ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE

K121702 · Orthocor Medical · ILX · May 6, 2013 · Physical Medicine

Device Facts

• Record ID: K121702
• Device Name: ORTHOCOR ACTIVE DEVICE ORTHOCOR GENERAL USE ACTIVE DEVICE
• Applicant: Orthocor Medical
• Product Code: ILX · Physical Medicine
• Decision Date: May 6, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Device Story

OrthoCor Active Device is a portable, battery-operated, non-invasive shortwave diathermy device. It delivers electromagnetic energy at 27.12 MHz via two applicator coils using inductive coupling. The device operates by athermal means, avoiding deep tissue heat generation. It is positioned on the body using a wrap to treat specific locations. The device is intended for general use; it is operated by the patient or clinician. Output is a pulsed RF signal (6.5±0.5µWs/cm³). The device provides palliative relief for postoperative pain and edema, potentially benefiting patients by reducing recovery discomfort.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by bench and safety testing, including compliance with IEC 60601-1 and IEC 60601-1-2 standards. Performance testing focused on energy/area measurements, confirming the subject device matches the predicate's energy deposition profile.

Technological Characteristics

Portable, battery-operated shortwave diathermy device. Operates at 27.12 MHz RF frequency. Delivers pulsed RF signal via inductive coupling using two applicator coils. Energy density: 6.5 µWs/cm³. Peak power: 0.5W. Duty cycle: 0.4%. Standards: IEC 60601-1 (General Safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OrthoCor Active Knee System (K091996)

Submission Summary (Full Text)

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A final order reclassifying shortwave diathermy (SWD) 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, a preamendments Class III device, into class II, and renaming the device "nonthermal shortwave therapy" (SWT), was published on October 13, 2015. See here: https://www.federalregister.gov/documents/2015/10/13/2015-

25923/physical-medicine-devices-reclassification-of-shortwavediathermy-for-all-other-uses-henceforth-to

While the device submitted and cleared through K121702 may serve as a valid predicate device for a new SWT device, please refer to the aforementioned final order for current regulatory requirements for this device type.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 6, 2013

OrthoCor Medical % MEDicept, Inc. . Mr. David Rothkopf President 200 Homer Avenue Ashland, MA 01721

Re: K121702

Trade/Device Name: OrthoCor Active Device Regulation Number: 21 CFR 890.5290(b) Regulation Name: Shortwave Diathermy for All Other Uses Regulatory Class: Class III Product Code: ILX Dated: April 17, 2013 Received: April 18, 2013

Dear Mr. Rothkopf:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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.

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 (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. David Rothkopf

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address:

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to:

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address:

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Joyce M. Whang -ś

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K121702

Device Name: OrthoCor Active Device

Indications for Use:

The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Prescription Use & 21CFR 801, Subpart D OR Over-the-Counter Use _ 21 CFR 876.1500

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

# Joyce M. Whang -S

Division Sign Off Office of Device Evaluation

K121702

510 (K) ______________________________________________________________________________________________________________________________________________________________________

OrthoCor Medical

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# K 121702

#### 510(k) Summary of Safety and Effectiveness in accordance with 21 CFR 807.92(a)(1) Date this 510(k) Summary was prepared: May 2, 2013

A) Manufacturer: OrthoCor Medical, Inc. 4848 IDS Center 80 8th Street Minneapolis, MN 55402 Contact: John Dinusson Contact: MEDIcept, Inc. 200 Homer Ave Ashland, MA 01721 Telephone: [phone] Fax: [phone] Contact: F. David Rothkopf B) Trade Name OrthoCor Active Device Common Name: Shortwave Diathermy Classification Name: Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat. Device Regulations: 21 CFR 890.5290(b) Class: III Product Code: ILX C) Predicate: K091996 - OrthoCor Active Knee System

D) Device Description:

The OrthoCor General Use Device (marketed as the OrthoCor Active Device) is a portable (battery operated) non-invasive shortwave diathermy medical device. Through the use of resonators and two applicator coils, the device applies electromagnetic energy at a radio frequency (RF) of 27.12MHz for the treatment of medical conditions by means other than the generation of deep heat within body tissues, i/e/. by athermal means. The OrthoCor General Use Device delivers the pulsed RF signal of 6.5±0.5µWs/cm³ to the tissue target via inductive coupling using two applicator coils. It is a general use device and can be positioned on the body with a wrap designed to hold the device in place at the location that requires treatment.

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#### E) Intended Use:

The device is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

F) Substantial Equivalence Summary

| | OrthoCor General Use Device | OrthoCor Active Knee System |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | TBD | K091996 |
| Indication for Use | Adjunctive use in the palliative<br>treatment of postoperative edema<br>and pain in superficial soft tissue | Adjunctive use in the palliative<br>treatment of postoperative edema<br>and pain in superficial soft tissue |
| Exposure | 30 minutes | 30 minutes |
| Anatomical site | General Use | Knee |
| Clinical data submitted | No | No |
| Electrical Specifications | | |
| Peak Power | 0.5W | 0.5W |
| Average Output Power<br>(over 1 second) | 2mW | 2mW |
| Energy Density (μ) | 6.5 | 6.5 |
| Voltage | 3V | 3V |
| Therapy control burst width | 2ms/PPR 2±.03Hz | 2ms/PPR 2±.03Hz |
| Burst frequency | 2Hz | 2Hz |
| Duty Cycle (%) | 0.4% | 0.4% |
| Current | 10mA | 10mA |
| Frequency - short wave | 27.12 MHz | 27.12 MHz |
| Peal B Field (T) | 0.004042 T* | 0.004042 T* |
| Output impedance | 50 Ohm | 50 Ohm |
| Physical Specifications | | |
| Applicator Size,<br>Coil perimeter | 108.6cm | 108.6cm |
| Applicator Type | Induction coil | Induction coil |

* Value calculated by: B=V(u *2μο), u = Energy Density , μο= Magnetic Constant = 4π*107

#### G) Conformity to Standards

There were no FDA guidance documents identified for this device.

- IEC 60601-1 Medical Electrical Equipment Part I: General Reguirements for Basic . Safety and Essential Performance
- IEC 60601-1-2 Medical Electrical Equipment- Part 2: General Requirements for Safety-. Collateral Standard: Electromagnetic Compatibility- Requirements and Tests

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#### H) Performance Testing

The results of the bench and safety testing indicated that the new device is as safe and as effective as the predicate device. The energy/area is the most relevant measure because it is the total energy deposited into the body per specific area. The OrthoCor device and the predicate device all have similar energy/area measurements.

#### Conclusion

OrthoCor Medical, Inc. believes that based on the indications for use, technological characteristics, and comparison to predicate devices, the OrthoCor General Use Device has been shown to be substantially equivalent to the predicate and safe and effective for its intended use.