(126 days)
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.
The document describes the Nitta M&T Safety Box, a disposable and non-sterile sharps container, and its compliance with relevant standards. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Objective | Acceptance Criteria (ISO 23907-1:2019 Requirements) | Reported Device Performance |
|---|---|---|
| Container Stability | No more than 0 failures per container were observed when placed at a 15° inclination. | Meets ISO23907-1:2019 Requirements - No more than 0 failures per container were observed. |
| Handle Strength | No failures were observed when suspended for at least 60 minutes. | Meets ISO23907-1:2019 Requirements - No failures were observed. |
| Puncture Resistance | Average force required to be a minimum of 16N and an average of 18N or greater. | Meets ISO23907-1:2019 Requirements - All Nitta M&T products were found to meet the acceptance criteria. Testing resulted in a minimum force of 18.6 N was observed (presumably average). |
| Resistance to Damage (Drop/Impact Test) | No evidence of leakage or damage resulting in a breach of the sharps containment area after a 1m drop. | Meets ISO23907-1:2019 Requirements - No evidence of leakage or damage resulting in a breach of the sharps containment area were observed. All Nitta M&T products met the acceptance criteria. |
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 explicitly state the sample size used for each test. The testing was performed on the "subject device" (Nitta M&T Safety Box) which comprises various models. The data provenance is not explicitly mentioned with respect to country of origin, but Nitta M&T (Thailand) Co., Ltd. is based in Thailand. The studies appear to be prospective, laboratory-based performance tests as opposed to retrospective data analysis.
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 is a physical medical device (sharps container), not an AI or diagnostic device that requires expert evaluation for ground truth. The acceptance criteria are based on objective, quantifiable metrics defined by international standards (ISO 23907-1:2019). Therefore, expert consensus for ground truth is not applicable in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is objective performance testing against a standard, not a subjective evaluation requiring adjudication.
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
Not applicable. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is conformance to the objective, measurable requirements outlined in the international standard ISO 23907-1:2019. This involves physical measurements and observations of the device's behavior under specific test conditions.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not 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.
September 14, 2021
Nitta M&T (Thailand) Co., Ltd. % Vaibhav Rajal Official Correspondent for Nitta M&T (Thailand) Co., Ltd. mdi Consultants Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021
Re: K211464
Trade/Device Name: Nitta M&T Safety Box Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: MMK Dated: August 4, 2021 Received: August 4, 2021
Dear Vaibhav Rajal:
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,
Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211464
Device Name Nitta M&T Safety Box
Indications for Use (Describe)
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
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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General Specifications Table
| Model No. | Weight(g) | Capacity(Total)ml | Capacity(Fullline) | Dimensions ofgoods (mm) (L xW x H) | Colors |
|---|---|---|---|---|---|
| NT-001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base andtransparent lid |
| NT-003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base andtransparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base andtransparent lid |
| NT-006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base andtransparent lid |
| NT-007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base andtransparent lid |
| NT-008 | 48 g | 210 | 160 | 78 x 50 x 82 | Red / Yellow |
- Intended to be used in areas where there is no unsupervised patient access.
