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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for "The VAULT" device, based on the provided text:

Acceptance Criteria and Reported Device Performance

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

Study Information

Sample Size used for the Test Set and the Data Provenance:
- Sample Size: The document does not explicitly state a specific numerical sample size for most tests (e.g., "Numerous tests" for puncture resistance). For impact resistance, it refers to "The box" (singular), implying at least one box was tested. For capacity, it refers to "The vault" (singular).
- Data Provenance: The document does not specify the country of origin or whether the tests were retrospective or prospective. It describes the testing methodologies performed by Stik Stoppers for "The VAULT."
Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The performance criteria are based on physical characteristics and functional tests of the device, not on expert interpretation of medical images or data. Therefore, "ground truth" in the medical diagnostic sense is not relevant here.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As noted above, this device relies on physical performance and functional testing rather than human interpretation requiring adjudication.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a medical device (sharps container), not an AI-assisted diagnostic tool or an imaging device. Therefore, MRMC studies and AI assistance metrics are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance criteria is based on direct observation and measurement of the device's physical properties and functional performance under defined test conditions (e.g., whether the box leaked, whether needles punctured the box, whether the lid reopened).
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning model requiring training data.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a physical device.

Summary

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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 WaySpringfield, OR 97477
D. Address of Manufacturing site	Jenn Feng Electric Industrial Co.,LTDOFFICE:NO.424 Fwushing RoadTaoyuan Taiwan, R O C
E. Applicants Phone Numbers	1-800-300-1989Fax 208-265-6330
F. Address of Sterilizing site	N/A-Product is non-sterile
G. Date of application	March 10, 1999

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

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 feetonto a concrete floor resulting in NO visible damage to box andNO needle ejection.
Puncture Resistance.................	Puncture resistance was tested by weighted pressure to needles ondifferent box parts. Numerous tests resulted in the needlesbending before they would puncture box. Pressure tested all partsof the box exceeded 7 lbs. of weight. These tests indicate the vaultis very puncture resistant.
Overfill Detection.................	The box is designed with a horizontal opening in the top to alloweasy sharps disposal and also overfill level detection. Sharps lay onthere side allowing for user observation of contents.
Leak Protection.................	The sides and bottom of the box are a single molded piece designednot to leak. Water was added to the box to the top of the sidesresulting in no leakage when kept in proper upright position.
Sharps access andClosure.................	The boxes lid is designed to close and not be reopened eliminatingsharps access. Testing showed no visible access after closure ifused following OSHA standards.
Stability.................	The box is designed to sit on a flat surface in an upright position. Itfits easily into the top tray of a paramedic jump box and remainsvery stable.
Locking Mechanism.................	The VAULT has a one directional locking lid . It is not designed tobe reopened after use.
Handling.................	The Vault is compact and easily transported after use. It can beplaced in larger secondary sharps containers if necessary for easytransport to final disposal. Although it is safe to handle by itself.
Capacity.................	The vault was filled with liquid to determine volume of space inthe box, test results indicated 3 ozs. . Sharps volume varied bythe size and type of sharps used. The volume indicated sufficentspace 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2049 or (301) 443-6597 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:

(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 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)

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
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.(b)
Classification. Class II (performance standards).