(114 days)
Not Found
No
The device description and intended use clearly define a physical container for sharps disposal. There is no mention of any software, data processing, or analytical capabilities that would suggest the use of AI or ML. The performance studies focus on the physical properties and safety of the container.
No.
The device is described as a receptacle for the disposal of contaminated medical sharps, with no mention of it being used for diagnosis, treatment, or prevention of disease.
No
The device is a sharps container, intended for the safe disposal of contaminated medical sharps. Its purpose is to contain hazardous waste, not to diagnose medical conditions.
No
The device description clearly states it is constructed of injection molded polypropylene plastic and describes physical characteristics and performance testing related to the container's material and structure, indicating it is a physical hardware device.
Based on the provided information, the Tiger Sharps Container is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a receptacle for used, contaminated medical sharps and act as an enclosure for transport and disposal. This is a physical containment and disposal function.
- Device Description: The device is a plastic container designed for safe disposal of sharps. It does not perform any diagnostic testing or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a medical device, specifically a container for hazardous waste, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only are used with appropriate mounting accessories.
Product codes
MMK
Device Description
Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the level line on the product identification label.
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
Qualified personnel in health care facilities and other facilities in which medical sharps may be used. Not for use in areas with unsupervised patient access.
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
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Tiger Sharps Container met all of the requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
The following performance tests were conducted for the subject device:
Puncture: per ASTM F2132-01(2008)e1 = Pass
Resistance to Damage/Leaking after Drop: per ISO 23907-2012 = Pass
Handle Strength: per ISO 23907-2012 = Pass
Container Stability: per ISO 23907-2012 = Pass
Stacking: Per 49 CFR 178.606 = Pass
Vibration: Per 49 CFR 178.608 = Pass
Drop test: Per 49 CFR 178.603 = Pass
The non-clinical data demonstrate that the Tiger Sharps Container is as safe, as effective, and performs as well as the predicate device, Medline Sharps Containers , cleared under K143693.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 31, 2019
International Marketing Specialists Inc. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive Chandler, Arizona 85249
Re: K190240
Trade/Device Name: Tiger Sharps Containers Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: April 21, 2019 Received: April 29, 2019
Dear Charles Mack:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Tiger Sharps Containers
Indications for Use (Describe)
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only be used with appropriate mounting accessories.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Model | Weight (empty) | Capacity (total) | Capacity (full line) | Dimensions of finished goods (in) (L x W x H) | Colors | Acceptable sites of use | Model | Lid
configuration | Dimensions of Sharps disposal
aperture (inches) | Locking
mechanism | Needle
unwinder | Requirements
for
mounting |
|------------|----------------|------------------|----------------------|-----------------------------------------------|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|-----------------------|-------------------------------------------------------------------------------|----------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Quart | 109 grams | 28 Oz | 23.5 Oz | 3.91x3.91x6.37 | Red base and transparent lid | The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All the containers are intended to be used in areas where there is no unsupervised patient access. | 1 Quart | Dual opening
