(135 days)
Not Found
No
The description focuses on the mechanical design of the needle (fenestrations, materials) and its intended use for delivering anesthetic. There is no mention of any computational or algorithmic components, let alone AI/ML.
Yes
The device is a needle used to deliver local anesthesia for nerve blocking, which is a therapeutic intervention.
No
The device is described as a needle for delivering local anesthesia for nerve blocks, not for diagnosis.
No
The device description clearly states it consists of a plastic hub and a stainless steel cannula, which are physical hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide local or regional nerve blocking by the injecting of a local anesthesia." This is a therapeutic procedure performed directly on a patient's body.
- Device Description: The device is a needle designed for injecting substances into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed for testing biological samples in vitro (outside the body). This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
IMD's New Fenestrated Nerve Block Needle is a single patient use peripheral nerve block needle with injection capabilities. It can be used to provide local or regional nerve blocking by the injecting of a local anesthetic.
It is to be used only under the direction of a licensed clinician.
Product codes (comma separated list FDA assigned to the subject device)
CAZ
Device Description
The IMD Inc. Fenestrated Nerve Block Needle shares major similarities with the predicate device(s), inasmuch as the configuration, materials, use, labeling and safety issues remain basically unchanged to the IMD predicates. It consists of a plastic hub, and a stainless steel cannula. It has the same pencil point and same side outlet (only more). The addition of fenestrations is similar to predicate anesthesia catheters.
The IMD New Fenestrated Peripheral Nerve Block Needle is an anesthetic needle for peripheral nerve blocks using a local anesthetic solution. The distinct advantage offered by IMD's Fenestrated Peripheral Nerve Block Needle is due to the fenestrations. These eliminate the critical locating of the desired nerve to be blocked and only require that the needle be located in the general area for effective use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed clinician
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
Its safety and effectiveness was further tested cli under IDE G040058 and appropriate IRBs.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
No record of unexpected patient problems or adverse reactions were found in our O review of the FDA's MAUDE, Safety Alert, and MDR databases;
The device and its packaging are tested by an independent lab for sterility, with O validated sterilization, and will be subjected to inspection / testing by Interlity, with process OC, and finished goods QC, and monitored in the field by means of our
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.
K052946, K073187, K070354, K931644, K030830, K991543
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
SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 0 2012
SUBMITTED BY: IMD INC.
560 Hwy 39 P O Box 510 Huntsville UT 84317 (800)-824-8223. or (801) 745-4700
-
- DEVICE NAME (Trade/common, and classification): IMD's Fenestrated Peripheral Nerve Block Needle;
Product Code: CAZ (BSP, MEB)
- DEVICE NAME (Trade/common, and classification): IMD's Fenestrated Peripheral Nerve Block Needle;
Regulation Nos .: 868.5140 (868.5150, 880.5725)
02. PREDICATE DEVICES:
- MPS Acacia Nerve Block Needle, K052946, cleared 12/08/2005; .
- Life-Tech's Peripheral Nerve Block Support Tray, K073187, cleared 04/22/2008. .
See also the FDA's 510(k) database of several other products under the same or similar classification (BSP, 868.5150; MEB, 880.5725), also found SE, or preammendment.
- IMD's Anesthetic Needles (Touhy, Quincke and Pencil Point), K070354, cleared . 10/05/2007; identical materials, manufacturers, sterilizers as IMD's Fenestrated Needle:
- IMD's Anesthetic Needle (Gertie Marx), K931644, 09/22/1993; also identical . materials, manufacturers, sterilizers;
- . B. Braun Nerve Block Catheter, K030830, 07/15/2003; fenestrations;
- I-Flow Corp's Intraop Catheter, K991543, 10/25/1999; fenestrations. .
-
- DESCRIPTION: The IMD Inc. Fenestrated Nerve Block Needle shares major similarities with the predicate device(s), inasmuch as the configuration, materials, use, labeling and safety issues remain basically unchanged to the IMD predicates. It consists of a plastic hub, and a stainless steel cannula. It has the same pencil point and same side outlet (only more). The addition of fenestrations is similar to predicate anesthesia catheters.
