Buzzy® is intended to control pain associated with needle procedures (e.g., injections, vascular access, cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and the temporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings).

VibraCool® is intended for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery. It is also indicated for use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension.

Device Description

Buzzy® and VibraCool® devices are external use, skin contacting vibration devices that can be used with heat (for VibralCool® Flex, VibraCool® Pro UE and VibraCool® Pro LE)or cold therapy (for all Buzzy® and VibraCool® models) to provide pain relief. The brand names encompass the same two shapes of vibrating devices using the same motor. Buzzy Pro and VibraCool Pro are a new shape with the same motor submitted in this 510K. To accommodate various uses and anatomical locations, the Buzzy and VibraCool devices are available in three different shapes and are provided with different sets of accessories.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Buzzy® and VibraCool® devices, not a medical imaging AI device. Therefore, much of the requested information regarding AI acceptance criteria, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is not applicable to this document.

However, I can extract the relevant information concerning the device's performance validation based on the provided text.

Here's the breakdown of what is available and what is not:

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

The document does not explicitly state "acceptance criteria" in a tabulated format with numerical targets that the device had to meet for pain reduction. Instead, it refers to a clinical study that evaluated the device's effect on pain.

Implicit "Acceptance Criteria" (based on study results):

Reduced pain during/after vaccination. The study results show a statistically significant reduction in pain scores for the Buzzy group compared to the control.

Reported Device Performance (from Clinical Study - Table 4):

Performance Metric	Reported Device Performance (Buzzy Group)	Control Group Performance	Statistical Significance
Pulse	Lower after injection	Not specified	p=.037 (lower for Buzzy)
Average Pain (FLACC Score) During Vaccination	6.07 (SD = 2.34)	9.07 (SD = 1.2)	p=.001
Average Pain (FLACC Score) After Vaccination	1.13 (SD = 1.53)	4.2 (SD = 1.24)	p=.001

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

Sample Size: N = 60 (for the clinical study in infants).
Data Provenance: The document does not specify the country of origin. It indicates it was a "Prospective, randomized study" of infants receiving the MMR vaccine.

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

Number of Experts: Not explicitly stated as "experts" for ground truth, but "nurses and parents" rated the pain using the FLACC scale. No specific qualifications (e.g., years of experience) are provided for these raters.

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

Adjudication Method: Not specified. Pain was rated by nurses and parents, but it's not clear if there was any conciliation or adjudication process if their ratings differed.

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

MRMC Study: No, this is not an AI device. The study evaluated the direct effect of the Buzzy device on pain compared to a control.

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

Standalone Performance: Not applicable, as this is a non-AI therapeutic device.

7. The type of ground truth used

Type of Ground Truth: Pain scores rated by nurses and parents using the FLACC (Faces, Legs, Arms, Cry, Console) scale, which is an observational pain scale. This could be considered observational/clinical assessment data as ground truth.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a non-AI device; there is no "training set" in the context of machine learning. The clinical study described in Table 4 is the validation study for the device's efficacy.

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

Ground Truth Establishment for Training Set: Not applicable, as there is no training set for an AI model.

Summary of Non-AI Related Information from Document:

The document outlines the FDA's 510(k) clearance for Buzzy® and VibraCool® devices based on their substantial equivalence to a predicate device (K130631 Buzzy®). The primary changes and justifications for substantial equivalence include:

Addition of VibraCool models: Justified by using the same vibration device, external use, and supporting clinical data for vibration + heat/cold therapy for pain.
Addition of "Pro" lines (Buzzy Pro, VibraCool Pro): Justified as being identical in materials, motor, circuitry, functionality, and intended use, differing only in shape.
Updated Indications for Use: Clarified "needle procedures" for Buzzy with examples, and refined VibraCool's indications regarding myofascial pain, stating these clarifications do not introduce new questions of safety/effectiveness.
Expanded Patient Population: Buzzy with cold pack is now indicated for 1 year and older (vs. 4+), and VibraCool/Pro with hot pack for 12 years and older. This was supported by a clinical study.

Non-Clinical Testing:

Temperature testing (device surface and skin surface).
Seal integrity/strength testing of hot packs.
Shelf stability tests of hot packs.
Electrical safety and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-11, CFR 47 FCC Part 15).

Clinical Testing:

A prospective, randomized study evaluated the effect of Buzzy on pain in 60 infants (12-month olds) receiving the MMR vaccine.
Results: The Buzzy group showed significantly lower average pain scores (FLACC scale) during and after vaccination compared to the control group (p=.001 for both). Pulse was also lower after injection for Buzzy (p=.037).
Ground Truth: Pain rating by nurses and parents using the FLACC scale.

