(114 days)
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.
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.
The provided text describes the regulatory clearance of "Tiger Sharps Containers" and includes information about its performance testing. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Device Performance (Result) | Standard/Method |
|---|---|---|
| Puncture Resistance | Pass | ASTM F2132-01(2008)e1 |
| Resistance to Damage/Leaking after Drop | Pass | ISO 23907-2012 |
| Handle Strength | Pass | ISO 23907-2012 |
| Container Stability | Pass | ISO 23907-2012 |
| Stacking | Pass | 49 CFR 178.606 |
| Vibration | Pass | 49 CFR 178.608 |
| Drop test | Pass | 49 CFR 178.603 |
| Biocompatibility | Demonstrated compliance | Related international standards |
| Sterility | Not applicable (device is non-sterile) | N/A |
| Product Specifications (e.g., dimensions, capacity, materials) | Demonstrated compliance | Related international standards |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for each performance test. It only states that "Performance testing was provided in support of the substantial equivalence determination." The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable as the device is a sharps container and the performance tests described are physical and mechanical tests, not clinical evaluations requiring expert interpretation of medical data. Therefore, there is no "ground truth" established by medical experts in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as #3. The performance tests are objective measurements against established standards.
5. 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
This information is not applicable. The device is a physical sharps container, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a physical sharps container and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests appears to be defined by the consensus standards (e.g., ASTM F2132-01(2008)e1, ISO 23907-2012, 49 CFR) themselves. These standards specify the test methods and the acceptable criteria for "passing" a test, rather than relying on expert clinical consensus, pathology, or outcomes data in a medical sense.
8. The sample size for the training set
This information is not applicable. The device is a physical product that undergoes engineering performance testing, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for a machine learning model.
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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
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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
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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 | Lidconfiguration | Dimensions of Sharps disposalaperture (inches) | Lockingmechanism | Needleunwinder | Requirementsformounting |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 openingHinge | Opening 1: 1.70 x 1.18;Opening 2: 0.7 diameter;Opening 3: 0.83 x 0.31 | Hinged closure | located in the lidand above thecontainmentarea. Theunwinder has around entry portfor the needle to | a. Non-Locking WireWall Bracket(Covidien)b. Stabilizer/holder withDouble face adhesivetape mountingc. Free standing |
| 5 Quart | 450 grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | 5 Quart | CounterBalance | 8.67 x 2.36 x 2.27 | Hinged closure | pass through,allowing it to befully enclosedwithin thecontainer. | a. Locking wall bracket(Covidien)b. Wall enclosurec. 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 bracketc. Stainless steel orplastic stabilizer/holderd. 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 bracketc. Stainless steel orplastic stabilizer/holderd. 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 plasticstabilizer/holderb. Free standing | |||
| 3 Gallon | 559 grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | 3 Gallon | CounterBalance | 9.37 x 3.34 | Counterbalanceddoor | a. Locking wire bracket(Bemis)b. Plastic wall bracketc. Plasticstabilizer/holderd. 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 andhinge closure | a. Stainless steel or plasticstabilizer/holderb. Free standing |
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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 SharpsContainers | Medline SharpsContainers | K143693 | Tiger Sharps Containers |
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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 | PatientContact(Direct/Indirect)? |
|---|---|---|---|
| Lid | Polypropylene | Formolene® PolypropyleneHomopolymer | No |
| Base | Polypropylene | Formolene® PolypropyleneHomopolymer | No |
| Color power | Hififast ScarletHF4Y | 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.
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| Model | Weight(empty) | Capacity(total) | Capacity(fullline) | Dimensions offinished goods (in)(L x W x H) | Colors | Acceptable sites of use |
|---|---|---|---|---|---|---|
| 1 Quart | 109grams | 28 Oz | 23.5 Oz | 3.91x3.91x6.37 | Red baseandtransparentlid | The target population is forqualified personnel inhealth care facilities andother facilities in whichmedical sharps may beused. All the containers areintended to be used inareas where there is nounsupervised patientaccess. |
| 5 Quart | 450grams | 140 Oz | 119 Oz | 10.60 x4.70x10.64 | ||
| 2Gallon | 453grams | 7.8Quarts | 6 Quarts | 10.84x6.86x10.36 | ||
| 2 Gallon B | 453grams | 7.8Quarts | 6 Quarts | 10.22x7.02x13.30 | ||
| 15 liter | 625grams | 15 liter | 12 liter | 9.50x14.77x12.03 | ||
| 3 Gallon | 559grams | 2.9 Gal | 2.45 Gal | 14.86x7.25x14.00 | ||
| 8 Gallon | 1172grams | 7.8 Gal | 6.5 Gal | 10.92x15.61x17.27 |
| Model | Lidconfiguration | Dimensions ofSharps disposalaperture (inches) | Lockingmechanism | Needleunwinder | Requirements formounting |
|---|---|---|---|---|---|
| 1 Quart | Dual openingHinge | Opening 1: 1.70 x1.18; Opening 2:0.7 diameter;Opening 3: 0.83 x0.31 | Hinged closure | located inthe lid andabove thecontainmentarea. Theunwinderhas a round | a. Non-Locking WireWall Bracket(Covidien)b. Stabilizer/holder withDouble face adhesivetape mountingc. Freestanding |
| 5 Quart | CounterBalance | 8.67 x 2.36 x 2.27 | Hinged closure | entry portfor theneedle topass | a. Locking wall bracket(Covidien)b. Wall enclosurec. Freestanding |
| 2Gallon | Sliding | 2.40 x 5.04 | Sliding | through,allowing itto be fullyenclosedwithin thecontainer. | a. Locking wall bracket(Covidien)b. Plastic wall bracketc. Stainless steel or plasticstabilizer/holderd. Freestanding |
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| 2GallonB | Star Hinge | 2.83 Diameter | Sliding | a. Locking wall bracket(Covidien)b. Plastic wall bracketc. Stainless steel or plasticstabilizer/holderd. Freestanding |
|---|---|---|---|---|
| 15 liter | Sliding | $9.98 \times 3.43$ | Sliding | a. Stainless steel or plasticstabilizer/holderb. Freestanding |
| 3Gallon | CounterBalance | $9.37 \times 3.34$ | Counterbalanceddoor | a. Locking wire bracket(Bemis)b. Plastic wall bracketc. Plastic stabilizer/holderd. Free standing |
| 8Gallon | Rotary/Hinge | $3.94 \times 1.70$ | Rotary door andhinge closure | a. Stainless steel or plasticstabilizer/holderb. Freestanding |
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| 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 GallonB / 15 Liter3 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: RedLid: 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
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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.
§ 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).