The Uniever Disposable Epidural Anesthesia Needle is intended to injection into the epidural space / or placing the epidural catheter into the epidural space.

Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.

Device Description

The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER Disposable Nerve Blockade Needles are available in an array of sizes, lengths, and bevel and tip designs. Both have a tightly fitting removable stylet.

The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber, Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G (Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm.

The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut, K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm (Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber).

AI/ML Overview

The provided document is a 510(k) premarket notification for two medical devices: the Uniever Disposable Epidural Anesthesia Needle and the Uniever Disposable Nerve Blockade Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a device meets those criteria from scratch, which is typical for novel devices or PMAs (Premarket Approval Applications).

Therefore, the information for acceptance criteria and a detailed study proving performance against those criteria in the way one might expect for a new diagnostic or AI-based device is not explicitly present in this document. The document describes performance testing to ensure compliance with voluntary safety standards and internal functional specifications.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a formal table of acceptance criteria and reported device performance in the way requested for a new device. Instead, it describes performance testing conducted to demonstrate compliance with recognized international standards and internal specifications, implying that meeting these standards constitutes "acceptance."

Implicit Acceptance Criteria (based on compliance with standards):

Acceptance Criteria Category	Reported Device Performance (Summary)
Material Biocompatibility	Complies with ISO 10993-1, including cytotoxicity, sensitization, irritation, and pyrogenicity testing.
Sterilization (EtO)	Achieves a Sterility Assurance Level (SAL) of $10^{-6}$. In addition, endotoxin and particulate testing for CSF contact was performed.
Luer Connections	Complies with ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment - Part 1: General requirements).
Sterile Hypodermic Needles	Complies with ISO 7864 (Sterile hypodermic needles for single use).
Stainless Steel Needle Tubing	Complies with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods).
Functional Specifications	Passed verification/validation testing to internal functional specifications, demonstrating the devices are safe and effective. (Specific functional details not provided).

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

The document does not specify the sample size used for any of the performance tests (e.g., how many needles were tested for biocompatibility, sterility, or functional aspects). It also does not mention the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the underlying test reports, which are not included in this summary.

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

This type of information (experts, ground truth for a test set) is typically relevant for diagnostic devices or AI algorithms where a "truth" needs to be established (e.g., presence/absence of a disease). For a physical medical device like an anesthesia needle, "ground truth" is established by adherence to engineering performance standards and biological safety standards. Therefore, this information is not applicable in the context of this 510(k) summary. Quality engineers, material scientists, and microbiologists would have conducted and reviewed the tests, but they wouldn't be referred to as "experts establishing ground truth" in this manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As mentioned above, adjudication methods like 2+1 or 3+1 are used for interpreting ambiguous cases or establishing consensus in diagnostic studies. This is not applicable to the performance testing of a physical medical device like an anesthesia needle, where test results are typically objective measurements against a standard.

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:

This is explicitly for AI-assisted diagnostic devices. This 510(k) is for a physical epidural and nerve block needle, so an MRMC study is not applicable and was not done.

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

This is also explicitly for AI-driven algorithms. This 510(k) is for a physical medical device, so a standalone algorithm performance evaluation is not applicable and was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For this device, "ground truth" is defined by compliance with established international consensus standards (ISO standards) and verified internal functional specifications for physical and biological properties. It is not expert consensus on diagnostic images, pathology results, or patient outcomes data.

8. The sample size for the training set:

There is no "training set" in the context of this 510(k) for a physical medical device. Training sets are applicable to machine learning algorithms.

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

Again, no training set exists for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-000

January 14, 2015

Unisis Corp. % Ms. Diane Rutherford Submissions Manager Ken Block Consulting, Inc. 1201 Richardson Drive Suite 280 Richardson, Texas 75080-4403

Re: K142553

Trade/Device Name: Uniever Disposable Epidural Anesthesia Needle, Uniever Disposable Nerve Blocked Needle Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: Class II Product Code: BSP Dated: December 12, 2014 Received: December 15, 2014

Dear Ms. Rutherford,

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,

Erin -. Keith -S

Erin Keith 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) K142553

Device Name

Uniever Disposable Epidural Anesthesia Needle, Uniever Disposable Nerve Blocked Needle

Indications for Use (Describe)

The Uniever Disposable Epidural Anesthesia Needle is intended to injection into the epidural space / or placing the epidural catheter into the epidural space.

