(120 days)
Not Found
No
The description focuses on the physical components and intended use of a standard medical needle, with no mention of AI or ML capabilities.
No
The device is used to inject local anesthetics or facilitate epidural catheter placement, which are procedures that enable therapy but are not therapeutic in themselves.
No
The device, a Tuohy Epidural Needle, is used for injection of anesthetics or placement of epidural catheters, which are therapeutic and procedural actions, not diagnostic.
No
The device description explicitly details physical components like a plastic cannula hub, stainless steel cannula, stainless steel stylet, and a polypropylene sheath, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device function: The Remington Medical, Inc. Tuohy Epidural Needle is used to inject substances (local anesthetics) into a patient's body or to facilitate the placement of a catheter within the body. This is an in vivo procedure, not an in vitro diagnostic test.
- Intended Use: The intended use clearly states the device is for injecting anesthetics or placing catheters in a patient.
The description and intended use of the Tuohy Epidural Needle align with a surgical or procedural device used directly on a patient, not a device used for laboratory testing of specimens.
N/A
Intended Use / Indications for Use
Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
Product codes
BSP
Device Description
The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.
Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath.
Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).
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
Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles including verification/validation testing to internal functional specifications (e.g. catheter placement, and bond strength between cannula, hub, and stylet) including comparison data (e.g., needle flow) to the K990519 predicate device. These tests demonstrated that the Remington Medical Inc. Tuohy Epidural Needles are substantially equivalent to the predicate device. Visual inspection of the test catheter under magnification confirmed no negative impact to the catheter post-placement. Testing confirmed that the Remington Medical Inc. Tuohy Epidural Needles comply with relevant standards, specifically ISO standards 7864 and 6009. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility (ISO 10993-1) and sterilization. Biocompatibility testing performed includes cytotoxicity, sensitization, irritation or intracutaneous reactivity, and acute systemic toxicity. Pyrogenicity was also tested.
Key Metrics
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 4, 2015
Remington Medical, Inc. Caitlin Senter, M.S., RAC Regulatory Affairs Manager 6830 Meadowridge Court Alpharetta, GA 30005
Re: K150266
Trade/Device Name: Remington Medical Inc. Tuohy Epidural Needles Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: May 1, 2015 Received: May 4, 2015
Dear Ms. Senter:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
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 devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150266
Device Name
Remington Medical, Inc. Tuohy Epidural Needle
Indications for Use (Describe)
Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" on the right. The word "Remington" is in a larger, bolder font than the word "MEDICAL", which is stacked below it.
Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle
| Preparation Date | June 2, 2015 |
|---|---|
| Applicant | Remington Medical, Inc. |
| 6830 Meadowridge Court, | |
| Alpharetta, GA, USA 30005 | |
| Registration Number: 1056553 | |
| Owner/Operator Number: 9006473 | |
| Contact Person | Caitlin Senter, MS, RAC |
| Regulatory Affairs Manager | |
| 770-888-8520, extension 207 | |
| caitlins@remmed.com | |
| Trade Proprietary | |
| Name(s) | Remington Medical, Inc. Tuohy Epidural Needle |
| Common Name (s) | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Classification Name | 21 CFR 868.5150 (Anesthesia conduction needle); |
| Product Code: BSP | |
| Device Class: | Class II |
Section 5 - 510(k) Summary
Legally Marketed Devices to Which Substantial Equivalence is Claimed:
Myco Medical Supplies, Inc. Dr. Japan's Phoenix Epidural & Spinal Needles, (K990519) B. Braun Medical, Inc. Perican™ Ultra Needle, (K133632)
Description of the Device:
The Tuohy Epidural Needle is a device used for the injection of anesthetic agents into a patient for regional anesthesia administration or to facilitate the placement of an epidural catheter for continuous infusion of local anesthetics.
Tuohy Epidural Needles consist of a plastic cannula hub, containing a stainless steel bushing, affixed to a stainless steel cannula with medical grade adhesive and a stainless steel stylet affixed to a plastic stylet hub with medical grade adhesive. The cannula hub has the option of a permanent, fixed wing or a removable wing depending on user preference. The needle assembly is protected with a polypropylene sheath.
Tuohy Epidural Needles are provided as a sterile, single use, disposable devices. The Tuohy Epidural Needles will be available in a variety of lengths and gauges. They may be packaged individually or included in regional anesthesia trays (kits).
Intended Use/Indications for Use
Remington Medical, Inc. Tuohy Epidural Needles are to be used to inject local anesthetics into a patient to provide regional anesthesia or to facilitate the placement of an epidural catheter.
