(216 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like neural networks, deep learning, or algorithms that learn from data. The device description focuses on physical therapy modalities (electromagnetic fields and heat).
Yes.
The device is indicated for "adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis," which are therapeutic claims.
No
The device is indicated for "adjunctive use in the temporary relief of pain," which is a therapeutic rather than a diagnostic purpose. It delivers therapies like pulsed electromagnetic field and thermal exchange, which are treatments, not diagnostic assessments.
No
The device description explicitly states it is a "portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field... and thermal exchange therapy" and includes "general use wraps and therapy is delivered with single-use OrthoPods". This indicates the device is a hardware system that delivers physical therapy, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the temporary relief of pain associated with conditions like over-exertion, strains, sprains, and arthritis. This is a therapeutic use, not a diagnostic one.
- Device Description: The device delivers transcutaneous pulsed electromagnetic field and thermal exchange therapy. These are physical therapies applied to the body, not tests performed on samples taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly described as a non-invasive system for delivering physical therapy for pain relief.
N/A
Intended Use / Indications for Use
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
Product codes (comma separated list FDA assigned to the subject device)
ILX, IMD, IRT
Device Description
The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.
The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
General Use
Indicated Patient Age Range
adult users
Intended User / Care Setting
For prescription use (Rx) 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)
Non-clinical performance testing was conducted to verify the subject device performance.
Electrical safety and electromagnetic compatibility (EMC): The systems comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing: The software is classified as a Basic Level of Documentation. Testing and documentation for a Basic Level of Documentation are provided in the submission in compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (June 2023).
Non-Clinical Testing Summary: The following testing was conducted to satisfy the under the Special Controls under regulation 890.5290(0): Peak output power; Pulse width; Pulse frequency; Duty cycle; Characteristics of other types of modulation that may be used; Average measured output powered into the RF antenna/applicator; Specific absorption rates in saline gel test load or other appropriate model; Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and Characterization of the deposited energy density in saline gel test load or other appropriate model. Temperature testing was completed on participants of varying skin types to demonstrate that the devices were capable of maintaining a skin temperature of 40 - 45 degrees Celsius for 20 minutes.
Clinical Study: In compliance with the special controls for regulation 890.5290(b), a clinical study was performed. 120 patients were enrolled, 48 in the Active System (Shortwave Diathermy + Heating Therapy) group and 43 in the SOC group, both males, over 18 years of age, with a history of pain in superficial soft tissue, such as in the ankle, back, knee, wrist, elbow, shoulder, foot, or neck. The incidence of adverse events in this study was notably low, with only 3.3% of participants (4 out of 120) experiencing minor complications. These events were distributed equally across both the Active System + Standard of Care (SOC) and Standard of Care (SOC) groups. The nature of these events were mild, consisting of shoulder pain, sleepiness, discomfort associated with the device wrap, and a tingling or numb sensation in the cervicothoracic region. Critically, there were no reports of serious adverse events or unanticipated adverse device effects. The lack of significant complications and the minimal occurrence of adverse events reinforces the safety profile of the Active System treatment, affirming its suitability for clinical use in pain management. This study was conducted in compliance with the Special Controls under regulation 21 CFR 890.5290(b)(2)(iv). The study examined the change from baseline in pain assessment scores at the end of 2 weeks of study treatment using the Mankowski scale. The SOC group experienced a 10% reduction in pain while the Active System + SOC group had 36% reduction in pain. The findings from this clinical study report establish the Active System as an adjunctive therapy is a significantly more effective intervention for pain management in soft tissue injuries, than Standard of Care (SOC) alone as outlined in the study protocol. Specifically, the study primarily enrolled participants in the foot, knee and shoulder groups. The clinical data was clinically meaningful in the foot, knee and shoulder.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 890.5290 Shortwave diathermy.
(a)
Shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions —(1)Identification. A shortwave diathermy for use in applying therapeutic deep heat for selected medical conditions is a device that applies to specific areas of the body electromagnetic energy in the radiofrequency (RF) bands of 13.56 megahertz (MHz) or 27.12 MHz and that is intended to generate deep heat within body tissues for the treatment of selected medical conditions such as relief of pain, muscle spasms, and joint contractures, but not for the treatment of malignancies.(2)
Classification. Class II (performance standards).(b)
Nonthermal shortwave therapy —(1)Identification. A nonthermal shortwave therapy is a prescription device that applies to the body pulsed electromagnetic energy in the RF bands of 13.56 MHz or 27.12 MHz and that is intended for adjunctive use in the palliative treatment of postoperative pain and edema of soft tissue by means other than the generation of deep heat within body tissues as described in paragraph (a) of this section.(2)
Classification: Class II (special controls). The device is classified as class II. The special controls for this device are:(i) Components of the device that come into human contact must be demonstrated to be biocompatible.
