(168 days)
Not Found
No
The summary describes a standard electrical stimulation needle for regional anesthesia and does not mention any AI or ML components or functionalities.
No
The device is used to inject anesthetics and assist in pinpointing the area of application, which are procedures for diagnosis or treatment, but the device itself does not provide therapy or treatment.
No
The device is used to inject anesthetics and uses electrical stimulation to pinpoint the area of application for the injection, which are therapeutic actions, not primarily diagnostic ones. While locating the area of application might involve some assessment, its primary function isn't to diagnose a condition or illness.
No
The device description explicitly mentions "electrically insulated anesthesia conduction needles" and "a cable and connector," indicating physical hardware components are part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Intended Use: The intended use of Havel's electrically insulated anesthesia conduction needles is to "puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia." This is a procedure performed on the patient's body, not on a specimen taken from the body.
- Device Description: The description focuses on the physical needle and its function in delivering anesthetic and potentially using electrical stimulation for localization. There is no mention of analyzing biological samples.
Therefore, this device falls under the category of a surgical or procedural device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.
Product codes (comma separated list FDA assigned to the subject device)
CAZ, BSP
Device Description
Drawings and a bill of materials for the EchoStim device are attached.
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
physician
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)
Not Found
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.
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
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).
0
063380
510(k) ECHOSTIM FACET TIP HAVEL'S INC.
APR 2 5 2007
A. DEVICE NAME
Proprietary Name(s): EchoStim Facet Tip
Common Name(s): Kit Conduction Anesthetic
B. Establishment Registration Number: 9611481
C. Address of Manufacturing Site and Distributor:
Manufacturer:
HAKKO MEDICAL CO., LTD 3055, Togura, Oaza Togura-machi Hanishina-gun, Nagano-ken 389-08, Japan
Distributor:
Havel's Inc. 3726 Lonsdale Street Cincinnati, OH 46227
D. Classification:
Device Classification Name: Kit, Conduction Anesthetic
21CFR 868.5140 Class II
Product Code: CAZ BSP
E. Statement of substantial equivalence:
Predicate Devices:
The EchoStim Facet Tip Needle is substantially equivalent to the Pajunk needle predicated devices in that it is similar with respect to materials, technological characteristics and intended use.
A comparison chart of the two devices is attached.
1
F. Indication for use:
Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.
G. Description of device(s):
Drawings and a bill of materials for the EchoStim device are attached.
H. Sterilization
Sterilization is by ETO and is validated to 10-6.
-
I. Performance standards/special controls:
Performance standards under Section 514 of the Act have not been developed for these devices. -
J. Proposed labeling: Draft labeling is attached.
Each Product Label will have the following information:
Complete product description
Manufactured by: Hakko Medical Co., Ltd.
Distributed by: Havel's Incorporated 3726 Lonsdale Street Cincinnati, Oh 45227 (513) 271-2117 Made in Japan
STERILE SINGLE USE ONLY
CAUTION: Do not use if package has been opened or damaged. Store in a cool, dry place. Federal law restricts this device to sale by or on the order of a physician.
Sterile unless opened or damaged
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Patrick Carrothers Vice President Marketing Havel's, Incorporated 3726 Lonsdale Street Cincinnati, Ohio 45227
APR 2 5 2007
Re: K063380
Trade/Device Name: EchoStim Facet Tip Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: April 4, 2007 Received: April 10, 2007
Dear Mr. Carrothers:
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
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). please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Susan Kung
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital,
Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k)NUMBER K063380
DEVICE NAME: EchoStim Facet Tip
INDICATION FOR USE:
Havel's electrically insulated anesthesia conduction needles are used to puncture the tissue in order to gain entry and locally inject anesthetics to induce regional anesthesia. An electrical stimulus may be applied to the needle via a cable and connector to assist the physician to pinpoint the area of application.
Prescription Use X (Per 21 CFE 801.109) OR
Over-The-Counter-Use (Options Format 1-2-96)
(please do not write below this line-continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Chas. W.
r of Anasthesiology, General Hospical, ion Control, Damal Devices
) Number: K063386