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The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts include hand/wrist, elbow, foot/ankle, knee, and lower back.

The BioWave BioWraps are washable, wrappable bands made from a stretchable neoprene-like outer and silver fiber conductive inner fabric. The electrodes are secured to the skin through the wrapping of the bands. The BioWraps are intended for use on the hand/wrist, elbow, foot/ankle, knee, and lower back. When used alongside a conductive cream, the electrodes provide a low current density with uniform current distribution. The BioWraps are to be used alongside cleared BioWave neurostimulator devices (the BioWavePRO® RX (K052289), BioWaveHOME® RX (K152437), and BioWaveGO® OTC (K180943)).

The BioWave BioWraps are cutaneous electrodes designed for use with BioWave neurostimulators. The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices, rather than a detailed clinical study proving the device meets specific acceptance criteria in a comparative effectiveness study with human readers.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format of a clinical trial endpoint. Instead, it describes performance characteristics for substantial equivalence to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable. The "study" described is bench testing, not a clinical trial with a test set of patients or medical images.
• Data Provenance: Not applicable for clinical data. The testing described is laboratory-based bench testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. Ground truth as typically understood in medical device AI (e.g., expert consensus on diagnosis) is not relevant for this type of bench testing. The "ground truth" here is the adherence to engineering specifications and international standards.

4. Adjudication Method for the Test Set:

• Not applicable. There was no clinical test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for cutaneous electrodes, which does not typically involve such studies. The device is not an AI-powered diagnostic tool, but rather an accessory to a neurostimulator. It does not involve human readers for interpretation in the way AI in radiology would.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is not an algorithm. The performance described is the physical and electrical characteristics of the garment electrodes themselves.

7. The Type of Ground Truth Used:

• The "ground truth" for the bench testing was based on engineering specifications, material science principles, and compliance with international standards (e.g., ISO 10993 for biocompatibility) and comparisons to the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set was used.

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The BioWaveGO Rx is indicated for prescription use for:

· Symptomatic relief of chronic, intractable pain

· Symptomatic relief of acute pain

· As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME. The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.

This FDA 510(k) summary for the BioWaveGO Rx device does not contain a typical acceptance criteria table and performance study results. Instead, it focuses on demonstrating substantial equivalence to a predicate device (BioWaveGO, K180943) through a comparison of specifications.

The document explicitly states: "No additional testing was required for this Special 510(k)." This indicates that a new performance study with acceptance criteria was not conducted for the BioWaveGO Rx as part of this submission because it is deemed substantially equivalent in performance to its predicate. The substantial equivalence is based on the device being identical in design and indications to the predicate, with the only change being its availability for prescription use rather than over-the-counter.

Therefore, many of the requested elements for a performance study are not applicable or cannot be extracted from this document, as a specific new performance study wasn't part of this 510(k) submission.

Despite the lack of a dedicated performance study for this specific submission, I can present the information that is available and explain the context:

1. Acceptance Criteria and Reported Device Performance

As no new performance study was conducted, there are no specific acceptance criteria or reported device performance results from a new study presented in this document. The "performance" assessment is by comparison to the predicate device, asserting that its performance is equivalent due to identical design and function. The acceptance criteria, in this context, would be that the BioWaveGO Rx device demonstrates substantial equivalence to its predicate across all specified characteristics.

The table below summarizes the comparison points that implicitly serve as "performance" metrics for substantial equivalence:

