(78 days)
No
The summary describes a mechanical device for spinal injections and does not mention any AI or ML components or functionalities.
Yes
The device is described as administering anesthetic agents to provide regional anesthesia and anti-inflammatory medications, which are therapeutic interventions.
No
Explanation: The device is described as an "injection system" for the administration of contrast media, anesthetic agents, and anti-inflammatory medications. Its intended use is for "procedures where injection is required," not for diagnosing conditions.
No
The device description explicitly states it integrates a flexible Catheter with a Needle, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Laurimed Spinal Injection System Function: The Laurimed Spinal Injection System is a device used to deliver substances directly into the body (specifically the spinal epidural space). It is used for therapeutic and diagnostic imaging purposes (contrast media). It does not analyze specimens taken from the body.
The description clearly states its purpose is for injection of medications and contrast media into the spinal epidural space. This is an in vivo procedure (within the living body), not an in vitro procedure (outside the living body).
N/A
Intended Use / Indications for 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 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.
Product codes
BSP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space of the spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Results of non-clinical testing demonstrated that the Spinal Injection System is safe and effective for its intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 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.
1
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 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.
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_ ×
OR
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