(29 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (StimuCath™ continuous nerve block set) seeking market clearance, not an AI/ML device study. Therefore, the information requested in the prompt, which is typically found in studies evaluating AI/ML device performance, is not present in the provided document.
The document describes the device, its intended use, technological characteristics, and performance tests conducted to demonstrate substantial equivalence to predicate devices. However, these tests are traditional engineering and biocompatibility tests, not studies on the statistical performance of an AI model concerning a specific medical task.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance in the context of AI/ML metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for a test set for AI/ML evaluation.
- Data provenance (country of origin, retrospective/prospective) for AI/ML data.
- Number of experts or their qualifications for establishing ground truth for AI/ML.
- Adjudication method for an AI/ML test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes for AI assistance.
- Standalone (algorithm only) performance for an AI/ML model.
- Type of ground truth (e.g., expert consensus, pathology, outcomes data) used for AI/ML.
- Sample size for a training set for AI/ML.
- How ground truth for the training set was established for AI/ML.
The "Performance tests" section lists engineering and biological tests demonstrating the device's physical and material properties, rather than diagnostic or prognostic performance evaluated by AI. These include:
-
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
The conclusion states that "The results of the laboratory tests demonstrate that the device is as safe and effective as the legally marketed predicate devices." This refers to its physical and functional safety and efficacy, not the performance of an AI algorithm.
{0}------------------------------------------------
| 123 |
|---|
| ర్యాల |
| j |
510(k) Summary
| Submitter: | ARROW International, Inc.2400 Bernville RoadReading, PA 19605-9607 USA |
|---|---|
| Contact person: | Brandon Epting, Regulatory AssociatePhone: 610-378-0131, ext. 8498Fax: 610-374-5360Email: 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 towhich the device issubstantially 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 ananesthesia conduction catheter that is electrically conductive.Using peripheral nerve stimulation, the user can locate specificnerves or nerve plexuses for continuous nerve blockanesthesia or analgesia. |
| Intended use of the device: | The Arrow StimuCath™ continuous nerve block set permitsplacement for catheters next to nerves and nerve plexuses forcontinuous nerve block anesthesia or analgesia. It is indicatedfor use up to 72 hours. |
| Technologicalcharacteristics: | The proposed device has the same technologicalcharacteristics as the predicate devices. |
| Performance tests: | Tests were performed to demonstrate substantial equivalencein 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 deviceis as safe and effective as the legally marketed predicatedevices. |
{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
مه محمد من معاهدات المحارث من محمد المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث المحارث ال
§ 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).