c1Trac
Device Facts
| Record ID | K222912 |
|---|---|
| Device Name | c1Trac |
| Applicant | Zimmer Medizinsysteme GmbH |
| Product Code | ITH · Physical Medicine |
| Decision Date | May 16, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5900 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
clTrac is a powered traction device for spinal decompression; used by healthcare professionals in clinical settings. Device consists of a console with 7" touch screen, rotary knob, and motor-gear unit. Operator sets traction force (15-900 N) and mode (static/intermittent) via interface. Motor applies force to a traction cord connected to patient-worn belts. Patient safety is managed via a handheld interrupt button; therapy pauses if pressed or if tension sensors detect anomalies (e.g., non-identical sensor readings). Device provides non-surgical, non-invasive pain management. Output is mechanical traction force; healthcare providers use this to relieve pressure on spinal structures, potentially reducing patient pain and symptoms.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing and compliance with voluntary consensus standards including ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 14971, and ISO 10993-1.
Technological Characteristics
ABS housing, aluminum ground plate, steel control knob. Motor-gear unit for traction. 100-240V AC power. 7" touch screen interface. Dual tension sensors for safety monitoring. Software-controlled force delivery. Sterilization not applicable (non-invasive). Connectivity: standalone device. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, IEC 62304, ISO 14971, ISO 10993-1.
Indications for Use
Indicated for patients suffering from pain and symptoms related to muscular or skeletal pressure, including herniated/prolapsed/bulging discs, degenerative disc/joint disease, facet syndrome, radicular pain, spinal root impingement, hypomobility, compression fractures, and joint pain.
Regulatory Classification
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.
Predicate Devices
- Eltrac 471 (K151640)
Submission Summary (Full Text)
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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.
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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
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## 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)
| <div> <span style="font-size:10pt"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span style="font-size:10pt"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
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Image /page/3/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The word "zimmer" is in bold, gray letters. Below it, in a smaller font, are the words "MedizinSysteme" also in gray. The background is white.
## 510(k) Summary clTrac K222912
- 1. Basic Information-Submitter:
510(k) Owner:
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
- 2. Device Name:
Trade Name: Common Name: Classification Name: Requlation Number: Product Code: Classification:
clTrac Equipment, Traction, Powered Power traction equipment 21 CFR 890.5900 ITH Class II
- 3. Predicate Device: Company Name:
Eltrac 471 – K151640 Enraf-Nonius B.V.
- 4. 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
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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<br>Zimmer MedizinSysteme GmbH<br><i>cl</i> Trac<br>K222912 | PREDICATE DEVICE<br>Enraf-Nonius B.V.<br>Eltrac 471<br>K151640 |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Physical Medicine Devices<br>21 CFR 890.5900<br>ITH – Equipment, Traction, Powered | Physical Medicine Devices<br>21 CFR 890.5900<br>ITH – Equipment, Traction, Powered |
| Indications<br>for Use | <i>cl</i> Trac is intended to provide relief<br>for the management of pain and<br>symptoms from a variety of<br>pressures on muscular or skeletal<br>structures. <i>cl</i> Trac may be used to<br>treat pain and symptoms<br>associated with the following<br>conditions: herniated discs, bulging<br>or protruding intervertebral discs,<br>degenerative disc disease. | The ELTRAC 471 Traction device,<br>with its accessories, is intended to<br>provide relief for the management of<br>pain and symptoms from a variety of<br>pressures on muscular or skeletal<br>structures. The ELTRAC 471<br>Traction device may be used to treat<br>pain and symptoms associated with<br>the following conditions: herniated<br>discs, bulging or protruding<br>intervertebral discs, degenerative<br>disc disease, posterior facet |
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Image /page/5/Picture/0 description: The image shows the logo for Zimmer MedizinSysteme. The logo is in gray and consists of the word "zimmer" in a bold, sans-serif font. Below the word "zimmer" is the word "MedizinSysteme" in a smaller, lighter font. The logo is simple and modern.
| ATTRIBUTE | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>cl Trac<br>K222912 | PREDICATE DEVICE<br>Enraf-Nonius B.V.<br>Eltrac 471<br>K151640 |
|-----------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | posterior facet syndrome, acute<br>facet problems, radicular pain,<br>prolapsed discs, spinal root<br>impingement, hypomobility,<br>degenerative joint disease, facet<br>syndrome, compression fractures,<br>joint pain, and discogenic pain. | syndrome, acute facet problems,<br>radicular pain, prolapsed discs,<br>spinal root impingement,<br>hypomobility, degenerative joint<br>disease, facet syndrome,<br>compression fractures, joint pain,<br>and discogenic pain. |
The Indications for Use statement for clTrac is identical to the predicate device.
