SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE

K082674 · Spectra Medical Devices, Inc. · FMF · Nov 28, 2008 · General Hospital

Device Facts

• Record ID: K082674
• Device Name: SPECTRA-GLASS LOR (LOSS OF RESISTANCE SYRINGE, 5CC METAL L/S OR L/L TIP, SPECTRA-GLASS LOR (LOSS OF RESISTANCE) SYRINGE
• Applicant: Spectra Medical Devices, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Nov 28, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.

Device Story

Glass Loss of Resistance (LOR) syringe; used by clinicians during epidural procedures. Device functions as a manual tool to verify needle tip placement in the epidural space by detecting loss of resistance; operates via tactile feedback provided to the clinician. Not intended for injection or aspiration. Used in clinical settings; provides physical confirmation of needle position to assist in epidural anesthesia placement.

Clinical Evidence

Bench testing only.

Technological Characteristics

Glass piston syringe; manual operation; non-powered; intended for tactile feedback during epidural needle placement. No electronic components or software.

Indications for Use

Indicated for use in conjunction with an epidural needle to verify needle tip placement in the epidural space via the Loss of Resistance technique. Not intended for injection or aspiration.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 28 2008

Mr. Scott Henderson International Engineering Manager Spectra Medical Devices, Incorporated 260-F&H Fordham Road Wilmington, Massachusetts 01887

Re: K082674

Trade/Device Name: Spectra, GLASS LOR SYRINGE Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: September 12, 2008 Received: September 15, 2008

Dear Mr. Henderson:

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.

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.

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Page 2 - Mr. Henderson

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); good manufacturing practice requircments 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) promarket notification. The FDA finding of substantial equivalence of 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Clive

Chiu S. Lin. Ph. D Division 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

K082671

1 of 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Spectra, GLASS LOR SYRINGE Device Name:

Indications for Use:

The Spectra, "GLASS LOR SYRINGE" [Loss of Resistance Syringe] is intended for use, in conjunction with an epidural needle, to verify the needle tip placement in the cpidural space by the Loss of Resistance technique as explained in standard medical textbooks. These syringes are not intended for injection or aspiration.

Prescription Use X (Part 21 CFR 801 Subpert D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

concurrence of cdrh, office of device evaluation (ode)

SECTION 3, PAGE 1

Anton Vimin

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

510(k) Number: k082674