** Intended for use with mounting accessories.
| ModelNo. | Lidconfiguration | Lockingmechanism | Dimensions ofaperture(mm) | Needle unwinder | Mounting Accessories |
|---|---|---|---|---|---|
| NT-001 | Opening Hinge | Hinged closure | 45 x 38 | Luer slip and luer lock needle unwinder, and Pen-needle unwinding port are in the lid and above the containment area. | A) FreestandingB) Rubber StabilizerC) Metal pole mounting bracketD) Metal hook bracket |
| NT-002 | Opening Hinge | Hinged closure | 106 x 41.6 | A) FreestandingB) Rubber StabilizerC) Metal pole mounting bracketD) Metal hook bracket | |
| NT-003 | Opening Hinge | Hinged closure | 185 x 44.8 | A) FreestandingB) Lockable wall mount cabinetC) Metal pole mounting bracketD) Metal hook bracket | |
| NT-005 | Opening Hinge | Hinged closure | 185 x 44.8 | A) FreestandingB) Rubber StabilizerC) Metal pole mounting bracket |
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Nitta M&T
ni 12120 Thailand
| NT-004 | Opening Hinge | Hingedclosure | 240 x 55.8 | Luer slip and luer lockneedle unwinder is in thelid and above thecontainment area. | D) Metal hook bracketA) Freestanding |
|---|---|---|---|---|---|
| NT-006 | CounterBalance | CounterBalance | 198 x 55 | n/a | A) FreestandingB) Lockable wall mountcabinetC) Metal pole mountingbracketD) Metal hook bracket |
| NT-007 | CounterBalance | CounterBalance | 198 x 55 | n/a | A) FreestandingB) Rubber StabilizerC) Metal pole mountingbracketD) Metal hook bracket |
| NT-008 | Opening Hinge | Hingedclosure | n/a | Pen-needle unwindingport is in the lid andabove the containmentarea. | A) Freestanding |
Accessories
Nitta M&T offers several mounting accessories for own sharps containers.
| Manufacture | Part Number | Description |
|---|---|---|
| SARAYA | 77251 1L Rubber stands | Table top Rubber Stabilizer of NT-001 |
| SARAYA | 77248 1L SS pole bracket | Holding bracket for pole mounting of NT-001 |
| SARAYA | 77256 1L SS hook type bracket | Hook type bracket of NT-001 |
| FINEPRO | 77252 1.5L Rubber stand | Table top Rubber Stabilizer of NT-002 |
| SARAYA | 77249 1.5L SS pole bracket | Holding bracket for pole mounting of NT-002 |
| SARAYA | 77257 1.5L SS hook type bracket | Hook type bracket of NT-002 |
| SARAYA | 77250 3.2L/7.6L SS pole bracket | Table top Rubber Stabilizer of NT-003, NT-005, NT-006, NT-007 |
| SARAYA | 77258 3.2L/7.6L SS hook type bracket | Holding bracket for pole mounting of NT-003, NT-005, NT-006, NT-007 |
| Nitta M&T | NT-010 3.2L Lockable wall mount cabinet | Lockable wall mounting cabinet of NT-003, NT-006 |
| Nitta M&T | NT-016 Rubber Stabilizer for 3.2L/7.6LSafety Box | Table top Rubber Stabilizer of NT-003, NT-005, NT-006, NT-007 |
| Nitta M&T | NT-017 7.6L Lockable wall mount cabinet | Lockable wall mounting cabinet of NT-005,007 |
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Image /page/5/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The logo has a shadow effect, which makes it appear to be three-dimensional. The logo is simple and easy to read.
i 12120 Thailand
510(k) Summary
The assigned 510(k) number is K211464
1. Submitter's Identification:
Nitta M&T (Thailand) Co., Ltd. 19/52 Unit G5, Phaholyothin Road, Moo 10 Khlong Hueng Khlong Luang Pathumthani, 12120 Thailand.
Date: July 28, 2021
Contact: Mr. Mamiko Oshiro
Nitta M&T (Thailand) Co., Ltd. 19/52 Unit G5, Phaholyothin Road, Moo 10 Khlong Hueng Khlong Luang Pathumthani, 12120 Thailand Email: osiromamiko@nittamold.com
2. Name of the Device:
Nitta M&T Safety Box
Regulation Description: Hypodermic single lumen needle. Product Code: MMK Regulation Number: 880.5570 Device Class: ll
3. Information on Predicate Devices:
Predicate Device:
- Trade/Device Name: North American Rescue Sharps Shuttle
- . Regulation Number: 21 CFR 880.5570
- Regulation Name: Hypodermic Single Lumen Needle
- Regulatory Class: Class II
- Product Code: MMK
Second Predicate Device:
- 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
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Image /page/6/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is a light blue color. The letters are connected to each other, and the logo has a shadow effect.