- 5. 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.
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<br>Characteristics | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>cl Trac<br>K222912 | PREDICATE DEVICE<br>Enraf-Nonius B.V.<br>Eltrac 471<br>K151640 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | Traction therapy utilize a software<br>controlled motor to deliver force via<br>a cord and harness to apply<br>traction to the patient. | Traction therapy utilize a software<br>controlled motor to deliver force via<br>a cord and accessories to apply<br>traction to the patient. |
| Display | Display with touch screen & central<br>knob | Display with touch screen |
| Conditions of use | The device is intended for use by<br>health care professional users<br>only. | The device is intended for use by<br>professional users only. |
| Technology | Setting of treatment parameters<br>via a touch screen and central<br>control knob. | Setting of treatment parameters<br>via a touch screen. |
| Technology | Therapy start, pause and stop with<br>buttons on touch screen. | Therapy start, pause and stop with<br>buttons on touch screen. |
| Technological<br>Characteristics | SUBJECT DEVICE<br>Zimmer MedizinSysteme GmbH<br>cl Trac<br>K222912 | PREDICATE DEVICE<br>Enraf-Nonius B.V.<br>Eltrac 471<br>K151640 |
| | Patient interrupt button to interrupt<br>therapy at any time.<br>Therapy only starts if the patient<br>interrupt button has been<br>connected and button has been<br>pressed. | Patient stop switch to interrupt<br>therapy at any time.<br>Treatment will not start if patient<br>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<br>Intermittent | Not publicly available |
| Storage treatment<br>protocols | Yes<br>A treatment protocol can be stored<br>on the "Favorites" screen. | Yes<br>A treatment protocol can be stored<br>into the device's memory. |
| Traction Time | 1 - 99 minutes | to 150 minutes |
| System stops &<br>alerts | clTrac is designed with<br>safety/warning features so that<br>cervical traction treatment<br>decisions are made with care. In<br>addition, treatment times are<br>limited, treatment will not start if<br>the patient interrupt button in not<br>connected and pressed. The<br>patient is able to stop the<br>treatment at any time by clicking<br>on the patient interrupt button<br>during a treatment a pop-up will<br>show on the screen, accompanied<br>by and acoustic signal. The<br>treatment will be paused, the force<br>will be reduced to 10N.<br>Furthermore, an automatic system<br>stop if the tension sensors detect<br>inappropriate tension or the<br>measurement results of the 2<br>tensions sensors are not identical. | Eltrac 471 is designed with<br>safety/warning features so that<br>traction treatment decisions are<br>made with care. Treatment will not<br>start if patient stop is not<br>connected. In addition, treatment<br>times are limited, and the patient is<br>able to stop the treatment at any<br>time with a switch. If it is pressed,<br>the force will lower. |
| Principal of operation | Processor on main board to control<br>step motor that applies traction to<br>traction cord<br>Traction is delivered via traction<br>cord that is connected to traction<br>harness | A software controlled motor<br>delivers force via cord<br>Traction is delivered via traction cord<br>that is connected to accessories |
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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<br>Organization | Standards Title |
|-------------------------------------------------------------------------------------------------------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ES60601-<br>1:2005/(R)2012 and<br>A1:2012,<br>C1:2009/(R)2012 and<br>A2:2010/(R)2012<br>(Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance |
| 60601-1-2:2014<br>(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance<br>- Collateral standard: Electromagnetic disturbances -<br>Requirements and tests |
| 60601-1-6:2013<br>(Edition 3.1) | IEC | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential performance -<br>Collateral standard: Usability |
| 62366-1:2015<br>(Edition 1.0) | IEC | Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| 62304:2015<br>(Edition 1.1) | IEC | Medical devices software -software life cycle processes |
| 14971:2019<br>(Edition 3.0) | ISO | Medical devices - Application of risk management to<br>medical devices |
| 15223-1:2016<br>(Edition 3) | ISO | Medical devices - Symbols to be used with medical<br>device labels, labeling, and information to be supplied -<br>Part 1: General requirements |
| 10993-1:2018<br>(Edition 5) | ISO | Biological evaluation of medical devices - Part 1:<br>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<br>Zimmer MedizinSysteme GmbH<br>clTrac<br>K222912 | PREDICATE DEVICE<br>Enraf-Nonius B.V.<br>Eltrac 471<br>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.
- 7. Clinical Performance:
Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness.
- 8. Conclusion:
Zimmer MedizinSysteme GmbH has demonstrated that the clTrac device is substantially equivalent to the predicate device.
