BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE

K052843 · Busse Hospital Disposables, Inc. · FMI · Apr 17, 2006 · General Hospital

Device Facts

• Record ID: K052843
• Device Name: BUSSE HOSPITAL DISPOSABLES NEEDLE STICK BLOCK/CUBE
• Applicant: Busse Hospital Disposables, Inc.
• Product Code: FMI · General Hospital
• Decision Date: Apr 17, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries. The Needle Stick Block is a safety device designed to help the health care facilities to minimize the risk of needle sticks. Busse Hospital Disposable intent to sell this device individually and as part of safety trays in which needle is involved. The intended use will remain the same whether is sold individually or as part of a tray.

Device Story

Needle Stick Block is a sterile, latex-free, single-needle holder designed to prevent needle stick injuries in healthcare settings. The device features a foam insert that provides puncture resistance and retains the needle securely for at least one hour after insertion. It is used by healthcare professionals during procedures to temporarily hold used sharps before final disposal in a sharps container. The device is sold either individually or as a component of safety trays. By providing a stable, puncture-resistant receptacle, it minimizes the risk of accidental needle sticks during the interval between needle removal from the patient and final disposal.

Clinical Evidence

No clinical data. Evidence consists of bench testing and a simulated use study. Bench tests evaluated puncture resistance of the foam insert and vessel wall, and needle retention capability (minimum one hour). A simulated use study was conducted by experienced medical experts to confirm functional equivalence to the predicate device.

Technological Characteristics

Single-needle holder featuring a puncture-resistant foam insert. Sterile and latex-free. Designed for temporary needle retention. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a single needle holder for healthcare facilities to temporarily secure used needles after removal from patients until final disposal, aiding in the prevention of needle stick injuries.

Regulatory Classification

Identification

A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

Predicate Devices

• SharpsAway Disposal Cup

Submission Summary (Full Text)

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Image /page/0/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 slightly overlapping each other. Below the word "busse" is the phrase "Hospital Disposables" in a smaller, sans-serif font. The logo is in black and white.

# APR 17 2006

## SUMMARY

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS NEEDLE STICK BLOCK

| 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: | Sept 23, 2005 |
| Date Summary Revised: | February 27, 2006 |
| Product Trade Name: | Needle Stick Block |
| Common Name: | needle, hypodermic, single lumen. |
| Classification: | Class II, 21 CFR 880.5570, FMI |
| Predicate Device: | SharpsAway Disposal Cup |
| Description: | Sterile/ Latex Free/ Needle Stick Block<br>The proposed Needle Stick Block was created to<br>help prevent needle sticks by providing a means of<br>moving used sharps from procedure and hold it<br>temporarily until procedure is completed to then be<br>disposed off in a sharps container. |
| Intended Use: | The Needle Stick Block is a single needle holder to<br>be used after the needle is removed from the patient<br>and until it can be properly disposed, therefore,<br>aiding in the prevention of needle stick injuries.<br>The Needle Stick Block is a safety device designed<br>to help the health care facilities to minimize the risk<br>of needle sticks.<br>Busse Hospital Disposable intent to sell this device<br>individually and as part of safety trays in which<br>needle is involved. The intended use will remain the<br>same whether is sold individually or as part of a<br>tray. |

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Image /page/1/Picture/0 description: The image shows the logo for Busse Hospital Disposables. The logo features the word "busse" in a bold, sans-serif font, with the letters closely spaced together. Below the word "busse" are the words "Hospital Disposables" in a smaller, less bold font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.

#### 510(k) SUMMARY OF SUBSTANTIAL EQUIVALENCE NEEDLE STICK BLOCK

Summary of tests performed to prove the substantial equivalence of the Needle Stick Block with the predicate device:

- A) Determination of puncture resistance of the foam insert for both devices.
- B) Determination of puncture resistance of vessel wall for Needle Stick Block and SharpsAway predicate device.
- C) Test to show that once inserted, Needle Stick Block with foam insert exerts enough resistance to retain needle for at least one hour under normal circumstances.
- D) Simulate use study by experienced medical experts (at least 1 year experience with handling needles using the predicate instrument)
- 1. Same intended use
- 2. Same features

Technological Characteristics [21 CFR 807.92(a)(6)] The subject device has the same Technological Characteristics as a legally marketed predicate device.

#### Conclusion [21 CFR 807.92(b)(3)]

The above statements are accurate representations of the device Busse intents to market. 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:

Mathurmo Oksic (Signature)

**Muhamad Ansari** (printed name)
Title: Director of Regulatory Affairs
Date: 312106

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "U.S. Department of Health and Human Services". The symbol in the center appears to be three curved lines that resemble a stylized bird or abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2006

Mr. Muhamad Ansari Director of Regulatory Affairs Busse Hospital Disposables, Incorporated 75 Arkay Drive P.O. Box 11067 Hauppauge, New York 11788

Re: K052843

Trade/Device Name: Needle Stick Block Regulation Number: 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: February 27, 2006 Received: March 7, 2006

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 (IPMA), 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. Muhamad 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/dsma/dsmamain.html

Sincerely yours,

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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K05284 3

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#### INDICATIONS FOR USE

510(k) Number (if known): K052843

Device Name: Needle Stick Block.

Indication for Use: The Needle Stick Block is a single needle holder to be used after the needle is removed from the patient and until it can be properly disposed, therefore, aiding in the prevention of needle stick injuries

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 – CONINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF.)

Arun Dima

gr. General Hospil.

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