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Image /page/4/Picture/0 description: The image shows the logo for Remington Medical. The logo consists of a blue geometric shape on the left and the words "Remington MEDICAL" in blue on the right. The word "Remington" is in a larger font than the word "MEDICAL", which is directly below it.
Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle
Technological Characteristics:
The technological characteristics (design, specifications, and performance) of the subject device and the predicate devices are substantially equivalent. Remington Medical Inc. Tuohy Epidural Needles meet performance standards where applicable for:
Hub to Needle Bond Strength: ISO 7864
Color: ISO 6009
| | Subject Device:
Remington Medical Inc. Tuohy
Epidural Needles | Predicate Device:
Myco Medical Supplies, Inc.
Dr. Japan's Phoenix Epidural &
Spinal Needles (K990519) | Predicate Device:
B. Braun Medical, Inc.
Perican™ Ultra Needle,
(K133632) |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | Class II | Class II |
| FDA Product
Code | BSP | BSP | BSP |
| Regulation | 21 CFR 868.5150 | 21 CFR 868.5150 | 21 CFR 868.5150 |
| Indications for
Use Statement | Remington Medical, Inc. Tuohy
Epidural Needles are to be used to
inject local anesthetics into a
patient to provide regional
anesthesia or to facilitate the
placement of an epidural catheter. | Spinal and Epidural needles are to
be used to inject local anesthetics
into a patient to provide regional
anesthesia. | The B. Braun Perican Ultra
needle is intended for use in
injecting local anesthetics
and/or analgesics into a patient
to provide regional anesthesia
and/or to facilitate the
placement of a catheter. |
| Cannula
Material | Metal, Stainless Steel | Metal, Stainless Steel | Metal, Stainless Steel |
| Cannula Depth
Marking | 10 mm, Wide Band | Wide Band | Wide Band |
| Cannula Hub
Material | Plastic (Polycarbonate), Stainless
Steel Bushing and UV Cured
Medical Grade Adhesive | Plastic, Metal Bushing, and
Adhesive | Plastic, Spacer (Bushing) and
Adhesive |
| Stylet Material | Metal, Stainless Steel | Metal, Stainless Steel | Metal, Stainless Steel |
| Stylet Hub
Material | Color-coded Plastic
(Polycarbonate) and UV Cured
Medical Grade Adhesive | Color-coded Plastic and Adhesive | |
| Gauge/Length
(inches)/Color
Depiction | 17 GA 3.5", 5.0" Violet | 16 GA 3.5" White | |
| | 18 GA 3.5", 5.0" Pink | 17 GA 3.5", 6.0" Violet | |
| | 19 GA 2.0" Cream | 18 GA 2.5", 3.5", 6.0" Pink | |
| | 20 GA 3.5", 5.0", 6.0" Yellow | 20 GA 3.5", 4.5", 6.0" Yellow | |
| | 22 GA 3.5" Black | 22 GA 2.5", 3.5" Black | |
| Final Needle
Assembly
Protection | Sheath | Sheath | Sheath |
| Sterilization
Method | ETO | ETO | ETO |
5
Traditional 510(k) Notification Remington Medical Inc. Tuohy Epidural Needle
Performance Data:
Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles including verification/validation testing to internal functional specifications (e.g. catheter placement, and bond strength between cannula, hub, and stylet) including comparison data (e.g., needle flow) to the K990519 predicate device. These tests demonstrated that the Remington Medical Inc. Tuohy Epidural Needles are substantially equivalent to the predicate device. Visual inspection of the test catheter under magnification confirmed no negative impact to the catheter post-placement. Testing confirmed that the Remington Medical Inc. Tuohy Epidural Needles comply with relevant standards, specifically ISO standards 7864 and 6009. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility (ISO 10993-1) and sterilization. Biocompatibility testing performed includes cytotoxicity, sensitization, irritation or intracutaneous reactivity, and acute systemic toxicity. Pyrogenicity was also tested.
Clinical testing:
Clinical testing was not required.
Conclusion:
The results of the non-clinical testing demonstrated that the subject device, Remington Medical Inc. Tuohy Epidural Needles, is substantially equivalent to the predicate devices, Myco Medical Supplies, Inc. Dr. Japan's Phoenix Epidural & Spinal Needles and B. Braun Medical, Inc. Perican™ Ultra Needle, (K133632) with respect to intended use, materials, design, and technological characteristics.