(286 days)
Not Found
No
The device description and performance studies focus on the physical properties and safety features of a sharps container, with no mention of AI or ML.
No
The North American Rescue Sharps Shuttle is a container designed to safely hold and transport discarded sharps, preventing injuries. It does not directly treat or diagnose any medical condition.
No
The device is a sharps container designed for the safe disposal and transport of used medical sharps, not for diagnosing medical conditions.
No
The device description clearly indicates it is a molded polypropylene container, which is a physical hardware product, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Sharps Shuttle Function: The North American Rescue Sharps Shuttle is a container designed to safely collect and transport used medical sharps (needles, syringes, etc.). Its purpose is to prevent accidental needlestick injuries and facilitate safe disposal.
- Lack of Diagnostic Function: The device itself does not perform any diagnostic tests on biological samples. It is a container for hazardous waste.
The description clearly outlines its function as a safety container for sharps, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
MMK
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Point of procedure - non clinical conditions including first responders at point of care and battlefield medics. Not intended for a stationary horizontal surface.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The North American Rescue Sharps Shuttle was tested for impact resistance and puncture resistance 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".
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/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.
1
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
2
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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3
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 Rescue |
| 35 Tedwall Court | |
| Greer, SC 29650-4791 USA | |
| 510(k) Contact | North American Rescue, LLC |
| William Slevin | |
| 35 Tedwall Court | |
| Greer, SC 29650-4791 | |
| 864-675-9800 (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 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). | |
| 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 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. | |
| Technological | |
| Characteristics | The North American Rescue Sharps Shuttle is cylindrical, with a conical taper, a temporary closure |
| capability, which can be reopened for the storage of additional sharps prior to permanent locking. | |
| Non-Clinical Performance | |
| Testing Conclusion | The North American Rescue Sharps Shuttle was tested for impact resistance and puncture resistance |
| 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". | |
| 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 Equivalence | |
| Summary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing the North American |
| Rescue Sharps Shuttle was shown to be substantially equivalent to the predicate device, the Sage | |
| Sharps Shuttle K972279. |
4
Additionally, a comparison between the North American Rescue Sharps Shuttle and the predicate device is summarized below:
| Feature | North American Rescue
Sharps Shuttle | Sage Sharps Shuttle
K972279 | Substantially
Equivalent |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Device
Classification | 21 CFR §880.5570: Class II | 21 CFR §880.5570: Class II | Yes |
| Product Code | MMK – Container Sharps | FMI – Needle, Hypodermic, Single
Lumen | Yes |
| Device Common
Name as Cleared
by FDA | Container, Sharps | Container, Sharps | Yes |
| Indications for use | The North American Rescue Sharps
Shuttle is a non-sterile, single use,
portable transportable sharps
container. Its permanent closure
system protects the user prior to
disposal via incineration. | The Sharps Shuttle and Sharps Shuttle
with locking mechanism are single use,
non-sterile, disposable , sharps
transport containers for use in any
setting where standard sharps
containers are not conveniently
accessible, such as EMS, home health
care, etc. | Yes |
| Patient Population | Single use only | Single use only | Yes |
| Environment
of
Use | Point of procedure - non clinical
conditions including first responders at
point of care and battlefield medics.
Not intended for a stationary
horizontal surface. | Point of procedure - non clinical
conditions, EMS and home health care.
Not intended for a stationary
horizontal surface. | Yes |
| Feature | North American Rescue
Sharps Shuttle | Sage Sharps Shuttle
K972279 | Substantially
Equivalent |
| Device
Description | 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 of
Operation | 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 Rescue
Sharps Shuttle | Sage Sharps Shuttle
K972279 | Substantially
Equivalent |
| Volume | Approximately
6.41" (H) (163mm) by 1.33" (W I.D.)
(34mm),