(ii) Appropriate analysis/testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iii) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Non-clinical performance testing must characterize the output waveform of the device and demonstrate that the device meets appropriate output performance specifications. The output characteristics and the methods used to determine these characteristics, including the following, must be determined:
(A) Peak output power;
(B) Pulse width;
(C) Pulse frequency;
(D) Duty cycle;
(E) Characteristics of other types of modulation that may be used;
(F) Average measured output powered into the RF antenna/applicator;
(G) Specific absorption rates in saline gel test load or other appropriate model;
(H) Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
(I) Characterization of the deposited energy density in saline gel test load or other appropriate model.
(iv) A detailed summary of the clinical testing pertinent to use of the device to demonstrate the effectiveness of the device in its intended use.
(v) Labeling must include the following:
(A) Output characteristics of the device;
(B) Recommended treatment regimes, including duration of use; and
(C) A detailed summary of the clinical testing pertinent to the use of the device and a summary of the adverse events and complications.
(vi) Nonthermal shortwave therapy devices marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with these special controls.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
December 18, 2024
Caerus Corporation % Jean-Marie Toher Regulatory Consultant MEDIcept Inc 200 Homer Avenue Ashland, Massachusetts 01721
Re: K241395
Trade/Device Name: Active System; Avenue8 Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave Diathermy Regulatory Class: Class II Product Code: ILX, IRT, IMD Dated: December 2, 2024 Received: December 2, 2024
Dear Jean-Marie Toher:
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 (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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Vivek J. Pinto -S
Vivek Pinto, PhD, MBA 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
3
Indications for Use
510(k) Number (if known) K241395
Device Name Active System: Avenue8
Indications for Use (Describe)
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
K241395
CAERUS CORP
CAERUSCORP.COM 8611 W 35W SERVICE DRIVE NE, SUITE 180 BLAINE, MN 55449
510(k) SUMMARY
I. SUBMITTER
| 510(k) Holder: | Caerus Corporation
8611 W 35W Service Dr NE Ste 180
Blaine MN 55449 |
| ---------------- | --------------------------------------------------------------------------- |
|---|
- Contact Person: Jean-Marie Toher Regulatory Consultant MEDIcept, Inc. jtoher(@medicept.com
Date Prepared: December 18, 2024
II. DEVICES
| Trade Name: | Active System |
|---|---|
| Classification Name: | Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat |
| Regulatory Class: | Class II |
| Product Codes: | ILX - Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat |
| IMD - Hot Or Cold Disposable Pack | |
| Trade Name: | Avenue8 |
| Classification Name: | Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat |
| Regulatory Class: | Class II |
| Product Codes: | ILX - Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat |
| IRT – Powered Heating Pad |
PREDICATE DEVICES III.
Primary Predicate: K121702 - OrthoCor Active Device Secondary Predicate (Active System): K092044 - OrthoCor Knee Active System Secondary Predicate (Avenue8): K202337 - HiDow Pulsed electromagnetic field wrap
IV. DEVICE DESCRIPTION
The Caerus Active System is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) and thermal exchange
Image /page/4/Picture/14 description: The image shows the logo for CAERUS. The logo features the word "CAERUS" in a sans-serif font. To the left of the word is a stylized graphic that resembles a bird's wing or a stylized leaf. The logo is presented in a monochromatic color scheme, with the text and graphic in a dark color against a light background.
5
therapy. The Active System includes general use wraps and therapy is delivered with single-use OrthoPods, sold separately.
The Caerus Avenue8 device is a portable, compact, lightweight, non-invasive system designed to deliver transcutaneous pulsed electromagnetic field (non-thermal shortwave diathermy) therapy and electronic heat.
INDICATIONS FOR USE V.
The Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
VI. INTENDED USE
The Active System is intended to be worn for one two-hour treatment of 2 30-minute non-thermal shortwave diathermy treatments per day by adult users. For prescription use (Rx) only.
The Avenue8 is intended to be worn for two 30-minute treatments per day by adult users. For prescription use (Rx) only.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE VII. DEVICE
In accordance with the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] issued July 28, 2014, the comparison between the predicate devices and the subject devices is shown to be substantially equivalent by comparing the indications for use, principles of operation, technological characteristics, and performance testing similarities and differences (Table 2). The technological characteristic differences do not raise different questions of safety and effectiveness than the predicate device.
