K Number
K972595
Device Name
ALDRETE EPIDURAL NEEDLE WITHOUT INTRODUCER
Manufacturer
Date Cleared
1998-05-20

(313 days)

Product Code
Regulation Number
868.5150
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.
Device Description
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More Information

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No
The summary describes a physical medical device (epidural needle) and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.

No
The device is described as a needle used for injecting local anesthetics to provide regional anesthesia, which is an intervention. It does not actively treat or prevent a disease, nor does it restore, modify, or correct body function or structure in a therapeutic way.

No
Explanation: The device is intended for the injection of local anesthetics for regional anesthesia, which is a therapeutic function, not a diagnostic one.

No

The device is described as a "Single Shot Epidural Needle," which is a physical medical device, not software.

Based on the provided information, the Aldrete Single Shot Epidural Needle is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the injection of local anesthetics to provide regional anesthesia. This is a procedure performed directly on a patient's body, not on a sample of bodily fluid or tissue in vitro (outside the body).
  • Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological samples (blood, urine, tissue, etc.)
    • Detecting or measuring substances in those samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions

Therefore, the Aldrete Single Shot Epidural Needle is a medical device used for a therapeutic procedure, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.

Product codes

73 BSP

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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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).

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle.

MAY 2 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Joseph E. Harms Needle & Infusion Technologies, Inc. 917 Klosterman Road, East Tarpon Springs, FL 34689

Re: K972595 Aldrete Single Shot Epidural Needle Regulatory Class: II (two) Product Code: 73 BSP Dated: February 23, 1998 February 24, 1998 Received:

Dear Mr. Harms:

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 (for the indications for use stated in the enclosure) to 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. 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 (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 to 895. A substantially equivalent determination assumes compliance 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) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.

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Page 2 - Mr. Joseph E. Harms

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 our 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/dsmamain.html".

Sincerely yours,

Thomas J. Callahan, Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EXHIBIT I
510(k) Number (if known):K972595
Device Name:Aldrete Single Shot Epidural Needle
Indications For Use:The Aldrete Single Shot Epidural Needle is intended to be used for the injection of local anesthetics to provide regional anesthesia.

(FLUASE DO NOT WRITE BELOW TIMS LINE - CONTINUE ON ANOTHER PAGE IF NERIDED)

Concurrence of CDRH, Office of Dovice Evaluation (ODE)

Christy Foreman for wigs

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number: K972595

Image /page/2/Picture/6 description: The image shows the words "Prescription Use" and the phrase "(Per 21 CFR 801.109)" in a bold, serif font. An arrow points down at the text. The text is likely part of a medical or pharmaceutical label, indicating that the product is intended for use only with a prescription.

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1888 - 199

ાર

Over-The-Counter Use

(Optional Formal 1-2-96)

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