Tiger Sharps Containers

K190240 · International Marketing Specialists, Inc. · MMK · May 31, 2019 · General Hospital

Device Facts

• Record ID: K190240
• Device Name: Tiger Sharps Containers
• Applicant: International Marketing Specialists, Inc.
• Product Code: MMK · General Hospital
• Decision Date: May 31, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

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. 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.

Device Story

Tiger Sharps Containers are injection-molded polypropylene receptacles for used, contaminated medical sharps; designed for single-use disposal. Containers feature puncture-resistant, leak-resistant, and impact-resistant construction; translucent lids allow visual fill-level determination. Models range from 1 Quart to 8 Gallons with various lid configurations (hinged, sliding, counterbalanced, rotary) and integrated needle unwinder ports. Used in healthcare facilities by qualified personnel; mounted via wall brackets, stabilizers, or free-standing. Device acts as a secure enclosure during transport to disposal. Benefits include safe containment of hazardous sharps, reducing risk of accidental injury to healthcare staff.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via ASTM F2132-01(2008)e1 (puncture resistance) and ISO 23907-2012 (drop, handle strength, stability). Transport safety verified via 49 CFR 178.606 (stacking), 49 CFR 178.608 (vibration), and 49 CFR 178.603 (drop test).

Technological Characteristics

Materials: Polypropylene (Formolene Homopolymer). Manufacturing: Injection molded. Dimensions: 1 Quart to 8 Gallon capacities. Standards: ISO 23907, ASTM F2132, 49 CFR 178.603/606/608. Features: Puncture/leak/impact resistant, translucent lids, integrated needle unwinder, various mounting options. Non-sterile.

Indications for Use

Indicated for safe disposal of hazardous sharps (hypodermic needles, syringes, lancets, blood needles) by qualified personnel in healthcare facilities. Not for use in areas with unsupervised patient access.

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

• Medline Sharps Containers (K143693)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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)

K190240

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) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{3}------------------------------------------------

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

| 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<br>configuration | Dimensions of Sharps disposal<br>aperture (inches) | Locking<br>mechanism | Needle<br>unwinder | Requirements<br>for<br>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<br>Hinge | Opening 1: 1.70 x 1.18;<br>Opening 2: 0.7 diameter;<br>Opening 3: 0.83 x 0.31 | Hinged closure | located in the lid<br>and above the<br>containment<br>area. The<br>unwinder has a<br>round entry port<br>for the needle to | a. Non-Locking Wire<br>Wall Bracket<br>(Covidien)<br>b. Stabilizer/holder with<br>Double face adhesive<br>tape mounting<br>c. Free standing |
| 5 Quart | 450 grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | | | 5 Quart | Counter<br>Balance | 8.67 x 2.36 x 2.27 | Hinged closure | pass through,<br>allowing it to be<br>fully enclosed<br>within the<br>container. | a. Locking wall bracket<br>(Covidien)<br>b. Wall enclosure<br>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<br>(Covidien)<br>b. Plastic wall bracket<br>c. Stainless steel or<br>plastic stabilizer/holder<br>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<br>(Covidien)<br>b. Plastic wall bracket<br>c. Stainless steel or<br>plastic stabilizer/holder<br>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<br>stabilizer/holder<br>b. Free standing |
| 3 Gallon | 559 grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | | | 3 Gallon | Counter<br>Balance | 9.37 x 3.34 | Counterbalanced<br>door | | a. Locking wire bracket<br>(Bemis)<br>b. Plastic wall bracket<br>c. Plastic<br>stabilizer/holder<br>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<br>hinge closure | | a. Stainless steel or plastic<br>stabilizer/holder<br>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: [phone] Email: [e-mail]

