(319 days)
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No
The summary describes a kit for nerve blocks using electrical stimulation and anesthetic infusion, with no mention of AI or ML technologies.
Yes
The device is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, which is a therapeutic intervention aimed at managing pain or facilitating surgical procedures.
No
The device is used for injecting local anesthetic to achieve nerve blocks and to locate peripheral nerves via electrical stimulation. It is a therapeutic and interventional device, not one designed to diagnose a condition or disease.
No
The device description explicitly mentions a "kit" including an "insulated hollow needle" and a "catheter," 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 clearly describes a procedure performed on the patient's body (injecting local anesthetic to block peripheral nerves). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description of a "Nerve Block Infusion Kit" aligns with a device used for a medical procedure on a patient, not for laboratory testing of specimens.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, laboratory procedures, or any of the typical characteristics of an IVD.
Therefore, the CLA Kit (Nerve Block Infusion Kit) is a medical device used for a therapeutic or diagnostic procedure performed directly on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle.
Product codes
73 CAZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, possibly representing people or services provided by the department.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 3 2000
Mr. Earl Smart HDC Corporation 2109 O'Toole Avenue San Jose, CA 95137
Re: K994059 CLA Kit (Nerve Block Infusion Kit) Regulatory Class: II (two) Product Code: 73 CAZ Dated: September 6, 2000 September 7, 2000 Received:
Dear Mr. Smart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., urffinished) and further process (e.g., sterilize) you must submit a new 510 (k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS
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Page 2 - Mr. Earl Smart
inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 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" (21 CFR 807.97) . Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
James F. Dillard III
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use statement
APPENDIX # 5
Indications for Use Statement
| 510(k) Number | K_994059 |
|---|---|
| Device Name | CLA Kit (Nerve Block Infusion Kit) |
| Indications for Use | The CLA Kit (Nerve Block Infusion Kit) is intended for the injection of local anesthetic to achieve peripheral nerve conduction blocks, by use of an insulated hollow needle for electrical stimulation to locate peripheral nerves, and the injection of local anesthetic either directly through the needle, or for up to 72 hours via a catheter inserted through the needle. |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K971059
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ✓ |
Supplemental information A for 510(k) K994059.doc
: