(232 days)
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.
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.
The provided document is an FDA 510(k) clearance letter for the clTrac device, a powered traction equipment. It focuses on demonstrating substantial equivalence to a predicate device (Eltrac 471) rather than a deep dive into specific performance study details with acceptance criteria for an AI/ML-based medical device.
Therefore, many of the requested details regarding acceptance criteria, specific study types (MRMC, standalone), sample sizes for test and training sets, expert qualifications, and ground truth establishment methods for an AI/ML device are NOT present in this document.
The document details the device's indications for use, technological characteristics, and compliance with various voluntary general and electrical safety standards. It explicitly states:
- Clinical Performance: Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/effectiveness."
This means the 510(k) clearance was based on non-clinical performance (bench testing, electrical safety, software validation, usability, risk management, and biocompatibility) and comparison to a predicate, not on a study demonstrating clinical performance with specific metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML device clearances.
Here's a breakdown of what can be extracted or inferred based on the provided text, and where the information is missing:
1. A table of acceptance criteria and the reported device performance
The document doesn't present "acceptance criteria" in the way one would for an AI/ML diagnostic or prognostic device (e.g., target specificity, sensitivity thresholds). Instead, it refers to compliance with established medical device standards and the device's operational specifications.
| Acceptance Criteria Category (Inferred from document) | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Indications for Use Equivalence | Identical to predicate device | Stated as "identical" to the predicate device (Eltrac 471). |
| Technological Equivalence | Similar design, display, conditions of use, technology (software control, patient interrupt), power supply, and safety features to predicate. | "No significant technological differences" stated. "The subject device has all features of the predicate device." Differences (e.g., central control knob in addition to touchscreen) do not affect safety or performance. |
| Applied Force Accuracy | Applied force shall not exceed +/-10% of the target force as set by the operator. | "When device is operational, the applied force shall not exceed +/-10% of the target force as set by the operator." (This is a design specification and implied acceptance criterion, not a direct performance result from a specific test report in this summary doc). |
| Electrical Safety | Compliance with ANSI AAMI ES60601-1 | "X" (Compliant) |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | "X" (Compliant) |
| Usability | Compliance with IEC 60601-1-6 and IEC 62366-1 | "X" (Compliant) for both. Note: Predicate's compliance status not publicly available for these. |
| Software Life Cycle Processes | Compliance with IEC 62304 | "X" (Compliant) |
| Risk Management | Compliance with ISO 14971 | "X" (Compliant) |
| Biocompatibility | Compliance with ISO 10993-1 | "X" (Compliant). Note: Predicate's compliance status not publicly available for this. |
| Manufacturing Quality System | Compliance with 21 CFR Part 820 (QS Regulation) | Implied by 510(k) clearance, as stated in the general provisions of the letter. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical test set. The performance testing was primarily bench testing and engineering verification/validation against standards.
- Data Provenance: Not applicable for clinical data. The testing mentioned (electrical safety, EMC, usability, software, risk, biocompatibility) would be performed in a lab setting by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set requiring expert-established ground truth.
4. Adjudication method for the test set
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This device is a powered traction equipment, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is electro-mechanical, not an AI/ML algorithm. Its "performance" refers to its physical operation and safety, not an intelligent diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. Ground truth for an AI/ML algorithm is not relevant here. The "ground truth" for the device's functionality would be engineering specifications and measurements (e.g., force output measured by a calibrated sensor, electrical safety limits).
8. The sample size for the training set
- Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is for a medical device clearance (clTrac, a powered traction equipment) that relies on demonstrating substantial equivalence to a predicate device and compliance with general device safety and performance standards. It explicitly states that clinical testing was "not applicable." As such, the detailed requirements for AI/ML device clearances (like test set/training set sizes, expert ground truth establishment, MRMC studies) are not relevant to this specific FDA submission and are not found in this document.
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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.