The conclusion is that based on non-clinical testing and clinical evidence from published studies, the new and modified devices do not raise new issues of safety or effectiveness and are substantially equivalent to the predicate.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

May 15, 2023

MMJ Labs, LLC % Amy Baxter, MD CEO Pain Care Labs a dba of MML Labs, LLC 195 Arizona Ave LW08 Atlanta, GA 30307

Re: K202993

Trade/Device Name: Buzzy® (models: Mini Healthcare, Mini Personal, XL Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro Healthcare, Pro Upper Extremity (UE), Pro Lower Extremity (LE), Pro Durable Medical Equipment (DME))

Regulation Number: 21 CFR 890.5975 Regulation Name: Therapeutic Vibrator Regulatory Class: Class I Product Code: PHW, IME Dated: March 1, 2023 Received: March 2, 2023

Dear Dr. Baxter:

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.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 (OS) 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).

Sincerely.

Amber T. Ballard -S

Amber Ballard. Ph.D. Assistant Director 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

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Indications for Use

510(k) Number (if known) K202993

Device Name

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro)

VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro Healthcare, Pro Upper Extremity (UE), Pro Durable Medical Equipment (DME))

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for PainCareLabs. The logo consists of a circular design on the left and the text "PainCareLabs" on the right. The circular design is made up of several smaller shapes in blue and gold. The text is in a sans-serif font and is black.

510(k) Summary K202993

DATE PREPARED

May 15, 2023

MANUFACTURER AND 510(k) OWNER

MMJ Labs, LLC 195 Arizona Avenue, LW08 Atlanta, GA 30307, USA Telephone: +1 (877) 805-2899

Official Contact: Amy Baxter, MD, CEO

REPRESENTATIVE/CONSULTANT

Amy Baxter, MD

DEVICE INFORMATION

Proprietary Names/Trade Names:	Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro), VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro Healthcare, Pro Upper Extremity (UE), Pro Lower Extremity (LE), Pro Durable Medical Equipment (DME))
Primary Regulation:	Classification name: Therapeutic vibrator (21 CFR 890.5975, Product Code: PHW [Cold pack and vibrating massager], Class I / 510(k) Exempt)
Secondary Regulation:	Classification name: Cold pack (21 CFR 890.5700, Product Code: IME [Pack, hot or cold, reusable], Class I / 510(k) Exempt)

PREDICATE DEVICE IDENTIFICATION

510(k) Number	Predicate Device Trade Name	Manufacturer
K130631	Buzzy®	MMJ Labs, LLC

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DEVICE DESCRIPTION

INDICATIONS FOR USE

Buzzy:

VibraCool:

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

MMJ Labs believes that the Buzzy and VibraCool are substantially equivalent to the predicate device based on the information summarized in Tables 1-3 below.

The subject devices have similar or identical design and dimensions, identical mechanism of action, similar or identical vibration settings, and use similar or identical materials to the original Buzzy devices cleared in K130631. The main differences between the subject and predicate devices are:

the addition of the VibraCool accessories, .
. the optional addition of heat therapy mode with VibraCool Flex, VibraCool Pro Upper, and VibraCool Lower Extremity,
. the added "Pro" lines of Buzzy and VibraCool, and
updated indications for use. ●

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510(k) Summary

Image /page/5/Picture/1 description: The image contains the logo for Pain Care Labs. The logo consists of a circular graphic on the left and the text "Pain Care Labs" on the right. The circular graphic is made up of several smaller circles in shades of blue and yellow. The text "Pain Care Labs" is in a sans-serif font.