Hinge | Opening 1: 1.70 x 1.18;
Opening 2: 0.7 diameter;
Opening 3: 0.83 x 0.31 | Hinged closure | located in the lid
and above the
containment
area. The
unwinder has a
round entry port
for the needle to | a. Non-Locking Wire
Wall Bracket
(Covidien)
b. Stabilizer/holder with
Double face adhesive
tape mounting
c. Free standing |
| 5 Quart | 450 grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | | | 5 Quart | Counter
Balance | 8.67 x 2.36 x 2.27 | Hinged closure | pass through,
allowing it to be
fully enclosed
within the
container. | a. Locking wall bracket
(Covidien)
b. Wall enclosure
c. Free standing |
| 2 Gallon | 453 grams | 7.8 Quarts | 6 Quarts | 10.84x6.86x10.36 | | | 2 Gallon | Sliding | 2.40 x 5.04 | Sliding | | a. Locking wall bracket
(Covidien)
b. Plastic wall bracket
c. Stainless steel or
plastic stabilizer/holder
d. Free standing |
| 2 Gallon B | 453 grams | 7.8 Quarts | 6 Quarts | 10.22x7.02x13.30 | | | 2 Gallon B | Star Hinge | 2.83 Diameter | Sliding | | a. Locking wall bracket
(Covidien)
b. Plastic wall bracket
c. Stainless steel or
plastic stabilizer/holder
d. Free standing |
| 15 liter | 625 grams | 15 liter | 12 liter | 9.50x14.77x12.03 | | | 15 liter | Sliding | 9.98 x 3.43 | Sliding | | a. Stainless steel or plastic
stabilizer/holder
b. Free standing |
| 3 Gallon | 559 grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | | | 3 Gallon | Counter
Balance | 9.37 x 3.34 | Counterbalanced
door | | a. Locking wire bracket
(Bemis)
b. Plastic wall bracket
c. Plastic
stabilizer/holder
d. Free standing |
| 8 Gallon | 1172 grams | 7.8 Gal | 6.5 Gal | 10.92x15.61x17.27 | | | 8 Gallon | Rotary/Hinge | 3.94 x 1.70 | Rotary door and
hinge closure | | a. Stainless steel or plastic
stabilizer/holder
b. Free standing |
4
5
K190240
510(k) Summary
Date of Preparation: April 21, 2019
I. Submitter Information:
| Submitter Name: | International Marketing Specialists Inc. |
|---|---|
| Address: | 1278 Highway 461, Somerset, Kentucky 42503 |
| Contact Person: | Mr. Rod Calderon, Manager |
US Agent and Correspondent
Mr. Charles Mack Principal Engineer IRC 2950 E Lindrick Drive, Chandler, Arizona 85249 USA Tel: 931-625-4938 Email: charliemack@irc-us.com
II. Device
| Trade Name: | Tiger Sharps Container |
|---|---|
| Common Name: | container, sharps |
| Regulation Number: | 21 CFR§880.5570 |
| Regulation Name: | Hypodermic single lumen needle |
| Regulatory Class: | II |
| Product Code: | MMK |
III. Predicate Device Information
| Manufacturer | Predicate Device | 510(k) Number | Submitted Device |
|---|---|---|---|
| Medline Sharps | |||
| Containers | Medline Sharps | ||
| Containers | K143693 | Tiger Sharps Containers |
6
IV. Device Description:
Tiger Sharps Containers constructed of injection molded polypropylene plastic. They are designed for a single-use (disposable) by healthcare professionals. No part of the container is intended to come in contact with patients. The containers are designed to be puncture resistant, leak resistant on the sides and bottom, impact resistant, closable and stable.
Lids and closures are uncolored translucent material allowing for a visual determination of fill level. The base is made from a high strength material to support the capacity of the container. The recommended fill level is engraved onto the plastic and corresponds to the level line on the product identification label.
| Parts & Accessories | Material | Material Specification | Patient
Contact
(Direct
/Indirect)? |
|---------------------|--------------------------|-----------------------------------------|----------------------------------------------|
| Lid | Polypropylene | Formolene® Polypropylene
Homopolymer | No |
| Base | Polypropylene | Formolene® Polypropylene
Homopolymer | No |
| Color power | Hififast Scarlet
HF4Y | PPR007BTS | No |
V. Intended Use / Indications for Use
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only are used with appropriate mounting accessories.
