The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Device Description

The GRP Sharps Container is a blow molded HDPE bottle with a spun-weld iris at the opening. The iris acts as an aperture, allowing a vertical sharps drop. The device has a yellow safety ring which prevents the cap from locking closed during use. The device has a white 2.5″ cap which contains a sealing gasket. Once the GRP Sharps Container is full, the safety ring is removed prior to pacing the cap on. When the safety ring has been removed, the cap locks down for a tight seal. The device is available in four sizes: 1.5 quart, 1 gallon, 2 gallon and 3 gallon. The containers are identical except for capacity.

AI/ML Overview

The provided text describes a 510(k) premarket submission for a medical device: GRP Sharps Container. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria, ground truth, and expert adjudication in the way an AI/ML device would.

Therefore, many of the requested categories (sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable to this submission, as it is for a physical device (sharps container) and not an AI/ML diagnostic or prognostic tool.

However, I can extract the acceptance criteria based on compliance with standards and the reported performance as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from recognized standards/guidance)	Reported Device Performance
Puncture Resistance: Complies with ASTM F 2132-01 (reapproved 2008), "Standard Specification for Puncture Resistance of Materials used in Collectors for Discarded Medical Needles and other Sharps"	Complies with ASTM F 2132-01 (reapproved 2008)
Impact Resistance: (Likely BSI 7320:1994.4 Impact Resistance based on listed tests)	BSI 7320:1994.4 Impact Resistance (Testing conducted in accordance with)
Leak Resistance: Conforms to CSA Z316.6-95, 3.9.2.1 -- "Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste - Leak Resistance" (Also references OSHA 29CFR for Leakage)	Conforms to CSA Z316.6-95 Leak ResistanceComplies with CSA CZ316.5-95 and OSHA 29CFR (for Leakage)
Container Stability/Topple Resistance: Conforms to CSA Z316.6-07 "Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste - Container Stability"	Conforms to CZA Z316.6-07 Topple resistance
Handle Strength and Fill Capacity: (Likely CSA Z316.6-07 based on listed tests)	CSA Z316.6-07 Handle Strength and Fill Capacity (Testing conducted in accordance with)
Sharps Injury Protection: ISO 23907 First edition 2012-09-01 "Sharps injury protection - Requirements and test methods - Sharps containers"	ISO 23907 First edition 2012-09-01 Sharps injury protection - Requirements and test methods - Sharps containers (Testing conducted in accordance with)
Guidance Document Compliance: "Guidance on the Content and Format of Premarket Notification (510(k)) submissions for Sharps, dated October 1993"	FDA Guidance Document "Guidance on the Content and Format of Premarket Notification (510(k)) submissions for Sharps, dated October 1993, was used to help identify applicable physical and mechanical features."

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated as a "test set" in the context of typical AI/ML studies. The testing would have involved a sufficient number of physical GRP Sharps Container units to ensure compliance with the specified standards for each model size.
Data Provenance: The tests conducted are non-clinical, laboratory-based physical and mechanical performance tests on the manufactured device itself, rather than data from human subjects or clinical settings. The provenance is from these specific laboratory tests against recognized standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This submission is for a physical medical device (sharps container) and not an AI/ML algorithm that requires expert-established ground truth from data for diagnostic or prognostic purposes. Compliance is determined by objective physical testing against established international and national standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. See point 3. Ground truth is derived from objective performance against engineering 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 is a physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. See point 5.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Objective performance against established engineering standards and regulatory requirements. For example, puncture resistance is directly measured against the criteria specified in ASTM F 2132-01. Leak resistance is measured against CSA Z316.6-95.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the text "EMERGO GROUP" with a logo in between the two words. Above the text, the image also shows the text "MAY 0-2-2014 K132476". The text is in black and the background is white.

