The HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal.

Device Description

The HealthBeacon HB2 Sharps Bin device is the combination of the:

. Outer Enclosure, which remains in the home, and
The single use Inner Sharps Bin, which is disposed of, once full. .

The HealthBeacon HB2 Sharps Bin comprises:

A custom-shaped sharps bin molded in puncture-resistant polypropylene . plastic.
. An integral sliding and permanently locking lid to close over after use and prior to dispatch to the destruction facility.
A custom enclosure (the "HealthBeacon HB2 enclosure") for the sharps bin. ● The HealthBeacon HB2 Enclosure provides:
- o A neutral and attractive cover for the sharps bin whilst it is being used in a domestic environment.
- o A double trap door access path to the sharps bin to prevent fingeraccess to the sharps bin and its contents of used syringes while in the Enclosure with the side door closed.
o A counter of syringes being deposited that will give the user a warning when the sharps bin is getting close to full.

The HealthBeacon HB2 Sharps Bin is molded from 2mm (0.08 inch) polypropylene in 3 snap-together sections. The sharps bin door is a sliding door that once fully closed, locks and cannot be re-opened. The HealthBeacon HB2 Enclosure is a neutrally colored enclosure for the sharps bin. The enclosure is molded from ABS plastic and has interlocks so that the sharps bin can only be fitted in the correct orientation within the enclosure. The enclosure door flap lines up with the sharps bin opening, and there is a spring-loaded trap-door within the enclosure that prevents direct access into the sharps bin itself.

The HealthBeacon HB2 Enclosure has a small electronics module to count and record the used hypodermic syringes being deposited. The usage information is passed to a cloud-based tracking database to provide compliance information. The tracking database also provides prompts to the user on a display screen in the HealthBeacon HB2 Enclosure. The prompts inform the user when the next selfadministered injection is due and the injection site to be used, so that they are rotated in time and thus lower the chance of adverse reactions. The patient can also elect to have text message reminders sent their cell phone.

The HealthBeacon HB2 Enclosure is powered by a Medical Device Certified (to IEC60601-1) power supply. This supplies electrical power for the small electronic counter unit.

AI/ML Overview

The provided FDA 510(k) summary (K172719) for the HealthBeacon HB2 Sharps Bin describes acceptance criteria through compliance with a consensus standard and specific performance tests. The document, however, does not contain information related to AI or machine learning models. Therefore, many of the requested fields regarding AI model testing (like expert adjudication, MRMC studies, standalone performance, training set details) are not applicable.

Here's the information based on the provided document:

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Set by Standard/Test)	Reported Device Performance
ISO 23907:2012 Requirements:	Passed:
- Stability	- Passed
- Strength of the handles	- Passed
- Resistance to penetration	- Passed
- Permanence of the final closure	- Passed
- Resistance to damage and leakage after dropping	- Passed
Usage Counter Accuracy:	Passed:
- Accurately count syringes regardless of size	- Will accurately count syringes regardless of size
- Mechanism functional for 5-year device life	- Remains functional for 5 years

Explanation of Missing Information due to Device Type:

The HealthBeacon HB2 Sharps Bin is a physical medical device (a sharps container), not a software or AI-powered diagnostic/analytic tool. As such, the concept of "ground truth," "test sets," "training sets," "experts for ground truth," "adjudication," and "AI assistance" in the context of diagnostic accuracy, which are typical for AI/ML-based medical devices, do not apply to this submission. The "study" here refers to the physical and functional testing of the sharps bin.

Here's a breakdown of the remaining points, indicating N/A where not applicable to this physical device:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated in terms of a "test set" for diagnostic accuracy. The testing was done on the physical device itself (likely multiple units, but not quantified as a "sample size" in the AI/ML sense).
Data Provenance: N/A for data provenance for diagnostic accuracy. The testing was conducted by an "independent testing laboratory" on the physical product to ISO standards.

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

N/A: No expert review for diagnostic ground truth is applicable for this physical device. The "ground truth" here is the physical performance against engineering standards.

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

N/A: No adjudication method for diagnostic performance is applicable.

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

No: This is a physical device, so no MRMC study involving human readers or AI assistance was performed.

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

N/A: This is a physical device; there is no algorithm or standalone performance in the AI/ML context. The closest analogy might be the usage counter working automatically (standalone) without human intervention, which was tested for accuracy.

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

Engineering Standards/Physical Performance: The "ground truth" for this device's performance is adherence to the requirements of the ISO 23907:2012 standard and accurate counting functionality, as determined by laboratory testing.

8. The sample size for the training set

N/A: There is no training set for an AI/ML model for this device.

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

N/A: There is no training set for an AI/ML model for this device.