• Symptomatic relief of acute pain
• As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | - Symptomatic relief of chronic, intractable pain
• Symptomatic relief of acute pain
• As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain | Identical |
  | Connectivity | Bluetooth Capable: Yes
  Smartphone Interface: Yes | Bluetooth Capable: Yes
  Smartphone Interface: Yes | Identical |
  | Regulatory Classification (Use) | Prescription (similar to BioWaveHOME reference device) / Over-the-Counter (BioWaveGO predicate) | Prescription | Similar (Aligns with reference, differentiates from predicate, but justified by professional oversight) |
  | Power Source | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | One 3.2V 1100mAh rechargeable lithium iron phosphate battery | Identical (to BioWaveGO predicate) |
  | Line Current Isolation | Battery + interlocks | Battery + interlocks | Identical |
  | Patient Leakage Current | None | None | Identical |
  | Number of Output Modes/Channels | One / One | One / One | Identical |
  | Output Regulation | Regulated Voltage | Regulated Voltage | Identical |
  | Software/Firmware/Microprocessor Control | Yes | Yes | Identical |
  | Safety Features | Automatic Overload Trip: Yes (software)
  Automatic No-Load Trip: Yes (software)
  Automatic Shut Off: Yes
  Patient Override Control: Yes
  Many safety interlocks | Automatic Overload Trip: Yes (software)
  Automatic No-Load Trip: Yes (software)
  Automatic Shut Off: Yes
  Patient Override Control: Yes
  Many safety interlocks | Identical |
  | Indicator Display | On/Off Status: Yes
  Low Battery: Yes
  Voltage/Current Level: Yes (% of full scale) | On/Off Status: Yes
  Low Battery: Yes
  Voltage/Current Level: Yes (% of full scale) | Identical |
  | Timer Range | 30 minutes | 30 minutes | Identical |
  | Compliance with Standards| Voluntary Standards: Yes
  21 CFR 898: Yes | Voluntary Standards: Yes
  21 CFR 898: Yes | Identical |
  | Physical Dimensions | Weight: 6 ounces
  Dimensions: 3.0" x 4.0" x 1.0" | Weight: 6 ounces
  Dimensions: 3.0" x 4.0" x 1.0" | Identical (to BioWaveGO predicate) |
  | Housing Materials | ABS via conventional injection molding | ABS via conventional injection molding | Identical |
  | Waveform/Shape | Biphasic / Sum of 2 sine waves | Biphasic / Sum of 2 sine waves | Identical |
  | Maximum Output Voltage | 80V p-p @ 500 Ω (20 V AC RMS) (BioWaveGO predicate) | 80V p-p @ 500 Ω (20 V AC RMS) | Identical (to BioWaveGO predicate) |
  | Maximum Output Current | 160mA p-p @ 500 Ω (40mA RMS) (BioWaveGO predicate) | 160mA p-p @ 500 Ω (40mA RMS) | Identical (to BioWaveGO predicate) |
  | Pulse Width | Continuous modulation | Continuous modulation | Identical |
  | Frequency (Hz) | 4062 Hz + 3940 Hz (BioWaveGO predicate) | 4062 Hz + 3940 Hz | Equivalence based on frequency difference (to BioWaveHOME) |
  | Beat Frequency (Hz) | 122 Hz | 122 Hz | Identical |
  | Net Charge (mC per pulse) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | 0 @ 500 Ω (biphasic - AC coupled continuous wave) | Identical |
  | Maximum Current Density | 6.9 ma rms per cm² @ 500 Ω | 6.9 ma rms per cm² @ 500 Ω | Identical |
  | Maximum Power Density | 0.19 W rms per cm² @ 500 Ω | 0.19 W rms per cm² @ 500 Ω | Identical |

2. Sample size used for the test set and the data provenance

Not applicable. As stated, "No additional testing was required for this Special 510(k)." The evidence for substantial equivalence relies on the existing clearance of the predicate device (BioWaveGO, K180943) and a reference device (BioWaveHOME, K152437), not a new clinical or performance test set for the BioWaveGO Rx.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new human-read test set was established. This submission is a comparison of technical specifications against previously cleared devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication was part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic imaging device or a device involving human readers or AI assistance in interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical neuromodulation device, not an algorithm, and its performance is inherent to its electrical stimulation characteristics, not a standalone algorithmic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the BioWaveGO Rx, the "ground truth" for its substantial equivalence claim is the demonstrated safety and efficacy of its predicate device (BioWaveGO, K180943), which previously underwent its own regulatory clearance process. The current submission's "ground truth" is that the new device largely mirrors the predicate's technical and performance characteristics.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set was used.

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The BioWaveGO Neuromodulation Pain Therapy Device is indicated for:

• Symptomatic relief of chronic, intractable pain
• Symptomatic relief of acute pain
• As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.

The provided text describes the BioWaveGO Neuromodulation Pain Therapy Device, its indications for use, and a comparison with predicate devices to establish substantial equivalence for FDA clearance. However, it does not contain specific acceptance criteria, a detailed study proving device performance against those criteria, or information on sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on regulatory clearance through substantial equivalence, which compares a new device to existing legally marketed predicate devices, rather than an independent performance study with defined acceptance criteria and statistical analysis.