Table 1. Comparison of the subject (Buzzy®) and predicate (Buzzy®) devices
			Predicate Device (K130631) - Buzzy®		Subject Device (K202993) – Buzzy®
Model Names	Buzzy® MiniHealthcare	Buzzy XLHealthcare	Buzzy® MiniPersonal	Buzzy® XLPersonal	Buzzy MiniHealthcare	Buzzy XLHealthcare	Buzzy® MiniPersonal	Buzzy® XLPersonal	Buzzy® Pro
Indications forUse	Control pain associated with injections, venipuncture, IV starts, cosmeticinjections and the temporary relief of minor injuries (muscle or tendonaches, splinters and bee stings). Also intended to treat myofascial paincaused by trigger points, restricted motion and muscle tension					To control pain associated with needle procedures (e.g., injections, vascular access,cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and thetemporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings).
Age(s)		Patients 4 years and older.				Patients 1 year and older when used with cold pack.
Size (in)	2⅝" x 1⅞" x ⅞"	3¼" x 2⅛" x 1⅛"	2⅝" x 1⅞" x ⅞"	3¼" x 2⅛" x 1⅛"	2⅝" x 1⅞" x ⅞"	3¼" x 2½" x 1⅛"	2⅝" x 1⅞" x ⅞"	2⅝" x 1⅞" x ⅞"	3" x 2¼" x ¾"
Mechanism ofAction	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy1	Mechanicalvibration withcold therapy1	Mechanicalvibration withcold therapy1	Mechanicalvibration withcold therapy1	Mechanicalvibration withcold therapy1
VibrationSettings	A: 0.1 m/s2F: 200±10 Hz	A: 0.1 m/s2F: 200±10 Hz	A: 0.1 m/s2F: 200±10 Hz	A: 0.1 m/s2F: 200±10 Hz	A: 0.1 m/s2F: 200±10 Hz1	A: 0.1 m/s2F: 200±10 Hz1	A: 0.1 m/s2F: 200±10 Hz1	A: 0.1 m/s2F: 200±10 Hz1	A: 0.1 m/s2F: 200±10 Hz1
VibrationMode	Continuous orintermittentvibration	Continuousvibration	Continuousvibration	Continuousvibration	Continuous orintermittentvibration1	Continuousvibration1	Continuousvibration1	Continuousvibration1	Continuousvibration1
Power On/Off	Automaticshut-off after3 min.	Manual powerswitch	Automaticshut-off after 3min.	Manual powerswitch	Automaticshut-off after3 min.1	Manual togglepower switch1	Automaticshut-off after3 min.1	Manual togglepower switch1	Manual togglepower switch1
Patient Use	Multi-patient	Multi-patient	Single patient	Single patient	Multi-patient	Multi-patient	Single patient	Single patient	Multi-patient
AccessoriesIncluded	Ice packsHands-freestrap	Ice packsHands-freestrap	Ice packs	Ice packsHands-free strap	Ice packsHands-freestrap2	Ice packsHands-freestrap2	Ice packs1	Ice packsHands-freestrap1	Ice packsHands-freestrap2
OTC / Rx	OTC	OTC	OTC	OTC	OTC1	OTC1	OTC1	OTC1	OTC1

¹Identical to predicate device

2 Similar to predicate device. No new questions of safety and effectiveness.

³ Similar to predicate device. Non-clinical testing was submitted to support the change in technology.

