(26 days)
Not Found
Not Found
No
The description focuses on mechanical and electrical controls, redundant circuitry, and simplified software based on switches and fixed rate settings. There is no mention of learning, adaptation, or complex data processing characteristic of AI/ML.
No
The description indicates the device is used for movement of a telescoping rod and features like "distraction is progressing," and a predicate device "CF Automator". The reference to "distraction" often suggests medical applications like bone distraction, which would make the device therapeutic. However, without explicit "intended use" or "indications for use" information, directly stating it's a therapeutic device is an assumption. The device could also be used for industrial or other non-medical applications that involve precise movements. However given the term "distraction," it is most likely a medical device, which would mean it's therapeutic in nature. The problem is with the word "therapeutic". Since the device moves a "telescoping rod" and it is said that "distraction is progressing" it could be connected to bone distraction. But this detail cannot confirm it directly as a "therapeutic device" as we are not provided the direct intended use.
No
The description mentions "redundant self diagnostic and circuitry controls" and the device will "error if the encoder does not verify that distraction is progressing within tolerable accuracy". While it performs self-diagnostics and error checks, this is for the device's operation, not for diagnosing a patient's medical condition.
No
The device description explicitly details hardware components such as control circuitry, drive components, battery, housing, telescoping rod, switches, and a motor. It also describes physical mechanisms like axial force and impact load requirements, and the use of a final drive gear as an encoder. While software is mentioned, it is clearly integrated with and controls these physical components.
Based on the provided information, it is highly unlikely that the Automator 2000 is an In Vitro Diagnostic (IVD) device. Here's why:
- Lack of Intended Use/Indications for Use: The most crucial piece of information for determining if a device is an IVD is its intended use. This section is explicitly marked as "Not Found." IVDs are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Without an intended use related to analyzing biological samples, it cannot be an IVD.
- Device Description Focus: The device description focuses entirely on the mechanical and electrical aspects of the device: control circuitry, drive components, battery, housing, telescoping rod, movement mechanisms, and safety features. There is no mention of handling or analyzing biological samples.
- No Mention of IVD-Related Activities: The description does not mention any activities typical of IVDs, such as sample preparation, reagent use, or analytical measurements of biological markers.
- Predicate Device: The predicate device, "CF Automator," is also described in a way that suggests a mechanical or electromechanical function, not an IVD function.
Conclusion:
The description strongly suggests that the Automator 2000 is a mechanical or electromechanical device, likely used for controlled movement or positioning, possibly in a medical context (given the mention of "distraction" and "lengthening adjustments," which could relate to orthopedic procedures). However, there is no evidence to support it being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
GKF, GKR, CHL, CGZ, CDS, JIX, CEM, JFP, CGA, JGS, KHP, JJS
Device Description
Automator 2000 has the control circuitry, drive components, and battery contained in a single housing. The compact and entirely self contained design of Automator 2000 simplifies the installation of the product. Furthermore, external cables are no longer vulnerable to damage or being inadvertently unplugged in the design of Automator 2000. Automator 2000's machined aluminum housing is a robust design that comfortably accommodates the axial force and impact load requirements of the device. Additionally, the conductive aluminum housing has been designed to preclude radio frequency interference. Automator 2000's design has retained the CF Automator's redundant self diagnostic and circuitry controls to assure that the telescoping rod may move only the amount it is intended to move, and only when it is intended to move. Since each Automator 2000 device has its own control circuitry, the complexity built into the CF Automator circuitry for controlling multiple drive units has been removed. Since Automator 2000 is programmed using switches on the control board rather than through an IR communication link to a doctor's master computer, further communication circuitry has also been rendered unnecessary. Consequently, Automator 2000 has a more simplified circuit board and software package. Automator 2000 has 7 rate setting to chose from and the movement amount per increment is held constant at 1/360th mm. Both systems have been designed to use the final drive gear as an encoder to verify the position of the telescoping rod. Each system will error if the encoder does not verify that distraction is progressing within tolerable accuracy. Both systems check current on the motor circuit to verify the motor runs only when it is supposed to, and furthermore, check current during motor pulses to verify that current is not higher than expected, Both motor circuits have switches that remain open between motor pulses to prevent the motor from receiving current. Both systems use a watch-dog circuit to confirm software operation nearly continuously. Both systems have redundant audio and visual alarms. Furthermore, both units use the same design telescoping rod, which may be used to make manual lengthening adjustments at any time.
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
Not Found
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)
Not Found
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.
Not Found
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
§ 864.5600 Automated hematocrit instrument.
(a)
Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).(b)
Classification. Class II (performance standards).
0
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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 2 1998
Paul W. MacDonald . Director of Quality Assurance/Regulatory Affairs Nova Biomedical 200 Prospect Street Waltham, Massachusetts 02254-9141
K981426 Re : STAT Profile Ultra F, G, H, I, J, K and L Analyzers Requlatory Class: I & II GKF, GKR, CHL, CGZ, CDS, JIX, CEM, JFP, Product Code: CGA, JGS, KHP, JJS April 16, 1998 Dated: Received: April 16, 1998
Dear Mr. MacDonald:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with ---the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
The motor chosen for Automator 2000 provides higher torque, is a preferable size for the Automator 2000 housing design, and requires less power.
Housing & Enclosure: The CF Automator (predicate device) has separately enclosed components that mount to the external fixator frame: drive units, controller, and battery pack. The components are connected by cables. By comparison, Automator 2000 has the control circuitry, drive components, and battery contained in a single housing. The compact and entirely self contained design of Automator 2000 simplifies the installation of the product. Furthermore, external cables are no longer vulnerable to damage or being inadvertently unplugged in the design of Automator 2000.
Automator 2000's machined aluminum housing is a robust design that comfortably accommodates the axial force and impact load requirements of the device. Additionally, the conductive aluminum housing has been designed to preclude radio frequency interference. By comparison, the CF Automator components are housed in delrin (a plastic composite), which is shaped by plastic injection molding.
Circuitry and Software/ Safety Features: Automator 2000's design has retained the CF Automator's redundant self diagnostic and circuitry controls to assure that the telescoping rod may move only the amount it is intended to move, and only when it is intended to move. Since each Automator 2000 device has its own control circuitry, the complexity built into the CF Automator circuitry for controlling multiple drive units has been removed. Since Automator 2000 is programmed using switches on the control board rather than through an IR communication link to a doctor's master computer, further communication circuitry has also been rendered unnecessary. Consequently, Automator 2000 has a more simplified circuit board and software package.
Programming the device has been simplified as well. The predicated device (CF Automator) allowed the physician to choose from 14 rate settings and 7 rhythm settings for the number of adjustment increments made by the device each day. Automator 2000 has 7 rate setting to chose from and the movement amount per increment is held constant at 1/360th mm.
Regarding motor control, Automator 2000 and the CF Automator very similar software and circuitry safety features. Certain conditions that applied to the CF Model do not apply to Automator 2000 - for example, an unplugged drive unit or unplugged battery. Similarities between the two operating systems include the following: Both systems have been designed to use the final drive gear as an encoder to verify the position of the telescoping rod. Each system will error if the encoder does not verify that distraction is progressing within tolerable accuracy. Both systems check current on the motor circuit to verify the motor runs only when it is supposed to, and furthermore, check current during motor pulses to verify that current is not higher than expected, Both motor circuits have switches that remain open between motor pulses to prevent the motor from receiving current. Both systems use a watch-dog circuit to confirm software operation nearly continuously. Both systems have redundant audio and visual alarms. Furthermore, both units use the same design telescoping rod, which may be used to make manual lengthening adjustments at any time.