(405 days)
No
The description focuses on Resonance Frequency Analysis and calculating ISQ from a physical measurement, with no mention of AI or ML terms or concepts.
No
The device is used for measuring implant stability, not for treating a disease or condition.
Yes
The device measures and displays the Implant Stability Quotient (ISQ), which is a diagnostic indicator (measure of implant stability) derived from the resonance frequency value. It is used by professional clinicians to assess the stability of implants.
No
The device description clearly states it is a "portable, handheld instrument" and involves a "measurement tip on the handheld instrument" that interacts with a "Smartpeg" attached to the implant. This indicates the device includes physical hardware components beyond just software.
Based on the provided information, the Osstell Beacon is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health status.
- Osstell Beacon's Function: The Osstell Beacon directly measures the stability of an implant in situ within the patient's oral cavity or maxillofacial region. It does not analyze a specimen taken from the body.
- Measurement Method: It uses a non-invasive technique (Resonance Frequency Analysis) applied directly to the implant and a connected component (Smartpeg).
Therefore, the Osstell Beacon falls under the category of a medical device used for direct measurement within the body, not an IVD.
N/A
Intended Use / Indications for Use
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Product codes
EKX
Device Description
The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the implant and is derived from the resonance frequency value obtained from the Smartpeg.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity and maxillofacial region.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional clinicians / Dental practice or operating room.
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)
Clinical studies were not required to validate the modifications in the Osstell Beacon. Based on the Risk Analysis, the verification and validation testing confirms the Beacon performs as intended. The Osstell Beacon was subjected to the same preclinical requirements and testing as the primary predicate device. Additionally, cleaning and disinfection recommendations were validated in the event the Osstell Beacon should become contaminated due to a damaged barrier sleeve. Performance testing was conducted to confirm compliance to the design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Osstell ISQ (K082523)
Reference Device(s)
Tellos ISO Buddy (K143445), Implantmed SI-1015 (K161957)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2019
Osstell AB % Cherita James Regulatory Consultant M Squared Associates, Inc 575 8th Ave Suite 1212 New York, NY 10018
Re: K181888
Trade/Device Name: Osstell Beacon Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: July 23, 2019 Received: July 24, 2019
Dear Cherita James:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181888
Device Name Osstell Beacon
Indications for Use (Describe)
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
510(k) Summary
The following information is provided as required by 21 CFR § 807.87 for the Osstell Beacon 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.
| Sponsor: | Osstell AB
Stampgatan 14
411 01 Goteborg
Sweden |
| ----------------- | ----------------------------------------------------------------- |
|---|
Contact: Cherita James M Squared Associates, Inc. 575 8th Ave, Suite 1212 New York, New York 10018 Ph. 347-954-0624 Fax. 703-562-9797 CJames@MSquaredAssociates.com
| Revision Date: | August 19, 2019 |
|---|---|
| Proprietary Name: | Osstell Beacon |
| Common Name: | Dental implant stability analyzer |
| Regulatory Class: | Class 1 |
| Regulation: | 872.4200 |
| Product Codes: | EKX - handpiece, direct drive, ac-powered |
| Predicate Device: | Osstell ISQ (K082523)-Primary |
| Tellos ISO Buddy (K143445) and Implantmed SI-1015 (K161957)- Reference |
Device Description:
The Osstell Beacon is a modification of the Osstell ISQ (K082523). The system is designed to measure implant stability in the oral cavity and maxillofacial region. Similar to K082523, the Osstell Beacon is a portable, handheld instrument that involves the use of the noninvasive technique, Resonance Frequency Analysis. The system involves the use of a Smartpeg (aluminum rod) attached to the implant by means of a screw. The Smartpeg is excited by a magnetic pulse from the measurement tip on the handheld instrument. The resonance frequency, which is the measure of implant stability, is calculated from the response signal. Results are displayed as the Implant Stability Quotient (ISQ). The ISQ is a measurement of the implant and is
4
K181888
derived from the resonance frequency value obtained from the Smartpeg.
Intended Use:
Osstell Beacon is intended for use as a Dental Implant Stability Analyzer
Indications for Use:
Osstell Beacon is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Summary of the Technological Characteristics:
The modifications to the Osstell ISQ since its previous clearance in K082523 include the following changes:
- . Enclosure design is smaller to be fully handheld. The measurement probe with tip is integrated into the enclosure and referred to as the measurement tip
- . Not possible to sterilize (autoclave). The device must be used with a transparent barrier sleeve. Commercially available transparent, barrier sleeves are recommended in the Instructions for Use.
- Different plastic material used in the enclosure (all being food grade compliant, 21 CFR §181.32 and 21 CFR §177.1580)
- . Updated user interface to make the measurement procedure even more easy and intuitive
- The device cannot measure while charging
- Bluetooth data communication .