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510(k) Summary

Table 2. Comparison of the subject (VibraCool) and predicate (Buzzy®) devices
	Predicate Device (K130631)				Subject Device (K202993) - VibraCool
Modelnames	Buzzy® MiniHealthcare	Buzzy® XLHealthcare	Buzzy® MiniPersonal	Buzzy® XLPersonal	VibraCool Easy Fit	VibraCool Extended	VibraCool Plantar	VibraCool Flex
Indicationsfor Use	Control pain associated with injections, venipuncture, IV starts, cosmeticinjections and the temporary relief of minor injuries (muscle or tendonaches, splinters and bee stings). Also intended to treat myofascial paincaused by trigger points, restricted motion and muscle tension				VibraCool is intended for the temporary relief of minor injuries (muscle or tendon aches) andthe treatment of myofascial pain post-surgery. It is also indicated for use prior to or duringphysical therapy to treat myofascial pain caused by trigger points, restricted motion andmuscle tension.
Age(s)	Patients 4 years and older.				Patients 4 years and older when used with cold pack. Patients 12 and older with hot pack.
Size (in)	2⅝" x 1⅞" x ⅞"	3¼" x 2⅝" x 1⅛"	2⅝" x 1⅞" x ⅞"	3¼" x 2⅝" x 1⅛"	2⅝" x 1⅞" x ⅞"	3¼" x 2⅝" x 1⅛"	3¼" x 2⅝" x 1⅛"	3¼" x 2⅝" x 1⅛"
Mechanismof Action	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcoldtherapy3	Mechanicalvibration withcoldtherapy3	Mechanicalvibration withcoldtherapy3	Mechanicalvibration withheat or coldtherapy3
VibrationSettings	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz1
VibrationMode	Continuous orintermittentvibration	Continuousvibration	Continuousvibration	Continuousvibration	Continuousvibration1	Continuousvibration1	Continuousvibration1	Continuousvibration1
PowerOn/Off	Automatic shut-off after 3 min.	Manual powerswitch	Automatic shut-off after 3 min.	Manual powerswitch	Automatic shut-offafter 10 min.2	Manual toggle powerswitch1	Manual toggle powerswitch1	Manual toggle powerswitch1
Patient Use	Multi-patient	Multi-patient	Single patient	Single patient	Single patient1	Single patient1	Single patient1	Single patient1
AccessoriesIncluded	Ice packsHands-freestrap	Ice packsHands-freestrap	Ice packs	Ice packsHands-free strap	Two-chamber icepackCompression strap2	Four-chamber icepackCompression strap2	Single-chamber icepackD-ring strap2	Two-chamber ice packHeat packNeoprene pocket2
OTC / Rx	OTC	OTC	OTC	OTC	OTC1	OTC1	OTC1	OTC1
Table 3. Comparison of the subject (VibraCool Pro) and predicate (Buzzy®) devices
	Predicate Device (K130631)				Subject Device (K202993) - VibraCool Pro
ModelNames	Buzzy® MiniHealthcare	Buzzy® XLHealthcare	Buzzy® MiniPersonal	Buzzy® XLPersonal	VibraCool Pro DME(Durable MedicalEquipment)	VibraCool Pro UE(Upper Extremity)	VibraCool Pro LE(Lower Extremity)	VibraCool ProHealthcareVibraCool ProHealthcare
Indicationsfor Use	Control pain associated with injections, venipuncture, IV starts, cosmeticinjections and the temporary relief of minor injuries (muscle or tendonaches, splinters and bee stings). Also intended to treat myofascial paincaused by trigger points, restricted motion and muscle tension					VibraCool is intended for the temporary relief of minor injuries (muscle or tendon aches) andthe treatment of myofascial pain post-surgery. It is also indicated for use prior to or duringphysical therapy to treat myofascial pain caused by trigger points, restricted motion andmuscle tension.
Age(s)	Patients 4 years and older.					Patients 4 years and older when used with cold pack. Patients 12 and older with hot pack.
Size (in)	2 7⁄ 8" x 1 7⁄ 8" x 7⁄ 8"	3 1⁄ 4" x 2 1⁄ 8" x 1 1⁄ 8"	2 7⁄ 8" x 1 7⁄ 8" x 7⁄ 8"	3 1⁄ 4" x 2 1⁄ 8" x 1 1⁄ 8"	3" x 2¼" x 3/4"	3" x 2¼" x 3/4"	3" x 2¼" x 3/4"	3" x 2¼" x 3/4"
Mechanismof Action	Mechanicalvibrationwith coldtherapy	Mechanicalvibrationwith coldtherapy	Mechanicalvibrationwith coldtherapy	Mechanicalvibration withcold therapy	Mechanicalvibration withcoldtherapy3	Mechanicalvibration withheat and coldtherapy3	Mechanicalvibration withheat and coldtherapy3	Mechanicalvibration withcoldtherapy3
VibrationSettings	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz1	A: 0.1 m/s²F: 200±10 Hz or100±10 Hz1, 2
VibrationMode	Continuous orintermittentvibration	Continuousvibration	Continuousvibration	Continuousvibration	Continuousvibration1	Continuousvibration1	Continuousvibration1	Continuousvibration1
PowerOn/Off	Automatic shut-off after 3 min.	Manual powerswitch	Automatic shut-off after 3 min.	Manual powerswitch	Manual toggle powerswitch1	Manual togglepower switch1	Manual togglepower switch1	Manual toggle powerswitch1
Patient Use	Multi-patient	Multi-patient	Single patient	Single patient	Multi-patient1	Single patient1	Single patient1	Multi-patient1
AccessoriesIncluded	Ice packsHands-free®strap	Ice packsHands-free®strap	Ice packs	Ice packsHands-free strap	Ice pack2	Ice packHeat packD-ring strap2	Ice packHeat packCompression strap2	Ice packsStraps2
OTC / Rx	OTC	OTC	OTC	OTC	OTC / Rx2	OTC / Rx2	OTC / Rx2	OTC / Rx2

¹Identical to predicate device

2 Similar to predicate device. No new questions of safety and effectiveness.

³ Similar to predicate device. Non-clinical testing was submitted to support the change in technology.

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PainCareLabs

510(k) Summary

¹Identical to predicate device

² Similar to predicate device. No new questions of safety and effectiveness.

³ Similar to predicate device. Non-clinical testing was submitted to support the change in technology.

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Image /page/8/Picture/1 description: The image contains the logo for PainCareLabs. The logo consists of a circular design with interwoven strands of blue, orange, and yellow, positioned to the left of the company name. The text "PainCareLabs" is written in a simple, sans-serif font, with the "PainCare" portion in a slightly bolder typeface than "Labs".