Summary

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May 11, 2018

HealthBeacon Ltd Joyce Power Quality Manager Unit 20, Naas Road Business Park, Muirfield Drive Dublin 12 Ireland

Re: K172719

Trade/Device Name: HealthBeacon HB2 Sharps Bin Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: MMK Dated: April 3, 2018 Received: April 4, 2018

Dear Joyce Power:

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 of medical device-related adverse events) (21 CFR 803); good

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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.

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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. 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) K172719

Device Name

HealthBeacon HB2 Sharps Bin

Indications for Use (Describe)

The HealthBeacon HB2 Sharps Bin outer enclosure is a neutral gray color body with duck egg sides. The approximate dimensions are: width 9.5 inches by depth 9.4 inches and height 6.9 inches, with a weight of 51b, including an empty sharps bin.

The inner, single-use sharps bin has a yellow semi-translucent body with a blue lid. The approximate dimensions of the bin are: width 9 inches by depth 7 inches and height of 4.5 inches. The gross volume is 2.4 US quarts, with an empty weight of 11oz.

The outer enclosure has a trap door to allow the used sharps to be deposited into the inner sharps bin. The aperture of the trap door, and thus the maximum size of a used sharp, is 6.5 by 1 inches.

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) SUMMARY - K172719

HealthBeacon HB2 Sharps Bin

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

HealthBeacon Ltd Unit 20 Naas Road Business Park Muirfield Drive Dublin 12 Ireland

Phone: +353 1 450 8480

Contact Person: Joyce Power, Quality Manager Email: joyce@healthbeacon.com

Date Prepared: 04 May 2018

Name of Device

HealthBeacon HB2 Sharps Bin.

Common or Usual Name

Sharps bin

Classification Name/Product Code/CFR Reference

Class II, Accessory to hypodermic single lumen needle, 21 CFR 880.5570

Product Code: MMK

Predicate Device

Medline Sharps Container [K132767]

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Intended Use / Indications for Use

The outer enclosure has a trap door to allow the used sharps to be deposited into the inner sharps bin. The aperture of the trap door, and thus the maximum size of a used sharp, is 6.5 by 1 inches.

Device Description

The HealthBeacon HB2 Sharps Bin device is the combination of the:

. Outer Enclosure, which remains in the home, and
The single use Inner Sharps Bin, which is disposed of, once full. .

The HealthBeacon HB2 Sharps Bin comprises:

A custom-shaped sharps bin molded in puncture-resistant polypropylene . plastic.
. An integral sliding and permanently locking lid to close over after use and prior to dispatch to the destruction facility.
A custom enclosure (the "HealthBeacon HB2 enclosure") for the sharps bin. ● The HealthBeacon HB2 Enclosure provides:
- o A neutral and attractive cover for the sharps bin whilst it is being used in a domestic environment.
- o A double trap door access path to the sharps bin to prevent fingeraccess to the sharps bin and its contents of used syringes while in the Enclosure with the side door closed.

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o A counter of syringes being deposited that will give the user a warning when the sharps bin is getting close to full.
The HealthBeacon HB2 Sharps Bin is molded from 2mm (0.08 inch) polypropylene in 3 snap-together sections. The sharps bin door is a sliding door that once fully closed, locks and cannot be re-opened. The HealthBeacon HB2 Enclosure is a neutrally colored enclosure for the sharps bin. The enclosure is molded from ABS plastic and has interlocks so that the sharps bin can only be fitted in the correct orientation within the enclosure. The enclosure door flap lines up with the sharps bin opening, and there is a spring-loaded trap-door within the enclosure that prevents direct access into the sharps bin itself.

The HealthBeacon HB2 Enclosure is powered by a Medical Device Certified (to IEC60601-1) power supply. This supplies electrical power for the small electronic counter unit.

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Comparison of Technological Characteristics

The HealthBeacon HB2 Sharps Bin has the same intended use, technological characteristics, and principles of operation as its predicate device. The minor implementation differences between the HealthBeacon HB2 Sharps Bin and its predicate device raise no new issues of safety or effectiveness.