i 12120 Thailand
4. Indications for Use Statement:
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
General Specifications Table
| Model No. | Weight(g) | Capacity(Total) ml | Capacity(Full line) | Dimensions ofgoods (mm) (L xW x H) | Colors |
|---|---|---|---|---|---|
| NT-001*/** | 149 | 1,000 | 735 | 113 x 109 x 135 | Red / Yellow |
| NT-002*/** | 210 | 1,970 | 1,490 | 151 x 150 x 137 | Red / Yellow base andtransparent lid |
| NT-003*/** | 441 | 3,350 | 2,780 | 132 x 246 x 198 | Red / Yellow base andtransparent lid |
| NT-004* | 563 | 5,060 | 3,750 | 136 x 279 x 210 | Red / Yellow |
| NT-005*/** | 660 | 8,015 | 6,750 | 132 x 246 x 400 | Red / Yellow base andtransparent lid |
| NT-006*/** | 456 | 3,350 | 2,500 | 136 x 235 x 210 | Red / Yellow base andtransparent lid |
| NT-007*/** | 674 | 8,015 | 6,750 | 136 x 245 x 422 | Red / Yellow base andtransparent lid |
| NT-008 | 48 g | 210 | 160 | 78 x 50 x 82 | Red / Yellow |
- Intended to be used in areas where there is no unsupervised patient access.
** Intended for use with mounting accessories.
| ModelNo. | Lidconfiguration | Lockingmechanism | Dimensions ofaperture(mm) | Needle unwinder | Mounting Accessories |
|---|---|---|---|---|---|
| NT-001 | Opening Hinge | Hingedclosure | 45 x 38 | Luer slip and luer lockneedle unwinder, andPen-needle unwindingport are in the lid andabove the containmentarea. | A) FreestandingB) Rubber StabilizerC) Metal pole mountingbracketD) Metal hook bracket |
| NT-002 | Opening Hinge | Hingedclosure | 106 x 41.6 | A) FreestandingB) Rubber Stabilizer |
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Image /page/7/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is a light blue color. The logo is slightly tilted to the right. The background is white.
ani 12120 Thailand
| NT-003 | Opening Hinge | Hinged closure | 185 x 44.8 | C) Metal pole mountingbracketD) Metal hook bracket | |
|---|---|---|---|---|---|
| NT-005 | Opening Hinge | Hinged closure | 185 x 44.8 | A) FreestandingB) Lockable wall mountcabinetC) Metal pole mountingbracketD) Metal hook bracket | |
| NT-004 | Opening Hinge | Hinged closure | 240 x 55.8 | Luer slip and luer lockneedle unwinder is in thelid and above thecontainment area. | A) Freestanding |
| NT-006 | CounterBalance | CounterBalance | 198 x 55 | n/a | A) FreestandingB) Lockable wall mountcabinetC) Metal pole mountingbracketD) Metal hook bracket |
| NT-007 | CounterBalance | CounterBalance | 198 x 55 | n/a | A) FreestandingB) Rubber StabilizerC) Metal pole mountingbracketD) Metal hook bracket |
| NT-008 | Opening Hinge | Hinged closure | n/a | Pen-needle unwindingport is in the lid andabove the containmentarea | A) Freestanding |
Accessories
Nitta M&T offers several mounting accessories for own sharps containers.
| Manufacture | Part Number | Description |
|---|---|---|
| SARAYA | 77251 1L Rubber stands | Table top Rubber Stabilizer of NT-001 |
| SARAYA | 77248 1L SS pole bracket | Holding bracket for pole mounting of NT-001 |
| SARAYA | 77256 1L SS hook type bracket | Hook type bracket of NT-001 |
| FINEPRO | 77252 1.5L Rubber stand | Table top Rubber Stabilizer of NT-002 |
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Image /page/8/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a stylized, cursive font. The color of the text is a gradient of blue, with the top of the letters being a lighter shade of blue and the bottom of the letters being a darker shade of blue. The logo is set against a white background.
