HealthBeacon HB2 Sharps Bin

K172719 · Healthbeacon, Ltd. · MMK · May 11, 2018 · General Hospital

Device Facts

• Record ID: K172719
• Device Name: HealthBeacon HB2 Sharps Bin
• Applicant: Healthbeacon, Ltd.
• Product Code: MMK · General Hospital
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Indications for Use

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 Story

Device consists of outer enclosure and replaceable, single-use inner sharps bin; used in home setting by patient. Outer enclosure features trap door for syringe deposition; electronic counter tracks number of deposited syringes. Device provides user prompts via display screen regarding injection timing and site rotation; optional text message reminders available. Usage data transmitted to cloud-based tracking database. Power supplied by IEC60601-1 certified supply. Benefits include safe sharps containment, transport, and improved patient adherence to injection schedules.

Clinical Evidence

Bench testing only. Device tested to ISO 23907:2012 for stability, handle strength, penetration resistance, closure permanence, and drop-test leakage/damage resistance. Usage counter accuracy and 5-year functional life verified through bench testing.

Technological Characteristics

Sharps bin: polypropylene (yellow body, blue lid). Enclosure: ABS plastic. Dimensions: 9.5" x 9.4" x 6.9" (enclosure). Power: IEC60601-1 certified supply. Connectivity: Cloud-based tracking database. Standards: ISO 23907:2012.

Indications for Use

Indicated for single patients in home settings for the disposal of used, contaminated medical sharps.

Regulatory Classification

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.

Predicate Devices

• Medline Sharps Container (K132767)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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 ([e-mail]) or phone [phone] 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 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.

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: [phone]

Contact Person: Joyce Power, Quality Manager Email: [e-mail]

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 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.

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 5lb, 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.

# 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 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.

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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 HB2<br>Sharps Bin<br>(K172719) | Medline Sharps<br>Container<br>(K132767) | SE Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The HealthBeacon<br>HB2 Sharps Bin is<br>intended for use by a<br>single patient in the<br>home setting. The<br>HealthBeacon HB2<br>Sharps Bin comprises<br>an outer enclosure<br>that remains in the<br>home. The outer<br>enclosure contains a<br>replaceable, single-<br>use sharps bin that is<br>intended to provide a<br>receptacle for used,<br>contaminated medical<br>sharps. The single-<br>use sharps bin also<br>acts as an enclosure<br>during transport of the<br>used sharps to<br>ultimate disposal | Medline Sharps<br>Containers are<br>intended to provide a<br>receptacle for used,<br>contaminated medical<br>sharps and act as an<br>enclosure during<br>transport to ultimate<br>disposal | Same intended use of<br>receptacle and safe<br>enclosure for sharps<br>transport.<br>HB2 is specifically<br>intended for home use. |
| Materials | Sharps bin:<br>polypropylene: Body<br>yellow, lid blue.<br>Biohazard symbol on<br>sharps bin labelling | Translucent<br>polypropylene: Body<br>red, lid white. | Sharps bin body to be<br>red or any color<br>is allowed as long as it<br>is appropriately<br>labelled with bio<br>hazard symbol |
| | Enclosure: Molded<br>ABS | Optional Enclosure:<br>ABS plastic | Same materials |
| Feature | HealthBeacon HB2<br>Sharps Bin<br>(K172719) | Medline Sharps<br>Container<br>(K132767) | SE Comparison |
| Capacities | 1 size: nominal 2.4<br>US quart (2.3 litres) | 2 sizes: nominal 1 US quart and 5 US quart | Similar, both devices<br>easily lifted. HB2 is<br>midway in capacity<br>between the Medline<br>device capacities |
| Sharps Bin<br>Dimensions | Inches: 9 x 7x 4.5<br>mm: 226 x 172 x 110 | 1 US quart:<br>Inches:3.75 x 3.75 x 6<br>mm: 95 x 95 x 153<br>5 US quart:<br>Inches: 10.4 x 4.4 x<br>9.2<br>mm: 265 x 113 x 233 | Reflects the device<br>capacities, differences<br>do not affect the safety<br>or effectiveness |
| Weight | 11 oz, (316 g) | 1 US quart: 3.78 oz,<br>107 g<br>5 US quart: 12.7oz,<br>360 g | Similar |
| Enclosure<br>Dimensions | Width: 9.5 inch (242<br>mm)<br>Depth: 9.4 inch<br>(235 mm)<br>Height: 6.9 inch (171<br>mm)<br>Weight (including<br>empty sharps bin):<br>5lb (2.3 kg) | Not applicable,<br>optional accessory | HealthBeacon HB2<br>Enclosure is part of the<br>sharps bin device |
| Fill indication | 1. Fill line on side of<br>body. Fill level<br>ascertained by<br>shadow through<br>translucent yellow<br>side wall.<br>2. Transparent inner<br>trap door enables<br>direct line of sight into<br>the top of the sharps<br>bin. | Fill line on side of<br>body. Fill level<br>ascertained by<br>shadow through<br>translucent red side<br>wall. | Items#2 &3 allow the<br>patient to have prior<br>warning of the<br>impending need for the<br>replacement of the<br>inner sharps bin,<br>without the need to<br>remove the sharps bin<br>from the enclosure for<br>inspection. Differences<br>do not affect the safety<br>or effectiveness |
| Feature | HealthBeacon HB2<br>Sharps Bin<br>(K172719) | Medline Sharps<br>Container<br>(K132767) | SE Comparison |
| | 3. Electronic counter<br>in outer enclosure<br>provides "bin nearly<br>full" and "bin full"<br>messages on the<br>enclosure display<br>screen. | | |
| Lid | Opening door in outer<br>enclosure, with<br>integral inner trap<br>door | Counter balanced lid<br>with trap door | Similar: Both have a<br>trap door arrangement |
| Access path | The HealthBeacon<br>HB2 Enclosure<br>sharps-disposal<br>aperture door has an<br>integral trap door so<br>that there is no direct<br>path into the inner<br>sharps bin. The outer<br>door has to be closed<br>to open the inner trap<br>door | Counter balanced lid<br>provides a torturous<br>path for safe disposal<br>of syringe into the<br>sharps bin | Same end effect -<br>there is no direct<br>access to the sharps<br>bin contents. |
| Lid locking for<br>transport to<br>disposal site | Sharps bin removed<br>from enclosure and<br>the sharps bin access<br>door is closed; when<br>self- locking latches<br>permanently seal the<br>sharps bin | Counter balanced lid<br>has plastic spring<br>clips to keep it closed<br>during transport | Similar: The<br>HealthBeacon HB2<br>Sharps Bin solution is<br>permanent and can<br>only be opened by<br>deliberate destruction<br>of the door |
| Standards | ISO23907:2012 | Not publicly declared | Differences do not<br>affect the safety or<br>effectiveness |

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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).