Therefore, the requested information cannot be fully extracted from the provided text. I will detail what can be inferred or is explicitly stated.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., minimum pain reduction, specific accuracy metrics). Instead, it focuses on functional and electrical safety compliance.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The "Performance Testing Summary" outlines a list of tests conducted, but it does not specify the sample size of devices tested or any patient data provenance. The clearance is based on comparison to predicates and engineering/safety testing, not clinical performance data in patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. The document describes technical performance testing and safety evaluations, not a study that would require expert-established ground truth related to clinical outcomes or image interpretation.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical or interpretive "ground truth" establishment by experts is mentioned, an adjudication method is not applicable to the described engineering and safety tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in this document. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the BioWaveGO device. It is a physical medical device providing electrical stimulation, not an algorithm, and it is intended for human use, either over-the-counter or with a prescription (for its predicate).

7. The Type of Ground Truth Used

The "ground truth" for the tests described appears to be based on engineering specifications, safety standards, and functional requirements of the device. For example, ensuring the session timer is operational only during active treatment means verifying the device's software behaves according to its design specification under various conditions. There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth for the technical tests performed.

8. The Sample Size for the Training Set

This information is not provided. Since this is a hardware device cleared based on substantial equivalence and engineering tests, rather than an AI/ML algorithm or a device requiring a clinical efficacy trial with a training set, this concept is not applicable in the context described.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no mention of a training set for an algorithm or a device requiring such.

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The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for:

• · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
• · Symptomatic relief of acute pain
• · Symptomatic relief of post-operative pain

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain. Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following:

• . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues.
• . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave.
• . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary.
• . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave.
  The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.

This is a 510(k) premarket notification for the BiowaveHOME Neuromodulation Pain Therapy System. This type of submission relies on demonstrating substantial equivalence to a predicate device rather than conducting a new clinical study with specific acceptance criteria as you would typically find in a PMA or De Novo submission.

Therefore, the provided document does not contain the information requested about acceptance criteria and a study proving device performance against those criteria in the way you would expect for a novel device.

Here's why and what information can be extracted:

• No new performance study: The document explicitly states that this is a "Special 510(k)" and that the "purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewave Neuromodulation Pain Therapy Device (K072123)." It emphasizes that the modified BiowaveHOME device "has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123." This means Biowave Corporation is leveraging the prior clearance of the predicate device (K072123) and argues that the modifications are minor and do not significantly alter the device's fundamental safety or effectiveness.
• Basis for Substantial Equivalence: The submission focuses on comparing the BiowaveHOME with its predicate (Homewave Neuromodulation Pain Therapy Device, K072123) and other related predicate devices (Deepwave (BiowavePRO), K053389; Deepwave Percutaneous (BiowavePENS), K053389) on design, function, intended use, and indications. The argument is that since the modified device is so similar to an already cleared device, it is "substantially equivalent" and does not require new efficacy studies.

Therefore, many of your requested items about a performance study, acceptance criteria, sample sizes, experts, ground truth, and MRMC studies, are not applicable or not present in this type of submission.

However, I can provide the available information:

• Device Name: BiowaveHOME Neuromodulation Pain Therapy System
• Product Code: GZJ (Transcutaneous electrical nerve stimulator for pain relief)
• Indications for Use:
  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain
  • Symptomatic relief of acute pain
  • Symptomatic relief of post-operative pain

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Not applicable/Not provided. This submission does not define new acceptance criteria for a clinical performance study because it's based on substantial equivalence to a predicate device. Performance is assumed to be equivalent to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not applicable/Not provided. No new clinical "test set" was used for performance validation in this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. No independent expert review of a test set for ground truth was conducted for this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable/Not provided. No test set adjudication method is mentioned as no new clinical study was conducted.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable/Not provided. This device is a pain therapy system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/Not provided. This is a hardware neuromodulation device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable/Not provided. No new ground truth assessment for clinical performance was performed for this 510(k). The "ground truth" for its effectiveness is implicitly tied to the prior clearance of its predicate device, based on the studies that supported that predicate.

8. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

   • Not applicable/Not provided. As above, no training set is relevant here.

In summary, this document is an FDA 510(k) clearance letter and its associated summary for a device that is essentially a modified version of an already cleared device. It relies on demonstrating substantial equivalence rather than presenting new clinical study data with specific acceptance criteria.

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The Homewave Neuromodulation Pain Therapy Device is indicated for:

• . Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain
• Symptomatic relief of acute pain .
• Symptomatic relief of post-operative pain .

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices.

Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows:

• Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave)
• . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use.
• . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave.

The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.

This K072123 document is a Special 510(k) summary for the Biowave Homewave Neuromodulation Pain Therapy Device. It describes minor modifications made to a previously cleared device (Deepwave Neuromodulation Pain Therapy Device, K052289) and asserts substantial equivalence to predicate devices.

