Anesthesia withTuohy Needle and Catheter (K813186)I-Flow Corporation Nerve Block Infusion Kit (K984502)I-Flow Corporation Intra Op Catheter (K991543) |
| DESCRIPTION: | The B. Braun Nerve Block Catheter consists of polyamide tubingwith an open or closed rounded tip, and will be available in sizesranging from 18 G to 24 G, with a length ranging from 400 mm to1010 mm. A soft tip version of the catheter (with a Pebax soft tipwelded to the catheter body) will also be available in a closed tipconfiguration. |
| ●INTENDED USE: | The B. Braun Nerve Block Catheter is a device intended to provide,via percutaneous administration, continuous and/or intermittentinfusion of local anesthetics near a nerve for regional anesthesia andpain management during the pre-operative, perioperative andpostoperative periods associated with general and orthopedic surgery. |
| SUBSTANTIALEQUIVALENCE: | The B. Braun Nerve Block Catheter has the same materials,method of construction, and similar design as the Perifix® EpiduralCatheters that are marketed under the B. Braun Medical Inc.Premarket Notifications K971233 and K813186. TheB. Braun Nerve Block Catheter differs from the Perifix EpiduralCatheter in the intended use, the location of catheter markings, andthe size range. |
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SUBSTANTIAL EQUIVALENCE (continued):
.
The indications for the B. Braun Nerve Block Catheter are similar to the indications for the Nerve Block Infusion Kit and the Intra Op Catheter that are marketed by I-Flow Corporation under the Premarket Notifications K984502 and K991543.
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Patricia D. Wilson Regulatory Affairs Specialist B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109
Re: K030830
Trade/Device Name: B. Braun Nerve Block Catheter Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: CFR Product Code: II Dated: June 11, 2003 Received: June 18, 2003
Dear: Ms. Wilson
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.
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
JUL 15 2003
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Page 2 - Ms. Wilson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Suser Pumm
Susan Runner, DDDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use Statement
Page
| 510(k) Number (if known): | K030830 |
|---|---|
| Device Name: | B. Braun Nerve Block Catheter |
Indications For Use:
The B. Braun Nerve Block Catheter is a device intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics near a nerve for regional anesthesia and pain management during the pre-operative and postoperative and postoperative periods associated with general and orthopedic surgery.
Susan Runo!
(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
B. Braun Medical Inc. 510(k) Premarket Notification B. Braun Nerve Block Catheter
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§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).