(736 days)
The Omnispec ED1000 is intended for relief of minor muscle aches and pains, temporary increase in local blood circulation and activation of connective tissue.
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.
The provided document is a 510(k) summary for the Medispec Omnispec ED1000, a therapeutic massager. It details the device's characteristics, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.
However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML model's performance. The performance testing section specifically refers to hardware and software validation, biocompatibility, safety standards, and physical parameters of the shockwave output. It emphasizes that this device is a physical therapeutic massager, not an AI/ML powered device.
Therefore, I cannot provide the requested information regarding AI/ML model acceptance criteria, study design, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as these elements are not present in the provided document for this specific device.
The "Performance Testing" section states:
"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."
And the "Clinical Testing" section states:
"Not applicable"
This indicates that the device's performance was evaluated through non-clinical, engineering, and bench testing, rather than studies involving AI/ML performance metrics.
In summary, none of the specific requests related to AI/ML model acceptance criteria and validation studies can be fulfilled from the provided text because the device described is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 6Gaithersburg, MD 20877 |
| Phone: | 1-240-552-7310 |
| Fax: | 301-972-6098 |
| Contact Person: | Mr. Avner Spector |
| Email: | spector@medispec.com |
| Date Prepared: | July 12th, 2022 |
2. DEVICE INFORMATION
| Proprietary Name: | Omnispec™ ED1000 |
|---|---|
| Common Name: | Therapeutic Massager |
| ClassificationName: | Massager, Therapeutic, Electric |
| RegulationNumber: | 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 | OrthoGold100TM (MainPredicateDevice) | D-ACTOR® 200(PredicateDevice) | Omnispec ™ED1000(SubjectDevice) | ComparisonNotes |
|---|---|---|---|---|
| 510(k) Number | K210451 | K173692 | K210166 | NA |
| Product Code | ISA | ISA | ISA | Same |
| Regulation | 21 CFR890.5660 | 21 CFR 890.5660 | 21 CFR890.5660 | Same |
| Intended Use | Relief of minormuscle achesand pains,temporaryincrease in localblood circulationand activation ofconnectivetissue | Relief of minormuscle aches andpains, temporaryincrease in localblood circulationand activation ofconnective tissue | Relief of minormuscle achesand pains,temporaryincrease in localblood circulationand activationof connectivetissue | Same |
| Prescription/OTCuse | Prescription | Prescription | Prescription | Same |
| Mode of Action | Unfocusedpressure pulses | Radial (unfocused)pressure waves, orextracorporealpulse activationrespectively | Pressure pulses | Doesn'taffect safetyandeffectiveness |
| Mechanism ofAction | Extracorporeallyinducedunfocusedpressure pulses | Pneumaticallygeneratedvibrations +unfocusedpressure pulses | Extracorporeallyinducedpressure pulses | Similar |
| ShockwaveGeneration | Electrohydraulic,spark gapelectrode | Pneumatic /ballistic | Electrohydraulic,spark gapelectrode | Same /Similar,respectively |
| CouplingSolution | FDA-clearedultrasound gel | FDA-clearedultrasound gel | FDA-clearedultrasound gel | Same |
| User Interface | Touch screenpanel, touchwheel, foot | Specific descriptionnot available | Touch screenpanel, hand-held applicator | Equivalent toOrthoGold100TM |
| Description | OrthoGold100TM (MainPredicateDevice) | D-ACTOR® 200(PredicateDevice) | OmnispecTMED1000(SubjectDevice) | ComparisonNotes |
| switch, hand-held applicator | ||||