ni 12120 Thailand
| SARAYA | 77249 1.5L SS pole bracket | Holding bracket for pole mounting of NT-002 |
|---|---|---|
| SARAYA | 77257 1.5L SS hook type bracket | Hook type bracket of NT-002 |
| SARAYA | 77250 3.2L/7.6L SS pole bracket | Table top Rubber Stabilizer ofNT-003, NT-005, NT-006, NT-007 |
| SARAYA | 77258 3.2L/7.6L SS hook type bracket | Holding bracket for pole mounting ofNT-003, NT-005, NT-006, NT-007 |
| Nitta M&T | NT-010 3.2L Lockable wall mount cabinet | Lockable wall mounting cabinet ofNT-003, NT-006 |
| Nitta M&T | NT-016 Rubber Stabilizer for 3.2L/7.6LSafety Box | Table top Rubber Stabilizer of NT-003,NT-005, NT-006, NT-007 |
| Nitta M&T | NT-017 7.6L Lockable wall mount cabinet | Lockable wall mounting cabinet of NT-005,007 |
5. Device Description:
Nitta M&T Safety Boxes are disposable and non-sterile sharps container and its lid are made of puncture resistant, leak proof polypropylene. These containers are offered in various volumes, sizes, and lid styles. Mounting accessories (brackets) are available for use with 1.0L, 1.5L, 3.2L and 7.6L containers in locking and non-locking variations. Equipped with visible final lock mechanism. A design that allows you to determine and clearly differentiate the permanent and temporary closure engagement by the position of final lock claws.
Device Parts:
| Parts &Accessories | Product | Material | Patient Contact(Direct/Indirect)? |
|---|---|---|---|
| Lid | All | Polypropylene | No |
| Base | All | Polypropylene | No |
| Lever | NT-001 / NT-002 / NT-003 / NT-004 / NT-005 / NT-008 | ABS | Yes |
6. Technological Characteristic Comparison Table:
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Image /page/9/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The letters are connected and flow together.
Nitta M&T (Thailand) Co., Ltd.
19/52 Unit G5, Phaholyothin Rd., Moo 10
Khlong Nueng, Khlong Luang Pathumthani 12120 Thailand
| Characteristic | Submitted Subject Device | Predicate Device | Second Predicate Device | Comparison |
|---|---|---|---|---|
| 510(k) | NA | K152340 | K190240 | n/a |
| Device Name | Nitta M&T Safety Box | North AmericanRescue Sharps Shuttle | Tiger Sharps Containers | n/a |
| Product code | MMK | MMK | MMK | Same |
| Regulation No. | 21 CRF 880.5570 | 21 CRF 880.5570 | 21 CRF 880.5570 | Same |
| Class | II | II | II | Same |
| Size | 0.2 / 1L / 1.5L / 3.2L / 5.0L /7.6L | - | 1 Quart / 5 Quart / 2 Gallon / 2GallonB / 15 Liter3 Gallon/ 8 Gallon | Different |
| Dimensions(mm) | 113 x 109 x 135 / 151 x 150 x137 / 132 x 246 x 198 / 136 x279 x 210 / 132 x 246 x 400 /136 x 235 x 210 / 136 x 245 x422 / 78 x 50 x 82 | Approximately 6.41"(H) (163mm) by 1.33"(W I.D.) (34mm) | 3.91x3.91x6.37 / 10.60x4.70x10.64 / 10.84x6.86x10.36/ 10.22x7.02x13.30 /9.50x14.77x12.03 /14.86x7.25x14.00/10.92x15.61x17.27 | Different |
| Weight range | 48-674 g | Approximately 1.5oz | 109-1172 g | Different |
| No. of Pieces | 2-6 | 2-3 | 2-3 | Different |
| Material | Poly-propylene | Poly-propylene | Poly-propylene | Different |
| Base Color | Red / Yellow | Non-colored | Red | Different |
| Clarity | Opaque/translucent | translucent | Opaque/translucent | Different |
| Method ofManufacture | Injection Molded | Injection Molded | Injection Molded | Same |
| Performancetesting(puncture,impact,drop, stability,integrity) | Pass | Pass | Pass | Same |
| Standards | ISO23907-1:2019 | ISO 23907, ASTM F2132-01 | ISO 23907, ASTM F 2132 | Same |
| Technicalcharacteristics | Refer to statement inSummary of TechnologicalCharacteristics section | Refer to statement inSummary ofTechnologicalCharacteristics section | Refer to statement in Summaryof Technological Characteristicssection | Yes |
| Lidconfigurations/aperturedimensions | Refer to table below inIndication for Usesection | Refer to table below inIndication for Usesection | Refer to table below inIndication for Usesection | Yes |
| Accessories | Mounting accessories(brackets) are available foruse with 1.0L, 1.5L, 3.2L and7.6L containers in locking andnon-locking variations. | Mounting accessories(brackets) are availablefor use with 1g and 2gcontainers in lockingand non-lockingvariations. | Mounting accessories(brackets) are available for usewith 1qt, 5qt, 2g and 3gcontainers in locking and non-locking variations. | Different |
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Image /page/10/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The letters are connected and have a shadow effect.