Table 1. Substantial Equivalence Subject Device Active System (K241395) Compared to the Predicate Devices OrthoCor Active Device (K121702) and OrthoCor Knee Active System (K092044)
| Characteristic | OrthoCor Active
System (K241395) | OrthoCor General
Use Device
(Primary Predicate)
K121702 | OrthoCor Active Knee
System (Secondary
Predicate)
K092044 | Equivalence
Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Regulatory
Class | Class II | Class II | Class II | Same |
| Regulatory
Number | 21 CFR 890.5290(b)
21 CFR 890.5710 | 21 CFR 890.5290(b)
21 CFR 890.5710 | 21 CFR 890.5290(b)
21 CFR 890.5710 | Same |
| Characteristic | OrthoCor Active
System (K241395) | OrthoCor General
Use Device
(Primary Predicate)
K121702 | OrthoCor Active Knee
System (Secondary
Predicate)
K092044 | Equivalence
Comparison |
| Regulation
Name | Shortwave
Diathermy, For Use
Other Than Applying
Therapeutic Deep
Heat | Shortwave
Diathermy, For Use
Other Than Applying
Therapeutic Deep
Heat | Shortwave Diathermy, For Use
Other Than Applying
Therapeutic Deep Heat | Same |
| Product Code | ILX, IMD | ILX | ILX, IMD | Similar |
| Indication for
use | Adjunctive use in the
temporary relief of
pain, such as pain
associated with over-
exertion, strains,
sprains, and arthritis. | Adjunctive use in the
palliative treatment
of postoperative
edema and pain in
superficial soft tissue | Adjunctive use in the palliative
treatment of postoperative
edema and pain in superficial
soft tissue. Temporary relief of
minor aches and pains
associated with overexertion,
strains, sprains, and arthritis. | Performance
testing justified
substantial
equivalence |
| Anatomical site | General Use | General Use | Knee | Similar |
| Frequency -
short wave | 27.12 MHz | 27.12 MHz | 27.12 MHz | Same |
| Output
Impedance | 50 Ohm | 50 Ohm | 50 Ohm | Same |
| Burst Frequency | 2 Hz | 2 Hz | 2 Hz | Same |
| Therapy Control
Burst Width | 2 ms | 2 ms/PPR 2Hz | 2 ms/PPR 2Hz | Same |
| Exposure | 1 hour | 30 minutes | 30 minutes | Performance
testing justified
substantial
equivalence |
| Energy
Deposited Via | Induction Coil | Induction Coil | Induction Coil | Same |
| Peak Generator
Power | 1.35 W | .5 W | .5 W | Performance
testing justified
substantial
equivalence |
| Heating Method | Chemical | NA | Chemical | Same |
Image /page/5/Picture/13 description: The image shows the logo for CAERUS. The logo features the word "CAERUS" in a simple, sans-serif font. To the left of the word, there is a stylized graphic that resembles a crescent shape with a pointed element extending upwards, possibly representing a sail or a stylized leaf. The overall design is clean and modern.
6
Image /page/6/Picture/3 description: The image shows the word "CAERUS" in a sans-serif font. To the left of the word is a stylized graphic that resembles a bird's wing or a stylized leaf. The image is in black and white, and the background is a light gray color.
7
Table 2. Substantial Equivalence Subject Device Avenue8 (K241395) Compared to the Predicate Devices OrthoCor Active Device (K121702) and HiDow Pulsed electromagnetic field wrap (K202337)
| Characteristic | Avenue8 (K241395) | OrthoCor General
Use Device
(Primary
Predicate)
K121702 | HiDow Pulsed Electromagnetic
Field Wrap
(Secondary Predicate)
K202337 | Equivalence
Comparison |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Regulatory
Class | Class II | Class II | Class II | Same |
| Regulatory
Number | 21 CFR 890.5290(b)
21 CFR 890.5740 | 21 CFR
890.5290(b) | 21 CFR 890.5290
21 CFR 890.5740 | Similar |
| Regulation
Name | Shortwave
Diathermy, For Use
Other Than
Applying
Therapeutic Deep
Heat | Shortwave
Diathermy, For Use
Other Than
Applying
Therapeutic Deep
Heat | Shortwave Diathermy | Similar |
| Product Code | ILX, IRT | ILX | ILX, IRT | Similar |
| Indication for
use | Adjunctive use in
the temporary relief
of pain, such as pain
associated with
over-exertion,
strains, sprains, and
arthritis. | Adjunctive use in
the palliative
treatment of
postoperative
edema and pain in
superficial soft
tissue | Adjunctive use in the palliative
treatment of postoperative edema
and pain in superficial soft tissue.