| Main UnitDimensions[mm] | 218 x 400 x 459(H x W x D) | Specific value notavailable | 369 x 364 x 359(H x W x D) | Similar toOrthoGold100TM, bothsuitable fordesktop use |
| ShockwaveApplicatorDimensions[mm] | 230 x Ø 70 | 4: 6mmOD,15mmOD,20mmOD,35mmOD | 130 x Ø 90 | Similar, allare intendedto be hand-held |
| PulsesFrequency | Selectable, 1 - 8Hz in steps of0.5 Hz | Selectable, 1-21Hz | Selectable, 2-2.5 Hz, 120 or160pulses/minute | Similar,OmnispecTMED1000'sfrequenciesare withinthePredicates'range |
| Operating Mode | Continuous | Continuous | Continuous | Same asOrthoGold100TM |
| Peak compress-ional acousticpressure pc[Mpa] | 9.27 at energylevel 16 | 18.5 | 13.8 | SimilarOmnispecTMED1000'spressure iswithin therange of D-ACTOR®200 |
| Peakrarefactionalacousticpressure [Mpa] | -1.52 at energylevel 16 | 6.8MPa at 5 bar | 2.0 | SimilarOmnispecTMED1000'spressure iswithin therange of D-ACTOR®200 |
| Positive peakpressureamplitude [Mpa] | 0.43 - 9.27 atenergy level 1 -16 | 5 bar/18.5Mpa3bar/13.4MPa | 13.8 | SimilarOmnispecTMED1000'spressure is |
| Description | OrthoGoldTM 100TM (MainPredicateDevice) | D-ACTOR® 200(PredicateDevice) | OmnispecTM ED1000(SubjectDevice) | ComparisonNotes |
| within therange of D-ACTOR®200 | ||||
| Distancebetween focusand targetlocation | n/a | n/a | 65mm | Doesn'taffect safetyandeffectiveness |
| Maximumpenetrationdepth (-6dB) | 25.4mm atenergy level 16 | 32 mm | 110mm | Doesn'taffect safetyandeffectiveness |
| Negative peakpressureamplitude (MPa) | -0.17 to -1.52 atenergy level 1 -16 | 5bar/6.8MPa3bar/5.0MPa | 2.0 | SimilarOmnispecTMED1000'spressure iswithin therange of thepredicates |
| Energy flowdensity | 0.00017-0.04403mJ/mm2at energy level1-16 | 5bar/0.284mJ/mm23bar/0.176mJ/mm2 | 0.14 mJ/mm2 | SimilarOmnispecTMED1000'senergy flowdensity iswithin therange of thepredicates |
| Derived focalacoustic pulseenergy (mJ) | 0.022 - 2.278 atenergy level 1 -16 | 5bar/6.5mJ3bar/2.4mJ | 1.035 at 14.5kV | Similar,OmnispecTMED1000'senergy iswithinOrthoGold100TM'srange |
| Rise time (ns) | 1.89 - 0.28 atenergy level 1 -16 | Ultrasonic pulse:2.5μsSonic pulse: 25μs- 2.5ms | 39 | SimilarOmnispecTMED1000'srise time iswithin therange of D- |
| Description | OrthoGold100TM (MainPredicateDevice) | D-ACTOR® 200(PredicateDevice) | OmnispecTMED1000(SubjectDevice) | ComparisonNotes |
| ACTOR®200 | ||||
| Compress-ionalpulse duration(μs) | 1.23 - 0.77 atenergy level 1 -16 | Ultrasonic pulse:5.0μsSonic pulse: 50μs- 5.0ms | 0.136 | Similar |
| Applicator WetShelf Life | Specific ValueNot Available | Specific Value NotAvailable | 6 months | NA |
| Applicator DryShelf Life | Specific ValueNot Available | Specific Value NotAvailable | 18 months | NA |
| Applicator UseLife | 100,000 pulsesat energy level 1- 10; 70,000pulses at energylevel 11 - 16 | Specific Value NotAvailable | 110,000 pulses | Similar,OmnispecTMED1000 hasonly oneenergy level |
| PatientContactingMaterials | Membrane:SiliconeCoupling Media:Ultrasound Gel | Coupling Media:Ultrasound Gel | Membrane:SiliconeCoupling Media:Ultrasound Gel | Equivalent |
| Compliance withConsensusStandards | IEC 60601-1,IEC 60601-1-2,60601-2-36, ISO60601-1-6, ISO62304, Draft IEC63045, ISO10993-1 | IEC 60601-1, IEC60601-1-2, ISO62304, IEC 62304,IEC 61000-3-2,IEC 61000-3-3,ISO 10993-1 | IEC 60601-1,IEC 60601-1-2,60601-2-36,ISO 60601-1-6,ISO 62304, IEC61846, ISO10993-1 | Equivalent,Draft IEC63045 isequivalent toIEC 61846but appliesto unfocusedpressurepulses |
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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.
§ 890.5660 Therapeutic massager.
(a)
Identification. A therapeutic massager is an electrically powered device intended for medical purposes, such as to relieve minor muscle aches and pains.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.