(736 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on the electro-hydraulic mechanism of shock wave generation, not AI/ML processing.
Yes
The device is intended for the relief of minor muscle aches and pains, temporary increase in local blood circulation, and activation of connective tissue, which are all therapeutic purposes.
No
The device description and intended use indicate it is a therapeutic device for pain relief, blood circulation increase, and connective tissue activation, not for diagnosing conditions.
No
The device description explicitly states it is a "portable, self-contained Shock Wave Therapy unit" that employs an "electro-hydraulic method of creating shock waves" and includes a "Shock Wave Applicator (SWA)". This indicates a physical hardware component that delivers the therapy, not just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Omnispec ED1000 Function: The description clearly states that the Omnispec ED1000 is a Shock Wave Therapy unit that applies pressure pulses directly to the patient's skin for the relief of muscle aches and pains, increased blood circulation, and activation of connective tissue. It does not involve the analysis of specimens taken from the body.
The device is a therapeutic device that applies physical energy to the body, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
ISA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremities, from the shoulder to the wrist, and to the lower extremities from the hip to the foot.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 demonstrated that the Omnispec™ ED1000 is substantially equivalent to the predicate devices, and that it is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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 |
| Gaithersburg, 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 |
| Classification | |
| Name: | Massager, Therapeutic, Electric |
| Regulation | |
| 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
5
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
100TM (Main
Predicate
Device) | D-ACTOR® 200
(Predicate
Device) | Omnispec ™
ED1000
(Subject
Device) | Comparison
Notes |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K210451 | K173692 | K210166 | NA |
| Product Code | ISA | ISA | ISA | Same |
| Regulation | 21 CFR
890.5660 | 21 CFR 890.5660 | 21 CFR
890.5660 | Same |
| Intended Use | Relief of minor
muscle aches
and pains,
temporary
increase in local
blood circulation
and activation of
connective
tissue | Relief of minor
muscle aches and
pains, temporary
increase in local
blood circulation
and activation of
connective tissue | Relief of minor
muscle aches
and pains,
temporary
increase in local
blood circulation
and activation
of connective
tissue | Same |
| Prescription/OTC
use | Prescription | Prescription | Prescription | Same |
| Mode of Action | Unfocused
pressure pulses | Radial (unfocused)
pressure waves, or
extracorporeal
pulse activation
respectively | Pressure pulses | Doesn't
affect safety
and
effectiveness |
| Mechanism of
Action | Extracorporeally
induced
unfocused
pressure pulses | Pneumatically
generated
vibrations +
unfocused
pressure pulses | Extracorporeally
induced
pressure pulses | Similar |
| Shockwave
Generation | Electrohydraulic,
spark gap
electrode | Pneumatic /
ballistic | Electrohydraulic,
spark gap
electrode | Same /
Similar,
respectively |
| Coupling
Solution | FDA-cleared
ultrasound gel | FDA-cleared
ultrasound gel | FDA-cleared
ultrasound gel | Same |
| User Interface | Touch screen
panel, touch
wheel, foot | Specific description
not available | Touch screen
panel, hand-
held applicator | Equivalent to
OrthoGold
100TM |
| Description | OrthoGold
100TM (Main
Predicate
Device) | D-ACTOR® 200
(Predicate
Device) | OmnispecTM
ED1000
