SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09

K032981 · Invamed Technologies, Inc. · BSP · Apr 22, 2004 · Anesthesiology

Device Facts

• Record ID: K032981
• Device Name: SPPRO ESP, MODELS ESP 603-18-05, ESP 603-18-09
• Applicant: Invamed Technologies, Inc.
• Product Code: BSP · Anesthesiology
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.

Device Story

SPpro™ ESP is an anesthesia conduction needle with an integrated sharps injury protection mechanism. Device delivers local anesthetics or therapeutic agents into non-vascular body cavities; used for single-dose or continuous regional anesthesia (via catheter). Operation involves manual insertion by clinician; post-procedure, clinician activates active shielding system—a sliding hub mechanism with plastic sheath—to cover needle tip and cannula, preventing accidental needle-stick injuries. Device is single-use and disposed of in sharps containers. Benefits include reduced risk of sharps injuries to healthcare personnel during and after regional anesthesia procedures. Clinical utility is identical to standard conduction needles, with added safety feature.

Clinical Evidence

Bench testing and simulated clinical testing performed. No human clinical trials conducted. Testing followed FDA's 'Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features' (Dec 2002) to verify functional performance of the shielding mechanism and ensure no impact on the therapeutic delivery function.

Technological Characteristics

Anesthesia conduction needle with active shielding system. Features a second hub section integrated with the luer hub that slides to lock over the needle tip, plus a plastic sheath covering the cannula. Materials selected for transient external tissue contact. Single-use, sterile. Standalone mechanical device.

Indications for Use

Indicated for patients requiring regional anesthesia via conduction needle for single-dose administration or continuous regional anesthesia via catheter. No specific age or gender restrictions noted. Contraindicated for vascular access.

Regulatory Classification

Identification

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

Predicate Devices

• Manan Epidural Needle (K980536)
• Manan Spinal Needles (K983620)
• Perifix Safety Epidural Needle (K013610)

Submission Summary (Full Text)

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K032981

APR 2 2 2004

Image /page/0/Picture/2 description: The image contains the text "InVaMed" in a large, bold font at the top left of the image. Below this text, there is another line of text that reads "These are wondrous". The background of the image is black, and the text is white, creating a high contrast. There is also a small, blurry image in the center of the image.

Tim Duvall President Office Number [phone]

InVaMed Technologies, Inc. 9955 Titan Park Circle / Littleton, CO 80125 Corp. Phone [phone] Fax [phone]

# 510(k) Summary - Dated September 19, 2003

### General Information

| Classification: | Class II |
|-----------------|-----------------------------------------------------------------------------|
| Trade Name: | SPpro™ - ESP |
| Submitter: | InVaMed Technologies, Inc.<br>9955 Titan Park Circle<br>Littleton, CO 80125 |
| Contact: | Tim Duvall<br>President<br>[phone] |

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#### Device Identification

- A. Common Name
Epidural Needle with Sharps Injury Protection Feature Spinal Needle with Sharps Injury Protection Feature

- B. Classification Name
Needle, Conduction, Anesthetic (W/WO Introducer)

#### C. Regulation Number

858.5150

D. Panel

Anesthesiology

E. Product Code

BSP

- F. Class
Class II

#### Predicate Devices

Manan Epidural Needle from Manan Medical Products, Inc. K980536 Manan Spinal Needles from Manan Medical Products, Inc. K983620 Perifix Safety Epidural Needle from B. Braun Medical, Inc. K013610

#### Device Description Information

#### Intended Use

The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.

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#### Device Description

The SPpro™ ESP anesthesia conduction needle is a single use device for injection of local anesthetics into body cavities other than blood vessels. The device will be packaged as sterile single units or incorporated into kits. The device is designed with a tip shield and sheath mechanism integrated with the introducer hub to aid in the prevention of sharps injuries. After activation the shield covers the introducer tip. The device is disposed of according to institutional procedure in a sharps container.

#### Biocompatibility

Although the SPpro™ ESP sharps injury protection device has no direct contact with internal body fluids the materials and assembly methods were selected to provide for transient external tissue contact biocompatibility.

Biocompatibility testing on the therapeutic portion of the device included all tests performed on the predicate devices. The therapeutic devices are already approved devices made for InVaMed Technologies by Manan Medical Products, Inc.

#### Device Performance/Product Testing

Functional and simulated clinical testing was performed to support that there are no new issues or effectiveness raised by adding the sharps injury protection feature. The SPpro™ ESP met all functional requirements and specifications. Clinical simulation testing was in accordance with the Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Features: Guidance for Industry and FDA issued on December 31, 2002.

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#### Technology Characteristics

The therapeutic device is equivalent technologically to the devices mentioned under predicate devices above. The therapeutic devices are already approved devices made for InVaMed Technologies by Manan Medical Products, Inc.

The safety feature, which has been integrated with the therapeutic portion of the device, is the reason for this submission. The safety feature is an active shielding system that that incorporates a second hub section integrated with the luer portion of the needle that slides up from the needle hub and locks over the needle tip. A second feature incorporates a plastic sheath attached to the sliding portion and the luer hub, which covers the previously exposed canula of the needle.

#### Substantial Equivalence

The InVaMed SPpro ESP needle incorporates an active needle tip cover mechanism to minimize needle stick injuries when used to access non-vascular areas of the body to administer local anesthetics. The basic design, methods of manufacturing, and materials used in the therapeutic portion of the device are substantially equivalent to the predicate devices, Manan Epidural Needle and Manan Spinal Needles from Manan Medical Products, Inc. While basic design, methods of manufacturing, and materials used in the safety portion of the device differ the technological equivalence exist between the predicate devices, Perifix® Safety Epidural Needle from B. Braun Medical, Inc. Our application for this device is substantially equivalent to the aforementioned devices already approved for use. The clinical indications for use remain unchanged. InVaMed believes the SPpro ESP anesthesia conduction needle is substantially equivalent to currently marketed anesthesia conduction needles and an anesthesia conduction needle with sharps injury protection features.

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Image /page/4/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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure with three flowing lines representing the body and arms.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 2 2 2004

Mr. Tim Duvall President InVaMed Technologies; Incorporated 9955 Titan Park Circle Littleton, Colorado 80125

Re: K032981

Trade/Device Name: SPpro ESP, Modcls ESP 603-18-05 and ESP 603-18-09 Regulation Number: 21 CFR 868.5150 Regulation Name: Anesthesia Conduction Needle Regulatory Class: II Product Code: BSP Dated: March 16, 2004 Received: March 19, 2004

Dear Mr. Duvall:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Tim Duvall

You must comply with all the Act's requirements, including, but not limited to: registration r ou indist configry with a 807); labeling (21 CFR Part 801); good manufacturing practice and home (2) as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet form nroduct radiation control provisions (Sections 531-542 of the Act); appreadio, and other will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence in your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n 900 donto the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj over it Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Ravis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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):

K032981

Device Name: SPpro ESP

Indications For Use:

The SPpro™ ESP is an anesthesia conduction needle incorporating a needle tip shielding mechanism to aid in the prevention of needle-stick injuries after use to deliver an anesthetic and/or therapeutic agent to provide regional anesthesia. The needle can be used for a single dose administration or in conjunction with a catheter for continuous regional anesthesia.

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A.W. Westerhem

esthesiology, General Hospital,

Page 1 of i

510(k) Number. K032981

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