(286 days)
The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use, portable transportable sharps container. Its permanent closure system protects the user prior to disposal via incineration.
The North American Rescue Sharps Shuttle is approximately 6.41" in length, with a sharps aperture of approximately 1" in diameter.
The North American Rescue Sharps Shuttle are injected or blow molded single use, non-sterile disposable, transportable sharps collectors and transport containers intended for use where standard sharps containers are not conveniently accessible. The North American Rescue Sharps Shuttle is a portable collector that provides an alternate to resheathing a needle with its original protective cover. The North American Rescue Sharps Shuttle is designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes.
The North American Rescue Sharps Shuttle is cylindrical, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal via incineration. In addition to the temporary closing mechanism, the North American Rescue Sharps Shuttle has a locking mechanism designed with a locking tab to permanently close the container.
The North American Rescue Sharps Shuttle is a non colored, translucent plastic and is approximately 6.41 inches long by 1 inch in diameter. The cap is red opaque plastic with a hinged cap, which is snapped and locked close contains the biohazardous sharps. Each North American Rescue Sharps Shuttle is individually labeled with a biohazard symbol and fill line. The North American Rescue Sharps Shuttle is available as a single device or as a kit of six (6).
This document is a 510(k) Summary for a medical device called the "North American Rescue Sharps Shuttle." This type of document is generally for substantial equivalence determinations, not for proving a device meets specific clinical acceptance criteria in the same way an AI/ML algorithm might. Instead, it demonstrates that the new device is as safe and effective as a legally marketed predicate device.
Therefore, the following information about acceptance criteria and study design is interpreted within the context of a 510(k) submission for a non-active medical device (a sharps container), rather than an AI/ML diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Material Properties: | |
| * Material: Polypropylene | * Device is made of polypropylene. (Demonstrates equivalence to predicate) |
| Functional Safety (Puncture Resistance): | |
| * Conformity to ASTM F2132-01 (2008)e1 "Puncture of Materials used in Resistance of Materials containers for discarded used in containers for medical needles and other Sharps" (Puncture Resistance Standard) | * The North American Rescue Sharps Shuttle was tested for puncture resistance per ASTM F2132-01 (2008)e1. The conclusion is that it is "substantially equivalent" to the predicate, which also met this standard. Therefore, it implicitly meets the standard, as the predicate was also tested via bench testing per the same standard. |
| * Conformity to ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods - Sharps containers for puncture resistance section 5.3 (Puncture Resistance Standard) | * The North American Rescue Sharps Shuttle was tested for puncture resistance per ISO 23907, section 5.3. The conclusion is that it is "substantially equivalent" to the predicate. |
| Functional Safety (Resistance to Damage and Leakage after Dropping): | |
| * Conformity to ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods - Sharps containers for resistance to damage and leakage after dropping, section 5.4 (Drop Test Standard) | * The North American Rescue Sharps Shuttle was tested for resistance to damage and leakage after dropping per ISO 23907, section 5.4. The conclusion is that it is "substantially equivalent" to the predicate. |
| Dimensional & Design Equivalences: | |
| * Similar dimensions (length, width, volume) to predicate device (Sage Sharps Shuttle K972279) | * NA Rescue Sharps Shuttle: Approx. 6.41" (H) x 1.33" (W I.D.), <0.75l capacity. * Sage Sharps Shuttle: Approx. 6.385" (H) x 1.11" (W I.D.), <0.75l capacity. (Deemed substantially equivalent) |
| * Similar weight to predicate device (Sage Sharps Shuttle K972279) | * NA Rescue Sharps Shuttle: Approx. 1.5oz. * Sage Sharps Shuttle: Approx. 1.5oz. (Deemed substantially equivalent) |
| * Similar closure mechanism (temporary and permanent locking tab) to predicate. | * Device has cylindrical shape, conical taper, temporary closure, and a permanent locking mechanism with a locking tab, similar to the predicate. (Deemed substantially equivalent) |
| Intended Use & Patient Population: | |
| * Non-sterile, single use, portable transportable sharps container with permanent closure system, protecting user prior to disposal via incineration. Accepts blood needles, lancets, small syringes. Used in point-of-procedure, non-clinical conditions (first responders, battlefield medics). | * The device matches this description and intended use, and is deemed substantially equivalent to the predicate which also has a similar intended use (EMS, home health care, accepting angio-caths, blood needles, lancets, small syringes). The environments of use are comparable (non-clinical, portable). |
| Biocompatibility: | |
| * Biocompatibility not applicable per ISO 10993 (implied acceptance criteria for non-patient contact device) | * Biocompatibility not applicable per ISO 10993. (Deemed substantially equivalent to predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" sample size in the conventional sense of clinical trials or AI/ML evaluations. The testing described (impact resistance, puncture resistance, resistance to damage and leakage after dropping) involves physical product samples, not patient data.