It is also indicated for the
temporary relief of minor aches
and pains associated with
overexertion, strains, sprains, and
arthritis. | Performance
testing justified
substantial
equivalence |
| Anatomical site | General Use | General Use | General Use | Same |
| Frequency -
short wave | 27.12 MHz | 27.12 MHz | 27.12 MHz | Same |
| Output
Impedance | 50 Ohm | 50 Ohm | Not Publicly Available | Same |
| Burst
Frequency | 2 Hz | 2 Hz | Not Publicly Available | Same |
| Therapy
Control Burst
Width | 2 ms | 2 ms/PPR 2Hz | Not Publicly Available | Same |
| Exposure | 1 hour | 30 minutes | Not Publicly Available | Performance
testing justified
substantial
equivalence |
| Characteristic | Avenue8 (K241395) | OrthoCor General
Use Device
(Primary
Predicate)
K121702 | HiDow Pulsed Electromagnetic
Field Wrap
(Secondary Predicate)
K202337 | Equivalence
Comparison |
| Energy
Deposited Via | Induction Coil | Induction Coil | Not Publicly Available | Same |
| Peak Generator
Power | 1.35 W | .5 W | Not Publicly Available | Performance
testing justified
substantial
equivalence |
| Heating Method | Electrical | NA | Electrical | Same |
Image /page/7/Picture/4 description: The image shows the logo for CAERUS. The logo features the company name in a simple, sans-serif font, with the letters "CAERUS" clearly visible. To the left of the name is a stylized graphic element that resembles a bird's wing or a stylized leaf, adding a touch of visual interest to the overall design.
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VIII. PERFORMANCE DATA
Non-clinical performance testing was conducted to verify the subject device performance. The following performance data was provided in support of the substantial equivalence determination.
Electrical safety and electromagnetic compatibility (EMC):
The systems comply with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing:
The software is classified as a Basic Level of Documentation. Testing and documentation for a Basic Level of Documentation are provided in the submission in compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (June 2023)
Non-Clinical Testing Summary:
The following testing was conducted to satisfy the under the Special Controls under regulation 890.5290(0):
- Peak output power: .
- Pulse width; ●
- Pulse frequency; .
- Duty cycle; ●
- Characteristics of other types of modulation that may be used; .
- Average measured output powered into the RF antenna/applicator;
Image /page/8/Picture/17 description: The image shows the logo for CAERUS. The logo features the company name in a simple, sans-serif font, with the letters "CAERUS" clearly visible. To the left of the name is a stylized graphic element that resembles a wing or a stylized leaf, adding a unique visual element to the logo.
9
- Specific absorption rates in saline gel test load or other appropriate model;
- Characterization of the electrical and magnetic fields in saline gel test load or other appropriate model for each RF antenna and prescribed RF antenna orientation/position; and
- Characterization of the deposited energy density in saline gel test load or other appropriate model.
- Temperature testing was completed on participants of varying skin types to demonstrate that the devices were capable of maintaining a skin temperature of 40 - 45 degrees Celsius for 20 minutes.
Clinical Study:
In compliance with the special controls for regulation 890.5290(b), a clinical study was performed. 120 patients were enrolled, 48 in the Active System (Shortwave Diathermy + Heating Therapy) group and 43 in the SOC group, both males, over 18 years of age, with a history of pain in superficial soft tissue, such as in the ankle, back, knee, wrist, elbow, shoulder, foot, or neck. The incidence of adverse events in this study was notably low, with only 3.3% of participants (4 out of 120) experiencing minor complications. These events were distributed equally across both the Active System + Standard of Care (SOC) and Standard of Care (SOC) groups. The nature of these events were mild, consisting of shoulder pain, sleepiness. discomfort associated with the device wrap, and a tingling or numb sensation in the cervicothoracic region. Critically, there were no reports of serious adverse events or unanticipated adverse device effects. The lack of significant complications and the minimal
occurrence of adverse events reinforces the safety profile of the Active System treatment, affirming its suitability for clinical use in pain management.
This study was conducted in compliance with the Special Controls under regulation 21 CFR 890.5290(b)(2)(iv). The study examined the change from baseline in pain assessment scores at the end of 2 weeks of study treatment using the Mankowski scale. The SOC group experienced a 10% reduction in pain while the Active System + SOC group had 36% reduction in pain.
The findings from this clinical study report establish the Active System as an adjunctive therapy is a significantly more effective intervention for pain management in soft tissue injuries, than Standard of Care (SOC) alone as outlined in the study protocol. Specifically, the study primarily enrolled participants in the foot, knee and shoulder groups. The clinical data was clinically meaningful in the foot, knee and shoulder.
CONCLUSIONS IX.
The substantial equivalence tables and performance testing results demonstrate that the Caerus Corporation Active System and Avenue8 devices are substantially equivalent to the OrthoCor Active Device.
Image /page/9/Picture/13 description: The image shows the logo for CAERUS. The logo features the word "CAERUS" in a sans-serif font. To the left of the word is a stylized graphic that resembles a leaf or a flame. The logo is presented in black against a light gray background.
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CAERUSCORP.COM 8611 W 35W SERVICE DRIVE NE, SUITE 180 BLAINE, MN 55449
Image /page/10/Picture/2 description: The image shows the word "CAERUS" in all capital letters. To the left of the word is a stylized graphic that resembles a leaf or a wing. The text and graphic are in a dark color, set against a light background. The overall impression is clean and modern.