7
| Model | Weight
(empty) | Capacity
(total) | Capacity
(full
line) | Dimensions of
finished goods (in)
(L x W x H) | Colors | Acceptable sites of use |
|------------|-------------------|---------------------|----------------------------|-----------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Quart | 109
grams | 28 Oz | 23.5 Oz | 3.91x3.91x6.37 | Red base
and
transparent
lid | The target population is for
qualified personnel in
health care facilities and
other facilities in which
medical sharps may be
used. All the containers are
intended to be used in
areas where there is no
unsupervised patient
access. |
| 5 Quart | 450
grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | | |
| 2Gallon | 453
grams | 7.8
Quarts | 6 Quarts | 10.84x6.86x10.36 | | |
| 2 Gallon B | 453
grams | 7.8
Quarts | 6 Quarts | 10.22x7.02x13.30 | | |
| 15 liter | 625
grams | 15 liter | 12 liter | 9.50x14.77x12.03 | | |
| 3 Gallon | 559
grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | | |
| 8 Gallon | 1172
grams | 7.8 Gal | 6.5 Gal | 10.92x15.61x17.27 | | |
| Model | Lid
configuration | Dimensions of
Sharps disposal
aperture (inches) | Locking
mechanism | Needle
unwinder | Requirements for
mounting |
|-------------|-----------------------|-------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Quart | Dual opening
Hinge | Opening 1: 1.70 x
1.18; Opening 2:
0.7 diameter;
Opening 3: 0.83 x
0.31 | Hinged closure | located in
the lid and
above the
containment
area. The
unwinder
has a round | a. Non-Locking Wire
Wall Bracket
(Covidien)
b. Stabilizer/holder with
Double face adhesive
tape mounting
c. Freestanding |
| 5 Quart | Counter
Balance | 8.67 x 2.36 x 2.27 | Hinged closure | entry port
for the
needle to
pass | a. Locking wall bracket
(Covidien)
b. Wall enclosure
c. Freestanding |
| 2
Gallon | Sliding | 2.40 x 5.04 | Sliding | through,
allowing it
to be fully
enclosed
within the
container. | a. Locking wall bracket
(Covidien)
b. Plastic wall bracket
c. Stainless steel or plastic
stabilizer/holder
d. Freestanding |
8
| 2
Gallon
B | Star Hinge | 2.83 Diameter | Sliding | a. Locking wall bracket
(Covidien)
b. Plastic wall bracket
c. Stainless steel or plastic
stabilizer/holder
d. Freestanding |
|------------------|--------------------|--------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 15 liter | Sliding | $9.98 \times 3.43$ | Sliding | a. Stainless steel or plastic
stabilizer/holder
b. Freestanding |
| 3
Gallon | Counter
Balance | $9.37 \times 3.34$ | Counterbalanced
door | a. Locking wire bracket
(Bemis)
b. Plastic wall bracket
c. Plastic stabilizer/holder
d. Free standing |
| 8
Gallon | Rotary/Hinge | $3.94 \times 1.70$ | Rotary door and
hinge closure | a. Stainless steel or plastic
stabilizer/holder
b. Freestanding |
9
| Element of comparison | Subject Device | Predicate Device |
|---|---|---|
| Company | International Marketing Specialists Inc. | Medline Industries, Inc. |
| FDA510(K) Number | K190240 | K143693 |
| Device Name | Tiger Sharps Containers | Medline Sharps Containers |
| Intended Use | Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. | Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. |
| Product Code | MMK | MMK |
| Regulation Number | 21CFR880.5570 | 21CFR880.5570 |
| Class | II | II |
| Capacities | 1 Quart / 5 Quart / 2 Gallon / 2 Gallon | |
| B / 15 Liter | ||
| 3 Gallon/ 8 Gallon | 1G / 2G / 8G / 10G / 12G / 18G | |
| Prescribed | OTC | OTC |
| Weight Range (grams) | 109 - 1172 | 303 - 2388 |
| No. of Piece | 2-3 | 2-3 |
| Material | Polypropylene | Polypropylene |
| Color | Base: Red | |
| Lid: Transparent | Red | |
| Clarity | Opaque/translucent | Opaque/translucent |
| Non-sterile | Yes | Yes |
| Method of Manufacture | Injection Molded | Injection Molded |
| Performance testing (puncture, impact, drop, stability, integrity etc.) | Pass | Pass |
| Standards | ISO 23907, ASTM F 2132 | ISO 23907, ASTM F 2132 |
| Disposable or Re-usable? | Disposable | Disposable |
Comparison of Technological Characteristics with the Predicate Device
10
VI. Non Clinical Performance Testing:
Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Tiger Sharps Container met all of the requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate compliance with the requirements of the consensus standards noted below.
Performance Testing
The following performance tests were conducted for the subject device: Puncture: per ASTM