(232 days)
Not Found
No
The device description focuses on mechanical traction and control via a touch screen and rotary knob. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent decision-making based on data. The performance studies reference compliance with standards and equivalence to a predicate device, not AI/ML performance metrics.
Yes
The device description explicitly states, "The cl Trac is a non-invasive therapeutic device," and its intended use is to provide "relief for the management of pain and symptoms" from various muscular or skeletal conditions.
No
The device description clearly states that "Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures." This indicates it is a therapeutic device used for treatment, not for diagnosing conditions.
No
The device description explicitly details physical hardware components such as a console with ABS housing, aluminum ground plate, touch screen, steel control knob, cord, patient interrupt button, motor-gear unit, and traction cord. It is a powered traction device, not solely software.
Based on the provided information, the clTrac device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of clTrac is to provide pain relief and manage symptoms from pressure on muscular or skeletal structures through spinal traction. This is a therapeutic treatment applied directly to the patient's body.
- Device Description: The description details a powered traction device that applies force to the spine. It is a non-invasive therapeutic device used by healthcare professionals.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The clTrac does not interact with or analyze any bodily specimens.
The clTrac is a therapeutic medical device used for physical treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.
Product codes
ITH
Device Description
The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device.
The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscular or skeletal structures; spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals (HCP); professional users only.
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)
The clTrac device has been investigated and tested against and complies with the following voluntary standards: ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), IEC 60601-1-2:2014 (Edition 4.0), IEC 60601-1-6:2013 (Edition 3.1), IEC 62366-1:2015 (Edition 1.0), IEC 62304:2015 (Edition 1.1), ISO 14971:2019 (Edition 3.0), ISO 15223-1:2016 (Edition 3), ISO 10993-1:2018 (Edition 5).
Key results: According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices. clTrac has been designed and tested more, recently, so newer standards and additional standards are used to support 510(k). Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5900 Power traction equipment.
(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(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). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 16, 2023
Zimmer MedizinSysteme GmbH % Scott Blood Principal Consultant Ouality and Regulatory Services 151 Gleasondale Road Stow, Massachusetts 01775
Re: K222912
Trade/Device Name: clTrac Regulation Number: 21 CFR 890.5900 Regulation Name: Power Traction Equipment Regulatory Class: Class II Product Code: ITH Dated: April 17, 2023 Received: April 20, 2023
Dear Scott Blood:
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.
1
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) 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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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-device-safety/medical-device-reportingmdr-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.
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222912
Device Name clTrac
Indications for Use (Describe)
clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.
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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary clTrac K222912
-
- Basic Information-Submitter:
510(k) Owner:
- Basic Information-Submitter:
Zimmer MedizinSysteme GmbH Junkersstrasse 9 89231 Neu-Ulm Germany Establishment Registration: 8010720
Ms. Ute Killet Manager Regulatory Affairs Phone: +49-731-9761-216 Fax: +49-731-9761-118 E-mail: u.killet@zimmer.de
Official Correspondent:
Scott Blood Principal Consultant Phone: 978.729.5978 Fax: +49 731 9761 118 E-Mail: scottgara@gmail.com
Date Summary Prepared:
May 11, 2023
-
- Device Name:
Trade Name: Common Name: Classification Name: Requlation Number: Product Code: Classification:
- Device Name:
clTrac Equipment, Traction, Powered Power traction equipment 21 CFR 890.5900 ITH Class II
-
- Predicate Device: Company Name:
Eltrac 471 – K151640 Enraf-Nonius B.V.
- Predicate Device: Company Name:
-
- Device Description:
The clTrac is powered traction equipment that offers both static and intermittent traction. Spinal traction is a form of decompression that relieves the pressure on the spine. Traction is a non-surgical, non-invasive and non-pharmaceutical treatment for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures
- Device Description:
Page 1 of 6
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Image /page/4/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a line above the "z" and "i". Below the word "zimmer" is the phrase "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.
The clTrac is intended to be used by healthcare professionals (HCP) on their patients. When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator. clTrac applies a specific force onto the traction cord. The applied force is set by the operator by means of the touch screen and rotary knob. A patient interrupt button is available for the patient to pause the therapy. The cl Trac is a non-invasive therapeutic device.