# 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<br>Containers | Medline Sharps<br>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<br>Contact<br>(Direct<br>/Indirect)? |
|---------------------|--------------------------|-----------------------------------------|----------------------------------------------|
| Lid | Polypropylene | Formolene® Polypropylene<br>Homopolymer | No |
| Base | Polypropylene | Formolene® Polypropylene<br>Homopolymer | No |
| Color power | Hififast Scarlet<br>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<br>(empty) | Capacity<br>(total) | Capacity<br>(full<br>line) | Dimensions of<br>finished goods (in)<br>(L x W x H) | Colors | Acceptable sites of use |
|------------|-------------------|---------------------|----------------------------|-----------------------------------------------------|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Quart | 109<br>grams | 28 Oz | 23.5 Oz | 3.91x3.91x6.37 | Red base<br>and<br>transparent<br>lid | The target population is for<br>qualified personnel in<br>health care facilities and<br>other facilities in which<br>medical sharps may be<br>used. All the containers are<br>intended to be used in<br>areas where there is no<br>unsupervised patient<br>access. |
| 5 Quart | 450<br>grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | | |
| 2Gallon | 453<br>grams | 7.8<br>Quarts | 6 Quarts | 10.84x6.86x10.36 | | |
| 2 Gallon B | 453<br>grams | 7.8<br>Quarts | 6 Quarts | 10.22x7.02x13.30 | | |
| 15 liter | 625<br>grams | 15 liter | 12 liter | 9.50x14.77x12.03 | | |
| 3 Gallon | 559<br>grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | | |
| 8 Gallon | 1172<br>grams | 7.8 Gal | 6.5 Gal | 10.92x15.61x17.27 | | |

| Model | Lid<br>configuration | Dimensions of<br>Sharps disposal<br>aperture (inches) | Locking<br>mechanism | Needle<br>unwinder | Requirements for<br>mounting |
|-------------|-----------------------|-------------------------------------------------------------------------------------|----------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| 1 Quart | Dual opening<br>Hinge | Opening 1: 1.70 x<br>1.18; Opening 2:<br>0.7 diameter;<br>Opening 3: 0.83 x<br>0.31 | Hinged closure | located in<br>the lid and<br>above the<br>containment<br>area. The<br>unwinder<br>has a round | a. Non-Locking Wire<br>Wall Bracket<br>(Covidien)<br>b. Stabilizer/holder with<br>Double face adhesive<br>tape mounting<br>c. Freestanding |
| 5 Quart | Counter<br>Balance | 8.67 x 2.36 x 2.27 | Hinged closure | entry port<br>for the<br>needle to<br>pass | a. Locking wall bracket<br>(Covidien)<br>b. Wall enclosure<br>c. Freestanding |
| 2<br>Gallon | Sliding | 2.40 x 5.04 | Sliding | through,<br>allowing it<br>to be fully<br>enclosed<br>within the<br>container. | a. Locking wall bracket<br>(Covidien)<br>b. Plastic wall bracket<br>c. Stainless steel or plastic<br>stabilizer/holder<br>d. Freestanding |

{8}------------------------------------------------

| 2<br>Gallon<br>B | Star Hinge | 2.83 Diameter | Sliding | a. Locking wall bracket<br>(Covidien)<br>b. Plastic wall bracket<br>c. Stainless steel or plastic<br>stabilizer/holder<br>d. Freestanding |
|------------------|--------------------|--------------------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 15 liter | Sliding | $9.98 \times 3.43$ | Sliding | a. Stainless steel or plastic<br>stabilizer/holder<br>b. Freestanding |
| 3<br>Gallon | Counter<br>Balance | $9.37 \times 3.34$ | Counterbalanced<br>door | a. Locking wire bracket<br>(Bemis)<br>b. Plastic wall bracket<br>c. Plastic stabilizer/holder<br>d. Free standing |
| 8<br>Gallon | Rotary/Hinge | $3.94 \times 1.70$ | Rotary door and<br>hinge closure | a. Stainless steel or plastic<br>stabilizer/holder<br>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<br>B / 15 Liter<br>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<br>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< 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

# Sterility Information

The Tiger Sharps container is non-sterile; therefore no sterility testing was performed.

# Clinical Testing:

Not Applicable.

#### VIII. Conclusions:

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.