The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine. The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.

AI/ML Overview

The provided document is a 510(k) summary for the Trucath Spinal Injection System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/ML-driven device.

This submission is for a medical device that appears to be a physical product (a catheter/needle system), not a software or AI/ML device. Therefore, many of the requested categories (like sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device. For physical devices like this, acceptance criteria would typically relate to performance aspects like material strength, sterility, leakage, fluid flow, dimensions, etc., which are usually covered in internal design specifications and verification/validation testing.
Reported Device Performance: The document states: "Results of non-clinical testing demonstrated that the Trucath Spinal Injection System is safe and effective for its intended use" and "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, no specific performance metrics or acceptance criteria values are reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document refers to "non-clinical testing," which typically involves bench testing, material testing, and potentially some animal testing (though not mentioned here). It does not involve "test sets" in the context of data for AI/ML models.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in the context of AI/ML, refers to labels or diagnoses provided by experts. For a physical medical device, "ground truth" would be established by validated test methods and measurements against engineering specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data, which is not part of this device's submission.

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

No, an MRMC study was not done. This type of study is specific to AI-assisted diagnostic devices where human readers interpret images or data. The Trucath Spinal Injection System is a physical interventional medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided in the AI/ML sense. For this physical device, "ground truth" for performance would likely come from established engineering and biological test standards (e.g., ISO standards for medical devices, material testing, sterility checks, etc.). The document only states "non-clinical testing" was done to validate performance against design specifications.

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML model.

9. How the ground truth for the training set was established

Not applicable. This device does not use a training set.

In summary:

The provided 510(k) summary is for a physical medical device (Spinal Injection System) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that "non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications." However, it does not provide the specific performance data, acceptance criteria values, or details of the test methodologies that would be necessary to answer most of your detailed questions, as those questions are primarily relevant for AI/ML-driven medical devices.

Summary

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SEP % 8 2009

Special 510(k) Spinal Injection System

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Name, Address, Phone and Fax Number of Applicant A.

Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, CA 94063 Phone: (650) 587-5296 Fax: (650) 587-3823

B. Contact Person

Sevrina Ciucci Regulatory Affairs Consultant (408) 316-4837

C. Date Prepared

September 22, 2009

D. Device Name

Trade Name:	Trucath Spinal Injection System
Common Name:	Needle, Conduction, Anesthetic (w/wo introducer)
Classification Name:	Anesthesia Conduction Needle (21 CFR §868.5150, Product Code BSP)

ட். Predicate Devices

The Trucath Spinal Injection System is substantially equivalent to the Laurimed Spinal Injection System (K083909).

F. Device Description

The Trucath Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for use in injections into the epidural space of the spine.

The Trucath Spinal Injection System is supplied as a sterile, single patient use, disposable device.

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Intended Use

Indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Technological Comparison G.

The technological characteristics and principals of operation of the Trucath Spinal Injection System are substantially equivalent to the noted predicate device.

H.. Summary of Non-Clinical Data

Results of non-clinical testing demonstrated that the Trucath Spinal Injection System is safe and effective for its intended use.

l. Summary of Data

The Trucath Spinal Injection System has been carefully compared to a legally marketed device with respect to intended use and technological characteristics. In addition, non-clinical testing was conducted to validate the performance of the device and ensure the Trucath Spinal Injection System functions as intended and meets design specifications. The comparison and non-clinical results demonstrate that the device is substantially equivalent to the predicate device and is safe and effective for its intended use.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around the perimeter. In the center of the seal is a stylized caduceus symbol, which is a symbol of medicine and health. The caduceus is composed of three horizontal lines that curve downwards, resembling a stylized snake or serpent.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Ms. Sevrina Ciucci Regulatory Affairs Consultant Laurimed L.L.C. 500 Arguello Street, Suite 100 Redwood City, California 94063

SEP 2 3 2009

K091818 Re:

Trade/Device Name: Trucath Spinal Injection System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: August 24, 2009 Received: August 25, 2009

Dear Ms. Ciucci:

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 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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Page 2 - Ms. Ciucci

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 yours,

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

K 1691818 510(k) Number (if known):

Trucath Spinal Injection System Device Name:

Indications for Use:

The TruCath Spinal Injection System is indicated for use in injections into the epidural space. Not for use with other catheters or needles.

Prescription Use ×

OR (per 21 CFR 801.109) Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Schultze

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

KO 9.1818

Regulation Number and Section

§ 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).