(249 days)
No
The summary mentions "software driven" and "torque limiting software," but there is no indication of AI or ML algorithms being used for tasks like image analysis, prediction, or adaptive control beyond simple torque limitation. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
The device is intended for "drilling into bone, in conjunction with cranial surgical procedures" and "high speed insertion of screws and drilling of pilot holes," which are surgical procedures, not therapeutic interventions.
No
Explanation: The device is described as "intended for drilling into bone, in conjunction with cranial surgical procedures" and for "insertion of screws and drilling of pilot holes," which are therapeutic/surgical actions, not diagnostic ones.
No
The device is a handheld, cordless, battery-operated driver with physical components (stainless steel, aluminum, etc.) and accessories (drill bits, driver stems). While it contains software for torque limiting, it is not solely software.
Based on the provided information, the PINNACLE Driver is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "drilling into bone, in conjunction with cranial surgical procedures." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes." This describes a surgical tool used for mechanical manipulation of bone.
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The PINNACLE Driver does not perform this function.
The PINNACLE Driver is a surgical instrument used in vivo (within the living body) during a surgical procedure, not in vitro (in glass, or outside the body) for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with cranial surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HBE
Device Description
The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.
The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.
The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.
The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone, cranial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician. The PINNACLE is a prescription device.
healthcare facility/hospital
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)
Biocompatibility Testing
Study Type: Biocompatibility evaluation
Sample Size: Not explicitly stated, though performed on "exposed material of the driver as worst case, based on an implant device".
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The subject devices are considered non-toxic and biocompatible.
Electrical Safety and Electromagnetic Compatibility (EMC)
Study Type: Electrical safety and EMC testing
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The system complies with the IEC 60601-1 and IEC 60086-4 standards for safety and the ES60601-1 standard for EMC. Subject device complies with requirements in the applicable standards.
Software Verification and Validation Testing
Study Type: Software verification and validation testing
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern.
Bench Testing
Study Type: Simulated Use/Design Verification Testing (DVT)
Sample Size: The cycle was repeated 99 times.
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The subject device performed as intended after the 99 cycles.
Study Type: Screw Characterization
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The data collected was used as an input into the torque limiting software.
Study Type: Sterilization Validation
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: Having met the predetermined acceptance criteria, the method outlined on the IFU was validated as an effective means of sterilizing the subject device.
Study Type: Reprocessing (Cleaning) Validation
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: Automatic cleaning was validated as an effective means of cleaning the subject device.
Study Type: Packaging & Shipping Validation
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The packaging fully contained and protected the device from exposure to normal shipping hazards and the device functioned as intended after shipment.
Study Type: Battery Safety Testing
Sample Size: Not Found
Data Source: Not Found
Annotation Protocol: Not Found
Key Results: The subject devices comply with requirements in the applicable standards.
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.
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.
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
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2017
OsteoMed Kathryn Jayne Senior Specialist, Regulatory Affairs 3885 Arapaho Road Addison, TX 75001
Re: K162542
Trade/Device Name: OsteoMed Pinnacle Driver Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, and their Accessories Regulatory Class: Class II Product Code: HBE Dated: February 14, 2017 Received: April 18, 2017
Dear Kathryn Jayne:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Michael J. Hoffmann -S
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162542
Device Name PINNACLE Driver
Indications for Use (Describe)
The PINNACLE Driver is intended for drilling into bone, in conjunction with cranial surgical procedures.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in large, bold letters. The word is in blue, and the letters are slightly slanted to the right. There is a blue swoosh above the word and a gray swoosh below the word.
510(k) SUMMARY
I. SUBMITTER
OsteoMed 3885 Arapaho Rd. Addison, TX 75001 USA
Phone: 972-677-4766 Fax: 800-390-2620 Email: kjayne@osteomed.com
Contact Person: Kathryn A. Jayne Date Prepared: May 12, 2017
II. DEVICE
Name of the Device: PINNACLE Driver Common or Usual Name: Battery-operated drill/driver Classification Name: Drill, Bone, Powered Regulation: 882.4310 Regulatory Class: II Product Code: HBE Classification Panel: Neurology
III. PREDICATE DEVICE
The OsteoMed "B" Power System, K933101, is the primary predicate. The OsteoMed OsteoPower System, K971692, is the reference predicate.
