(108 days)
The Laurimed Spinal Injection System is intended for use in procedures where injection is required.
The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
The given 510(k) notification for the Laurimed Spinal Injection System (K080140) outlines the device's substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data. However, it does not contain the specific information required to answer your questions regarding acceptance criteria and a study that proves the device meets those criteria.
The document is a summary of the 510(k) and focuses on demonstrating substantial equivalence to legally marketed predicate devices, as well as reporting on non-clinical performance to ensure the device functions as intended and meets design specifications. It does not include details about specific acceptance criteria tables, clinical study designs, sample sizes for test or training sets, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot provide the requested information from the provided text. The document states:
- "Results of the non-clinical performance testing demonstrated that the Spinal Injection System is safe and effective for its intended use."
- "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."
These statements confirm that testing was performed, but they lack the granular detail about the acceptance criteria, study design, and results asked for in your prompt. Medical device submissions like this often include detailed test reports as part of the full submission, but only the summary is available here.
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510(k) Notification Spinal Injection System
510(k) Summary
MAY - 9 2008
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
в. Contact Person
Nancy Lincé Clinical and Regulatory Affairs Consultant (650) 759-6186
C. Date Prepared
January 21, 2008
D. Device Name
Spinal Injection System Trade Name: Common Name: Needle, Conduction, Anesthetic (w/wo Introducer) Anesthesia Conduction Needle (21 CFR §868.5150, Classification Name: Product Code BSP)
E. Predicate Devices
The Laurimed Spinal Injection System is substantially equivalent to the Epimed International, Inc. Blunt Nerve Block Needle (K041843); B. Braun Medical's Introcan Safety IV Catheter (K020785); Pajunk Medical Technology GmbH Anesthesia Conduction Needles (K040965); and the Smiths Medical ASD Portex Epidural Catheter (K062005).
ப Device Description
The Laurimed Spinal Injection System integrates a flexible Catheter with an atraumatic distal tip into a Needle designed for injections/infusion of local anesthetics into the epidural space of the spine.
The Spinal Injection System is supplied as a sterile, single patient use, disposable device.
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G. Intended Use
The Laurimed Spinal Injection System is intended for use in procedures where injection is required.
The Laurimed Spinal Injection System is indicated for use in spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
H. Technological Comparison
The technological characteristics and principals of operation of the Spinal Injection System are substantially equivalent to the noted predicate devices.
l. Summary of Non-Clinical Performance Data
Results of the non-clinical performance testing demonstrated that the Spinal Injection System is safe and effective for its intended use.
J. Summary of Data
The Spinal Injection System has been carefully compared to legally marketed devices 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 non-clinical performance results demonstrate that the device is substantially equivalent to the predicate devices and is safe and effective for its intended use.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 9 2008
Ms. Nancy Lincé Clinical and Regulatory Affairs Consultant Laurimed LLC 500 Arguello Street, Suite 100 Redwood City, California 94063
Re: K080140
Trade/Device Name: Spinal Injection System Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: April 4, 2008 Received: April 7, 2008
Dear Ms. Lincé:
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 such 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. Lincé
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Chris Litte, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K080140
Device Name: Spinal Injection System
Indications for Use:
Spinal epidural injections for administration of anesthetic agents to provide regional anesthesia. Not for use with other needles or catheters.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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 Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080140
§ 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).