The IMD New Fenestrated Peripheral Nerve Block Needle is an anesthetic needle for peripheral nerve blocks using a local anesthetic solution. The distinct advantage offered by IMD's Fenestrated Peripheral Nerve Block Needle is due to the fenestrations. These eliminate the critical locating of the desired nerve to be blocked and only require that the needle be located in the general area for effective use.
04. INDICATIONS FOR USE / INTENDED USE:
IMD's New Fenestrated Peripheral Nerve Block Needle is a single patient use peripheral
1
nerve block needle with injection capabilities. It can be used to provide local or regional
nerve blocking by the injecting of a local spactleti nerve blocking by the injection capabilities. It can
nerve blocking by the injecting of a local anesthetic.
It is to be used only under the direction of a licensed clinician.
-
- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The IMD's Fenestrated Peripheral Nerve Block Needle shares the identical characteristics, features, materials, methods of manufacture / manufacturer, packager, and sterilization, seatures, materials,
methods of manufacture / manufacturer, packager, and sterilization / sterilizer as two of the predicate needles. It's intended use is identical to other predication / sterilization / sterilization / sterilization / sterilization / sterilization/ sterili cather specificate necules. It's intended use is identical to other predicate
- No record of unexpected patient problems or adverse reactions were found in our O review of the FDA's MAUDE, Safety Alert, and MDR databases;
- The device and its packaging are tested by an independent lab for sterility, with O validated sterilization, and will be subjected to inspection / testing by Interlity, with process OC, and finished goods QC, and monitored in the field by means of our
- SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The IMD's Fenestrated Peripheral Nerve Block Needle shares the identical characteristics, features, materials, methods of manufacture / manufacturer, packager, and sterilization, seatures, materials,
- SAFETY AND EFFECTIVENESS: There are no substantive differences between the device defined in this 510(k) submission and the predicate devices. It is similar to the material and manufacturing / sterilization technologies that are currently used in other
similar medical devices, and identical in these areas to the U.T. similar medical devices, and identical in these areas to the IMD predicates .
developed and devices, and identical in these areas to the IMD predicates. It was developed and documented under IMD's Quality Management System, under the Quality System Regulation, 21 CFR Part 820, including design / change control, and is verifical / statify / change control, and is verified / validated to applicable standards / guidance documents, including vendors' and is vertifical.
validated to applicable standards / guidance documents, including vendors' and o It is designed and manufactured to be safe and effective when used as intended 's and our SOFF'
It is designed and manufactured to be safety and effective when used as intend licensed clinician's supervision. Its safe and effective when used as intended, under a
licensed clinician's supervision. Its safety and effectiveness was further tested cli under IDE G040058 and appropriate IRBs.
-
- IMD's Fenestrated Peripheral Nerve Block Needle share similar indications for use, and characteristics and functional features, and thus are substantially equivalent to
the currently marketed predicate devices, cited above the currently marketed predicate devices, cited above.
Signed: Woles Solum
- IMD's Fenestrated Peripheral Nerve Block Needle share similar indications for use, and characteristics and functional features, and thus are substantially equivalent to
Walter Zohmann President
Dated: 3-16-2012
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Walter Zohmann President International Medical Development Inc. (IMD) 560 Highway 39 P.O. Box 510 Huntsville, Utah 84317
Re: K113662
Trade/Device Name: Fenestrated Nerve Block Needle Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: March 16, 2012 Received: March 27, 2012
Dear Mr. Zohmann:
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 Eederal Register.
APR. 20 2007
3
Page 2 - Mr. Zohmann
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form (Text Version)
Indications for Use
化113662 510(k) Number (if known):
Fenestrated Nerve Block Needle Device Name: _
Indications for Use:
IMD's New Fenestrated Nerve Block Needle is a single patient use needle to provide local or regional nerve blocking by the injecting of a local anesthesia.
It is to be used only under the direction of a licensed clinician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Schuler
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page _ of _
510(k) Number: K113662