EPIDRUM

K093863 · Exmoor Plastics , Ltd. · FMF · May 10, 2010 · General Hospital

Device Facts

• Record ID: K093863
• Device Name: EPIDRUM
• Applicant: Exmoor Plastics , Ltd.
• Product Code: FMF · General Hospital
• Decision Date: May 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Epidrum is intended for use in epidural procedures between a luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space.

Device Story

Epidrum is a single-use, medical-grade polymer device used during epidural procedures. It connects between a standard Luer syringe and an epidural needle. The device features a small chamber with an expandable membrane. As the clinician advances the epidural needle, the device utilizes the loss-of-resistance (LOR) principle. When the needle tip enters the epidural space, the pressure change causes the membrane to deflate, providing an instantaneous, clear visual signal to the clinician. This visual confirmation assists the physician in verifying correct needle placement, replacing or supplementing the traditional tactile-only LOR technique. The device is intended for use by healthcare professionals in clinical settings where epidural anesthesia or analgesia is performed.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use device constructed from medical-grade polymers. Features a small chamber with a female Luer inlet and male Luer exit port. Includes an integrated expandable membrane that acts as a visual indicator for pressure changes. Operates via the loss-of-resistance principle. Non-electronic, mechanical device.

Indications for Use

Indicated for use in conjunction with an epidural needle to verify needle tip placement in the epidural space.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Predicate Devices

• Avid-Nit Loss of Resistance Syringe (K001731)

Submission Summary (Full Text)

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KOS3863

## MAY 1 0 2010

### 510k Summary of Epidrum

Owner:

ﺬ

ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

Exmoor Plastics Limited Lisieux Way Taunton Somerset TA1 2LB United Kingdom

Contact: Patrick East 044823 351040 Telephone: [phone] Fax: Email: [e-mail] [e-mail]

| Prepared on: | 29th September 2009 |
|--------------|---------------------|
|--------------|---------------------|

Trade Name: Epidrum

Common Name: Loss of Resistance Device

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Classification Name: Piston syringe

Class:

Regulation Number: 880.5860

Product Code: FMF

Device Description: The Epidrum comprises a small chamber, featuring a female Luer inlet port and a male Luer exit port on opposing sides, with an expandable membrane as one of the sides between the ports.

> The Epidrum is a single use device, manufactured from medical grade polymers.

- Intended use: The Epidrum is intended for use in epidural procedures between a luer syringe and an epidural needle to give a clear visual signal that the needle tip has entered the epidural space.
Indications for Use:

The Epidrum is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.

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| Equivalent Device: | Avid-Nit Loss of Resistance Syringe |
|--------------------|-------------------------------------------------------------------------------------------------|
| 510K Number: | K001731 |
| Manufacturer: | Avid Medical Inc.<br>9000 Westmont Drive<br>Stonehouse Commerce Park<br>Toano<br>Virginia 23168 |

| Comparison: | Epidrum | Avid-nit LOR Syringe |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | Intended for use between a<br>Luer syringe and an epidural<br>needle to give a clear visual<br>signal that the needle tip has<br>entered the epidural space. | Intended for use, in conjunction<br>with an epidural needle, to verify<br>the needle tip placement in the<br>epidural space by the Loss of<br>Resistance technique as explained<br>in standard medical textbooks. |
| Indications<br>For Use | | The AVID-NIT Loss of Resistance<br>Syringe is intended for use, in |

The Epidrum is intended for use, in conjunction with an epidural needle to verify the needle tip placement in the epidural space.

Syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space

#### Technological

- Differences: The design incorporates an expandable membrane which deflates when the needle tip enters the epidural space giving an instantaneous, clear, visual signal.
The loss of resistance to the plunger of the syringe, when the distal tip of the needle penetrates the epidural space, is sensed by touch via the user's thumb.

Conclusion: Although the Epidrum uses different senses of the user (visual:touch) from the Loss of Resistance Syringe mentioned above, it operates on precisely the same loss of resistance principle, has the same intended use and raises no new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming a stylized shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

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

Ms. Margaret Blackmore Exmoor Plastics LTD Lisieux Way Taunton, Somerset United Kingdom TA1 2LB

#### MAY 1 0 2010

Re: K093863

Trade/Device Name: EPIDRUM Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 26, 2010 Received: April 27, 2010

Dear Ms. Margaret Blackmore:

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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#### Page 2- Ms. Margaret Blackmore

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 (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Farrar

Anthony D. Watson, B.S., M.S., M.B.A. 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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Exmoor Epidrum

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Section 4 Page 1

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# Indications for Use

510(k) Number (if known):

Epidrum Device Name:

Indications For Use:

The Epidrum is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the epidural space.

Prescription Use YES (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

L Schuth

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

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1093863 510(k) Number: