(97 days)
Not Found
No
The summary describes a mechanical device (catheter and needle) and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is used for injections into the epidural space, which is a diagnostic and interventional procedure, not a therapeutic treatment itself. It facilitates the delivery of substances, but the device itself does not perform therapeutics.
No
Explanation: The device is described as an injection system used for administering substances into the epidural space, not for identifying or diagnosing a condition.
No
The device description clearly states it integrates a flexible Catheter with an atraumatic distal tip into a Needle, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "injections into the epidural space." This describes a procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as a "flexible Catheter with an atraumatic distal tip into a Needle." This is a physical instrument used for delivering substances into the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a tool for administering treatment or substances directly into the body.
N/A
Intended Use / Indications for Use
Indicated for use in injections into the epidural space. Not for use with other catheters or needles.
Product codes (comma separated list FDA assigned to the subject device)
BSP
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.
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 Trucath Spinal Injection System is safe and effective for its intended use.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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.
1
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.
2
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.
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); 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