The Epidural Catheter and accessories consists of an epidural, a stylet, a threading aid and a connector. The components are packaged in a tray. The tray is placed in a paperboard box with an outer box.

AI/ML Overview

This document describes a 510(k) summary for an Epidural Catheter and accessories, specifically K983125. The document is a premarket notification for a medical device and thus does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The 510(k) summary outlines the device's substantial equivalence to a legally marketed predicate device (Aries K840201), rather than presenting performance criteria and study results.

Here's why none of the requested information can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: This document is a regulatory submission for substantial equivalence, not a performance study report. It does not contain acceptance criteria for device performance or reported performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No test set data or study details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment or expert involvement in a study is described.
4. Adjudication method for the test set: Not applicable. No test set or adjudication process is mentioned.
5. 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 device is an Epidural Catheter, a physical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not present.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance study requiring ground truth is described.
8. The sample size for the training set: Not applicable. This document does not describe the development of an AI model or a training set.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth establishment for a training set is discussed.

In summary, the provided text is a 510(k) submission for an epidural catheter, focusing on its substantial equivalence to a predicate device for regulatory approval. It does not include information about clinical studies, performance criteria, or AI model development that would address the questions posed.

Summary

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Image /page/0/Picture/1 description: The image shows a logo for Rusch International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). Above the logo is the number K983125. The logo is in black and white and features a bold, sans-serif font.

Tall Pines Park laffrev, NH 03452 603) 532-7706 AX (603) 532-8211 or 6108

510 (k) Summary

Submitter Name, Address, and Date of Submission. 1.

Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, New Hampshire 03452

(603) 532-7706 Telephone: (603) 532-8211 Facsimile: 73451.1040@compuserve.com E-Mail:

Contact: Same as above

Name of the Device, Common, Proprietary (if Known), and 2. Classification.

Classification Name: Anesthesia Conduction Kit

Common Name: Epidural Catheter Kit

Proprietary Name: Epidural Catheter and accessories

Identification of the legally marketed device to which 3. the submitter claims equivalence.

The Epidural Catheter and accessories is substantially equivalent to the Aries (K840201).

Description of the Device. 4 .

The Epidural Catheter and accessories consists of an epidural, a stylet, a threading aid and a connector. The components are packaged in a tray. The tray is placed

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in a paperboard box with an outer box.

Intended Use of the Device. 5.

The Epidural Catheter and accessories is a product used to administer to a patient conduction, regional, or local anesthesia.

Summary of Technological Characteristics. 6.

The technological characteristics are the same as, or equivalent to, predicate devices in design use and materials.

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Image /page/2/Picture/10 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 17 1999

Mr. James R. Whitney Group Regulatory Affairs Associate Rüsch International Tall Pines Park Jaffrey, NH 03452

Re: K983125 Epidural Catheter Models 1210/1200 Requlatory Class: II (two) Product Code: 73 CAZ Dated: September 1, 1998 Received: September 8, 1998

Dear Mr. Whitney:

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 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 qeneral 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 leqally 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., unfinished) 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 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set

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Page 2 - Mr. James R. Whitney

forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 requlation 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,

Ath. A. Carlows L.

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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510(k) Number (if known):	K983125
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Device Name:___Epidural Catheter and accessories

Indications for Use:

To administer to a patient conduction, regional, or local anesthesia.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Krave

Prescription Use	✓
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Over-The-Counter Use___________

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).