Based on the provided document, there are no specific acceptance criteria or a study described that directly proves the device meets specific performance criteria through a clinical trial or performance study.

The document focuses on demonstrating substantial equivalence based on design and functional similarities to previously cleared predicate devices, rather than presenting new performance data against specific acceptance criteria. This is typical for a Special 510(k) for minor modifications.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: No such table is present as no new performance study was conducted or presented to satisfy specific criteria.
• Sample size used for the test set and the data provenance: No test set or associated data is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set was used to establish ground truth.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical nerve stimulator, not an AI-assisted diagnostic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of Device and Basis for Substantial Equivalence (as per the document):

The Homewave Neuromodulation Pain Therapy Device is a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and Deepwave PENS Neuromodulation Pain Therapy Device (K061166).

Key modifications in the Homewave device include:

• Smaller lithium-ion polymer rechargeable battery (approx. 3 hours vs. 8 hours for Deepwave).
• Custom connector with an electronic integrated circuit ("chip") that limits electrode use to 5 twenty-minute treatments or 100 minutes total.
• Fixed treatment time of 20 minutes (vs. adjustable 5-60 minutes for Deepwave).

The basis for substantial equivalence is stated as:
"Biowave Corporation's Homewave and Deepwave devices are similar in design and function. Both devices offer a dual sinusoidal signal with a frequency difference of 122 Hz. Both the proposed and predicate devices are software controlled TENS units that provide the user with pain reduction. The conclusion of this technical comparison is that Biowave's Homewave Device is substantially equivalent to the predicate devices for the indications specified."

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The Deepwave Percutaneous Neuromodulation Pain Therapy System is comprised of a percutaneous electrode array and the Deepwave Neuromodulation Pain Therapy Device. The Deepwave Percutaneous Neuromodulation Pain Therapy System is indicated for:

• Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain;
• Symptomatic relief of post-traumatic pain;
• Symptomatic relief of post-operative pain.

Biowave Corporation's Deepwave Percutaneous Neuromodulation Pain Therapy System is essentially identical to Biowave's Deepwave Neuromodulation Pain Therapy Device cleared under K052289 except that the proposed device includes a percutaneous electrode array instead of standard surface electrodes.

The percutaneous electrode array (PEA) is a sterile, single-use microneedle patch which facilitates the delivery of electrical signals through the skin into tissue. The size of the PEA patch is 2.5 inches in diameter. In the center of the patch is a 1.5 inch diameter array of 1014 microneedles made from medical grade 316L stainless steel which are 736 microns (0.736 millimeters) in length. When placed onto the skin the PEA feels like sandpaper or Velcro to the touch. The Feed Pad is a standard electrode that is 2" x 4" or 5" x 8" in size. The Deepwave Percutaneous Neuromodulation device sends a signal from the Feed Pad through the body to the PEA.

The Deepwave Percutaneous Neuromodulation Pain Therapy Device is a batterypowered device intended to provide clinicians with the ability to prescribe PENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller microneedle patch called a Percutaneous Electrode Array ("PEA") placed directly over the source of the pain (the treatment site).

The provided 510(k) summary does not contain information about acceptance criteria or a study designed to prove the device meets specific performance metrics. This document is a premarket notification for substantial equivalence, which primarily focuses on comparing a new device to existing legally marketed predicate devices to demonstrate that it is as safe and effective.

Therefore, many of the requested details are not applicable or not present in this type of submission.

Not Applicable/Not Provided based on the 510(k) Summary:

1. Table of acceptance criteria and reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria established for the new device.
2. Sample size for the test set and data provenance: No new clinical test set data is presented. The submission relies on the established safety and effectiveness of predicate devices.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no new test set requiring expert ground truth is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. This type of study is more common for diagnostic imaging devices to assess the impact of AI on human reader performance, which doesn't directly apply to a pain therapy system.
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable. This device is a physical therapy system, not an AI algorithm operating independently.
7. Type of ground truth used: Not applicable, as no new clinical study data requiring ground truth is presented.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's approach to demonstrating substantial equivalence:

The applicant, Biowave Corporation, establishes substantial equivalence for the Deepwave Percutaneous Neuromodulation Pain Therapy System (K061166) by comparing it to two predicate devices:

• Vertis NeuroScience Inc., Percutaneous Neuromodulation Control Unit and Accessories (K022241)
• Biowave Corporation's Deepwave Neuromodulation Pain Therapy Device (K052289)