Feature	HealthBeacon HB2Sharps Bin(K172719)	Medline SharpsContainer(K132767)	SE Comparison
Intended use	The HealthBeaconHB2 Sharps Bin isintended for use by asingle patient in thehome setting. TheHealthBeacon HB2Sharps Bin comprisesan outer enclosurethat remains in thehome. The outerenclosure contains areplaceable, single-use sharps bin that isintended to provide areceptacle for used,contaminated medicalsharps. The single-use sharps bin alsoacts as an enclosureduring transport of theused sharps toultimate disposal	Medline SharpsContainers areintended to provide areceptacle for used,contaminated medicalsharps and act as anenclosure duringtransport to ultimatedisposal	Same intended use ofreceptacle and safeenclosure for sharpstransport.HB2 is specificallyintended for home use.
Materials	Sharps bin:polypropylene: Bodyyellow, lid blue.Biohazard symbol onsharps bin labelling	Translucentpolypropylene: Bodyred, lid white.	Sharps bin body to bered or any coloris allowed as long as itis appropriatelylabelled with biohazard symbol
	Enclosure: MoldedABS	Optional Enclosure:ABS plastic	Same materials
Feature	HealthBeacon HB2Sharps Bin(K172719)	Medline SharpsContainer(K132767)	SE Comparison
Capacities	1 size: nominal 2.4US quart (2.3 litres)	2 sizes: nominal 1 US quart and 5 US quart	Similar, both deviceseasily lifted. HB2 ismidway in capacitybetween the Medlinedevice capacities
Sharps BinDimensions	Inches: 9 x 7x 4.5mm: 226 x 172 x 110	1 US quart:Inches:3.75 x 3.75 x 6mm: 95 x 95 x 1535 US quart:Inches: 10.4 x 4.4 x9.2mm: 265 x 113 x 233	Reflects the devicecapacities, differencesdo not affect the safetyor effectiveness
Weight	11 oz, (316 g)	1 US quart: 3.78 oz,107 g5 US quart: 12.7oz,360 g	Similar
EnclosureDimensions	Width: 9.5 inch (242mm)Depth: 9.4 inch(235 mm)Height: 6.9 inch (171mm)Weight (includingempty sharps bin):5lb (2.3 kg)	Not applicable,optional accessory	HealthBeacon HB2Enclosure is part of thesharps bin device
Fill indication	1. Fill line on side ofbody. Fill levelascertained byshadow throughtranslucent yellowside wall.2. Transparent innertrap door enablesdirect line of sight intothe top of the sharpsbin.	Fill line on side ofbody. Fill levelascertained byshadow throughtranslucent red sidewall.	Items#2 &3 allow thepatient to have priorwarning of theimpending need for thereplacement of theinner sharps bin,without the need toremove the sharps binfrom the enclosure forinspection. Differencesdo not affect the safetyor effectiveness
Feature	HealthBeacon HB2Sharps Bin(K172719)	Medline SharpsContainer(K132767)	SE Comparison
	3. Electronic counterin outer enclosureprovides "bin nearlyfull" and "bin full"messages on theenclosure displayscreen.
Lid	Opening door in outerenclosure, withintegral inner trapdoor	Counter balanced lidwith trap door	Similar: Both have atrap door arrangement
Access path	The HealthBeaconHB2 Enclosuresharps-disposalaperture door has anintegral trap door sothat there is no directpath into the innersharps bin. The outerdoor has to be closedto open the inner trapdoor	Counter balanced lidprovides a torturouspath for safe disposalof syringe into thesharps bin	Same end effect -there is no directaccess to the sharpsbin contents.
Lid locking fortransport todisposal site	Sharps bin removedfrom enclosure andthe sharps bin accessdoor is closed; whenself- locking latchespermanently seal thesharps bin	Counter balanced lidhas plastic springclips to keep it closedduring transport	Similar: TheHealthBeacon HB2Sharps Bin solution ispermanent and canonly be opened bydeliberate destructionof the door
Standards	ISO23907:2012	Not publicly declared	Differences do notaffect the safety oreffectiveness

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Summary of Performance Testing

Compliance to Consensus Standards

The HealthBeacon HB2 Sharps Bin has been tested to ISO 23907:2012 by an independent testing laboratory and passed all the ISO test requirements for:

. Stability
Strength of the handles .
. Resistance to penetration
Permanence of the final closure, and ●
Resistance to damage and leakage after dropping.

Usage Counter

The used syringe counter system has been tested to prove that it will accurately count the number of syringes deposited, no matter what the size of syringe and that the mechanism remains functional for the device life of 5 years.

Substantial Equivalence - Conclusion

Based on the intended use, technological characteristics, performance data, and nonclinical tests performed, the HealthBeacon HB2 Sharps Bin is substantially equivalent to and is as safe and as effective as the legally marketed predicate device, Medline Sharps Container (K132767).

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).

Acceptance Criteria and Reported Device Performance

Explanation of Missing Information due to Device Type:

Geeta K. Pamidimukkala -S

Indications for Use

Device Name

Indications for Use (Describe)

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510(k) SUMMARY - K172719

HealthBeacon HB2 Sharps Bin

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Name of Device

Common or Usual Name

Classification Name/Product Code/CFR Reference

Predicate Device

Intended Use / Indications for Use

Device Description

Comparison of Technological Characteristics

Summary of Performance Testing

Compliance to Consensus Standards

Usage Counter

Substantial Equivalence - Conclusion

§ 880.5570 Hypodermic single lumen needle.

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