Omnispec ED1000

K210166 · Medispec, Ltd. · ISA · Jan 27, 2023 · Physical Medicine

Device Facts

• Record ID: K210166
• Device Name: Omnispec ED1000
• Applicant: Medispec, Ltd.
• Product Code: ISA · Physical Medicine
• Decision Date: Jan 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5660
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

Device Story

Omnispec ED1000 is a portable, self-contained shock wave therapy unit for therapeutic massage. Device uses electro-hydraulic method: electrode within water-filled stainless-steel reflector chamber (Shock Wave Applicator) ignites electrical discharge; water evaporation creates shock wave; wave reflects off chamber through flexible membrane into patient skin. Device provides focused pressure pulses; second focus (F2) occurs within applicator membrane. Used in clinical settings by healthcare providers. Output is focused pressure pulses transmitted to treatment site. Benefits include relief of minor muscle aches/pains, increased local blood circulation, and connective tissue activation. Provider operates device via touch screen panel and hand-held applicator.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation confirmed design specifications. Biocompatibility per ISO 10993-1; electrical safety per ANSI AAMI ES60601-1; EMC per IEC 60601-1-2 and 60601-2-36; acoustic parameters per IEC 61846.

Technological Characteristics

Electro-hydraulic shock wave generator; spark gap electrode; stainless-steel reflector chamber; silicone membrane; ultrasound gel coupling. Dimensions: 369x364x359mm. Connectivity: standalone. Software: moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, 60601-2-36, ISO 60601-1-6, ISO 62304, IEC 61846, ISO 10993-1.

Indications for Use

Indicated for relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue in patients requiring therapeutic massage on upper extremities (shoulder to wrist) or lower extremities (hip to foot).

Regulatory Classification

Identification

A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.

Predicate Devices

• OrthoGold 100 (K210451)
• D-ACTOR 200 Vibration Massage System (K173692)

Submission Summary (Full Text)

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January 27, 2023

Medispec Ltd. Avner Spector CEO 203 Perry Parkway, Suite 6 Gaithersburg, Maryland 20877

#### Re: K210166

Trade/Device Name: Omnispec ED1000 Regulation Number: 21 CFR 890.5660 Regulation Name: Therapeutic Massager Regulatory Class: Class I Product Code: ISA Dated: November 16, 2022 Received: December 21, 2022

#### Dear Avner Spector:

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.

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

# Heather L. Dean -S

Heather Dean, PhD Assistant Director, Acute Injury Devices Team 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) K210166

Device Name Omnispec ED1000

Indications for Use (Describe)

The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| | Commercial Use (If not for RFF, skip to next section) |
|--|-------------------------------------------------------|
| | In Situ Treatment with RFF |

X | 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 Medispec logo. The logo features a stylized letter "M" with a blue circle around the top left portion of the letter. The rest of the logo is the word "MEDISPEC" in gray, block letters. The logo is simple and modern, and the colors are clean and professional.

# 510(k) Summary K210166

#### 1. SPONSOR

| Name: | Medispec, Ltd. |
|-----------------|------------------------------------------------|
| Address: | 203 Perry Pkwy Ste 6<br>Gaithersburg, MD 20877 |
| Phone: | 1-240-552-7310 |
| Fax: | 301-972-6098 |
| Contact Person: | Mr. Avner Spector |
| Email: | [e-mail] |
| Date Prepared: | July 12th, 2022 |

#### 2. DEVICE INFORMATION

| Proprietary Name: | Omnispec™ ED1000 |
|-------------------------|---------------------------------|
| Common Name: | Therapeutic Massager |
| Classification<br>Name: | Massager, Therapeutic, Electric |
| Regulation<br>Number: | 21 CFR 890.5660 |
| Product Code: | ISA |
| Device Class: | I |

#### 3. PREDICATE DEVICES

Equivalence is claimed to the OrthoGold 100™ of Tissue Regeneration Technologies, LLC, submissions number K210451, and D-ACTOR® 200 Vibration Massage System (K173692).

#### 4. INTENDED USE

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Image /page/4/Picture/0 description: The image shows the logo for Medispec. The logo consists of a blue circle with a gray "M" inside of it. The text "MEDISPEC" is written in gray, with each letter connected to the next.

