(37 days)
Not Found
No
The summary describes a physical medical device (catheter and accessories) used for nerve blocks with electrical stimulation for nerve location. There is no mention of software, algorithms, data processing, or any terms related to AI/ML. The performance studies focus on physical and functional characteristics of the device.
Yes
The device is used for continuous nerve block anesthesia or analgesia, which are therapeutic techniques aimed at managing pain or facilitating surgical procedures.
No
The device is an anesthesia conduction catheter used to deliver continuous nerve block anesthesia or analgesia, not to diagnose a condition. Its function is interventional, not diagnostic.
No
The device description clearly states it is an "anesthesia conduction catheter that is electrically conductive" and is available in a kit with "necessary accessories required to perform the procedure and fix the catheter in place." This indicates a physical, hardware-based medical device, not a software-only one.
Based on the provided information, the Arrow StimuCath™ Continuous Nerve Block Set is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- StimuCath™ Function: The StimuCath™ is a catheter used in vivo (within the body) to deliver anesthesia or analgesia directly to nerves. It uses electrical stimulation to help locate the nerves.
- Intended Use: The intended use clearly states it's for "continuous nerve block anesthesia or analgesia techniques." This is a therapeutic procedure, not a diagnostic test performed on a specimen.
- Device Description: The description focuses on its function as an "anesthesia conduction catheter" and its use in a clinical procedure.
Therefore, the StimuCath™ is a medical device used for a therapeutic purpose within the body, not an IVD used for testing specimens outside the body.
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. It is indicated for use up to 72 hours.
# Product codes (comma separated list FDA assigned to the subject device)
73 CAZ
# Device Description
The StimuCath™ Continuous Nerve Block Device is an anesthesia conduction catheter that is electrically conductive. Using peripheral nerve stimulation, the clinician can locate specific nerves or nerve plexuses for continuous nerve block anesthesia or analgesia. The StimuCath™ is available sterile in a kit with the necessary accessories required to perform the procedure and fix the catheter in place.
# 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests were performed to demonstrate substantial equivalence:
- Holding strength of Snap-Lock™ adapter to catheter .
- Snap force of Snap-Lock TM .
- Leak test (positive pressure) .
- Flow rate
- Biocompatibility tests
- Power and current density calculations .
- Clinical study .
The results of the laboratory tests, calculations and the clinical study demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
[K801912](https://510k.innolitics.com/search/K801912), [K831715](https://510k.innolitics.com/search/K831715), [K840287](https://510k.innolitics.com/search/K840287)
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
JUN 1 9 2002
StimuCath Continuous Nerve Block Set
510(k) Premarket Notification
121567
SECTION 3. 510K SUMMARY
| Submitter: | Arrow International Inc.
2400 Bernville Road
Reading, PA 19605 |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | William G. McLain
Manager, Regulatory Submissions
and Quality Systems |
| | Phone: 610-378-0131
Fax: 610-478-3188
E-mail: bill.mclain@arrowintl.com |
| Date summary prepared: | 5/8/02 |
| Device trade name: | StimuCath™ Continuous Nerve Block Set |
| Device common name: | Peripheral nerve stimulating catheter and needle |
| Device classification
name: | CAZ, Class II at 21 CFR 868.5140, Anesthetic Conduction Kit |
| Legally marketed devices
to which the device is
substantially equivalent: | K801912: Arrow TheraCath® Epidural Catheter
K831715: HDC Corp Neurotrac
K840287: Contiplex Continuous Nerve Block Set |
| Description of device: | The StimuCath™ Continuous Nerve Block Device is an
anesthesia conduction catheter that is electrically conductive.
Using peripheral nerve stimulation, the clinician can locate
specific nerves or nerve plexuses for continuous nerve block
anesthesia or analgesia.
The StimuCath™ is available sterile in a kit with the necessary
accessories required to perform the procedure and fix the
catheter in place. |
| Intended use of the
device: | 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. It
is indicated for use up to 72 hours. |
| Technological
characteristics: | The proposed device has similar technological characteristics
to the predicate devices including design, packaging,
sterilization and labeling. |
Comments of the country of the comments of
· · · · · · ·
1
Performance tests:
The following tests were performed to demonstrate substantial equivalence:
- Holding strength of Snap-Lock™ adapter to catheter .
- Snap force of Snap-Lock TM .
- Leak test (positive pressure) .
- Flow rate
- Biocompatibility tests
- Power and current density calculations .
- Clinical study .
Conclusions:
The results of the laboratory tests, calculations and the clinical study demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 . Corporate Boulevard Rockville MD 20850
JUN 1 9 2002
Arrow International Inc c/o Mr. William G. McLain Manager, Regulatory Submissions and Quality Systems 2400 Bernville Road Reading, PA 19605
Re: K021567
StimuCath™ Continuous Nerve Block Set Regulation Number: 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II (two) Product Code: 73 CAZ Dated: May 8, 2002 Received: May 13, 2002
Dear Mr. McLain:
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.
3
Page 2 - Mr. William G. McLain
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Deaht Ten
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification
SECTION 13. INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Ko21567
Device Name:
StimuCath™ Continuous Nerve Block device (SCNB).
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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K021567