(87 days)
The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.
The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device.
This document describes the MedSource Sharps Dart, a non-sterile, single-use disposable sharps container. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 23907 First edition 2012-09-01—Sharps injury protection—Requirements and test methods—Sharps containers: | |
| - Puncture Resistance (Section 4.2.4) | Testing was conducted and the product met the testing criteria. |
| - Leak Resistance (Section 4.2.5) | Testing was conducted and the product met the testing criteria. |
| - Definition of a pocket sharps container | The MedSource Sharps Dart complies with the definition of a pocket sharps container. |
| ASTM F2132-01 (Re-approved in 2008) Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps: | Testing by an independent laboratory met the requirements for puncture resistance. |
| FDA OSHA 29 CFR 1910.1030 (Impact Test) | Meets requirements by compliance to applicable parts of ISO 23907 (Impact Test). |
Study Details:
The provided document is a 510(k) summary for a medical device (MedSource Sharps Dart), which primarily demonstrates substantial equivalence to predicate devices rather than independent clinical study results for novel technology. Therefore, many of the requested details about typical AI/software studies are not applicable or not provided in this regulatory submission.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes performance testing of a physical medical device (sharps container) against established engineering standards (ISO 23907, ASTM F2132-01). It does not involve a "test set" in the context of AI/machine learning data.
The testing was conducted on samples of the MedSource Sharps Dart. The exact number of units tested is not specified in the summary, but it would involve a sufficient sample size to demonstrate compliance with the referenced standards. The provenance of this "data" is the manufactured MedSource Sharps Dart devices. The testing is prospective in the sense that newly manufactured devices were tested against existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is not applicable as the "ground truth" is defined by the technical specifications and performance criteria within the international and national standards (ISO 23907, ASTM F2132-01). These standards are developed by expert committees, but there is no explicit mention of experts establishing ground truth for a test set in the context of this device's performance testing.
4. Adjudication Method for the Test Set:
Not applicable. Device performance was assessed against defined criteria in the standards rather than human adjudication of results.
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 software device that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth is based on the objective performance criteria and test methods specified in the recognized international and national standards: ISO 23907 and ASTM F2132-01. These standards define the acceptable physical and mechanical properties for sharps containers, such as puncture resistance and leak resistance.
8. The Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this physical device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2015
MedSource International, LLC c/o Mr. Howard Cooper Principal Consultant EQACT INC. 11715 Fox Road Indianapolis, IN 46236
Re: K150333
Trade/Device Name: MedSource Sharps Dart Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: MMK Dated: March 10, 2015 Received: March 12, 2015
Dear Mr. Cooper:
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.
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Page 2 - Mr. Cooper
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 device-related 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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) K150333
Device Name
MedSource Sharps Dart
Indications for Use (Describe)
The MedSource Sharps Datt is a non-sterile single-use disposable sharps container with a permanent closure system for a contaminated 1 ml or smaller syringe. Its intended use is by health care professionals in a setting where standard sharps containers are not accessible such as EMS, home healthcare, and laboratories. Its permanent closure system protects the user prior to disposal by incineration or decontamination by autoclave.
MedSource Sharps Dart Model No. MS-64250 Color-Clear/translucent with red closure Length-17cm (6.7 in.) Diameter-3cm (1.2 in.) Empty Weight- 255 gm ( 0.9 oz)
| 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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Toll Free: 800-876-8264 Phone: 952-472-0131 Fax: 952-472-0136 www.gomedsource.com
Medical Supplies for the Healthcare Professional
4201 Norex Drive Chaska, MN 55318 USA
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SECTION 5
Date Prepared: May 8, 2015
1. General Information
| Submission Sponsor | Submission Correspondent | ||
|---|---|---|---|
| MedSource International4201 Norex DriveChaska, MN 55318 | Howard T. CooperEQACT, INC.11715 Fox Rd.Suite 400Indianapolis, IN 46236317-826-4398 office | ||
| Device Identification | Predicate identification | ||
| Characteristic | Submission Device | Predicate A | Predicate B |
| Trade name | MedSource Sharps Dart | Covidien Sharps Shuttle/Sharps Shuttle withLocking Mechanism* | B Travel Savvy SharpsContainer |
| 510(K) | K150333 | K972279 | K140285 |
| Regulatory Name | Hypodermic Single-Lumen Needle | Hypodermic Single-Lumen Needle | Hypodermic Single-Lumen Needle |
| Common name | Sharps Container | Sharps Container | Sharps Container |
| Product Code | MMK | FMI | MMK |
| Classification | Class II | Class II | Class II |
| CFR reference | 880.5570 | 880.5570 | 880.8570 |
| Classification Panel | General Hospital | General Hospital | General Hospital |
| Catalog No. | MS-64250 | Model 8801 | BTS-702 |
| *Covidien Sharps Shuttle, formerly Kendall P2 Shuttle Sharps Container manufactured by Sage Products |
2. Device Description
The MedSource Sharps Dart (MSD) sharps container consists of two injected molded parts-a tubular tapered cone and a polypropylene closure. Its small size of 0.6 L qualifies it as a pocket sharps container as defined by ISO 23907 First Edition 2012-09-01, Sharps injury protection-Requirements and test
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methods-Sharps containers. It is designed for the storage, such sharps as small syringes, blood needles, lancets, and angio-caths prior to disposal consideration. It's intended to be used in remote settings for sharps containers are not convenient and accessible such as EMS, home healthcare, etc. It is a single use device.
