CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07

K994059 · Hdc Corp. · CAZ · Oct 13, 2000 · Anesthesiology

Device Facts

• Record ID: K994059
• Device Name: CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07
• Applicant: Hdc Corp.
• Product Code: CAZ · Anesthesiology
• Decision Date: Oct 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5140
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

CLA Kit (Nerve Block Infusion Kit) facilitates peripheral nerve blocks. Components include insulated hollow needle for nerve localization via electrical stimulation and catheter for anesthetic infusion. Used by clinicians in clinical settings. Needle enables precise nerve identification; catheter allows continuous anesthetic delivery for up to 72 hours. Benefits include targeted pain management and extended anesthetic administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Kit includes insulated hollow needle for electrical stimulation and catheter for anesthetic delivery. Materials and specifications must comply with legally marketed component standards. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring peripheral nerve conduction blocks via local anesthetic injection. Used for nerve localization via electrical stimulation and anesthetic delivery via needle or catheter (up to 72 hours).

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
| ✓ | | |

Supplemental information A for 510(k) K994059.doc

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