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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)
| ☑ 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/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
-
- 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:
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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 DEVICEZimmer MedizinSysteme GmbHcl TracK222912 | PREDICATE DEVICEEnraf-Nonius B.V.Eltrac 471K151640 |
|---|---|---|
| Physical Medicine Devices21 CFR 890.5900ITH – Equipment, Traction, Powered | Physical Medicine Devices21 CFR 890.5900ITH – Equipment, Traction, Powered | |
| Indicationsfor Use | cl Trac is intended to provide relieffor the management of pain andsymptoms from a variety ofpressures on muscular or skeletalstructures. cl Trac may be used totreat pain and symptomsassociated with the followingconditions: herniated discs, bulgingor protruding intervertebral discs,degenerative disc disease. | The ELTRAC 471 Traction device,with its accessories, is intended toprovide relief for the management ofpain and symptoms from a variety ofpressures on muscular or skeletalstructures. The ELTRAC 471Traction device may be used to treatpain and symptoms associated withthe following conditions: herniateddiscs, bulging or protrudingintervertebral discs, degenerativedisc 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 DEVICEZimmer MedizinSysteme GmbHcl TracK222912 | PREDICATE DEVICEEnraf-Nonius B.V.Eltrac 471K151640 |
|---|---|---|
| posterior facet syndrome, acutefacet problems, radicular pain,prolapsed discs, spinal rootimpingement, hypomobility,degenerative joint disease, facetsyndrome, compression fractures,joint pain, and discogenic pain. | syndrome, acute facet problems,radicular pain, prolapsed discs,spinal root impingement,hypomobility, degenerative jointdisease, 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.
| TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSysteme GmbHcl TracK222912 | PREDICATE DEVICEEnraf-Nonius B.V.Eltrac 471K151640 |
|---|---|---|
| Design | Traction therapy utilize a softwarecontrolled motor to deliver force viaa cord and harness to applytraction to the patient. | Traction therapy utilize a softwarecontrolled motor to deliver force viaa cord and accessories to applytraction to the patient. |
| Display | Display with touch screen & centralknob | Display with touch screen |
| Conditions of use | The device is intended for use byhealth care professional usersonly. | The device is intended for use byprofessional users only. |
| Technology | Setting of treatment parametersvia a touch screen and centralcontrol knob. | Setting of treatment parametersvia a touch screen. |
| Technology | Therapy start, pause and stop withbuttons on touch screen. | Therapy start, pause and stop withbuttons on touch screen. |
| TechnologicalCharacteristics | SUBJECT DEVICEZimmer MedizinSysteme GmbHcl TracK222912 | PREDICATE DEVICEEnraf-Nonius B.V.Eltrac 471K151640 |
| Patient interrupt button to interrupttherapy at any time.Therapy only starts if the patientinterrupt button has beenconnected and button has beenpressed. | Patient stop switch to interrupttherapy at any time.Treatment will not start if patientstop 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 | StaticIntermittent | Not publicly available |
| Storage treatmentprotocols | YesA treatment protocol can be storedon the "Favorites" screen. | YesA treatment protocol can be storedinto the device's memory. |
| Traction Time | 1 - 99 minutes | to 150 minutes |
| System stops &alerts | clTrac is designed withsafety/warning features so thatcervical traction treatmentdecisions are made with care. Inaddition, treatment times arelimited, treatment will not start ifthe patient interrupt button in notconnected and pressed. Thepatient is able to stop thetreatment at any time by clickingon the patient interrupt buttonduring a treatment a pop-up willshow on the screen, accompaniedby and acoustic signal. Thetreatment will be paused, the forcewill be reduced to 10N.Furthermore, an automatic systemstop if the tension sensors detectinappropriate tension or themeasurement results of the 2tensions sensors are not identical. | Eltrac 471 is designed withsafety/warning features so thattraction treatment decisions aremade with care. Treatment will notstart if patient stop is notconnected. In addition, treatmenttimes are limited, and the patient isable to stop the treatment at anytime with a switch. If it is pressed,the force will lower. |
| Principal of operation | Processor on main board to controlstep motor that applies traction totraction cordTraction is delivered via tractioncord that is connected to tractionharness | A software controlled motordelivers force via cordTraction is delivered via traction cordthat 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 | StandardsOrganization | Standards Title |
|---|---|---|
| ES60601-1:2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R)2012(Consolidated Text) | ANSI AAMI | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance |
| 60601-1-2:2014(Edition 4.0) | IEC | Medical electrical equipment - Part 1-2: Generalrequirements 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: Generalrequirements for basic safety and essential performance -Collateral standard: Usability |
| 62366-1:2015(Edition 1.0) | IEC | Medical devices - Part 1: Application of usabilityengineering 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 tomedical devices |
| 15223-1:2016(Edition 3) | ISO | Medical devices - Symbols to be used with medicaldevice 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 DEVICEZimmer MedizinSysteme GmbHclTracK222912 | PREDICATE DEVICEEnraf-Nonius B.V.Eltrac 471K151640 |
|---|---|---|
| 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:
§ 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).