The MSD sharps container was designed using the above standard, ISO 23907, and its design includes the required features specified in the standard. It meets the performance requirements for the standard. In addition, it has also been tested by an independent laboratory to meet the requirements for puncture resistance specified in ASTM F2132-01 (Re-approved in 2008). Both standards are FDA recognized.
The predicate device, Covidien Sharps Shuttle, was selected because of its tubular-conical configuration with a polypropylene hinge-closure , which is very similar to the construction of the MedSource Sharps Dart. They are also similar in their weight and dimensions. When comparing such factors as Indications for Use, Performance, Technology, and method of manufacture, the data shows substantial equivalence between both the Covidein Sharps Shuttle and the MedSource Sharps Dart.
Although both devices are considered to be substantially equivalent, they have been or are being cleared at different periods of regulation. At the time that the predicate device was approved, there was not an FDA recognized standard for sharps container. However, Medsource Sharps Dart was designed following FDA recognized standards for the products with respect to puncture resistance testing and leak testing.
3. Standards
| Standard | Summary of Compliance toStandard |
|---|---|
| ISO 23907 First edition 2012-09-01—Sharps injuryprotection— Requirements and test methods—Sharps containers | Medsource Sharps Dart complianceto the definition of the pocketsharps container.1. Summary report prepareddemonstrating complianceto the standard for pocketsharps container2. Testing was conducted forpuncture resistance and leakresistance and product metthe testing criteria |
| ASTM F2132- 01 (2008) Standard Specification forPuncture Resistance of Materials Used in Containersfor Discarded Medical Needles and Other Sharps | See revised standards Summaryreport prepared demonstratingcompliance to standard.See Section 18. Performance Testing |
The following FDA recognized standards were used in the preparation of this 510K:
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| FDA OSHA | 29 CFR 1910.1030 | Meets requirements by complianceto applicable parts of ISO 23907 |
|---|---|---|
| (Impact Test) andASTM F 2132 (Puncture Resistance) |
4. Device Comparison
| Predicate ID | Submission Device | Predicate A | Predicate B |
|---|---|---|---|
| Trade | MedSource Sharps Dart | Covidien SharpsShuttle With Locking | B Travel Savvy SharpsContainer |
| Name | K150333 | K972279 | K140285 |
| Indications forUse | The MedSource SharpsDart is a non-sterilesingle-use disposablesharps container with apermanent closuresystem for acontaminated 1ml orsmaller syringe. Itsintended use is by healthcare professionals in asetting where standardsharps containers are notaccessible such as EMS,home healthcare andlaboratories. Itspermanent closuresystem protects the userprior to disposal byincineration ordecontamination byautoclave.MedSource Sharps DartModel No. MS-64250Color-Clear/translucentwith red closure | The Sharps Shuttleand Sharp Shuttlewith LockingMechanism aresingle use, non-sterile, disposable,sharps transportcontainers intendedfor use in any settingwhere standardsharps containers arenot convenientlyaccessible, such asEMS home healthcare, etc | The Travel SavvySharps Container is asingle-use deviceintended for disposalof sharps waste by asingle user in aprivate site of use.When mounted withthe appropriatebracket, the TravelSavvy SharpsContainer can beused for sharpsdisposal in vehicles.The B Travel SavvySharps containercolor is red. Thelength of the deviceis 6.5 inches, thewidth is 2.1 inchesand the height is 2.3inches. The apertureopening is 1.5 incheswide and the lengthis 2.5 inches. |
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| Length-17cm (6.7 in.)Diameter-3cm (1.2 in.)Empty Weight- 255 gm (0.9 oz) | |||
|---|---|---|---|
| RX or OTC | OTC | OTC | OTC |
| Material | Polypropylene | Polypropylene | Polypropylene |
| Sharps Access | Top opening | Top Opening | Top Opening |
| Sharps Closure | Hinged closure | Hinged closure | Hinged closure |
| Dimensions & Weight | Length-17cm (6.7 in.)Diameter-3cm (1.2 in.)Empty Weight- 255 gm (0.9 oz) | Approximately 6in. long & 1 in. diameterEmpty weight notavailable | The length of the device is 6.5 inches,the width is 2.1 inches and the heightis 2.3 inches. The aperture opening is1.5 inches wide and the length is 2.5inches. |
| Single use | Yes | Yes | Yes |
| Non-sterile | Yes | Yes | Yes |
| Translucent | Yes | Yes | Yes |
| Impact andleak resistance | Yes | Yes | Yes |
| NeedlePenetrationResistance- | Yes | Yes | Yes |
5. Comparison Results
| Category of comparison | Results | |
|---|---|---|
| 1. | Regulatory RequirementsCharacteristics | Equivalent |
| 2. | Indications for Use & RX/OTC | Equivalent |
| 3. | Design & Construction and Method ofManufacture | Equivalent |
| 4. | Technology | Equivalent |
| 5. | Product Features | Equivalent |
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6. Test Methods
| Test Methods | Standards |
|---|---|
| Puncture Resistance | ISO 23907- Section 4.2.4 |
| Resistance to Leakage | ISO 23907- Section 4.2.5 |
| Puncture Resistance | ASTM- F2132-01 |
7. Conclusion
The MedSource Sharps Dart sharps container was compared to the above predicate devices in such areas as technology, indications for use, materials of construction, performance testing, product testing, and product features. Based on the review of this data, the data supports the conclusion that the subject device is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised by the introduction this device. Therefore, we conclude that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices [Covidien Sharps Shuttle/ Sharps Shuttle with Locking Mechanism (K972279) and B Travel Savvy Sharps Container (K140285)].
§ 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).