IV. DEVICE DESCRIPTION
The PINNACLE Driver is a handheld, cordless, software driven, battery operated driver for high speed insertion of screws and drilling of pilot holes. The device operates in both the forward and reverse directions. A sterile, single use battery powers the device and is intended for use solely with the PINNACLE Driver. Accessories for the PINNACLE Driver include hex shank drill bits and driver stems. The optional driver stems are reusable while the drill bits are single use. The PINNACLE Driver may be sterilized in a sterilization tray and/or rigid sterilization container, both of which are available from OsteoMed.
The PINNACLE Driver is intended for use in a healthcare facility/hospital for use by a clinician. The PINNACLE is a prescription device.
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Image /page/4/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in large, bold letters. The word is in blue, and there is a gray oval around the word. The logo is simple and modern.
The PINNACLE Driver and lithium battery is made of medical grade stainless steel, aluminum, silicone, PEEK, gold plated brass, and medical plastic. The driver stems and drill bits are made of medical grade stainless steel. The sterilization trays and rigid sterilization containers are made of aluminum.
The PINNACLE Driver is a battery operated driver/drill that operates in both the forward and reverse directions. The PINNACLE Driver contains torque limiting software to prevent over-torquing and stripping of screws in drive mode.
INDICATIONS FOR USE V.
The PINNACLE Driver is intended for driving screws and for drilling into bone, in conjunction with cranial surgical procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
At a high level, the subject and predicate devices are based on the following same technological elements as demonstrated below.
| | Subject Device—
OsteoMed PINNACLE
Driver & Accessories | Primary Predicate—
OsteoMed “B” Power
System & Accessories | Reference Predicate—
OsteoMed OsteoPower
System & Accessories |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | Pending | K933101 | K971692 |
| Regulation No. | 882.4310 | 872.4120 | 872.4120 |
| Product Code | HBE | KIJ | KMW |
| Device Class | II | Unclassified | II |
| Regulatory Panel | Neurology | Dental | Dental |
| Indications for
Use | The PINNACLE Driver is
intended for driving
screws and for drilling
into bone, in conjunction
with cranial surgical
procedures. | The OsteoMed “B” Power
Handpiece System is
intended for drilling and
cutting bone and teeth and
for driving pins, screws,
and/or wires into bone for
dental, craniofacial,
orthognathic, mandibular,
hand, foot, wrist, or
extremity reconstruction
surgical procedures. | The OsteoPower System
and Accessories are
indicated for drilling or
cutting bone or teeth, and
for driving screws and/or
pins and wires into bone,
in conjunction with
dental, craniofacial,
craniotomies,
orthognathic, spinal,
mandibular, hand, foot,
wrist, and extremity
reconstruction surgical
procedures. |
| Power Source | Battery operated
(Lithium, single patient
use) | Battery operated
(rechargeable NiCad
battery) | AC/DC External power
supply |
| Material | --Handpiece and
battery—Aluminum,
PEEK, brass, medical
grade stainless steel,
silicone | --Handpiece and
battery—stainless steel,
aluminum, brass, silver,
medical grade plastics,
fiber reinforced ceramics | --Handpiece only—
stainless steel or carbide
--Cutting portion of the
drills or burrs—stainless
steel, carbide, diamond, or
fiber reinforced ceramic |
| | Subject Device—
OsteoMed PINNACLE
Driver & Accessories | Primary Predicate—
OsteoMed “B” Power
System & Accessories | Reference Predicate—
OsteoMed OsteoPower
System & Accessories |
| | --accessories—medical
grade stainless steel,
aluminum | --accessories—medical
grade stainless steel or
carbide | --Accessories—stainless
steel, aluminum, or
medical grade plastics |
| Speed | 2,000 RPM forward
