(245 days)
Not Found
No
The device description focuses on mechanical features, a simple electronic counter, and cloud-based tracking for compliance and reminders. There is no mention of AI or ML algorithms for analysis, prediction, or decision-making.
No.
The document describes a sharps container and its enclosure for safe disposal of contaminated medical sharps, with an electronic counter and reminder system. It is explicitly designed for containment and tracking, not for treating or diagnosing any medical condition.
No
The device is a sharps bin designed for the safe disposal and transport of contaminated medical sharps. While it includes an electronic counter and provides compliance information and reminders, its primary function is containment, not the diagnosis of a medical condition or disease.
No
The device description explicitly details physical components like an outer enclosure, inner sharps bin, plastic molding, sliding lid, and an electronics module with a power supply. While it includes software for counting and tracking, it is integrated into a hardware device.
Based on the provided information, the HealthBeacon HB2 Sharps Bin is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a receptacle for used medical sharps and facilitate their safe transport for disposal. This is a physical containment and disposal function, not a diagnostic one.
- Device Description: The device is primarily a physical container (sharps bin and enclosure) with an electronic counter and communication module for tracking usage and providing reminders. It does not perform any tests on biological samples or provide diagnostic information about a patient's health.
- Lack of Diagnostic Function: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely related to the safe handling and disposal of medical waste.
Therefore, the HealthBeacon HB2 Sharps Bin falls under the category of a medical device for waste management, not an in vitro diagnostic device.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
MMK
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.
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.
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
single patient in the home setting
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)
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.
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.
Medline Sharps Container [K132767]
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/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
1
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
2
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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3
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]
4
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.
5
- 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.
6
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
Sharps Bin
(K172719) | Medline Sharps
Container
(K132767) | SE Comparison |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 | Medline Sharps
Containers are
intended to provide a
receptacle for used,
contaminated medical
sharps and act as an
enclosure during
transport to ultimate
disposal | Same intended use of
receptacle and safe
enclosure for sharps
transport.
HB2 is specifically
intended for home use. |
| Materials | Sharps bin:
polypropylene: Body
yellow, lid blue.
Biohazard symbol on
sharps bin labelling | Translucent
polypropylene: Body
red, lid white. | Sharps bin body to be
red or any color
is allowed as long as it
is appropriately
labelled with bio
hazard symbol |
| | Enclosure: Molded
ABS | Optional Enclosure:
ABS plastic | Same materials |
| Feature | HealthBeacon HB2
Sharps Bin
(K172719) | Medline Sharps
Container
(K132767) | SE Comparison |
| Capacities | 1 size: nominal 2.4
US quart (2.3 litres) | 2 sizes: nominal 1 US quart and 5 US quart | Similar, both devices
easily lifted. HB2 is
midway in capacity
between the Medline
device capacities |
| Sharps Bin
Dimensions | Inches: 9 x 7x 4.5
mm: 226 x 172 x 110 | 1 US quart:
Inches:3.75 x 3.75 x 6
mm: 95 x 95 x 153
5 US quart:
Inches: 10.4 x 4.4 x
9.2
mm: 265 x 113 x 233 | Reflects the device
capacities, differences
do not affect the safety
or effectiveness |
| Weight | 11 oz, (316 g) | 1 US quart: 3.78 oz,
107 g
5 US quart: 12.7oz,
360 g | Similar |
| Enclosure
Dimensions | Width: 9.5 inch (242
mm)
Depth: 9.4 inch
(235 mm)
Height: 6.9 inch (171
mm)
Weight (including
empty sharps bin):
5lb (2.3 kg) | Not applicable,
optional accessory | HealthBeacon HB2
Enclosure is part of the
sharps bin device |
| Fill indication | 1. Fill line on side of
body. Fill level
ascertained by
shadow through
translucent yellow
side wall.
2. Transparent inner
trap door enables
direct line of sight into
the top of the sharps
bin. | Fill line on side of
body. Fill level
ascertained by
shadow through
translucent red side
wall. | Items#2 &3 allow the
patient to have prior
warning of the
impending need for the
replacement of the
inner sharps bin,
without the need to
remove the sharps bin
from the enclosure for
inspection. Differences
do not affect the safety
or effectiveness |
| Feature | HealthBeacon HB2
Sharps Bin
(K172719) | Medline Sharps
Container
(K132767) | SE Comparison |
| | 3. Electronic counter
in outer enclosure
provides "bin nearly
full" and "bin full"
messages on the
enclosure display
screen. | | |
| Lid | Opening door in outer
enclosure, with
integral inner trap
door | Counter balanced lid
with trap door | Similar: Both have a
trap door arrangement |
| Access path | The HealthBeacon
HB2 Enclosure
sharps-disposal
aperture door has an
integral trap door so
that there is no direct
path into the inner
sharps bin. The outer
door has to be closed
to open the inner trap
door | Counter balanced lid
provides a torturous
path for safe disposal
of syringe into the
sharps bin | Same end effect -
there is no direct
access to the sharps
bin contents. |
| Lid locking for
transport to
disposal site | Sharps bin removed
from enclosure and
the sharps bin access
door is closed; when
self- locking latches
permanently seal the
sharps bin | Counter balanced lid
has plastic spring
clips to keep it closed
during transport | Similar: The
HealthBeacon HB2
Sharps Bin solution is
permanent and can
only be opened by
deliberate destruction
of the door |
| Standards | ISO23907:2012 | Not publicly declared | Differences do not
affect the safety or
effectiveness |
7
8
9
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).