(41 days)
Not Found
No
The device description and summary of performance studies describe a physical needle and do not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is an epidural needle used for the placement of anesthetic agents and is not described as providing therapy itself.
No
Explanation: The device description states its purpose is for the placement of anesthetic agents, not for diagnosing conditions.
No
The device description explicitly states it is a stainless steel cannula with a plastic hub and a stylet, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The description clearly states the Epidural Needle is used for the placement of anesthetic agents directly into the epidural space of a patient. This is an invasive procedure performed on the patient's body, not a test performed on a specimen taken from the body.
The device is a surgical/procedural instrument, not a diagnostic test.
N/A
Intended Use / Indications for Use
The Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
Product codes
73 BSP
Device Description
The Tuohy 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 stainless steel wire shaft and a molded plastic hub.
The Tuohy Epidural Needle will be provided as a sterile, single use, disposable device. The 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
Not Found
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)
Non-Clinical Data: Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Manan Medical Products Epidural Needle (K980536)
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 RA/QA
Date Prepared:
February 19, 2003
Trade Name:
Tuohy Epidural Needle
Common Name:
Epidural Needle
Product Class/Classification:
Class II 868.5150 Needle, Conduction, Anesthetic
Predicate Device(s):
Manan Medical Products Epidural Needle (K980536)
Description:
The Tuohy 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 stainless steel wire shaft and a molded plastic hub.
The Tuohy Epidural Needle will be provided as a sterile, single use, disposable device. The Epidural Needle will be available in a variety of lengths and gauges.
1
Intended Use:
The 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 Tuohy Epidural Needle has identical physical and technical characteristics to the Manan Medical Products Epidural Needle marketed under K980536.
Non-Clinical Data:
Due to the fact that this product is purchased by Epimed from Manan Medical and is identical to the predicate device, bench testing to compare performance characteristics was not conducted.
Conclusion:
The comparison to the predicate device demonstrates that the Tuohy Epidural Needle is safe and effective and is substantially equivalent to the predicate device.
Very truly yours,
Epimed International, Inc.
Christopher B. Lake Manager of Regulatory Affairs/Quality Assurance
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines above them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 2003
Mr. Christopher B. Lake Epimed International. Incorporated 141 Sal Landrio Drive Crossroads Business Park Johnstown, New York 12095
Re: K030562
Trade/Device Name: Tuohy Epidural Needles; Models A-NE-009, A-NE-012, A-NE-014, A-NE-016, A-NE-029, A-NE-056, A-NE-057, A-NE-058, A-NE-059, A-NE-060, and A-NE-061 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II (two) Product Code: 73 BSP Dated: February 19, 2003 Received: February 21, 2003
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.
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
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Page 2 - Mr. Christopher B. Lake
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 (301) 594-4646. 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/dsma/dsmamain.html
Sincerely yours.
Susan Roeser
Susan Runner, DDS, MA Interim 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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Page 1 of 1
510(k) Number (if known): __K030562
Device Name: Epidural Needle
Indications For Use:
The Epidural Needle is intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Optional Format 3-10-98)
signature
510(k) Number