275 RPM reverse | 120-1800 RPM | 608-70,000 RPM |
| Battery | Disposable, lithium,
single use, sterile battery
(gamma) | Rechargeable Nickel
Cadmium battery | NA |
| Modes | Drill
Drive | Drill
Drive | Speed ranges SAFETY,
100%, 75%, 50%, 25%,
and Di (12.5%) of
maximum speed |
| Activation
Buttons | 1 Forward button
1 Reverse button | 1 Forward button
1 Reverse button | 1 Forward button
1 Reverse button |
| Insertion
Material | Bone | Bone | Bone |
| Screw
sizes/insertion | 1.2mm, 1.6mm, 2.0mm | 1.6mm, 2.0mm | 1.2mm, 1.6mm, 2.0mm |
| Collet | Pull-back collet | Pull-back collet | Twist collet |
| Accessories | Hex Shank drill bits, Hex
Shank driver stems,
sterilization trays, rigid
sterilization container | Round burrs, oval burrs,
twist drills, wire pass
twist drills, side cutting
burs, and end-cutting
drills, saw blades, K-
wires and pins, screw
drivers, burr racks, blade
containers, sterilization
trays, battery charger | Round burrs, oval burrs,
twist drills, wire pass
twist drills, side cutting
burrs, end-cutting drills,
saws, motor units,
modules, footswitches,
screw drivers |
| Sterilization of
re-usable devices | Pre-vacuum steam
(wrapped)—Hand piece
only
--Min. Temp: 132° C
(270°F)
--Full Cycle Time: 4
minutes
--Min Dry Time: 30
minutes
Pre-vacuum steam (rigid
container)—
1-Driver Case & 2-Driver
Case
--Min. Temp: 132° C
(270°F)
--Full Cycle Time: 4
minutes
--Min Dry Time: 30
minutes | Pre-vacuum Hi Vac
(wrapped or unwrapped)
Temp: 270-270 °F
Exposure Time: 4 min
Dry Time: min 8 min
270 °F Gravity
(wrapped on tray)
Temp: 270-270 °F
Exposure Time: 35 min
Dry Time: min 8 min | Pre-vacuum steam
(wrapped)
Temp: 132° C (270°F)
Dwell Time: 10 minutes
Dry Time: 70 minutes |
| | Subject Device—
OsteoMed PINNACLE
Driver & Accessories | Primary Predicate—
OsteoMed “B” Power
System & Accessories | Reference Predicate—
OsteoMed OsteoPower
System & Accessories |
| Parameter
Control
Technology | Software | Non-programmable,
discrete digital and analog
logic | Non-programmable,
discrete digital and analog
logic |
| Software/safety
features | -Senses torque to prevent
over-torquing & stripping
of screws | NA | Motor unit control switch
to temporarily disable the
Electric Drive |
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Image /page/5/Picture/0 description: The image shows the OsteoMed logo. The logo is in blue and white, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent a medical company.
OsteoMed PINNACLE Driver Submission K162542
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OsteoMed PINNACLE Driver Submission K162542
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the device was conducted in accordance with the FDA Blue Book Memorandum #G95-1.
- Cytotoxicity
- Sensitization
- Irritation ●
- Systemic toxicity
- Subchronic toxicity ●
- Genotoxicity ●
- Implantation
- Pyrogen testing ●
The device and associated accessories are considered tissue/bone/dentin contacting for a duration of less than 24 hours. However, OsteoMed conducted a biocompatibility evaluation of the exposed material of the driver as worst case. based on an implant device due to the close proximity to the patient. The sterilization trays and rigid containers are considered non-patient contacting.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the device. The system complies with the IEC 60601-1 and IEC 60086-4 standards for safety and the ES60601-1 standard for EMC.
Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software for this device was considered as "minor" level of concern as documented in this submission.
Bench Testing
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The following bench testing was conducted:
- Simulated Use/Design Verification Testing (DVT) ●
- Sterilization Validation
- . Reprocessing Validation
- . Shipping Validation
- . Battery Safety Testing
- Electrical Safety and Electromagnetic Compatibility .
Animal Study
No animal studies were needed to demonstrate substantial equivalence to the declared predicate.