These differences do not affect the substantial equivalence or performance of the device and do not change the intended use of the Osstell Beacon.
5
K181888
Summary of the Nonclinical Testing:
Based on the Risk Analysis, the verification and validation testing confirms the Beacon performs as intended. The Osstell Beacon was subjected to the same preclinical requirements and testing as the primary predicate device.
Though the recommendation require use of a transparent barrier sleeve, due to material changes, the device was evaluated in accordance with ISO 10993-1.
Additionally, cleaning and disinfection recommendations were validated in the event the Osstell Beacon should become contaminated due to a damaged barrier sleeve.
Performance testing was conducted to confirm compliance to the design specifications.
Osstell has provided information to support compliance of Beacon with applicable portions of the following standards and FDA Guidance documents:
- FDA Dental Handpieces Premarket Notification [510(k)] Submissions, 2007 ●
- . FDA Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, 2005
- . ISO 10993-1
- . ISO 10993-5
- . AAMI TIR12:2010
- AAMI TIR30:2011
- . ASTM E1837-96 (2014)
- ISO 17665-1
- ISO 17664
- IEC 60601-1, Ed 3 2005 ●
- . IEC 60601-1-2:2015
- . IEC 62133
Substantial Equivalence Discussion:
The changes to the enclosure, no longer capable to withstand sterilization and instead use of barrier sleeves, electronics, user interface and communication do not change the intended use, nor do they affect the substantial equivalence as compared to the Osstell ISQ previously cleared in
6
K082523.
| | Osstell
Beacon | Predicate
Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K# | To be assigned | K082523 | K143445 | K161957 | |
| Device name | Osstell Beacon | Osstell® ISQ | Tellos ISQ
Buddy
(marketed as
Penquin RFD) | Implantmed SI-1015
incl. Accessories | - |
| Company name | Osstell AB | Osstell AB | Tellos Medical
AB | W & H
DENTALWERK
BÜRMOOS GMBH | |
| Classification | Class I | Same | Same | Same | - |
| Regulation
Number | 872.4200 | Same | Same | Same | - |
| Classification
name | Handpiece,
Direct Drive,
AC-powered | Same | Same | Same | - |
| Intended Use | Dental implant
stability
analyzer | Same | Same | Mechanical drive for
dental instruments
with ISQ module
used to measure
implant stability. | Same |
| Indication for
use | Indicated for use
in measuring the
stability of
implants in the
oral cavity and
maxillofacial
region. | Indicated for use
in measuring the
stability of
implants in the
oral cavity and
craniofacial
region. | Indicated for use
in measuring the
stability of
dental implants
in the oral
cavity and the
maxillofacial
region. | Mechanical drive unit
with coolant supply
for transmission
instruments
with ISO 3964
(DIN13940)
compatible coupling
system, for use in
dental surgery,
implantology and
maxillofacial surgery
(CMF) for treatment
of dental hard tissue.
Includes ISQ module
used to measure
implant stability. | Subject, primary
predicate, and
K143445
reference device
are identical.
K161957
reference device
used for
Bluetooth
technology has a
different
indication,
however the
comparison is
only for
Bluetooth
technology and
does not have
specific
indications for
this technology |
| Description | Portable,
handheld
battery driven
instrument
indicated for use
in measuring the
stability of
implants in the
oral cavity and
maxillofacial
region. | Portable,
handheld, or
freestanding
instrument
indicated for use
in measuring the
stability of
implants in the
oral cavity and
craniofacial
region. | Hand-held.
battery-driven
device for
measuring the
relative stability
of a dental
implant. | - the control unit.
- a motor with cable
with or without light
(EM-19 LC/EM-19), - a wireless or wired
foot control (S-NW
or S-N2). - the Osstell Module
(SI-SQ) - and as an attachment
the surgical
handpieces | All are portable
handheld
devices, the
change in
configuration
compared to ISQ
which
incorporates the
device controls
and displays into
a single handheld
does not impact
the substantial |
| | Osstell
Beacon | Predicate
Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence |
| | | | | - (WS-56 L, WS-75
L, WS-91 L, WS-92
L and S-11 L).
The user can select
five different
programs. Switching
between
these programs is
performed by foot
control or via touch
display. | the device.
ISQ Buddy is
also portable,
handheld and
Implantmed uses
a wireless foot
pedal via
Bluetooth
technology.