(Subject
Device) | Comparison
Notes |
| | switch, hand-held applicator | | | |
| Main Unit
Dimensions
[mm] | 218 x 400 x 459
(H x W x D) | Specific value not
available | 369 x 364 x 359
(H x W x D) | Similar to
OrthoGold
100TM, both
suitable for
desktop use |
| Shockwave
Applicator
Dimensions
[mm] | 230 x Ø 70 | 4: 6mmOD,
15mmOD,
20mmOD,
35mmOD | 130 x Ø 90 | Similar, all
are intended
to be hand-held |
| Pulses
Frequency | Selectable, 1 - 8
Hz in steps of
0.5 Hz | Selectable, 1-21
Hz | Selectable, 2-
2.5 Hz, 120 or
160
pulses/minute | Similar,
OmnispecTM
ED1000's
frequencies
are within
the
Predicates'
range |
| Operating Mode | Continuous | Continuous | Continuous | Same as
OrthoGold
100TM |
| Peak compress-
ional acoustic
pressure pc
[Mpa] | 9.27 at energy
level 16 | 18.5 | 13.8 | Similar
OmnispecTM
ED1000's
pressure is
within the
range of D-
ACTOR®
200 |
| Peak
rarefactional
acoustic
pressure [Mpa] | -1.52 at energy
level 16 | 6.8MPa at 5 bar | 2.0 | Similar
OmnispecTM
ED1000's
pressure is
within the
range of D-
ACTOR®
200 |
| Positive peak
pressure
amplitude [Mpa] | 0.43 - 9.27 at
energy level 1 -
16 | 5 bar/18.5Mpa
3bar/13.4MPa | 13.8 | Similar
OmnispecTM
ED1000's
pressure is |
| Description | OrthoGoldTM 100TM (Main
Predicate
Device) | D-ACTOR® 200
(Predicate
Device) | OmnispecTM ED1000
(Subject
Device) | Comparison
Notes |
| | | | | within the
range of D-
ACTOR®
200 |
| Distance
between focus
and target
location | n/a | n/a | 65mm | Doesn't
affect safety
and
effectiveness |
| Maximum
penetration
depth (-6dB) | 25.4mm at
energy level 16 | 32 mm | 110mm | Doesn't
affect safety
and
effectiveness |
| Negative peak
pressure
amplitude (MPa) | -0.17 to -1.52 at
energy level 1 -
16 | 5bar/6.8MPa
3bar/5.0MPa | 2.0 | Similar
OmnispecTM
ED1000's
pressure is
within the
range of the
predicates |
| Energy flow
density | 0.00017-
0.04403mJ/mm2
at energy level
1-16 | 5bar/0.284mJ/mm2
3bar/0.176mJ/mm2 | 0.14 mJ/mm2 | Similar
OmnispecTM
ED1000's
energy flow
density is
within the
range of the
predicates |
| Derived focal
acoustic pulse
energy (mJ) | 0.022 - 2.278 at
energy level 1 -
16 | 5bar/6.5mJ
3bar/2.4mJ | 1.035 at 14.5
kV | Similar,
OmnispecTM
ED1000's
energy is
within
OrthoGold
100TM's
range |
| Rise time (ns) | 1.89 - 0.28 at
energy level 1 -
16 | Ultrasonic pulse:
2.5μs
Sonic pulse: 25μs
- 2.5ms | 39 | Similar
OmnispecTM
ED1000's
rise time is
within the
range of D- |
| Description | OrthoGold
100TM (Main
Predicate
Device) | D-ACTOR® 200
(Predicate
Device) | OmnispecTM
ED1000
(Subject
Device) | Comparison
Notes |
| | | | | ACTOR®
200 |
| Compress-ional
pulse duration
(μs) | 1.23 - 0.77 at
energy level 1 -
16 | Ultrasonic pulse:
5.0μs
Sonic pulse: 50μs - 5.0ms | 0.136 | Similar |
| Applicator Wet
Shelf Life | Specific Value
Not Available | Specific Value Not
Available | 6 months | NA |
| Applicator Dry
Shelf Life | Specific Value
Not Available | Specific Value Not
Available | 18 months | NA |
| Applicator Use
Life | 100,000 pulses
at energy level 1 - 10; 70,000
pulses at energy
level 11 - 16 | Specific Value Not
Available | 110,000 pulses | Similar,
OmnispecTM
ED1000 has
only one
energy level |
| Patient
Contacting
Materials | Membrane:
Silicone
Coupling Media:
Ultrasound Gel | Coupling Media:
Ultrasound Gel | Membrane:
Silicone
Coupling Media:
Ultrasound Gel | Equivalent |
| Compliance with
Consensus
Standards | IEC 60601-1,
IEC 60601-1-2,
60601-2-36, ISO
60601-1-6, ISO
62304, Draft IEC
63045, ISO
10993-1 | IEC 60601-1, IEC
60601-1-2, ISO
62304, 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, IEC
61846, ISO
10993-1 | Equivalent,
Draft IEC
63045 is
equivalent to
IEC 61846
but applies
to unfocused
pressure
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.
8
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.