Uniever Disposable Nerve Blockade Needle is intended to be used for injection of local anesthetic agent near the nerve for temporary pain control.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(k) SUMMARY

K142553

Submitter:	UNISIS Corp2675-1, NISHIKATAKoshigaya-shi, Saitama 343-0822 Japan
Contact Person:	Unisis CorpMr. Tadashi YasudaMedical Information Department2623-1, NISHIKATAKoshigaya-shi, Saitama 343-0822 JapanTEL: 048-990-8250FAX: 048-990-8251m-info@unisis.co.jp
Date Prepared:	August 28, 2014
Trade Name:	UNIEVER Disposable Epidural Anesthesia NeedleUNIEVER Disposable Nerve Blockade Needle
Common Name:	Epidural Anesthesia NeedleNerve Block Needle
Classification Name:	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Product Code:	BSP	Class 2 868.5150
Predicate Devices:	* K131006 LCCS AN-E Epidural Needle* K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle andK113207 Crawford needle [Sono]* K041843 Epimed Blunt Nerve Block Needle* K081864 Life-Tech ProLong Continuous Nerve Block Set
Device Description:	The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER DisposableNerve Blockade Needles are available in an array of sizes, lengths, and bevel andtip designs. Both have a tightly fitting removable stylet.The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber,Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G(Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm.The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut,K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm(Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber).
Statement ofIntended Use:	UNIEVER Disposable Epidural Anesthesia Needle is intended to be used forinjection into the epidural space/or placing the epidural catheter into the epiduralspace.UNIEVER Disposable Nerve Blockade Needle is intended to be used for injectionof local anesthetic agent near the nerve for temporary pain control.

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Summary of Technological Characteristics: As with the predicates, the UNIEVER Disposable Epidural Anesthesia and UNIEVER Disposable Nerve Blockade Needles are single use, terminally sterilized devices available in various gauge/length combinations including the overall combined ranges of 14G - 26G and 25mm to 260mm. The proposed devices share technological characteristics with the predicate devices. The proposed devices also have some differences in technological characteristics from those of the predicate devices. The differences in the technological characteristics are minor and reflect market strategy and do not impact the safety, effectiveness, or substantial equivalence of the device.

UNIEVER Disposable Epidural Anesthesia Needle offers various needle types as do the predicate devices. The UNIEVER Disposable Epidural Anesthesia Needle and both predicates identify the identical biocompatibility category, contact, and duration. UNIEVER Disposable Epidural Anesthesia Needles as well as both predicates are sterilized using ethylene oxide (EO) with Unisis specifying an SAL of 10-°.

Minor differences do exist between the UNIEVER Disposable Epidural Anesthesia Needle and the predicates. For example, the UNIEVER Disposable Epidural Anesthesia Needles offer a 14G needle while the two predicates have 15G [K110194] or 16G [K112515] as the largest gauge offered. The UNIEVER Disposable Epidural Anesthesia Needles also differ in the minimum and maximum needle lengths offered with the UNIEVER Epidural needles ranging from 30mm -160mm with the predicates offering 50mm - 150mm [K131006] and 20mm-180mm [K040965, K113207]. All the lengths offered for the UNIEVER Disposable Epidural Anesthesia Needles fall within the ranges offered by the identified predicates.

The UNIEVER Disposable Nerve Blockade Needle various needle types as do the predicate devices. Both the UNIEVER Blockade and the K041843 predicate identify the identical biocompatibility category, contact, and duration. UNIEVER Disposable Nerve Blockade Needles are sterilized using ethylene oxide (EO) to an SAL of 10°.

Minor differences do exist between the UNIEVER Disposable Nerve Blockade Needle and the predicates. For example, the UNIEVER Disposable Nerve Blockade Needles offer a 26G needle while the two predicates have 25G [K041843] or 20G [K081864] as the smallest gauge offered. The UNIEVER Disposable Nerve Blockade Needles also differ in the minimum and maximum needle lengths offered with the UNIEVER Blockade needles ranging from 25mm - 260mm with the predicates offering 38mm - 203.2mm [K041843] and 25mm - 150 mm [K081864].

As all the needles offered are tested for compliance to the same international standards (ISO 7864 and ISO 9626) this difference does not impact the safety, effectiveness, or substantial equivalence of the device.

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Tests were performed on the UNIEVER Disposable Spinal Epidural Anesthesia Summary of Performance Testing: Needles and the UNIEVER Disposable Nerve Blockade Needles including verification/validation testing to internal functional specifications which demonstrated that the devices are safe and effective. Testing confirmed that the UNIEVER Disposable Spinal Epidural Anesthesia Needles and the UNIEVER Disposable Nerve Blockade Needles comply with relevant voluntary safety standards, specifically ISO standards 594-1, 7864, and 9626. In addition, evaluations and validations have been performed to demonstrate compliance to the applicable standards for biocompatibility (ISO 10993-1) and sterilization including additional endotoxin and particulate testing for CSF contact. Biocompatibility testing performed includes cytotoxicity, sensitization and irritation. Pyrogenicity was also tested.
Conclusion: Unisis Corp considers the UNIEVER Disposable Epidural Anesthesia Needle and the UNIEVER Disposable Nerve Blockade Needle to be substantially equivalent to the predicate devices listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.

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).