ORTHOCOR KNEE SYSTEM BASIC

K091996 · Orthocor Medical · ILX · Dec 15, 2009 · Physical Medicine

Device Facts

• Record ID: K091996
• Device Name: ORTHOCOR KNEE SYSTEM BASIC
• Applicant: Orthocor Medical
• Product Code: ILX · Physical Medicine
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5290
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

Device Story

Portable, battery-operated non-invasive shortwave diathermy device; applies electromagnetic energy at 27.12 MHz via inductive coupling. System consists of knee wrap with medial and lateral slots for 'OrthoPods' to activate signal. Delivers pulsed RF signal of 6.5±0.5µWs/cm3 to superficial soft tissue. Used by licensed physicians or chiropractors; treatment applied directly through dressings, clothing, casts, or supports. Athermal operation (no deep heat generation). Intended to reduce post-operative pain and edema, potentially benefiting patient recovery.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative bench testing of output parameters and adherence to electrical/electromagnetic safety standards (IEC 60601-1, IEC 60601-1-2).

Technological Characteristics

Portable, battery-operated (3V-4.2V DC). Emits 27.12 MHz ± 5% RF energy. Inductive coupling via applicator coil. Pulsed signal: 2msec burst duration, 2Hz burst frequency, 6.5 µWs/cm³ energy density. Conforms to IEC 60601-1 (general safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for adjunctive palliative treatment of post-operative 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

• Ivivi Torino II (K070541)

Submission Summary (Full Text)

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KO91996

# DEC 1 5 2009

#### 510(k) Summary

| SUBMITTED BY: | ORTHOCOR MEDICAL, Inc.<br>1000 Westgate Drive, Suite 243,<br>Minneapolis, MN 55114<br>Registration: Awaiting Assignment |
|----------------------|-------------------------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 22, 2009 |
| CONTACT: | Advanced Medical Consortium<br>9907 Oakleaf Way<br>McCordsville, IN 46055<br>Tel: [phone] |
| TRADE NAME: | OrthoCor Knee System |
| COMMON NAME: | Shortwave Diathermy |
| CLASSIFICATION NAME: | Diathermy, Shortwave, For Use Other Than Applying<br>Therapeutic Deep Heat |
| DEVICE CLASS: | Class III |
| PRODUCT CODE: | ILX, 21 CFR 890.5290(b) |
| PREDICATE: | Ivivi K070541 (Torino II) |

#### DEVICE DESCRIPTION

The OrthoCor Knee System is a portable (battery operated) non-invasive shortwave diathermy medical device which applies electromagnetic energy at a radio frequency (RF) of 27.12 MHz 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 Knee System delivers the pulsed RF signal of 6.5±0.5µWs/cm3 to the tissue target via the inductive coupling with an applicator coil. OrthoPods are snapped into medial and lateral slots on the knee wrap to activate the system. Treatment may occur directly through dressings, clothing, casts, compression garments or supports. The OrthoCor device is substantial equivalent to the Ivivi Torino II device in parameters, treatment and power

#### INTENDED USE

- Adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft . tissue.
#### DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Equivalence was based on bench testing that showed the device produces the same outputs as the predicate as shown in the table below.

## COMPARISON TO PREDICATE DEVICES(s)

The OrthoCor Medical OrthoCor Knee System has the same intended use, target population, clinical setting, and technology as its predicate devices.

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| Device Features | Predicate<br>IVIVI Torino II K070541 | OrthoCor Knee System |
|----------------------------|--------------------------------------|-----------------------------------------|
| Technology | Deposit athermal RF energy in tissue | Deposit athermal RF energy in<br>tissue |
| Anatomical sites | Superficial soft tissues | Superficial soft tissues (knee) |
| Practitioner | Licensed physician/chiropractor | Licensed physician/chiropractor |
| Portable | Yes | Yes |
| How Energy Deposited | Induction (coil applicator) | Induction |
| Carrier Frequency | 27.12 MHz | 27.12 MHz ± 5% |
| Burst duration | 2msec | 2msec |
| Burst frequency-- | 2Hz | 2Hz |
| Energy Deposited Per Pulse | 6.5 µWs/cm³ | 6.5 µWs/cm³ |
| Electrical safety | Conforms with IEC 60601-1 | Conforms with IEC 60601-1 |
| Electromagnetic safety | Conforms with IEC 60601-1-2 | Conforms with IEC 60601-1-2 |
| Power required | Battery or Mains | 3V-4.2V DC (battery) |

### STANDARDS MET

- IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements 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

#### CONCLUSION

OrthoCor Medical, Inc. believes that the OrthoCor Knee System is substantially equivalent to the predicate device based on intended usage, technology comparison and system performance.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

DEC 1 5 2009

OrthoCor Medical, Inc. % Advanced Medical Consortium Ms. Ines Burgos 9907 Oakleaf Way McCordsville, IN 46055

Re: K091996

Trade/Device Name: OrthoCor Knee System Basic Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX Dated: November 27, 2009 Received: December 3, 2009

Dear Ms. Burgos:

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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

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Page 2 - Ms. Ines Burgos

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

Jonata

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications For Use Form

510(k) Number:

Device Name: OrthoCor Knee System Basic

Indications for Use: The OrthoCor Knee System Basic is indicated for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue.

Prescription Use X 21CFR 801, Subpart D

OR Over-the-Counter Use 21CFR 801.109

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hauley M. Dayle FOR M. MELKERSON
Division Sign Off

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091996