UNIEVER DISPOSABLE SPINAL ANESTHESIA NEEDLE by UNISIS CORP.

UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

Device Description

The UNIEVER Disposable Spinal Anesthesia Needles are available in an array of sizes, lengths, and bevel and tip designs. The UNIEVER Disposable Spinal Anesthesia Needle has a tightly fitting removable stylet that completely occludes the lumen to avoid tracking epithelial cells into the subarachnoid space. The needles are available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable Spinal Anesthesia Needles are also available with an introducer. Available sizes are 18G to 29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. The introducers are available in sizes of 18G-22G with needle lengths of 25-50mm.

AI/ML Overview

This document is a 510(k) summary for the UNIEVER Disposable Spinal Anesthesia Needle. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than a clinical study evaluating diagnostic or prognostic accuracy. Therefore, many of the requested elements for describing a study proving the device meets acceptance criteria are not directly applicable or available in this type of submission.

Based on the provided text, here's what can be extracted and inferred regarding acceptance criteria and performance, with limitations acknowledged:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from relevant standards or statements)	Reported Device Performance (from text)
Material/Design	Materials commonly used in medical devices (stainless steel, polycarbonate, polypropylene).	Manufactured with stainless steel, polycarbonate, and polypropylene.
Sterilization	Sterilized using ethylene oxide (EO).	Sterilized using ethylene oxide (EO).
Shelf Life	5-year shelf life.	Has a 5-year shelf life.
Biocompatibility	Compliant with biocompatibility standards (sensitization, irritation, cytotoxicity, pyrogenicity), including additional endotoxin and particulate testing for CSF contact.	Evaluations and validations performed to demonstrate compliance to biocompatibility (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, and Pyrogenicity) and sterilization including additional endotoxin and particulate testing for CSF contact.
Performance (General)	Compliance with relevant voluntary safety standards, specifically ISO standards 594-1, 7864, and 9626.	Testing confirmed compliance with ISO 594-1, 7864, and 9626.
Intended Use	Intended for injection of local anesthetic into the subarachnoid cavity for pain management.	Shares the same indications for use as both predicates.

Explanation of Limitations:

The acceptance criteria are largely based on adherence to established international standards (ISO) and common practices for medical devices of this type, rather than specific performance metrics like sensitivity, specificity, or accuracy (which would be relevant for diagnostic AI devices).
"Reported Device Performance" here refers to the direct statements of compliance or characteristics mentioned in the summary, not quantitative results from detailed performance studies. The document states "Tests were performed...demonstrated that the device is safe and effective" but does not provide the raw data or specific outcomes of these tests beyond affirming compliance with standards.

The following points address the remaining questions, but it's crucial to understand that a 510(k) summary for a spinal needle (a physical medical device, not an AI or diagnostic algorithm) does not typically involve the kind of performance studies common for AI/ML or diagnostic devices. Therefore, most of these fields will be marked "Not Applicable" or "Not Provided" in this context.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable/Not Provided: This type of information is not relevant for a physical device like a spinal needle, which undergoes bench testing and compliance verification rather than "test sets" of patient data for diagnostic accuracy. The testing mentioned (ISO standards, biocompatibility) would involve material samples or device prototypes in controlled environments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Provided: Ground truth, in the sense of expert consensus on diagnostic interpretations, is not part of the evaluation for a spinal needle. Compliance with standards and biocompatibility are typically assessed by laboratory technicians, engineers, and toxicologists, rather than medical experts forming a "ground truth" on patient outcomes for a test set.

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

Not Applicable/Not Provided: Adjudication methods are used to resolve disagreements among experts in establishing ground truth for diagnostic studies. This is not relevant for the type of testing described in this 510(k) summary.

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 a physical medical device, not an AI/ML algorithm. Therefore, an MRMC comparative effectiveness study involving human readers or AI assistance is entirely irrelevant.

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

Not Applicable: This is a physical medical device, not an algorithm. Standalone performance as described is not relevant.

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

Not Applicable/Inferred: While "ground truth" in the diagnostic sense is not used, the "truth" for this device's performance would be established by:
- Compliance with International Standards: Adherence to physical, mechanical, and safety specifications outlined in ISO 594-1, 7864, and 9626.
- Biocompatibility Testing: Results from validated laboratory tests (e.g., in vitro or in vivo) demonstrating absence of cytotoxicity, sensitization, irritation, pyrogenicity, and acceptable endotoxin/particulate levels.
- Material Characterization: Verification that materials are as specified and commonly used in medical devices.

8. The sample size for the training set

Not Applicable/Not Provided: There is no "training set" in the context of a physical medical device's 510(k) submission. This concept applies to AI/ML algorithms.

