(79 days)
No
The device description and intended use describe a standard mechanical needle for epidural procedures, with no mention of software, algorithms, or any components that would suggest AI/ML functionality. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is an epidural needle used for placement of anesthetic agents. It is an instrument for drug delivery, not a therapeutic device itself that administers therapy or treatment.
No
The device description states its intended use is for epidural placement of anesthetic agents, which is a therapeutic rather than a diagnostic function. It does not mention analyzing or interpreting any data to identify medical conditions or diseases.
No
The device description clearly states it is a physical needle made of stainless steel with a plastic hub and stylet, indicating it is a hardware device.
Based on the provided information, the RX Epidural Needle is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the placement of anesthetic agents in the epidural space for regional anesthesia. This is a procedure performed directly on a patient's body, not on a sample of biological material in vitro (outside the body).
- Device Description: The device is a needle and stylet designed for physical insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
IVD devices are used to examine specimens (like blood, urine, tissue) to provide information about a person's health status, diagnose conditions, or monitor treatment. The RX Epidural Needle does not perform any of these functions.
N/A
Intended Use / Indications for Use
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Product codes
BSP
Device Description
The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub. The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural
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)
Not Found
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
Section II
510(K) Summary
Company Information:
Epimed International, Inc. 141 Sal Landrio Drive Johnstown, NY 12095 (518) 725-0209 Contact: Christopher B. Lake Manager of QA/RA
Date Prepared:
October 31, 2005
Trade Name:
RX Epidural Needle
Common Name:
Epidural Needle
Product Class/Classification:
Class II 868.5150 Needle, Conduction, Anesthetic
Predicate Device(s):
Epimed International Epidural Needle (K030562)
Description:
The RX Epidural Needle consists of a stainless steel cannula with a ground beveled distal tip. A plastic hub is molded onto the proximal end of the cannula. A stylet is also provided with the device which consists of a custom trimmed shaft and a molded plastic hub.
The RX Epidural Needle will be provided as a sterile, single use, disposable device. The RX Epidural Needle will be available in a variety of lengths and gauges.
1
Intended Use:
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Comparison to Predicate:
The RX Epidural Needle has similar physical and technical characteristics to the Epimed International Epidural Needle marketed under K030562.
Conclusion:
The comparison to the predicate device demonstrates that the RX Epidural Needle is safe and effective and is substantially equivalent to the predicate device.
Epimed International, Inc.
Signature
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
2
Image /page/2/Picture/1 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, often used as a symbol of medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 7 2006
Mr. Christopher Lake Manager of Quality Assurance and Regulatory Affairs Epimed International, Inc. 141 Sal Landrio Dr. Crossroads Business Park Johnstown, NY 12095
Re: K053318
Trade/Device Name: RX Epidural Needle Regulation Number: 868.5150 Regulation Name: Anethesia conduction needle Regulatory Class: II Product Code: BSP Dated: November 28, 2005 Received: December 6, 2005
Dear Mr. Lake:
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.
3
Page 2 -- Mr. Lake
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) 276-0115. 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,
Susan Tunne
for 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
4
Indications for Use
510(k) Number (if known): unk. KOS 3318
Device Name: Rx Epidural Needle
Indications For Use:
The RX Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Prescription Use __ × (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)
Cee Sulion
ology General Hospital,
Control. Dental Devices
K093318
Page 1 of ____________________________________________________________________________________________________________________________________________________________________