The device consists of a console with ABS housing. The console consists of an aluminium ground plate, an ABS outer shell, a 7" touch screen and a steel central control knob. A 2.9m long cord with a plastic patient interrupt button is plugged into the console. The console is intended to be fastened to a standardized traction table using screws that are tightly screwed into its aluminium ground plate, with holes in a standardized pattern. The implemented motor-gear unit applies traction via a traction cord that is fixed into the console with a 360° swivel head with guide pulley. The traction cord is intended to be attached to hip and thoracic traction belts that are sold separately.
Indications for Use Statement:
clTrac is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. clTrac may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative ioint disease, facet syndrome, compression fractures, ioint pain, and discogenic pain.
| ATTRIBUTE | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
cl Trac
K222912 | PREDICATE DEVICE
Enraf-Nonius B.V.
Eltrac 471
K151640 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Physical Medicine Devices
21 CFR 890.5900
ITH – Equipment, Traction, Powered | Physical Medicine Devices
21 CFR 890.5900
ITH – Equipment, Traction, Powered |
| Indications
for Use | cl Trac is intended to provide relief
for the management of pain and
symptoms from a variety of
pressures on muscular or skeletal
structures. cl Trac may be used to
treat pain and symptoms
associated with the following
conditions: herniated discs, bulging
or protruding intervertebral discs,
degenerative disc disease. | The ELTRAC 471 Traction device,
with its accessories, is intended to
provide relief for the management of
pain and symptoms from a variety of
pressures on muscular or skeletal
structures. The ELTRAC 471
Traction device may be used to treat
pain and symptoms associated with
the following conditions: herniated
discs, bulging or protruding
intervertebral discs, degenerative
disc disease, posterior facet |
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| ATTRIBUTE | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
cl Trac
K222912 | PREDICATE DEVICE
Enraf-Nonius B.V.
Eltrac 471
K151640 |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | posterior facet syndrome, acute
facet problems, radicular pain,
prolapsed discs, spinal root
impingement, hypomobility,
degenerative joint disease, facet
syndrome, compression fractures,
joint pain, and discogenic pain. | syndrome, acute facet problems,
radicular pain, prolapsed discs,
spinal root impingement,
hypomobility, degenerative joint
disease, facet syndrome,
compression fractures, joint pain,
and discogenic pain. |
The Indications for Use statement for clTrac is identical to the predicate device.
-
- Technological Characteristics:
Both devices provide the traction therapy via a software-controlled motor to the traction cord that is connected to harness/belts that the patient wears. Both devices have a patient interrupt button in place ensuring that the therapy de-activates when the patient presses the button. In addition, treatment times are limited. Additionally, the therapy only starts if the patient interrupt button has been pressed at the clTrac device.
- Technological Characteristics:
Both devices have an electrical input of 100 – 240 V AC, 50/60 Hz. Both devices employ software with touch-screen control to adjust settings and store treatment protocols.
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
cl Trac
K222912 | PREDICATE DEVICE
Enraf-Nonius B.V.
Eltrac 471
K151640 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Traction therapy utilize a software
controlled motor to deliver force via
a cord and harness to apply
traction to the patient. | Traction therapy utilize a software
controlled motor to deliver force via
a cord and accessories to apply
traction to the patient. |
| Display | Display with touch screen & central
knob | Display with touch screen |
| Conditions of use | The device is intended for use by
health care professional users
only. | The device is intended for use by
professional users only. |
| Technology | Setting of treatment parameters
via a touch screen and central
control knob. | Setting of treatment parameters
via a touch screen. |
| Technology | Therapy start, pause and stop with
buttons on touch screen. | Therapy start, pause and stop with
buttons on touch screen. |
| Technological
Characteristics | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
cl Trac
K222912 | PREDICATE DEVICE
Enraf-Nonius B.V.
Eltrac 471
K151640 |
| | Patient interrupt button to interrupt
therapy at any time.
Therapy only starts if the patient
interrupt button has been
connected and button has been
pressed. | Patient stop switch to interrupt
therapy at any time.