- Sample Size: The document does not explicitly state the number of units tested for each non-clinical performance test. It only states that the device "was tested." Standard practice for such tests, governed by the cited ASTM and ISO standards, would involve a statistically relevant number of samples, but the exact count is not given here.
- Data Provenance: The "data" (test results) are from non-clinical laboratory testing of the manufactured device. There is no patient or clinical data involved in this specific 510(k) submission. Therefore, it is not applicable to discuss country of origin or retrospective/prospective nature of data as these are physical device tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this type of device and submission. "Ground truth" in the context of expert consensus is typically for diagnostic assessments (e.g., image interpretation). For a sharps container, the "ground truth" is established by adherence to performance standards (e.g., material does not puncture under specified force, container does not leak after specific drops). These are objective physical tests, not subjective expert evaluations. The qualifications would be of the laboratory technicians performing the tests and the engineers interpreting the results against the standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication in the sense of reconciling differing expert opinions, as the tests are objective physical 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
Not applicable. This device is a physical sharps container, not an AI or diagnostic imaging device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical sharps container, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for this device's performance is established by objective performance standards defined by organizations like ASTM and ISO. Specifically:
- ASTM F2132-01 (2008)e1 for puncture resistance.
- ISO 23907 (First edition 2012-09-01) sections 5.3 (puncture resistance) and 5.4 (resistance to damage and leakage after dropping).
Meeting these predefined, measurable criteria serves as the "ground truth" for the device's acceptable safety and efficacy properties in a non-clinical setting.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. There is no "training set" of data in this context. The manufacturing process itself (injection or blow molding) produces the devices, and quality control ensures consistency, but this is not a data "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set as understood for AI/ML, there is no ground truth established for it. The ground truth for the device's performance is established by the aforementioned industry standards, which inform the design and testing of the product.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 31, 2016
North American Rescue, LLC William Slevin Director. OA/RA 35 Tedwall Court Greer, South Carolina 29650
Re: K152340
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 Dated: April 28, 2016 Received: April 29, 2016
Dear William Slevin:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name North American Rescue Sharps Shuttle
Indications for Use (Describe)
The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use, portable transportable sharps container. Its permanent closure system protects the user prior to disposal via incineration.
The North American Rescue Sharps Shuttle is approximately 6.41" in length, with a sharps aperture of approximately 1" in diameter.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k)
152340
Summary
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Sharps Shuttle is provided below.