The basis for substantial equivalence is primarily focused on:

• Identical Indications for Use: All three devices (proposed and predicates) are indicated for "symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain" and "symptomatic relief of post-operative pain."
• Similar Design and Function:
  • The proposed device and the Vertis predicate are both Percutaneous Electrical Nerve Stimulation (PENS) devices using percutaneous electrodes.
  • The Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) is a Transcutaneous Electrical Nerve Stimulation (TENS) device using standard surface electrodes, and the new device is described as "essentially identical" to it, with the key difference being the use of a percutaneous electrode array instead of surface electrodes.
  • The percutaneous electrode array (PEA) in the proposed device is highlighted as penetrating less depth than the Vertis PEA, implying no increased safety risk.
  • Both the proposed device and the Vertis PENS device use a biphasic waveform and a beat frequency in the range of 100-200 Hz.
  • Both are software-driven PENS units designed for pain reduction.
• Similarity in Basic Unit Characteristics and Output Specifications: This is stated to be similar according to FDA guidance for Powered Muscle Stimulator 510(k)s.

In essence, the submission asserts that because the new device's indications, fundamental technology (electrical neuromodulation), and key technical specifications (waveform, frequency) are similar to already cleared devices, and its unique component (microneedle PEA) is designed in a way that doesn't introduce new safety or effectiveness concerns (e.g., less penetration than a predicate PEA), it is substantially equivalent and thus, as safe and effective.

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The Deepwave Neuromodulation Pain Therapy Device is indicated for:

• Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain;
• Symptomatic relief of post-traumatic acute pain .
• Symptomatic relief of post-operative pain .

The Biowave Corporation Neuromodulation Pain Therapy Device is a battery-powered device intended to provide clinicians with the flexibility to prescribe powered muscle stimulation and TENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller electrode pad ("Pain Site Pad") placed directly over the source of the pain (the treatment site).

The provided text for K052289, "Deepwave Neuromodulation Pain Therapy Device," is a 510(k) summary for a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for the test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication method for the test set.
• Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
• Details about a standalone (algorithm only) performance study.
• How ground truth was established for either test or training sets.

Instead, the submission focuses on comparing the proposed device's indications for use, design, and function to a predicate device to establish substantial equivalence. The key information provided is:

1. Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as performance metrics in a table. The "acceptance criteria" for a 510(k) submission generally revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done by showing identical or substantially equivalent indications for use and similar technological characteristics.
• Reported Device Performance: No specific performance metrics or clinical study results with numerical values are reported to demonstrate efficacy against pre-defined acceptance criteria. The claim of performance is implicitly that it performs equivalently to the predicate device for pain relief.

2. Sample Size and Data Provenance for Test Set: Not applicable. The document does not describe a clinical study with a test set in the conventional sense of a diagnostic or predictive device.

3. Number of Experts and Qualifications for Ground Truth: Not applicable. Ground truth, in the context of clinical studies for diagnostic accuracy, is not mentioned as such. The basis for efficacy is the established use of similar technology in the predicate device for pain relief.

4. Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned or applicable.

6. Standalone Performance Study: Not mentioned or applicable.

7. Type of Ground Truth Used: Not applicable in the context of diagnostic accuracy studies. The "ground truth" for the device's intended use (symptomatic relief of pain) is based on the therapeutic effect of electrical stimulation, which is a well-established mechanism for pain management. The submission relies on the established safety and efficacy of the predicate device.

8. Sample Size for Training Set: Not applicable. This is not a machine learning or AI device that requires a training set.

9. How Ground Truth for the Training Set Was Established: Not applicable.

Summary of Device Comparison (Basis for Substantial Equivalence):

The document states that the Deepwave Neuromodulation Pain Therapy Device's indications for use are identical to those of the predicate device (Chattanooga Group Forte Model CPS 200 Stimulator Device, K982828).

• Identical Indications:

  • Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain.
  • Symptomatic relief of post-traumatic acute pain.
  • Symptomatic relief of post-operative pain.

• Similar Design and Function: Both devices offer a biphasic waveform, sine waves, and a beat frequency in the range of 100-200 Hz. Both are software-driven TENS units that provide a treatment program for pain reduction.

Conclusion: The submission concludes that the Biowave Deepwave Device is substantially equivalent to the predicate devices for the specified indications based on the identical indications for use and similar technological characteristics. This type of 510(k) submission primarily relies on comparisons to legally marketed devices, rather than new extensive clinical trials, to demonstrate safety and effectiveness.

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