BUSSE PLASTIC LOR SYRINGE

K080804 · Busse Hosipital Disposables · CAZ · Jul 9, 2008 · Anesthesiology

Device Facts

• Record ID: K080804
• Device Name: BUSSE PLASTIC LOR SYRINGE
• Applicant: Busse Hosipital Disposables
• Product Code: CAZ · Anesthesiology
• Decision Date: Jul 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5140
• Device Class: Class 2

Intended Use

The plastic LOR syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique. The loss of Resistance Syringe is not intended for injection or aspiration.

Device Story

Single-use plastic syringe; used in conjunction with epidural needle to verify needle tip placement in epidural space via loss of resistance technique. Device filled with air or saline by clinician; provides tactile feedback to operator during epidural procedure. Not intended for injection or aspiration. Sold sterile, individually or in procedure kits. Available in luer lock and luer slip configurations.

Clinical Evidence

Bench testing only. Biocompatibility evaluation performed including Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, and L929 Mem Elution tests. All materials met safety requirements.

Technological Characteristics

Plastic syringe; luer lock or luer slip configuration. Single-use, sterile. No electronic components or software. Biocompatibility verified per standard testing protocols.

Indications for Use

Indicated for use with an epidural needle to verify needle tip placement in the epidural space via loss of resistance technique. Not for injection or aspiration. Prescription use only.

Regulatory Classification

Identification

An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.

Predicate Devices

• Loss of Resistance Syringe (K061737)

Submission Summary (Full Text)

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

Iusse
Hospital Disposables

Koron 4

# SUMMARY

# JUL - 9 2008

#### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Busse Plastic LOR Syringe

| Regulatory Affairs Contact: | Muhamad Ansari<br>Busse Hospital Disposables<br>PO Box: 11067<br>75 Arkay Dr.<br>Hauppauge NY 11788 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | 631-435-4711 Ext: 254 |
| Fax: | 631-435-2849 |
| Date Summary prepared: | March 13, 2008 |
| Product Trade Name: | Busse Plastic LOR Syringe |
| Common Name: | Conduction Anesthetic |
| Classification: | Class II, 21 CFR 868.5140 |
| Product Code: | CAZ |
| Predicate Device: | Loss of Resistance Syringe - (K061737) |
| Device Description: | The LOR plastic syringe is a single use device which is<br>sold as sterile individually packaged and sterile<br>packaged inside a kit/procedure tray. The syringe will<br>be available in luer lock and luer slip. |
| Intended Use: | Indication for Use: The plastic LOR syringe is intended<br>for use in conjunction with an epidural needle, to verify<br>the needle tip placement in the epidural space by the<br>loss of Resistance technique. The loss of Resistance<br>Syringe is not intended for injection or aspiration. |

-

.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for "busse Hospital Disposables". The word "busse" is in a bold, sans-serif font, with the letters overlapping each other. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is black and white.

# 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Summary of Testing: All mate rials used in the fabrication of the specialty needles were evaluated through biological qualification safety tests. The biocompatibility tests performed were: | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Kligman Maximization Test<br>2. Intracutaneous Injection Test<br>3. Systemic Injection Test<br>4. Rabbit Pyrogen Test<br>5. L929 Mem Elution Test<br>These materials have met the testing requirements and were found to be acceptable for the intended use. | |
| Technological Characteristics:<br>[21 CFR 807.92(a)(6)] | The subject device has the same Technological Characteristics as a legally marketed predicate device. |
| Conclusion:<br>[21 CFR 807.92(b)(3)] | The above statements are accurate representations of the device Busse intents to market.<br>Based on all the testing and comparison Busse believes the subject device is substantially equivalent to the predicate device<br>All data and information submitted in this premarket notification is truthful and accurate and no material fact has been omitted. |
| Manufacturer: | Busse Hospital Disposables. |
| Official Correspondent: | (Signature) |
| | Muhamad Ansari (printed name)<br>Title: Director of Regulatory Affairs<br>Date: 3/13/08 |

.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

JUL - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive Hauppauge, New York 11788

Re: K080804

Trade/Device Name: Busse Plastic LOR Syringes Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia Conduction Kit Regulatory Class: II Product Code: CAZ Dated: May 5, 2008 Received: June 18, 2008

Dear Mr. Ansari:

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.

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

#### Page 2 -Mr. Ansari

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 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket 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 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 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.

TRamuels-Lird, mD for/

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

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

### Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Busse Plastic LOR Syringes

Indication for Use: The Busse Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of resistance technique; it will be filled with air and/or saline during use. The Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.

Prescription Use __ X (Per 21 CFR 801Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number: K680804