UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle

K142553 · Unisis Corp. · BSP · Jan 14, 2015 · Anesthesiology

Device Facts

• Record ID: K142553
• Device Name: UNIEVER Disposable Epidural Anesthesia Needle, UNIEVER Disposable Nerve Blocked Needle
• Applicant: Unisis Corp.
• Product Code: BSP · Anesthesiology
• Decision Date: Jan 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UNIEVER Disposable Epidural Anesthesia Needle is intended to be used for 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 Story

Disposable stainless steel needles used for epidural anesthesia or nerve blockade; available in various gauges (14G-26G) and lengths (25mm-260mm); feature removable stylets and various tip designs (Huber, Hustead, Crawford, Back-Cut, K-3). Used by clinicians in clinical settings to inject anesthetic agents or place catheters. Provides physical access to epidural space or nerve sites; facilitates pain management. Benefits include temporary pain control and targeted anesthetic delivery.

Clinical Evidence

Bench testing only. Verification and validation testing performed to internal functional specifications. Compliance with ISO 594-1, ISO 7864, and ISO 9626 confirmed. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1. Pyrogenicity, endotoxin, and particulate testing for CSF contact performed.

Technological Characteristics

Single-use, terminally sterilized (EO, SAL 10^-6) needles. Materials comply with ISO 7864 and ISO 9626. Available in gauges 14G-26G and lengths 25mm-260mm. Tip designs include Huber, Hustead, Crawford, Back-Cut, and K-3. Includes removable stylet.

Indications for Use

Indicated for patients requiring epidural anesthesia or catheter placement, and patients requiring local anesthetic injection near a nerve for temporary pain control.

Regulatory Classification

Identification

An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.

Predicate Devices

• LCCS AN-E Epidural Needle (K131006)
• Pajunk Tuohy needle, Quincke needle, Chiba needle (K040965)
• Crawford needle [Sono] (K113207)
• Epimed Blunt Nerve Block Needle (K041843)
• Life-Tech ProLong Continuous Nerve Block Set (K081864)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

{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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

### 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) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 5. 510(k) SUMMARY

# K142553

| Submitter: | UNISIS Corp<br>2675-1, NISHIKATA<br>Koshigaya-shi, Saitama 343-0822 Japan | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Contact Person: | Unisis Corp<br>Mr. Tadashi Yasuda<br>Medical Information Department<br>2623-1, NISHIKATA<br>Koshigaya-shi, Saitama 343-0822 Japan<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | |
| Date Prepared: | August 28, 2014 | |
| Trade Name: | UNIEVER Disposable Epidural Anesthesia Needle<br>UNIEVER Disposable Nerve Blockade Needle | |
| Common Name: | Epidural Anesthesia Needle<br>Nerve 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<br>* K040965 Pajunk Tuohy needle, Quincke needle, Chiba needle and<br>K113207 Crawford needle [Sono]<br>* K041843 Epimed Blunt Nerve Block Needle<br>* K081864 Life-Tech ProLong Continuous Nerve Block Set | |
| Device Description: | The UNIEVER Disposable Epidural Anesthesia Needles and UNIEVER Disposable<br>Nerve Blockade Needles are available in an array of sizes, lengths, and bevel and<br>tip designs. Both have a tightly fitting removable stylet.<br><br>The UNIEVER Disposable Epidural Anesthesia Needles are available with Huber,<br>Hustead, or Crawford tips. Available sizes are 14G to 25G (Huber), 16G to 19G<br>(Hustead), and 16G to 22G (Crawford) for lengths of 30-160mm.<br><br>The UNIEVER Disposable Nerve Blockade Needles are available with Back-Cut,<br>K-3, or Huber tips. Available sizes are 18G, 20G to 26G for lengths of 25-260mm<br>(Back Cut and K-3), and 20G, 22G and 25G for lengths of 30-160mm (Huber). | |
| Statement of<br>Intended Use: | UNIEVER Disposable Epidural Anesthesia Needle is intended to be used for<br>injection into the epidural space/or placing the epidural catheter into the epidural<br>space.<br><br>UNIEVER Disposable Nerve Blockade Needle is intended to be used for injection<br>of local anesthetic agent near the nerve for temporary pain control. | |

{4}------------------------------------------------

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.

{5}------------------------------------------------

- 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.