Treatment will not start if patient
stop is not connected. |
| Power supply | 100 - 240 V AC, 50/60Hz | 100 - 240 V, 50/60 Hz |
| Traction tension | 15 - 900 N | Not publicly available |
| Traction modes | Static
Intermittent | Not publicly available |
| Storage treatment
protocols | Yes
A treatment protocol can be stored
on the "Favorites" screen. | Yes
A treatment protocol can be stored
into the device's memory. |
| Traction Time | 1 - 99 minutes | to 150 minutes |
| System stops &
alerts | clTrac is designed with
safety/warning features so that
cervical traction treatment
decisions are made with care. In
addition, treatment times are
limited, treatment will not start if
the patient interrupt button in not
connected and pressed. The
patient is able to stop the
treatment at any time by clicking
on the patient interrupt button
during a treatment a pop-up will
show on the screen, accompanied
by and acoustic signal. The
treatment will be paused, the force
will be reduced to 10N.
Furthermore, an automatic system
stop if the tension sensors detect
inappropriate tension or the
measurement results of the 2
tensions sensors are not identical. | Eltrac 471 is designed with
safety/warning features so that
traction treatment decisions are
made with care. Treatment will not
start if patient stop is not
connected. In addition, treatment
times are limited, and the patient is
able to stop the treatment at any
time with a switch. If it is pressed,
the force will lower. |
| Principal of operation | Processor on main board to control
step motor that applies traction to
traction cord
Traction is delivered via traction
cord that is connected to traction
harness | A software controlled motor
delivers force via cord
Traction is delivered via traction cord
that is connected to accessories |
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Image /page/6/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in a bold, sans-serif font, with a horizontal line above the "i" and "e". Below the word "zimmer" is the word "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray.
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There are no significant technological differences between the clTrac device and the predicate device. There are few and not significant technological differences between the subject device and the predicate device. Those differences have been discussed and do not affect device safety or performance. The subject device has all features of the predicate device. clTrac does not raise any new types of safety or effectiveness questions.
6. Performance data
The clTrac device has been investigated and tested against and complies with the following voluntary standards:
| Standards | Standards
Organization | Standards Title |
|-------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ES60601-
1:2005/(R)2012 and
A1:2012,
C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance |
| 60601-1-2:2014
(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance
- Collateral standard: Electromagnetic disturbances -
Requirements and tests |
| 60601-1-6:2013
(Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance -
Collateral standard: Usability |
| 62366-1:2015
(Edition 1.0) | IEC | Medical devices - Part 1: Application of usability
engineering to medical devices |
| 62304:2015
(Edition 1.1) | IEC | Medical devices software -software life cycle processes |
| 14971:2019
(Edition 3.0) | ISO | Medical devices - Application of risk management to
medical devices |
| 15223-1:2016
(Edition 3) | ISO | Medical devices - Symbols to be used with medical
device labels, labeling, and information to be supplied -
Part 1: General requirements |
| 10993-1:2018
(Edition 5) | ISO | Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process |
The following table shows a comparison of the performance testing in comparison to the predicate device:
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Image /page/8/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo consists of the word "zimmer" in a bold, sans-serif font, with a horizontal line above the "z" and "i". Below the word "zimmer" is the text "MedizinSysteme" in a smaller, sans-serif font. The logo is in gray color.
| Standards | SUBJECT DEVICE
Zimmer MedizinSysteme GmbH
clTrac
K222912 | PREDICATE DEVICE
Enraf-Nonius B.V.
Eltrac 471
K151640 |
|---------------------|-------------------------------------------------------------------|----------------------------------------------------------------|
| ANSI AAMI ES60601-1 | X | X |
| IEC 60601-1-2 | X | X |
| IEC 60601-1-6 | X | Not publicly available |
| IEC 62366-1 | X | Not publicly available |
| IEC 62304 | X | X |
| ISO 14971 | X | X |
| ISO 10993-1 | X | Not publicly available |
According to this comparison table all required performance tests were conducted and show substantial equivalence with the predicate devices. clTrac has been designed and tested more, recently, so newer standards and additional standards are used to support 510(k).
Testing has been performed and all components, subassemblies and/or full devices and systems have met the required specifications for the completed tests.
-
- Clinical Performance:
Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness.
- Clinical Performance:
-
- Conclusion:
Zimmer MedizinSysteme GmbH has demonstrated that the clTrac device is substantially equivalent to the predicate device.
- Conclusion: