(29 days)
Not Found
No
The summary describes a device for nerve block using electrical stimulation and a catheter, with no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an anesthesia conduction catheter used for continuous nerve block anesthesia or analgesia, which are therapeutic techniques to manage pain or facilitate medical procedures.
No
The device is described as an "anesthesia conduction catheter" used to "locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia." Its purpose is for treatment (anesthesia/analgesia), not for diagnosing a disease or condition. The performance studies also focus on physical properties and safety for its intended use, rather than diagnostic accuracy.
No
The device description explicitly states it is an "anesthesia conduction catheter that is electrically conductive," indicating it is a physical hardware device. The performance studies also focus on physical properties like flow rate, leak tests, and bond strength, further confirming it is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques." This is a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a catheter used for nerve stimulation and placement, which is a medical device used in a clinical setting, not a diagnostic test.
- 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 or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
This device is a medical device used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Arrow StimuCath™ continuous nerve block set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
Product codes
CAZ
Device Description
The StimuCath™ continuous nerve block device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the user can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nerves and nerve plexuses
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
Tests were performed to demonstrate substantial equivalence in the following areas:
- Flow rate
- Leak test (positive pressure)
- Holding strength of SnapLock™ adapter to catheter
- Snap force of SnapLock™
- Biocompatibility tests
- Power and current density calculations
- Bond strength
- Dielectric tests
- Peel back tests
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
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510(k) Summary
| Submitter: | ARROW International, Inc.
2400 Bernville Road
Reading, PA 19605-9607 USA |
|---------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Brandon Epting, Regulatory Associate
Phone: 610-378-0131, ext. 8498
Fax: 610-374-5360
Email: brandon.epting@arrowintl.com |
| Date summary prepared: | 03/24/03 |
| Device trade name: | StimuCath™ continuous nerve block set. |
| Device common name: | Peripheral nerve stimulating catheter and needle. |
| Device classification name: | CAZ, Class II, 21 CFR 868.5140, Anesthetic conduction kit. |
| Legally marketed devices to
which the device is
substantially equivalent: | - Arrow StimuCath™ continuous nerve block set (K021567).
- HDC® Corporation CLA™ regional block needle (K994059). |
| Description of the device: | The StimuCath™ continuous nerve block device is an
anesthesia conduction catheter that is electrically conductive.
Using peripheral nerve stimulation, the user can locate specific
nerves or nerve plexuses for continuous nerve block
anesthesia or analgesia. |
| Intended use of the device: | The Arrow StimuCath™ continuous nerve block set permits
placement for catheters next to nerves and nerve plexuses for
continuous nerve block anesthesia or analgesia. It is indicated
for use up to 72 hours. |
| Technological
characteristics: | The proposed device has the same technological
characteristics as the predicate devices. |
| Performance tests: | Tests were performed to demonstrate substantial equivalence
in the following areas: - Flow rate
- Leak test (positive pressure)
- Holding strength of SnapLock™ adapter to catheter
- Snap force of SnapLock™
- Biocompatibility tests
- Power and current density calculations
- Bond strength
- Dielectric tests
- Peel back tests |
| Conclusions: | The results of the laboratory tests demonstrate that the device
is as safe and effective as the legally marketed predicate
devices. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines that suggest a profile view of a person's head and shoulders.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 3 2003
Mr. Brandon Epting Regulatory Associate ARROW International, Incorporated 2400 Bernville Road Reading, Pennsylvania 19605-9607
Re: K030937
Trade/Device Name: StimuCath™ Continuous Nerve Block Set Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: March 24, 2003 Received: March 25, 2003
Dear Mr. Epting:
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 your 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.
2
Page 2 - Mr. Epting
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 (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.
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) 594-4646. 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 vours.
Suxer Runoes
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATIONS FOR USE STATEMENT
| 510(k) Number (if known): | K030937 |
|---|---|
| Device Name: | StimuCath™ continuous nerve block set |
| Indications for Use: | The Arrow StimuCath™ continuous nerve block set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
SAWutrsh
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number: K030937
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