(45 days)
Not Found
No
The summary describes a physical medical device (cannula and needle) and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is intended for the epidural placement of opiate drugs to elicit regional anesthesia, which is a therapeutic purpose.
No
The device is described as an introducer cannula for placing a catheter for regional anesthesia, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it consists of a plastic cannula and a stainless steel introducer needle, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "epidural placement, directly...to elicit regional anesthesia." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a "plastic cannula with a molded plastic hub" and a "stainless steel introducer needle." This is a physical instrument used for insertion into the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is purely procedural for delivering anesthesia.
N/A
Intended Use / Indications for Use
For the administration of anesthetic agents to provide regional anesthesia.
The Flexible Introducer Cannula is intended for the epidural placement, directly for the administration of anesthetic agents to elicit regional anesthesia.
Product codes
MIA
Device Description
The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
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
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters that appear to be handwritten. The sequence starts with the letters 'KO', followed by the numbers '5', '1', '8', and '6'. The sequence concludes with the letter 'D'. The characters are written in a casual, slightly slanted style.
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:
July 6, 2005
Trade Name:
Flexible Introducer Cannula
Common Name:
Anesthesia Conduction Needle
Product Class/Classification:
Class II - MIA, 21 CFR 868.5150
Predicate Device(s):
Custom Medical Concepts Spinal Cord Access Epidural Introducer System (K904380)
Description:
The Flexible Introducer Cannula consists of a plastic cannula with a molded plastic hub. The device is also packaged with a stainless steel introducer needle which is removed after the device has been placed.
1
Intended Use:
For the administration of anesthetic agents to provide regional anesthesia.
Comparison to Predicate:
The Flexible Introducer Cannula has similar physical and technical characteristics to the predicate device and a similar intended use to the predicate device.
Conclusion:
The testing performed and comparison to the predicate device demonstrates that the Flexible Introducer Cannula is safe and effective and is substantially equivalent to the predicate device.
Epimed International, Inc.
Pell
Christopher B. Lake Manager of Quality Assurance/Regulatory Affairs
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The bird is positioned above a wavy line, possibly representing water or a horizon. Encircling the bird and wavy line is text that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 2 2005
Mr. Christopher Lake Manager of QA/RA Epimed International, Incorporated 141 Sal Landrio Drive Johnstown, New York 12095
Re: K051860
Trade/Device Name: Flexible Introducer Cannula, Model 135-1837 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: MIA Dated: July 6, 2005 Received: July 12, 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 may or can been 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 - Mr. Lake
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r hat 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 or any I vith 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 promaticated 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,
Siran Rumpe
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): K051860
Device Name: Flexible Introducer Cannula
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
The Flexible Introducer Cannula is intended for the epidural placement, directly The Flexible Introducer cannuid is Inventour of the opents to elicit regional anesthesia.
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)
Amy Slocum
(Division Sic ness boy Ceneral Hospital, not Control ್ತ
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