Typical applications include: For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.

Device Description

This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. The sterile single patient use component includes the following: 2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered. 2.2 The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function). 2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.

AI/ML Overview

This K971851 510(k) submission describes a substantially equivalent determination for a medical device rather than a de novo or PMA submission. Therefore, it does not contain the typical detailed performance study information you would find for novel devices or those requiring higher levels of evidence.

Here's an analysis based on the provided text:

Acceptance Criteria and Device Performance

The document describes a Substantial Equivalence (SE) determination. This means the device, the Axiom Interpleural Anesthesia Catheter, is determined to be as safe and effective as a legally marketed predicate device. The "acceptance criteria" here are not performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) but rather the demonstration of substantial equivalence based on material, sterility, intended use, and general function.

Acceptance Criteria Category	Reported Device Performance (as demonstrated for SE)
Sterility	Substantially equivalent to predicate device(s)
Material	Substantially equivalent to predicate device(s)
Drainage Function	Substantially equivalent to predicate device(s)
Indications for Use	Substantially equivalent to predicate device(s)
General Operation	Simplicity of design assures effective operation

Study Information (Based on Substantial Equivalence Claim)

The document does not describe a clinical study with performance criteria like those found for AI/imaging devices. Instead, the "study" is a comparison to predicate devices to establish substantial equivalence.

Sample size used for the test set and the data provenance: Not applicable. No test set of patient data was used in the way it would be for an AI device. The "test" consists of comparing the new device's characteristics to those of legally marketed predicate devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of clinical performance, is not established by experts for this type of submission. The "ground truth" for substantial equivalence is the FDA's determination that the new device shares fundamental characteristics with existing approved devices.
Adjudication method for the test set: Not applicable. There was no adjudication of performance data. The FDA's review process determines substantial equivalence.
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 physical medical device (catheter), not an AI-powered diagnostic or assistive tool.
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 in the context of clinical performance. For a 510(k) substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the predicate device(s) and the new device's demonstrable similarity.
The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary regarding performance studies for K971851:

The submission for the Axiom Interpleural Anesthesia Catheter is a 510(k) for substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than on presenting de novo clinical performance data against specific metrics. Therefore, the detailed information typically requested for AI/diagnostic studies (sample sizes for test/training sets, expert ground truth, MRMC studies, etc.) is not present or relevant in this document. The "study" here is the regulatory comparison to predicate devices, focusing on design, materials, manufacturing, and intended use.

Summary

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K471851

AXIOM MEDICAL, INC.

555 West Victoria Rancho Dominguez, California 90220 Telephone 310-898-1779 • Facsimile 310-632-1326

JAN 2 2 1998

In compliance with the requirements of section 510(k) of the Food, Drug, and Cosmetic Act as amended, and 21 CFR Section 807.92(a)(1), This "510(k) Summary" is on a product we intend to market in 90 days.

Company name : Axiom Medical Inc. 555 W. Victoria Street Address : Rancho Dominguez, Ca. 90220 (310) 898 - 1779 Phone number : (310) 632 - 1326 Fax number : Contact person : Ridwan Hardy

Date of Submission: 05/16/1997

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DEVICE NAMES 1.0

1.1 Trade Name: Axiom Interpleural Anesthesia Catheter
1.2 Common Name: Anesthesia Catheter
1.3 Classification Name: Anesthesia Conduction Catheter (Per 21 CFR section 868.5120)

2.0 PRODUCT DESCRIPTION

This Axiom Interpleural Anesthesia Catheter is simplicity of design assures effective operation with added convenience. (see Exhibit A: Photograph and Exhibit B: Engineering Drawing) The sterile single patient use component includes the following:

2.1 A conveniently sized two Lumen Catheter made of Silicone round drain with radiopaque line that allows assessment of drain placement after wound closure. Various sizes starting from 18 Fr. up to 28 Fr. will be offered.
2.2 The first Lumen has a bigger inside diameter than the second lumen, and has a series of port openings (Eyes) into a passageway in the catheter wall that terminates at the first Funnel as a fluid outlet (Drainage function).
2.3 The second Lumen connected to the second Funnel as a fluid inlet (Irrigation function) and the Funnel is equipped with a three-way or four-way Stopcock.

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3.0 SUBSTANTIAL EQUIVALENCE COMPARISON

This device is substantially equivalent in sterility, material and drainage function with our Mills Filtered Mediastinal Sump, also is substantially equivalent in indications for use to Interpleural Anesthesia Kit with Polyurethane Catheter marketed by Arrow International, Medical Disposable Inc. and Baxter Pharmaseal. These companies offer Interpleural Anesthesia Kit and teflon epidural catheter.

4.0 INTENDED USE OF THE DEVICE

Typical applications include:

For use where a routine chest tube is required to drain fluids and exudates during surgery or after surgery. The additional lumen allows for application of topical anaesthetic to relieve pleural pain.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized caduceus-like symbol, with three parallel lines curving upwards and to the right, resembling a stylized human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 2 1998

Mr. Ridwan Hardy Axiom Medical, Inc. 555 West Victoria Street Rancho Dominguez, CA 90220

K971851 Re : Interpleural Anesthesia Catheter Regulatory Class: II (two) Product Code: 73 BSO Dated: November 3, 1997 November 5, 1997 Received:

Dear Mr. Hardy:

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 requlation (21 CFR Part 820) and that, through periodio (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. Ridwan Hardy

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 leqally 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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,
Thomas Y. Callahon

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): K971851

Device Name: Axiom Interpleural Anesthesia Catheter

Indications For Use:

Typical applications include:

For use where a routine chest tube is required to drain fluids and exudates . during surgery or after surgery. The additional lumen allows for application of local anaesthetic to relieve postoperative pain. Caution: The Delivery of local anaesthetic is intended for duration of use, less than 72 hours.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number	K971851

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

Revised: 01/16/98

Regulation Number and Section

§ 868.5120 Anesthesia conduction catheter.

(a)
Identification. An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.(b)
Classification. Class II (performance standards).