Section 5 - 510(k) Summary

1. Submission Sponsor

GRP and Associates P.O. Box 94 218 10th Avenue N. Clear Lake, lowa, 50428 USA Phone: (800) 207 0976 Fax: (641) 357 4063 Contact: Scott Rollefson, Manager of Operations

2. Submission Correspondent

Emergo Group 816 Congress Ave., Suite 1400, Austin, TX 78701 Cell Phone: 940 390 0961 Office Phone: (512) 327.9997 Fax: (512) 327 9998 Contact: Robert Seiple, RAC, Senior Consultant, QA/RA Email: project.management@emergogroup.com

3. Date Prepared

27 March 2014

4. Device Identification

Trade/Proprietary Name:	GRP Sharps Container, models 1.5Qt, 1G, 2G and 3G
Common/Usual Name:	Sharps Container
Classification Name:	hypodermic single lumen needle
Classification Regulation:	21CFR 880.5570
Product Code:	MMK
Device Class:	Class II
Classification Panel:	General Hospital

5. Predicate Devices

K112774 - BD RecyKleen Sharps Collector

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6. Device Description

7. Intended Use

There are four indications for use statements corresponding to the four sizes of container. These are reproduced below:

Indications for Use Statement: GRP-1.5 Ot

The empty device, as it sits, is a red container that measures 4"X4"X7.5" and weighs 602. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Indications for Use Statement: GRP-1G

The empty device, as it sits, is a red container that measures 9.75"X6"X9.75" and weighs 16oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Indications for Use Statement: GRP-2G

The empty device, as it sits, is a red container that measures 9.75"X6"X13.75" and weighs 11b 9oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Indication for Use Statement: GRP-3G

The empty device, as it sits, is a red container that measures 9.75"X6"X18.75" and weighs 2lbs. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

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8. Comparison of Technological Characteristics

The following table compares the GRP Sharps container to the BD Medical Systems sharps container with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Manufacturer	GRP Associates	BD Medical SurgicalSystems
Trade Name	Container, Sharps	BD Recykleen SharpsCollector
510(k) Number	TBD	K112774
Product Code	MMK	MMK
Regulation Number	21CFR 880.5570	21CFR 880.570
Regulation Name	Accessory to hypodermicsingle lumen needles	Accessory to hypodermicsingle lumen needles
Indications for Use	The empty device, as itsits, is a red container thatmeasures (x" by y" by z")four sizes) and weighsxlbs. The opening/closuremeasures 2.5" indiameter. The intendeduse of the vertical entry,single use, sharpscontainers, is to provide areceptacle for used,contaminated medicalsharps, and for enclosureduring transport toultimate disposal. Thecontainer is intended tobe used in hospitals,clinics, operating rooms,and laboratories bytechnicians, doctors,dentists, andveterinarians. The deviceis only intended for use inareas with nounsupervised patientaccess.	Sharps Collects areintended to be used fordisposal of contaminatedmedical sharps in healthcare facilities
Product classification	Class II	Class II
Manufacturer	GRP Associates	BD Medical SurgicalSystems
Trade Name	Container, Sharps	BD Recykleen SharpsCollector
Labeling:Biohazard labels visible ondevice	Yes	Yes
Disposal proceduresincluding in labeling	Yes	Yes
Assembly, mountingprocedures	None. Free standing on widebase	Free standing. Accessoriesavailable to bolt to wall.
Operating Instructions	Yes - IFU	Yes - IFU
Device Description:Volume:	1.5 Qt, 1 gallon, 2 gallon, and3 gallon sharps containers	8 quart and 26 gallon sharpscontainers
Materials of Construction	Blow molded HDPE	Polyolefinic resins, virginpolypropylene
Color	Red, opaque	Red, opaque
Puncture Resistance	Complies with ASTM 2132-01(2008) "Puncture Resistanceof Materials used incontainers for discardedmedical needles and otherSharps".	Complies with ASTM 2132-01 (2008) "PunctureResistance of Materialsused in containers fordiscarded medical needlesand other Sharps".
Closure	Spun-weld iris, functions asan aperture allowing verticaldrop of sharps.	Flexible aperture withlockable lid
Leakproof on sides andbottom	Conforms to CSA Z316.6-95Leak Resistance	Conforms to BS7320:1990Leakage test
Labeled or color-coded	Labeled and color coded,biohazard labeled. Seepicture above	Same - biohazard labeled
Single use or reusable	Single use	Single use
Intended Location	The container is intended tobe used in nursing homes,doctor's offices, dentaloffices, emergency room,emergency vehicles and labsfor the safe disposal ofhazardous sharps.	Intended for use in healthcare facilities
Includes features to bend,break or shear needles	No	No
Container full indication	Yes - clearly marked fill line	Yes - clearly marked fill line
Performance Standards:Container stability	Conforms to CZA Z316.6-07Topple resistance	Not available
Needle PenetrationResistance	Complies with ASTM F 2132-01	Same
Leakage	Complies with CSA CZ316.5-95 and OSHA 29CFR	Same

Table 5A – Comparison of Characteristics

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GRP and Associates Traditional 510(k) Premarket Submission GRP Sharps Containers

EMERGO OGROUP

・

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The performance testing summary demonstrates substantial equivalence between the subject and predicate devices. The GRP Sharps Containers have been tested by appropriate methods with respect to relevant FDA guidance documents, FDA recognized ASTM standard F2132-01, ISO 23907, OSHA regulations 29 CFR Part 1910:1030. No new issues of safety of effectiveness were raised from the testing performed and the GRP Sharps Containers are considered substantial equivalent to the predicate device.

