The Laurimed Spinal Injection System is indicated for use in spinal epidural iniections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.

Device Description

The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusions of contrast media, anesthetics, and anti-inflammatory medications into the epidural space of the spine.

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

AI/ML Overview

The provided text describes a 510(k) summary for the Laurimed Spinal Injection System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study to prove performance.

Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and study design for proving the device meets acceptance criteria is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Specified	"non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications." (General statement, no specific metrics)

Missing Information Summary

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified.
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, as no clinical study with ground truth establishment is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a medical instrument, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical instrument, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study requiring ground truth is described. The document refers to "non-clinical testing" and "design specifications."
The sample size for the training set: Not applicable, as the device is not an AI/ML product requiring a training set.
How the ground truth for the training set was established: Not applicable.

Information Present (Regarding Acceptance Criteria & Study)

Acceptance Criteria: Not explicitly stated as specific, quantifiable criteria in the document. The general statement made is that "non-clinical testing was conducted to validate the performance of the device and ensure the Spinal Injection System functions as intended and meets design specifications." This suggests an internal set of design specifications served as the acceptance criteria, but their details are not provided.
Study Proving Acceptance: The document refers to "non-clinical testing" that demonstrated the device is "safe and effective for its intended use" and "functions as intended and meets design specifications." This implies engineering and performance tests were conducted. However, no details about the methodology, specific tests, results, or comparison data are included in this 510(k) summary. The primary study mentioned is a "Technological Comparison" to a predicate device (Laurimed Spinal Injection System K080140) to establish "substantial equivalence."

In summary, the provided 510(k) document is a high-level summary focused on demonstrating substantial equivalence through non-clinical testing and comparison to a predicate device rather than detailing specific acceptance criteria and the comprehensive study data that proved those criteria were met.

Summary

{0}------------------------------------------------

510(k) Summary

MAR 1 8 2009

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

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

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

в. Contact Person

Sevrina Ciucci Regulatory Affairs Consultant (408) 316-4837

C. Date Prepared

December 26, 2008

D. Device Name

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

E. Predicate Devices

The Laurimed Spinal Injection System is substantially equivalent to the Laurimed Spinal Injection System (K080140).

F. Device Description

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

{1}------------------------------------------------

Intended Use

The Laurimed Spinal Injection System is intended for use in procedures where injection is required.

G. Technological Comparison

The technological characteristics and principals of operation of the Laurimed 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 Spinal Injection System is safe and effective for its intended use.

l. Summary of Data

The 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 Spinal Injection System functions as intended and meets design specifications. The comparison and nonclinical results demonstrate that the device is substantially equivalent to the predicate device and is safe and effective for its intended use.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image contains the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing-like shapes, rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle, also in blue.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-06 Silver Spring. MD 20993-0002

NOV 22 2009

Ms. Sevrian Ciucci Regulatory Affairs Consultant Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, California 94063

Re: K083909

Trade/Device Name: Spinal Injection System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: December 26. 2008 Received: December 30, 2008

Dear Ms. Ciucci:

This letter corrects our substantially equivalent letter of March 18, 2009.

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 (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.

{3}------------------------------------------------

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); 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Sutte Y. Michael Dms

Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Laurimed LLC

Indications for Use Statement

510(k) Number (if known): K

Device Name:

Spinal Injection System

Indications for Use:

Spinal epidural injections for the administration of contrast media, anesthetic agents to provide regional anesthesia, and anti-inflammatory medications. Not for use with other needles or catheters.

Prescription Use_ ×

Over-The-Counter Use

(per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sasa Runois

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

510(k) Number: Ka83909

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).