Omnispec™ ED1000TM is intended for the relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.

#### 5. DEVICE DESCRIPTION

Omnispec™ ED1000 is a portable, self-contained Shock Wave Therapy unit. It employs an electro-hydraulic method of creating shock waves. With this technique, an electrode, located within a water-containing stainless-steel reflector chamber called Shock Wave Applicator (SWA), ignites an electrical discharge, evaporating a small portion of the water and creating a shock wave reflecting outward off the reflector through a flexible membrane. The result is a shock (pressure) wave that passes through a conducting medium (patient). The shock wave is transmitted through the skin surface of the patient to the treatment site. The device provides focused pressure pulses where the second focus (F2) occurs within the membrane of the applicator. Treatment should only be applied to the upper extremities, from the shoulder to the wrist, and to the lower extremities from the hip to the foot.

#### 6. PERFORMANCE TESTING

Verification and validation testing were performed and demonstrated that Omnispec™ ED1000 met the design specifications and it was safe and effective for its intended use. All tests required by the verification and validation plan were completed and passed successfully.

Omnispec™ ED1000's software was validated and demonstrated to be of a moderate level of concern . Hazard analysis / risk management was performed and demonstrated that all risks were mitigated to an acceptable level.

The skin contacting component of the Shock Wave Applicator was tested for biocompatibility and found to conform to elements of ISO 10993-1.

Omnispec™ ED1000 was tested and demonstrated to conform to the general safety requirements of ANSI AAMI ES60601-1, as well as the electromagnetic compatibility requirements of IEC 60601-1-2 and 60601-2-36.

Ultrasonic energy parameters were evaluated using protocols from IEC 61846. Those tests demonstrated that the energy output of Omnispec™ ED1000 was within the safe limits and was demonstrated to be equivalent to the predicate device.

In addition, pressure stability, acoustic noise, cleaning and disinfection, drop and vibration, as well as Shock Wave Applicator shelf life verification and validation tests was also conducted. The performance testing has

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Image /page/5/Picture/0 description: The image shows the Medispec logo. The logo features two overlapping circles, one in blue and one in gray. The word "MEDISPEC" is written in gray, with the "M" partially obscured by the circles. The logo is simple and modern, and the colors are clean and professional.

demonstrated that the Omnispec™ ED1000 is substantially equivalent to the predicate devices, and that it is safe and effective for its intended use. The table below compares Omnispec™ ED1000's characteristics to the predicate devices.