Verification of
the Beacon
confirms it
performs as
intended. |
| Operation of
System | Measures the
frequency
response from
Smartpeg that is
directly attached
to the implant or
abutment. The
system includes
the following
components:
Instrument,
Osstell
Smartpeg,
Osstell
SmartPeg
Mount, Osstell
USB cable,
Osstell TestPeg
The technique
involves a
SmartPeg (10
mm x 3 mm)
that is attached
to the implant or
abutment. The
SmartPeg is
excited over a
range of
frequencies (1
kHz to 10 kHz)
and the
resonance
frequency is
measured with
the Osstell
Beacon
instrument and
software. The
resonance
frequency is | Measures the
frequency
response from
Smartpeg that is
directly attached
to the implant or
abutment. The
system includes
the following
components:
Instrument,
Osstell SmartPeg,
Osstell
Measurement
Probe, Osstell
SmartPeg Mount,
Osstell USB
Cable, Osstell
TestPeg
Same technique is
used in operating
the system as the
Osstell Beacon
device. | A
microcontroller
sends electric
pulses to a coil
in the
instrument tip.
As a
consequence,
magnetic pulses
are emitted that
affect the pin
connected to the
implant. The pin
then starts to
vibrate with its
resonance
frequency.
Vibration
creates an
alternating
magnetic field
which is being
picked up by
another coil in
the instrument
tip. The
electrical signal
from the
receiving coil is
analyzed and
the frequency is
determined. The
Frequency is
presented on the
display as an
"ISQ- value"
Resonance
frequency of the
ISQ peg as an
ISQ number, 1- | Referenced specific
to wireless foot pedal;
however, devices
include a ISQ module
used to measure
implant stability. | There is no
difference in the
system operation
between the
subject device
and K082523 or
K143445. |
| | Osstell
Beacon | Predicate Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence |
| | the stiffness of
the implant
system. The
Osstell Beacon
presents the
resonance
frequency as an
Implant
Stability
Quotient (ISQ)
value (scaled 0-
100). The ISQ
value is
proportional to
the stability of
the implant.
(In general, an
increase in ISQ
value from one
measurement
time to the next
indicates a
progression
towards higher
stability and a
lower ISQ value
may indicate a
loss in stability
and perhaps,
implant failure.)
Bluetooth
functionality for
device
production | number is
calculated from
the resonance
frequency. | | | |
| | purposes only | | | | |
| System
Components | Instrument
A portable,
handheld
instrument with
2 built-in
graphical
displays. The
unit operates
from a
rechargeable
power source
offering more
than 400 ISQ
measurements
between
charges.
The size of the
displays is 14 x
11 mm. | Instrument
A portable,
handheld, or
freestanding
instrument with
built-in graphical
display. The unit
operates from a
rechargeable
power source
offering over 6
hours of
continuous use
between charges.
The size of the
LCD display is 69
x 37 mm
The instrument
can be connected
to a PC via the
USB cable and the | Tellos ISQ
Buddy
instrument, ISQ
Peg, ISQ Peg
Driver and
instrument
charger.
Tellos ISQ
Buddy has two
LED-displays;
one on each side
of the
instrument for
easy reading.
Tellos ISQ
Buddy uses the
Osstell
SmartPegs, or
corresponding
Tellos pins, | - the control unit,
- a motor with cable
with or without light
(EM-19 LC/EM-19), - a wireless or wired
foot control (S-NW
or S-N2), - the Osstell Module
(SI-SQ) - and as an
attachment the
surgical handpieces - (WS-56 L, WS-75
L, WS-91 L, WS-92
L and S-11 L). | The change in
configuration and
components from
the ISQ which
incorporates the
device controls
and displays into
a single handheld
for the Beacon
does not impact
the substantial
equivalence of
the device.
Tellos ISQ
Buddy also is
portable,
handheld device
with LED
displays, and
employs
"SmartPegs or |
| Osstell
Beacon | Predicate
Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence | |
| The
measurement tip | can be transferred
to the optional | "ISQ Pegs"
from titanium. | | ISQ Pegs. The
Implantmed SI | |
| is held close to
the Smartpeg.
The | ISQ Data Manager
Software. | | | device, is
referenced
specific to | |
| measurement
electronics
sends the
excitation signal | Measurement
Probe with tip
The Measurement
Probe is connected | | | wireless foot
pedal, which also
utilizes Bluetooth
software | |
| to the coils in
the tip, and also | to the instrument
via the probe | | | functionality.. | |
| detects the
response signal
from the
detection coil in | cable and is held
close to the
Smartpeg. The
measurement | | | Verification of
the Beacon
confirms it | |
| the tip. The
microcontroller
in the | electronics sends
the excitation
signal to the coil | | | performs as
intended. | |
| instrument
calculates the
frequency of the | in the probe with
tip, and also
detects the | | | | |
| response signal,
and presents it
on the display | response signal
from the detection
coil in the probe | | | | |
| as a number, the
Implant
Stability | with tip. The
microcontroller in
the instrument | | | | |
| Quotient (ISQ).
Smartpeg | calculates the
frequency of the
response signal, | | | | |
| The stability of
the implant is
reflected by the | and presents it on
the display as a
number, the | | | | |
| resonance
frequency of the
"Smartpeg" | Implant Stability
Index (ISQ).
