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.

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).

AI/ML Overview

This FDA 510(k) premarket notification for the Remington Medical Inc. Tuohy Epidural Needle does not describe a study involving an AI/CADe device or its performance criteria, as it is for a physical medical device (an epidural needle).

Therefore, I cannot provide information on acceptance criteria and study details related to AI performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, or ground truth types in the context of an AI device.

The provided document details the substantial equivalence of a physical medical device (Tuohy Epidural Needle) to predicate devices. It focuses on the physical and functional characteristics of the needle.

However, I can extract the acceptance criteria and reported device performance for the physical device as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the physical device):

Acceptance Criteria (Standard)	Reported Device Performance (Remington Medical Inc. Tuohy Epidural Needles)
Hub to Needle Bond Strength	Complies with ISO 7864. Tests demonstrated substantial equivalence to predicate device; verification/validation testing to internal functional specifications (e.g., bond strength between cannula, hub, and stylet) was performed.
Color Coding	Complies with ISO 6009.
Catheter Placement (Functional)	Test confirmed no negative impact to the catheter post-placement through visual inspection under magnification. Testing was done to internal functional specifications.
Needle Flow	Comparison data to predicate device (K990519) performed; demonstrated substantial equivalence.
Biocompatibility	Complies with ISO 10993-1. Biocompatibility testing performed included: cytotoxicity, sensitization, irritation or intracutaneous reactivity, and acute systemic toxicity.
Pyrogenicity	Tested and confirmed.
Sterilization	Valuations performed to demonstrate compliance to applicable standards. (Method: ETO for both subject and predicate devices).
General Functional Specifications	Verification/validation testing to internal functional specifications (e.g. catheter placement, and bond strength between cannula, hub, and stylet) was performed. These tests demonstrated that the Remington Medical Inc. Tuohy Epidural Needles are substantially equivalent to the predicate device.

2. Sample sized used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample size for each performance test. It broadly states "Tests were performed on the Remington Medical Inc. Tuohy Epidural Needles."
Data Provenance: The tests are described as "non-clinical testing" conducted to internal functional specifications and relevant ISO standards. No information on country of origin of data (likely internal company testing) or whether it was retrospective or prospective is given, as it refers to engineering and laboratory testing, not human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device is a physical epidural needle, not an AI/CADe system requiring expert-established ground truth from images or other medical data. The "ground truth" for this device's performance is objective measurement against engineering specifications and relevant ISO standards.

4. Adjudication method for the test set:

Not applicable. No adjudication method is mentioned as it is not a clinical study involving subjective interpretation. Performance is measured against objective standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI device.

7. The type of ground truth used:

For the physical properties and performance (e.g., bond strength, flow, biocompatibility): The "ground truth" is established by international standards (ISO 7864, ISO 6009, ISO 10993-1) and internal functional specifications. These are objective, measurable criteria. For catheter placement, visual inspection under magnification was used to confirm no negative impact.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable. As this is not an AI device, there is no training set or ground truth in that context.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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: 1056553Owner/Operator Number: 9006473
Contact Person	Caitlin Senter, MS, RACRegulatory Affairs Manager770-888-8520, extension 207caitlins@remmed.com
Trade ProprietaryName(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:

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. TuohyEpidural 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 ProductCode	BSP	BSP	BSP
Regulation	21 CFR 868.5150	21 CFR 868.5150	21 CFR 868.5150
Indications forUse Statement	Remington Medical, Inc. TuohyEpidural Needles are to be used toinject local anesthetics into apatient to provide regionalanesthesia or to facilitate theplacement of an epidural catheter.	Spinal and Epidural needles are tobe used to inject local anestheticsinto a patient to provide regionalanesthesia.	The B. Braun Perican Ultraneedle is intended for use ininjecting local anestheticsand/or analgesics into a patientto provide regional anesthesiaand/or to facilitate theplacement of a catheter.
CannulaMaterial	Metal, Stainless Steel	Metal, Stainless Steel	Metal, Stainless Steel
Cannula DepthMarking	10 mm, Wide Band	Wide Band	Wide Band
Cannula HubMaterial	Plastic (Polycarbonate), StainlessSteel Bushing and UV CuredMedical Grade Adhesive	Plastic, Metal Bushing, andAdhesive	Plastic, Spacer (Bushing) andAdhesive
Stylet Material	Metal, Stainless Steel	Metal, Stainless Steel	Metal, Stainless Steel
Stylet HubMaterial	Color-coded Plastic(Polycarbonate) and UV CuredMedical Grade Adhesive	Color-coded Plastic and Adhesive
Gauge/Length(inches)/ColorDepiction	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 NeedleAssemblyProtection	Sheath	Sheath	Sheath
SterilizationMethod	ETO	ETO	ETO

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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.

Regulation Number and Section

§ 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).