THE VAULT

K990936 · Stik Stoppers, Inc. · FMI · May 18, 1999 · General Hospital

Device Facts

• Record ID: K990936
• Device Name: THE VAULT
• Applicant: Stik Stoppers, Inc.
• Product Code: FMI · General Hospital
• Decision Date: May 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT's in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.

Device Story

The Vault is a compact (1.5x5 inch) plastic, single-use, disposable, non-sterile sharps transport container. Designed for field use by paramedics and EMTs, it fits into medical jump kits. The device provides a safe, puncture-resistant, and leak-resistant alternative to resheathing needles or using non-sharps containers. It features a horizontal opening for one-handed sharps disposal and visual overfill detection. After use, the lid is permanently closed via a one-directional locking mechanism to prevent re-access and ensure safe transport to final disposal. The bright red color and biohazard labeling comply with OSHA standards. The device benefits patients and providers by reducing needle-stick risks in pre-hospital settings.

Clinical Evidence

Bench testing only. Testing included impact resistance (8-foot drop test with no needle ejection), puncture resistance (weighted pressure tests exceeding 7 lbs), leak protection (water-filled upright test), and closure integrity (no visible access after locking).

Technological Characteristics

Plastic, single-use, non-sterile sharps container. Dimensions: 1.5 x 5 inches. Features: one-directional locking lid, horizontal opening for overfill detection, puncture-resistant construction. No electronic components or software.

Indications for Use

Indicated for use by Paramedics and EMTs for portable sharps containment in medical jump kits where standard sharps containers are inaccessible.

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

• Sharp-Safe 1.5 (K955514)
• Sharps-a-Gator (K964387)
• Sharp Shuttle (K972279)

Submission Summary (Full Text)

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MAY 18 8 11 11

K990934

## PRE-MARKET NOTIFICATION: THE VAULT 510K SUMMARY ·

### 1. Identification of Applicant

| A. Company Name | Stik Stoppers |
|----------------------------------|-----------------------------------------------------------------------------------------------|
| B. Applicants Name | Darryl Crawford |
| | President |
| C. Street Address | 6 Hayden Bridge Way<br>Springfield, OR 97477 |
| D. Address of Manufacturing site | Jenn Feng Electric Industrial Co.,LTD<br>OFFICE:NO.424 Fwushing Road<br>Taoyuan Taiwan, R O C |
| E. Applicants Phone Numbers | 1-800-300-1989<br>Fax [phone] |
| F. Address of Sterilizing site | N/A-Product is non-sterile |
| G. Date of application | March 10, 1999 |

2. Device

| A.Trade or proprietary Name | The VAULT |
|-----------------------------|-----------|
|-----------------------------|-----------|

B. Common Name................................................................................................................................................................

C. Classification Name........................................................................................................................................................ Needle (CFR: 880.5570)

- D. Classification.........................................................................................................................II
- E. Panel......................................................................................................................................................................
- F. Procodes...................................................................................................................................................................

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## 3. General Description

The VAULT is a single-use , disposable , non-sterile, sharps transport container intended to be used in areas where larger sharps containers are not conveniently accessible, normally in the field use in paramedic and EMT jump kits. The Vaults design allows for easy one handed use by the EMT. Its function is to be available for portable sharps containment and as a alternative to using non-sharps containers or resheathing a needle with its original protective cover.

The VAULT is a 1.5x 5 inch box designed to set horizontally in a jump kit. The lid is designed to remain open until use and then permanently close for transportation of the contaminated sharps for safe disposal.

Each box is labeled with a biohazard label. The VAULT is also a bright red color to meet OSHA standards for warning of biohazard danger.

#### Substantial Equivalence 4.

A. Predicate Devices for Stik Stoppers , The VAULT

Sharp-Safe 1.5 K955514 Sharps-a-Gator K964387 Sharp Shuttle K972279

B. Rationale Discussion

The side by side comparisons show the equivalence of all four products. All four are plastic , disposable, non-sterile, portable , sharps transport containers intended for point of use sharps disposal. All devices are puncture and leak resistant, one-handed sharps disposal units which offer a means of closure.

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# 5.Design Features

| Impact Resistance................. | The box was filled with needles and dropped from a height of 8 feet<br>onto a concrete floor resulting in NO visible damage to box and<br>NO needle ejection. |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Puncture Resistance................. | Puncture resistance was tested by weighted pressure to needles on<br>different box parts. Numerous tests resulted in the needles<br>bending before they would puncture box. Pressure tested all parts<br>of the box exceeded 7 lbs. of weight. These tests indicate the vault<br>is very puncture resistant. |
| Overfill Detection................. | The box is designed with a horizontal opening in the top to allow<br>easy sharps disposal and also overfill level detection. Sharps lay on<br>there side allowing for user observation of contents. |
| Leak Protection................. | The sides and bottom of the box are a single molded piece designed<br>not to leak. Water was added to the box to the top of the sides<br>resulting in no leakage when kept in proper upright position. |
| Sharps access and<br>Closure................. | The boxes lid is designed to close and not be reopened eliminating<br>sharps access. Testing showed no visible access after closure if<br>used following OSHA standards. |
| Stability................. | The box is designed to sit on a flat surface in an upright position. It<br>fits easily into the top tray of a paramedic jump box and remains<br>very stable. |
| Locking Mechanism................. | The VAULT has a one directional locking lid . It is not designed to<br>be reopened after use. |
| Handling................. | The Vault is compact and easily transported after use. It can be<br>placed in larger secondary sharps containers if necessary for easy<br>transport to final disposal. Although it is safe to handle by itself. |
| Capacity................. | The vault was filled with liquid to determine volume of space in<br>the box, test results indicated 3 ozs. . Sharps volume varied by<br>the size and type of sharps used. The volume indicated sufficent<br>space for a single use sharps container. |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three parallel, curved lines that suggest the shape of a bird in flight.

Public Health Service

MAY 1 8 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Darryl Crawford President Stik Stoppers, Incorporated 6 Hayden Bridge Way Springfield, Oregon 97477

Re : K990936 Trade Name: The Vault Requlatory Class: II Product Code: FMI Dated: March 8, 1999 Received: March 19, 1999

Dear Mr. Crawford:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Crawford

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdalgov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski
Director

Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 19 of 19

510(k) Number (if known) K990936

Devise Name : THE VAULT

Indications For Use:

The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT's in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="signature" src="signature.jpg"/> |
|---------------------|--------------------------------------------|
| (Division Sign-Off) | |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | k990936 |

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)