The measurement | | | | |
| attached to the
implant. The
Smartpeg is a | probe has fixed
cable. | | | | |
| small aluminum
rod,
approximately 3 | Smartpeg
Same- No change
to the Smartpeg | | | | |
| mm in diameter
and 10 mm
long, with a | Data
communication | | | | |
| magnet
permanently
attached to its | The Osstell ISQ
Data Manager is a
Windows | | | | |
| top. The
Smartpeg is
screwed onto | 2000/NT/XP/Vista
based software
enabling storage, | | | | |
| the implant.
The Smartpeg
magnet is | viewing and
printing of
measured data. | | | | |
| excited by a
small magnetic
pulse generated | The Software is an
optional accessory
to the Osstell ISQ | | | | |
| by a coil in the | and is not integral | | | | |
| | Osstell
Beacon | Predicate
Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence |
| Power, Weight
and Size | measurement
tip. The
Smartpeg
vibrates freely
at the resonance
frequency for
some
milliseconds.
By means of the
magnet, the
vibration (the
"ringing") can
be picked up by
a second coil in
the instrument
tip.
Bluetooth
communication
The Osstell
Beacon contains
a built in
Bluetooth 4.0
low energy
module device
for production
purposes only.
Power source:
Lithium-ion cell | to the clinical
functioning of the
device.
Power source:
Lithium-ion cell | Re-chargeable
NiMh-batteries | Main dimension:
154x202x210 | Minor
differences in
power, weight
and size do not
affect the
performance of
the Beacon when
compared to the
Osstell ISQ.
ISQ Buddy is
also portable,
handheld. The
Implantmed
device is only
referenced for its
use of a
Bluetooth
wireless foot
pedal. |
| | (3.7V, 0.8 Ah)
Instrument Size:
210 x 35 x 25
mm
Instrument
Weight: 0.07kg
Accuracy: ±2
ISQ units | (3.7V, 2.2 Ah)
Instrument Size:
190 x 120 x 45
mm
Instrument
Weight: 0.4 kg
Accuracy: ±2 ISQ
units | | Features:
4 buttons for pump
on/off
Forward/reverse
Change programs
Motor control (on/off
and variable)
Power supply:
wireless
via 3xAA batteries | |
| Instrument
materials | ABS and PC
Plastic | ABS and PC
plastic | PC/ABS | N/A: Only
referenced specific to
wireless foot pedal. | No change. |
| Probe TIP
materials | ABS Plastic | Probe: PPSU,
stainless steel
Cable: silicone
Cable connector:
Natural
polyestersulfone | PEEK | N/A: Only
referenced specific to
wireless foot pedal. | Materials do not
effect the device
performance.
Beacon performs
as intended. |
| | Osstell
Beacon | Predicate
Device: Osstell
ISQ | Reference
Device:
Tellos ISQ
Buddy | Reference Device:
Implantmed SI-
1015 incl.
Accessories | Substantial
Equivalence |
| Device Display | 2 pcs OLED -
displays 14 x 11
mm | LCD - 69x 37-
mm | LED | N/A: Only
referenced specific to
wireless foot pedal. | Beacon display
meets the
requirements of
the end user and
is same as ISQ
Buddy. |
| Software Testing
and Validation | System and
software
verification and
validation
performed. | Same | Unknown | For the new wireless
foot control (S-NW)
software
verification/validation
of the functions of the
foot control was
conducted according
to IEC 62304:2006. | No change in
software required
for the
configuration
changes. |
| Mechanical/
Electrical safety
/Standards | The Osstell
Beacon is
designed and
manufactured
with applicable
standards:
IEC 60601-1
IEC 60601-1-2
IEC 62133 | Same | Same | EMC testing was
performed to evaluate
the risk of
communication
loss according to IEC
60601-1-2:2007 and
Electrical Safety
Tests done according
to IEC 60601-1-
1:2005. | All devices
substantially
equivalent for
intended use |
| Sterile
components/
methods | Instrument not
sterile and
cannot be
autoclaved/Must
use a
transparent,
barrier sleeve
SmartPeg
/single patient
use | Probe with cable
/autoclave
SmartPeg /single
patient use | Instrument not
sterile and
cannot be
autoclaved/Must
use a
transparent,
barrier sleeve
ISQ Peg/re-
sterilized | Surgical Handpieces | Transparent
barrier use in the
Beacon ensure no
cross
contamination
between patients. |
| Instrument
Cleaning and
Disinfection | Intended for use
with transparent
barrier ensure
no cross
contamination
between
patients.
Validated
cleaning and
HLD in the
event of barrier
damage. | Patient contacting
probe sterilizable | Intended for use
with transparent
barrier ensure
no cross
contamination
between
patients. | Cleaning: rinse under
demineralized
water (