(60 days)
Not Found
No
The device is a physical container for sharps and the description focuses on its mechanical properties and design for safe containment and disposal. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI/ML.
No
Explanation: The device is described as a sharps transport container for safe disposal, not a device intended to treat or diagnose a medical condition.
No
Explanation: The device is described as a sharps transport container for portable sharps containment. Its function is to safely store and transport contaminated sharps, not to diagnose medical conditions.
No
The device is a physical sharps container, not software. The description details its material, dimensions, and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the containment and transport of used sharps (needles, etc.) to prevent injury and facilitate safe disposal. This is a physical containment function, not a diagnostic one.
- Device Description: The description focuses on the physical characteristics of the container (size, material, closure mechanism) and its purpose as a sharps transport container.
- Performance Studies: The performance studies evaluate the physical integrity and safety features of the container (impact resistance, puncture resistance, leak protection, etc.). These are relevant to a sharps container, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Vault does not perform any such function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Paramedics and EMT's in their medical jump kits.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 there 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 boxes 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 sufficent space for a single use sharps container.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
MAY 18 8 11 11
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 |
| Springfield, OR 97477 | |
| D. Address of Manufacturing site | Jenn Feng Electric Industrial Co.,LTD |
| OFFICE:NO.424 Fwushing Road | |
| Taoyuan Taiwan, R O C | |
| E. Applicants Phone Numbers | 1-800-300-1989 |
| Fax 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...................................................................................................................................................................
1
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.
2
5.Design Features
| 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
there 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 boxes 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 sufficent
space for a single use sharps container. |
3
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.
4
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
5
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)
| (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)