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

Not Applicable/Not Provided: As there is no training set, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 31, 2014

Unisis Corp, Inc. c/o Ms. Diane Rutherford Submission Manager Ken Block Consulting 1201 Richardson Dr., Suite #280 Richardson, TX 75080

Re: K141126

Trade/Device Name: UNIEVER Disposable Spinal Anesthesia Needle Regulation Number: 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: October 2, 2014 Received: October 3, 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.

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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 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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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INDICATIONS FOR USE

510(k) Number: K141126

Device Name: UNIEVER Disposable Spinal Anesthesia Needle

Indications for Use:

UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injection of local anesthetic agent into the subarachnoid cavity for pain management.

Prescription Use __ X (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 CDHR, Office of Device Evaluation (ODE)

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5. 510(k) SUMMARY

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:	April 15, 2014
Trade Name:	UNIEVER Disposable Spinal Anesthesia Needle
Common Name:	Spinal Anesthesia Needle
Classification Name:	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Product Code:	BSP Class 2 868.5150
Predicate Device:	K112515 B.Braun Pencan Spinal Needles, Spinocan Spinal Needles,Spinal Introducer NeedlesK110194 Medline Medline Epidural and Spinal Needles
Device Description:	The UNIEVER Disposable Spinal Anesthesia Needles are available in an array ofsizes, lengths, and bevel and tip designs. The UNIEVER Disposable SpinalAnesthesia Needle has a tightly fitting removable stylet that completely occludesthe lumen to avoid tracking epithelial cells into the subarachnoid space. The needlesare available with a sharp (cutting)-tip or a blunt-tip. UNIEVER Disposable SpinalAnesthesia Needles are also available with an introducer. Available sizes are 18G to29G (K-3), and 22G to 29G (Pencil Point) for lengths of 30-150mm. Theintroducers are available in sizes of 18G-22G with needle lengths of 25-50mm.
Statement ofIntended Use:	UNIEVER Disposable Spinal Anesthesia Needle is intended to be used for injectionof local anesthetic agent into the subarachnoid cavity for pain management.
Summary ofTechnologicalCharacteristics:	As with the predicates, the UNIEVER Disposable Spinal Anesthesia Needles aresingle use, terminally sterilized devices available in various gauge/lengthcombinations including the overall ranges of 18G - 29G and 30mm to 150mm. Theproposed device shares technological characteristics with the predicate devices. Theproposed device also has some differences in technological characteristics fromthose of the predicate devices. The differences in the technological characteristicsare minor and reflect market strategy and do not impact the safety, effectiveness, orsubstantial equivalence of the device.

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Summary of Technological Characteristics: (Continued)

The UNIEVER Disposable Spinal Anesthesia Needles share the same indications for use with both predicates. One difference exists in that the K112515 predicate includes indications for CSF sample collection while both the UNIEVER and the K110194 predicate do not include this additional indication.

The UNIEVER Disposable Spinal Anesthesia Needles offer both Quincke and Pencil Point needle types as well as an introducer or guide needle [identical to both K112515 and K110194]. The UNIEVER Disposable Spinal Anesthesia Needles and the predicates are manufactured with materials commonly used in medical devices: stainless steel, polycarbonate, and polypropylene. Both the UNIEVER and the K110194 predicate identify the identical biocompatibility category, contact, and duration, and both reference testing for sensitization, irritation, and cytotoxicity. UNIEVER Disposable Spinal Anesthesia Needles as well as both predicates are sterilized using ethylene oxide (EO). UNIEVER Disposable Spinal Anesthesia Needles have a 5 year shelf life [identical to K112515].

Minor differences do exist between the UNIEVER Disposable Spinal Anesthesia Needles and the predicates. For example, the UNIEVER Disposable Spinal Anesthesia Needles offer a 29G needle while the two predicates have 25G [K110194] or 27G [K112515] as the smallest gauge offered. The UNIEVER Disposable Spinal Anesthesia Needles also differ in the minimum and maximum needle lengths offered with the UNIEVER needles ranging from 30mm - 150mm (28mm - 50mm for the introducer) with the predicates offering 25mm - 156mm (35mm for introducer) [K112515] and 90mm (38mm introducer) [K110194]. All the lengths offered for the UNIEVER Disposable Spinal Anesthesia Needles fall within the ranges offered by the identified predicates.

Manufacturers offer different needle gauges and needle lengths based on the marketability of the device. This is common in the marketplace. 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.

Tests were performed on the UNIEVER Disposable Spinal Anesthesia Needles Summary of Performance Testing: including verification/validation testing to internal specifications which demonstrated that the device is safe and effective. Testing confirmed that the UNIEVER Disposable Spinal Anesthesia 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 standards biocompatibility (Cytotoxicity, Sensitization, applicable for Irritation/Intracutaneous Reactivity, and Pyrogenicity) and sterilization including additional endotoxin and particulate testing for CSF contact.

Unisis Corp considers the UNIEVER Disposable Spinal Anesthesia Needle to be Conclusion: 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).