| Description | OrthoGold<br>100TM (Main<br>Predicate<br>Device) | D-ACTOR® 200<br>(Predicate<br>Device) | Omnispec ™<br>ED1000<br>(Subject<br>Device) | Comparison<br>Notes |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K210451 | K173692 | K210166 | NA |
| Product Code | ISA | ISA | ISA | Same |
| Regulation | 21 CFR<br>890.5660 | 21 CFR 890.5660 | 21 CFR<br>890.5660 | Same |
| Intended Use | Relief of minor<br>muscle aches<br>and pains,<br>temporary<br>increase in local<br>blood circulation<br>and activation of<br>connective<br>tissue | Relief of minor<br>muscle aches and<br>pains, temporary<br>increase in local<br>blood circulation<br>and activation of<br>connective tissue | Relief of minor<br>muscle aches<br>and pains,<br>temporary<br>increase in local<br>blood circulation<br>and activation<br>of connective<br>tissue | Same |
| Prescription/OTC<br>use | Prescription | Prescription | Prescription | Same |
| Mode of Action | Unfocused<br>pressure pulses | Radial (unfocused)<br>pressure waves, or<br>extracorporeal<br>pulse activation<br>respectively | Pressure pulses | Doesn't<br>affect safety<br>and<br>effectiveness |
| Mechanism of<br>Action | Extracorporeally<br>induced<br>unfocused<br>pressure pulses | Pneumatically<br>generated<br>vibrations +<br>unfocused<br>pressure pulses | Extracorporeally<br>induced<br>pressure pulses | Similar |
| Shockwave<br>Generation | Electrohydraulic,<br>spark gap<br>electrode | Pneumatic /<br>ballistic | Electrohydraulic,<br>spark gap<br>electrode | Same /<br>Similar,<br>respectively |
| Coupling<br>Solution | FDA-cleared<br>ultrasound gel | FDA-cleared<br>ultrasound gel | FDA-cleared<br>ultrasound gel | Same |
| User Interface | Touch screen<br>panel, touch<br>wheel, foot | Specific description<br>not available | Touch screen<br>panel, hand-<br>held applicator | Equivalent to<br>OrthoGold<br>100TM |
| Description | OrthoGold<br>100TM (Main<br>Predicate<br>Device) | D-ACTOR® 200<br>(Predicate<br>Device) | OmnispecTM<br>ED1000<br>(Subject<br>Device) | Comparison<br>Notes |
| | switch, hand-held applicator | | | |
| Main Unit<br>Dimensions<br>[mm] | 218 x 400 x 459<br>(H x W x D) | Specific value not<br>available | 369 x 364 x 359<br>(H x W x D) | Similar to<br>OrthoGold<br>100TM, both<br>suitable for<br>desktop use |
| Shockwave<br>Applicator<br>Dimensions<br>[mm] | 230 x Ø 70 | 4: 6mmOD,<br>15mmOD,<br>20mmOD,<br>35mmOD | 130 x Ø 90 | Similar, all<br>are intended<br>to be hand-held |
| Pulses<br>Frequency | Selectable, 1 - 8<br>Hz in steps of<br>0.5 Hz | Selectable, 1-21<br>Hz | Selectable, 2-<br>2.5 Hz, 120 or<br>160<br>pulses/minute | Similar,<br>OmnispecTM<br>ED1000's<br>frequencies<br>are within<br>the<br>Predicates'<br>range |
| Operating Mode | Continuous | Continuous | Continuous | Same as<br>OrthoGold<br>100TM |
| Peak compress-<br>ional acoustic<br>pressure pc<br>[Mpa] | 9.27 at energy<br>level 16 | 18.5 | 13.8 | Similar<br>OmnispecTM<br>ED1000's<br>pressure is<br>within the<br>range of D-<br>ACTOR®<br>200 |
| Peak<br>rarefactional<br>acoustic<br>pressure [Mpa] | -1.52 at energy<br>level 16 | 6.8MPa at 5 bar | 2.0 | Similar<br>OmnispecTM<br>ED1000's<br>pressure is<br>within the<br>range of D-<br>ACTOR®<br>200 |
| Positive peak<br>pressure<br>amplitude [Mpa] | 0.43 - 9.27 at<br>energy level 1 -<br>16 | 5 bar/18.5Mpa<br>3bar/13.4MPa | 13.8 | Similar<br>OmnispecTM<br>ED1000's<br>pressure is |
| Description | OrthoGoldTM 100TM (Main<br>Predicate<br>Device) | D-ACTOR® 200<br>(Predicate<br>Device) | OmnispecTM ED1000<br>(Subject<br>Device) | Comparison<br>Notes |
| | | | | within the<br>range of D-<br>ACTOR®<br>200 |
| Distance<br>between focus<br>and target<br>location | n/a | n/a | 65mm | Doesn't<br>affect safety<br>and<br>effectiveness |
| Maximum<br>penetration<br>depth (-6dB) | 25.4mm at<br>energy level 16 | 32 mm | 110mm | Doesn't<br>affect safety<br>and<br>effectiveness |
| Negative peak<br>pressure<br>amplitude (MPa) | -0.17 to -1.52 at<br>energy level 1 -<br>16 | 5bar/6.8MPa<br>3bar/5.0MPa | 2.0 | Similar<br>OmnispecTM<br>ED1000's<br>pressure is<br>within the<br>range of the<br>predicates |
| Energy flow<br>density | 0.00017-<br>0.04403mJ/mm2<br>at energy level<br>1-16 | 5bar/0.284mJ/mm2<br>3bar/0.176mJ/mm2 | 0.14 mJ/mm2 | Similar<br>OmnispecTM<br>ED1000's<br>energy flow<br>density is<br>within the<br>range of the<br>predicates |
| Derived focal<br>acoustic pulse<br>energy (mJ) | 0.022 - 2.278 at<br>energy level 1 -<br>16 | 5bar/6.5mJ<br>3bar/2.4mJ | 1.035 at 14.5<br>kV | Similar,<br>OmnispecTM<br>ED1000's<br>energy is<br>within<br>OrthoGold<br>100TM's<br>range |
| Rise time (ns) | 1.89 - 0.28 at<br>energy level 1 -<br>16 | Ultrasonic pulse:<br>2.5μs<br>Sonic pulse: 25μs<br>- 2.5ms | 39 | Similar<br>OmnispecTM<br>ED1000's<br>rise time is<br>within the<br>range of D- |
| Description | OrthoGold<br>100TM (Main<br>Predicate<br>Device) | D-ACTOR® 200<br>(Predicate<br>Device) | OmnispecTM<br>ED1000<br>(Subject<br>Device) | Comparison<br>Notes |
| | | | | ACTOR®<br>200 |
| Compress-ional<br>pulse duration<br>(μs) | 1.23 - 0.77 at<br>energy level 1 -<br>16 | Ultrasonic pulse:<br>5.0μs<br>Sonic pulse: 50μs<br>- 5.0ms | 0.136 | Similar |
| Applicator Wet<br>Shelf Life | Specific Value<br>Not Available | Specific Value Not<br>Available | 6 months | NA |
| Applicator Dry<br>Shelf Life | Specific Value<br>Not Available | Specific Value Not<br>Available | 18 months | NA |
| Applicator Use<br>Life | 100,000 pulses<br>at energy level 1<br>- 10; 70,000<br>pulses at energy<br>level 11 - 16 | Specific Value Not<br>Available | 110,000 pulses | Similar,<br>OmnispecTM<br>ED1000 has<br>only one<br>energy level |
| Patient<br>Contacting<br>Materials | Membrane:<br>Silicone<br>Coupling Media:<br>Ultrasound Gel | Coupling Media:<br>Ultrasound Gel | Membrane:<br>Silicone<br>Coupling Media:<br>Ultrasound Gel | Equivalent |
| Compliance with<br>Consensus<br>Standards | IEC 60601-1,<br>IEC 60601-1-2,<br>60601-2-36, ISO<br>60601-1-6, ISO<br>62304, Draft IEC<br>63045, ISO<br>10993-1 | IEC 60601-1, IEC<br>60601-1-2, ISO<br>62304, IEC 62304,<br>IEC 61000-3-2,<br>IEC 61000-3-3,<br>ISO 10993-1 | IEC 60601-1,<br>IEC 60601-1-2,<br>60601-2-36,<br>ISO 60601-1-6,<br>ISO 62304, IEC<br>61846, ISO<br>10993-1 | Equivalent,<br>Draft IEC<br>63045 is<br>equivalent to<br>IEC 61846<br>but applies<br>to unfocused<br>pressure<br>pulses |

