K092044 · Orthocor Medical · ILX · Dec 18, 2009 · Physical Medicine
Device Facts
Record ID
K092044
Device Name
ORTHOCOR KNEE SYSTEM, MEDIAN, LARGE, X-LARGE
Applicant
Orthocor Medical
Product Code
ILX · Physical Medicine
Decision Date
Dec 18, 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. Temporary relief of minor muscular and joint aches and pains associated with overexertion, strains, sprains, and arthritis
Device Story
Portable, battery-operated shortwave diathermy device; applies 27.12 MHz electromagnetic energy via inductive coupling coil applicator to superficial soft tissues. System includes disposable, air-activated OrthoPods for heat therapy, snapped into knee wrap slots. Used by licensed physicians/chiropractors in clinical settings; treatment applied through dressings, clothing, or casts. Athermal RF signal (6.5 µWs/cm³) targets pain and edema; heat from OrthoPods provides additional relief. Device intended for palliative pain management and reduction of edema; benefits patient through non-invasive, portable therapeutic delivery.
Clinical Evidence
Bench testing only. No clinical data presented. Equivalence established through comparative bench testing of output parameters against predicate device.
Technological Characteristics
Portable battery-operated (3V-4.2V DC) shortwave diathermy; 27.12 MHz carrier frequency; inductive coupling via coil applicator. Includes disposable air-activated heat packs. Conforms to IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility).
Indications for Use
Indicated for adjunctive palliative treatment of post-operative pain and edema in superficial soft tissue; temporary relief of minor muscular and joint aches/pains from overexertion, strains, sprains, and arthritis.
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.
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K092044
# DEC 1 8 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: 651-641-2829 |
| TRADE NAME: | OrthoCor Active Knee System |
| COMMON NAME: | Shortwave Diathermy |
| CLASSIFICATION NAME: | Diathermy, Shortwave, For Use Other Than Applying<br>Therapeutic Deep Heat<br>Hot or cold disposable pack |
| DEVICE CLASS: | Class III |
| PRODUCT CODE: | ILX, 21 CFR 890.5290(b)<br>IMD, 21 CFR 890.5710 |
| PREDICATE: | Ivivi K070541 (Torino II)<br>OrthoCor K091640 |
#### DEVICE DESCRIPTION
The OrthoCor Active 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/cm to the tissue target via the inductive coupling with an applicator coil. The system also includes disposable, single-use, air activated OrthoPods that provide heat. The OrthoPods are snapped into medial and lateral slots on the knee wrap. 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.
- . Temporary relief of minor muscular and joint aches and pains associated with overexertion, strains, sprains, and arthritis
## 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.
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## COMPARISON TO PREDICATE DEVICES(s)
The OrthoCor Medical, OrthoCor Active Knee System has the same intended use, target population, clinical setting, and technology as its predicate devices.
| Device Features | Predicate<br>IVIVI Torino II K070541 | OrthoCor Active 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 I: 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 Active Knee System Basic 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 U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
DEC 1 8 2009
OrthoCor Medical, Inc. % Advanced Medical Consortium Ms. Ines Burgos 9907 Oakleaf Way McCordsville, IN 46055
Re: K092044
Trade/Device Name: OrthoCor Knee System Regulation Number: 21 CFR 890.5290 Regulation Name: Shortwave diathermy Regulatory Class: Class III Product Code: ILX, IMD 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Ines Burgos
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Sincerely yours,
Mark A. Milliken
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
## Indications for Use:
OrthoCor Knee System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
Temporary relief of minor muscular and joint aches and pains associated with over-exertion, strains, sprains, and arthritis.
Prescription Use X 21CFR 801, Subpart D
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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)
FOR M.MELKERSON
Sigingical, Orthopedic, Division on of the Device
510(k) Number K092044
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
