(168 days)
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.
Drawings and a bill of materials for the EchoStim device are attached.
This 510(k) document describes a medical device called the EchoStim Facet Tip, which is an electrically insulated anesthesia conduction needle. The submission is for substantial equivalence to existing predicate devices, not for a novel device requiring extensive performance studies as might be seen for AI/ML-based devices.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. This document focuses on demonstrating that the EchoStim Facet Tip is substantially equivalent to already marketed devices based on materials, technological characteristics, and intended use.
Here's why each specific requested point is not applicable or not found in the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable. For a substantial equivalence submission of this type of medical device, the "acceptance criteria" are primarily met by demonstrating similarity to predicate devices, rather than through specific performance metrics outlined like a diagnostic accuracy table. There is no performance data reported in this document.
- Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of performance evaluation for this type of device in this submission. The evaluation is based on comparison to existing devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth establishment needed for a test set as described here.
- Adjudication method: Not applicable. No adjudication method is mentioned as there's no diagnostic decision-making process being evaluated.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a needle, not an AI/ML device, so MRMC studies and AI assistance are irrelevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
- The type of ground truth used: Not applicable. No ground truth in the context of diagnostic accuracy is relevant here.
- The sample size for the training set: Not applicable. There is no training set for a traditional medical device like this needle.
- How the ground truth for the training set was established: Not applicable. There is no training set.
Summary based on the provided document:
The provided document is a 510(k) premarket notification for an anesthesia conduction needle. The focus is on demonstrating substantial equivalence to predicate devices. There are no performance studies, acceptance criteria for performance metrics, or data related to AI/ML device evaluation within this document. The "performance" in this context refers to the device meeting its intended use by being similar to already approved needles.
Key information present related to comparison:
- Predicate Devices:
- Basis for Substantial Equivalence: "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."
- Comparison Data: "A comparison chart of the two devices is attached." (though not provided in the excerpt)
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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.
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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.
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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
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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.
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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
§ 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).