| Date Summary Prepared | May 31, 2016 |
|---|---|
| Manufacturer/Distributor/Sponsor | North American Rescue35 Tedwall CourtGreer, SC 29650-4791 USA |
| 510(k) Contact | North American Rescue, LLCWilliam Slevin35 Tedwall CourtGreer, SC 29650-4791864-675-9800 (phone)wslevin@narescue.com (email) |
| Trade Name | North American Rescue Sharps Shuttle |
| Common Name | Container Sharps |
| Code -Name -Classification | MMK – Hypodermic single lumen needle - 21 CFR 880.5570: Class II |
| Predicate Devices | Sage Sharps Shuttle K972279 (ownership acquired by Tyco/now Covidien) |
| Device Description | Device Description: The North American Rescue Sharps Shuttle are injected or blow moldedsingle use, non-sterile disposable, transportable sharps collectors and transport containersintended for use where standard sharps containers are not conveniently accessible. The NorthAmerican Rescue Sharps Shuttle is a portable collector that provides an alternate to resheathinga needle with its original protective cover. The North American Rescue Sharps Shuttle isdesigned to safely hold small low volume sharps such as blood needles, lancets, and smallsyringes. |
| The North American Rescue Sharps Shuttle is cylindrical, with a conical taper and a temporaryclosure capability, which can be reopened for the storage of additional sharps prior to terminaldisposal via incineration. In addition to the temporary closing mechanism, the North AmericanRescue Sharps Shuttle has a locking mechanism designed with a locking tab to permanentlyclose the container. | |
| The North American Rescue Sharps Shuttle is a non colored, translucent plastic and isapproximately 6.41 inches long by 1 inch in diameter. The cap is red opaque plastic with ahinged cap, which is snapped and locked close contains the biohazardous sharps. Each NorthAmerican Rescue Sharps Shuttle is individually labeled with a biohazard symbol and fill line. TheNorth American Rescue Sharps Shuttle is available as a single device or as a kit of six (6). | |
| Intended Use | The North American Rescue Sharps Shuttle is a molded polypropylene, non-sterile, single use,portable transportable sharps container. Its permanent closure system protects the user priorto disposal via incineration. |
| The North American Rescue Sharps Shuttle is approximately 6.41" in length, with a sharpsaperture of approximately 1" in diameter. | |
| TechnologicalCharacteristics | The North American Rescue Sharps Shuttle is cylindrical, with a conical taper, a temporary closurecapability, which can be reopened for the storage of additional sharps prior to permanent locking. |
| Non-Clinical PerformanceTesting Conclusion | The North American Rescue Sharps Shuttle was tested for impact resistance and puncture resistanceASTM F2132-01 (2008)e1 "Puncture of Materials used in Resistance of Materials containers fordiscarded used in containers for medical needles and other Sharps". |
| ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods -Sharps containers for puncture resistance section 5.3. | |
| ISO 23907 (First edition 2012-09-01) Sharps injury protection - Requirements and test methods -Sharps containers for resistance to damage and leakage after dropping, section 5.4. | |
| Substantial EquivalenceSummary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing the North AmericanRescue Sharps Shuttle was shown to be substantially equivalent to the predicate device, the SageSharps Shuttle K972279. |
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Additionally, a comparison between the North American Rescue Sharps Shuttle and the predicate device is summarized below:
| Feature | North American RescueSharps Shuttle | Sage Sharps ShuttleK972279 | SubstantiallyEquivalent |
|---|---|---|---|
| DeviceClassification | 21 CFR §880.5570: Class II | 21 CFR §880.5570: Class II | Yes |
| Product Code | MMK – Container Sharps | FMI – Needle, Hypodermic, SingleLumen | Yes |
| Device CommonName as Clearedby FDA | Container, Sharps | Container, Sharps | Yes |
| Indications for use | The North American Rescue SharpsShuttle is a non-sterile, single use,portable transportable sharpscontainer. Its permanent closuresystem protects the user prior todisposal via incineration. | The Sharps Shuttle and Sharps Shuttlewith locking mechanism are single use,non-sterile, disposable , sharpstransport containers for use in anysetting where standard sharpscontainers are not convenientlyaccessible, such as EMS, home healthcare, etc. | Yes |
| Patient Population | Single use only | Single use only | Yes |