i 12120 Thailand
7. Summary of Non-Clinical Tests:
Performance testing was provided to validate and verify that the subject device met all of the requirements of related international standards, including biocompatibility, sterility, and product specifications. Results of these tests demonstrate the subject device met the acceptance criteria or specification in consensus standards provided below.
Summary of Performance Testing:
| Test Objective | Testing Standards | Test method | Performance Results |
|---|---|---|---|
| Container Stability | ISO 23907-1:2019 | The sharps containers were filled to fill line with material of a density of $(0.20±0.01)$ Kg/l. Placed the container in the most adverse position on its base for toppling on a surface with a minimum inclination angle of 15° | Meets ISO23907-1:2019 Requirements - No more than 0 failures per container were observed. |
| Handle Strength | ISO 23907-1:2019 | The sharps containers were filled to 150% of the manufacturer's allowable gross mass and were | Meets ISO23907-1:2019 Requirements - No failures were observed. |
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Image /page/11/Picture/0 description: The image shows the logo for Nitta M&T. The logo is written in a cursive font and is blue. The logo is on a white background. The letters are connected and have a shadow effect.
12120 Thailand
| then suspended by the handles for | |||
|---|---|---|---|
| a period of at least 60 minutes. | |||
| Punctureresistance | ISO 23907-1:2019 | Fix a hypodermic needle of nominalsize 0.8mm x 25mm conform toISO7864 in the needle holder. Placethe test specimen centrally on thetest specimen support (having6mm diameter hole) with theinside container surface facingupwards and lower the 21-gaugeneedle vertically (90 $\pm$ 5°) towardsthe test specimen at a rate of(100 $\pm$ 10) mm/min. Allow theneedle to pass through the testspecimen and penetrationresistance was recorded.Per the acceptance criteria, theaverage force was required to beminimum of 16 N and an averageof 18 N or greater. | Meets ISO23907-1:2019Requirements -As such, all Nitta M&Tproducts were found to meetthe acceptance criteria.Testing resulted minimumforce of 18.6 N was observed. |
| Resistance toDamage(Drop/ImpactTest) | ISO 23907-1:2019 | Sharps container at (23 $\pm$ 5) C or atleast 2 h and carry out the test thesame temperature. These aredesigned to conform to specificshipping and transportationrequirements such as UNregulations and ADR regulations.Drop tested at height of 1m pertest standard. | Meets ISO23907-1:2019Requirements -No evidence of leakage ordamage resulting in a breachof the sharps containmentarea were observed. As such,all Nitta M&T products werefound to meet theacceptance criteria forresistance to damage from avertical drop. |
8. Sterility Information
The subject device container is non-sterile; therefore, no sterility testing was performed.
9. Clinical Testing:
Not Applicable.
10. Conclusion:
The conclusions drawn from the non-clinical performance testing data demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate devices.
§ 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).