9. Non-Clinical Performance Data

Performance testing demonstrates compliance with the recognized consensus standard, ASTM F 2132-01, reapproved 2008, e1, "Standard Specification for Puncture Resistance of Materials used in Collectors for Discarded Medical Needles and other Sharps". In addition, the FDA Guidance Document "Guidance on the Content and Format of Premarket Notification (510(k)) submissions for Sharps, dated October 1993, was used to help identify applicable physical and mechanical features of the subject device.

Testing was conducted in accordance with:

ASTM F 2132-01 (reapproved 2008)e. Standard Specification for Puncture . Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps.
BSI 7320:1994.4 Impact Resistance .
. ISO 23907 First edition 2012-09-01 Sharps injury protection - Requirements and test methods - Sharps containers
. CSA Z316.6-95, 3.9.2.1 -- Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste - Leak Resistance
. CSA Z316.6-07 - Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste -Container Stability
CSA Z316.6-07 Evaluation of single-use and reusable medical sharps containers for . biohazardous and cytotoxic waste - Handle Strength and Fill Capacity
. CSA Z316.6-07 – Evaluation of single-use and reusable medical sharps containers for biohazardous and cytotoxic waste -Fill Capacity

10. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device nor is clinical testing applicable to sharps containers.

11. Statement of Substantial Equivalence

· By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device.

We have demonstrated in this 510(k) submission that the difference between the GRP

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Sharps Containers and the BD Sharps Collectors do not raise any questions regarding safety or effectiveness. Performance testing and compliance with voluntary standards, demonstrate that the GRP Sharps Containers are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, performance characteristics, and intended use. The GRP Sharps Containers, as designed and manufactured, are determined to be substantially equivalent to the referenced predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is composed of three abstract, curving lines. Encircling the caduceus is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", arranged in a circular fashion.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 2, 2014

GRP and Associates c/o Mr. Robert Seiple. RAC Senior Consultant Emergo Group Suite 1400 816 Congress Avenue Austin, TX 78701

Re: K132476

Trade/Device Name: GRP Sharps Container, models 1.5Qt, 1G, 2G, and 3G Regulation Number: 21 CFR 880.5570 Regulation Name: Sharps Container Regulatory Class: II Product Code: MMK March 18, 2014 Dated: Received: March 19, 2014

Dear Mr. Seiple:

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 reclassilied 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. Seiple

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ResourcesforYou/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.

Toistari Provisio-Shoth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH

Erin I. Keith, M.S. Acting 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) K132476

Device Name GRP Sharps Container

Indications for Use (Describe)

GRP Sharps Container: GRP 1.5QT: (1.5 qt capacity)

The empty device, as it sits, is a red container that measures 4"X4"X7.5" and weighs 6oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical shares, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, dentists, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

GRP Sharps Container GRP IG:

The empty device, as it sits, is a red container that measures 9.75"X6"X9.75" and weighs 16oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Page 1 of 2

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth F. Claverie -S 2014.05.01 22:40:41 -04'00'

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This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132476

Device Name GRP Sharps Container

Indications for Use (Describe)

GRP Sharps Container GRP 2G:

The empty device, as it sits, is a red container that measures 9.75"X6"X 13.75" and weighs 11b 9oz. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, and veterinaris. The device is only intended for use in areas with no unsupervised patient access.

GRP Sharps Container GRP 3G:

The empty device, as it sits, is a red container that measures 9.75"X6"X18.75" and weighs 21bs. The opening/closure measures 2.5" in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in hospitals, clinics, operating rooms, and laboratories by technicians, doctors, and veterinarians. The device is only intended for use in areas with no unsupervised patient access.

Page 2 of 2

Type of Use (Select one or both, as applicable)

J Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Elizabeth F. Claverie -S 2014.05.01 22:44:07 -04'00'

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This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Regulation Number and Section

§ 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).