| EnvironmentofUse | Point of procedure - non clinicalconditions including first responders atpoint of care and battlefield medics.Not intended for a stationaryhorizontal surface. | Point of procedure - non clinicalconditions, EMS and home health care.Not intended for a stationaryhorizontal surface. | Yes |
| Feature | North American RescueSharps Shuttle | Sage Sharps ShuttleK972279 | SubstantiallyEquivalent |
| DeviceDescription | The North American Rescue Sharps Shuttle is portable, transportable sharps container, with a permanent closure system which protects the end user prior to incineration.The North American Rescue Sharps Shuttle are injection molded single use, non-sterile disposable, sharps transport containers intended for use where standard sharps containers are not conveniently accessible. The North American Rescue Sharps Shuttle is a portable, pocket collector that provides an alternate to resheathing a needle with its original protective cover. The North American Rescue Sharps Shuttle is designed to safely hold small low volume sharps such as blood needles, lancets, and small syringes. | The Sage Sharps Shuttle is designed to be used by EMS, home health care etc.The Sage Sharps Shuttle are injection molded single use, non-sterile disposable, sharps transport containers intended for use where standard sharps containers are not conveniently accessible. The Sage Sharps Shuttle is a portable, pocket sharps collector that provides an alternate to resheathing a needle with its original protective cover, which may or may not be accessible and is not a recommended practice. The Sage Sharps Shuttle is designed to safely hold small low volume sharps such as angio-caths, blood needles, lancets, and small syringes. | Yes |
| Principles ofOperation | The North American Rescue Sharps Shuttle is portable, transportable sharps container, with a permanent closure system which protects the end user prior to incineration.The North American Rescue Sharps Shuttle is cylindrical, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal. In addition to the temporary closing mechanism, the North American Rescue Sharps Shuttle has a locking mechanism designed with a locking tab to permanently close the container.The North American Rescue Sharps Shuttle is designed for vertical and horizontal use for storage of blood needles, lancets and small syringes. | The Sage Sharps Shuttle is intended for use by EMS, home health care, etc. where standard sharps containers are not conveniently accessible.The Sage Sharps Shuttle is cylindrical, with a conical taper and a temporary closure capability, which can be reopened for the storage of additional sharps prior to terminal disposal. In addition to the temporary closing mechanism, the Sage Sharps Shuttle has a locking mechanism designed with a locking tab to permanently close the container.The Sage Sharps Shuttle is designed for vertical and horizontal use for storage of angio-caths blood needles, lancets, and small syringes. | Yes |
| Application | Storage of blood needles, lancets, and small syringes pending terminal disposal. | Storage of angio-caths, blood needles, lancets, and small syringes pending terminal disposal. | Yes |
| Feature | North American RescueSharps Shuttle | Sage Sharps ShuttleK972279 | SubstantiallyEquivalent |
| Volume | Approximately6.41" (H) (163mm) by 1.33" (W I.D.)(34mm), <0.75l capacity | Approximately6.385"(H) by 1.11" (W I.D.), with<0.75l capacity | Yes |
| Weight | Approximately 1.5oz | Approximately 1.5oz | Yes |
| Non-ClinicalTesting Summary | The North American Rescue SharpsShuttle was tested for impactresistance and puncture resistance perASTM 2132-01 (2008)e1 "Puncture ofMaterials used in Resistance ofMaterials containers for discardedused in containers for medical needlesand other Sharps".ISO 23907 (First edition 2012-09-01)Sharps injury protection –Requirements and test methods –Sharps containers, sections 5.3 and 5.4 | The Sage Sharps Shuttle was tested viabench testing, in side by sidecomparison with the North AmericanRescue Sharps Shuttle, to demonstrateefficacy per ASTM 2132-01 (2008)e1"Puncture of Materials used inResistance of Materials containers fordiscarded used in containers formedical needles and other Sharps". | Yes |
| Sterile | No | No | Yes |
| Biocompatiblematerials | Not applicable per ISO 10993 | Not applicable per ISO 10993 | Yes |
| Use | Non-clinical setting | EMS, home health etc. | Yes |
| Instructionsfor Use | Yes | No | No |
| Materials | polypropylene | polypropylene | Yes |
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§ 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).