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Image /page/6/Picture/0 description: The image shows the logo for Medispec. The logo consists of a stylized letter "M" with a blue circle around the top left portion of the letter. The rest of the word "MEDISPEC" is written in gray, sans-serif font.

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Image /page/7/Picture/0 description: The image shows the logo for Medispec. The logo consists of two overlapping circles, one in blue and one in gray, with the letter "M" in the center. The text "MEDISPEC" is written in gray, with the "M" connected to the circles. The logo is simple and modern, and the colors are calming and professional.

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Image /page/8/Picture/0 description: The image shows the Medispec logo. The logo features a stylized letter "M" with a blue arc above it. The word "MEDISPEC" is written in gray, with the "M" being connected to the arc. The font is sans-serif and appears to be a modern design.

### 7. CLINICAL TESTING

Not applicable

#### 8. SUMMARY

Omnispec™ ED1000 has the same intended use and similar design features as compared with the predicate systems. The devices share similar core technologies and principle of operation. The performance testing has demonstrated that the performance characteristics of Omnispec™ ED1000 are equivalent to those of other legally marketed therapeutic massagers, and

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Image /page/9/Picture/0 description: The image shows the Medispec logo. The logo features a stylized symbol resembling interconnected circles in blue and gray. To the right of the symbol, the word "MEDISPEC" is written in gray, with each letter clearly visible. The overall design is clean and professional, suggesting a company in the medical or technology field.

therefore it supports a determination of Substantial Equivalence for the proposed intended use.

Any differences between Omnispec™ ED1000 and the predicate device do not affect the safety or effectiveness, or raise different questions of safety and effectiveness.