Clinical Studies
No clinical studies were needed to demonstrate substantial equivalence to the declared predicate.
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Image /page/8/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OsteoMed" in a bold, sans-serif font. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern, and it is likely used to represent the company's brand.
Testing Summary | ||
---|---|---|
Test | Test Method Summary | Results |
Design Verification | ||
Testing (DVT) | Conducted on subject devices with | |
software and powered by single use | ||
batteries. The driver was switched | ||
to drill mode and a drill bit was | ||
used to drill a pilot hole. The mode | ||
was switched back to drive mode | ||
and a driver stem was used to fully | ||
seat a specified screw. Still in drive | ||
mode, the driver was used to | ||
remove screws. | The cycle was repeated | |
99 times and the subject | ||
device performed as | ||
intended after the 99 | ||
cycles. | ||
Screw | ||
Characterization | Released screws of various length | |
and diameter were used with the | ||
subject device. A torque analyzer | ||
was used to retrieve the data after | ||
the screw was seated or stripping | ||
noted. Torque and seat value was | ||
then calculated. | The data collected was | |
used as an input into the | ||
torque limiting software. | ||
Sterilization | ||
Validation | Sterilization validation was | |
conducted on subject devices per | ||
using overkill sterilization method | ||
validating an SAL of 10-6 per | ||
AAMI TIR12:2010. The validation | ||
was conducted using the | ||
sterilization parameters defined in | ||
IFU. The validation was conducted | ||
on individually wrapped drivers | ||
and the driver and accessories | ||
placed inside an organizational tray | ||
inside a rigid container. | Having met the | |
predetermined acceptance | ||
criteria, the method | ||
outlined on the IFU was | ||
validated as an effective | ||
means of sterilizing the | ||
subject device. | ||
Reprocessing | ||
(Cleaning) | ||
Validation | Automatic Cleaning Conducted on | |
subject devices in worst case | ||
configuration based on FDA | ||
Guidance document "Reprocessing | ||
Medical Devices in Health Care | ||
Settings: Validation Methods and | ||
Labeling" issued March 17, 2015. | ||
Worst case cleaning processing | ||
(minimum durations for the | ||
cleaning steps as defined in the | ||
IFU). Acceptance criteria was | ||
based on AAMI TIR 30. | Automatic cleaning was | |
validated as an effective | ||
means of cleaning the | ||
subject device. | ||
Test | Test Method Summary | Results |
Packaging & | ||
Shipping Validation | Shipping validation was conducted | |
on subject devices using ASTM | ||
D4169 after environmental | ||
conditioning per ASTM D4332-14. | The packaging fully | |
contained and protected | ||
the device from exposure | ||
to normal shipping | ||
hazards and the device | ||
functioned as intended | ||
after shipment. | ||
Battery Safety | ||
Testing | Conducted on subject devices per | |
IEC 60086-4 (ed.3) and Sixth | ||
Revised Edition of | ||
Recommendations on the Transport | ||
of Dangerous Goods, Manual of | ||
Tests and Criteria. | The subject devices | |
comply with requirements | ||
in the applicable | ||
standards. | ||
Biocompatibility | The biocompatibility evaluation for | |
the subject device was conducted | ||
in accordance with the FDA Blue | ||
Book Memorandum #G95-1. | The subject devices are | |
considered non-toxic and | ||
biocompatible. | ||
Electrical Safety | ||
and EMC Testing | Conducted on subject device per | |
IEC 60601-1, IEC 60086-4, and | ||
ES60601-1 | Subject device complies | |
with requirements in the | ||
applicable standards. |
T C 45
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Image /page/9/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in bold letters. The word "OSTEO" is in blue, and the word "MED" is in gray. The logo is surrounded by a gray and blue oval shape. The logo is simple and modern.
VIII. CONCLUSIONS
The basis of substantial equivalence for the device is based on similarities in indications for use, material, function, performance, design, technology, sterilizations, and operating principles. The non-clinical data support the substantial equivalence of the device and the verification and validation demonstrate that the device should perform as intended in the specified use conditions.
(End of Summary)