SUBSTANTIAL EQUIVALENCE DISCUSSION

Addition of VibraCool
The addition of VibraCool does not raise new or different questions of safety and effectiveness. Like the devices cleared in K130631, VibraCool uses the same vibration device and is intended for external use utilizing vibration and heat or cold therapy to relieve pain. VibraCool is to be used on a wider range of locations on the body (e.g., knees, ankles, and feet). However, it is still the same external, intact skin- contacting device. Additionally, questions regarding the efficacy of VibraCool are addressed by clinical data from several published clinical studies. These data support the efficacy of the combination of vibration and heat or cold therapy for physical therapy. Labeling will include a limit of 4 years and older patients when using cold.

The addition of a commercially available hot pack as a heat therapy mode with VibraCool Flex and VibraCool Pro Upper/Lower Extremity when used for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery and during physical therapy does not raise new or different questions of safety or effectiveness. The safety and effectiveness of VibraCool used with heat therapy are addressed by clinical data from several published clinical studies. Labeling will include a limit of 12 and older patients when using heat, and a shelf life of 3 years.

Addition of "Pro" Lines of Buzzy and VibraCool ●

The Buzzy Pro and VibraCool Pro are identical to the predicate device in terms of materials, vibration motor, circuitry, functionality, and intended use. They differ only in shape but are comparable in size to the predicate devices. Specifically, the Pro devices are distinguished by their rectangular shape to offer users a more professional looking alternative to the bee-shape of the other devices. It may be used with the same accessories as the other VibraCool devices. There are no new questions regarding safety and effectiveness.

. Updated Indications for Use Statements
- O Buzzy:

The updated statement uses "needle procedures" to capture the range of scenarios in which Buzzy would be used and then provides examples of these types of procedures. Vascular access, cannulation, and dialysis are equivalent to IV starts and lab draws and blood donation is equivalent to venipuncture. Dental injections are another type of needle procedure which has been clinically investigated for this use. The data support this indication as subjects reported a meaningful reduction in pain when using Buzzy compared to no intervention at all.

VibraCool: o
The indication for use statement associated with the predicate device (K130631) refers to temporary relief of minor injuries such as muscle or tendon aches. K130631's IFU also includes treating myofascial pain caused by trigger points, muscle tension and restricted motion. The updated VibraCool's IFU (K202993) includes treatment of myofascial pain post-surgery and treatment of myofascial pain caused by trigger points, restricted motion, and muscle tension prior to or during physical therapy. This change does not result in new intended use, as the subject VibraCool devices are, as the predicate devices, intended to provide temporary relief of minor overuse injuries and tendinitis. Rather, the new indications for use provide clarification on the context of use of the VibraCool devices. This change is therefore not expected to affect the safety and effectiveness of the subject device.
Patient population: O
When used with the cold pack, the Buzzy subject devices are indicated for use on patients of

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ages 1 and older, while the predicate device is indicated for patients of ages 4 and older. The use of a hot pack with the VibraCool or VibraCool Pro subject devices are indicated for use on patients 12 and up. This change in intended population does not raise new questions of safety and effectiveness. The labeling for heat packs will be for age 12 and up.

SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

Temperature testing (device surface and skin surface) over the entire treatment period, after the ● initial activation and after the maximum number (5) of boil-cool reuse cycles.
. Seal integrity/strength testing of hot packs
Shelf stability tests of hot packs
Electrical safety and electromagnetic compatibility: ●
- o IEC 60601-1 and AAMI/IEC 60601-1:2005 + AMD 1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11:2015 Medical Electrical Equipment Part 1-11: General requirements o for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- CFR 47, FCC Part 15 Radio Frequency Devices, Subpart B:2017 Unintentional Radiators o

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SUMMARY OF CLINICAL TESTING

The performance of the Buzzy devices on pediatric populations above the age of 1 year old was evaluated in various clinical settings for pain relief during vascular access and needle-related procedures. A study in infants published in a peer-reviewed scientific publication is summarized in Table 4 below.

Table 4. Clinical Studies - Pain Indication
Study Objective	Results	Reference
Prospective, randomized studyevaluating the effect of Buzzyon the pain of infants receivingMMR vaccine using the total"facial expression, legmovements, activity, cry,and consolability" (FLACC)scale rated by nurses andparents.Study Subjects: 12-month oldsN = 60	The pulse was lower after injection forBuzzy (p=.037). Average pain ratedwith FLACC (Faces, Legs, Arms, Cry,Console) was lower during (6.07 (SD =2.34)) and after vaccination (1.13 (SD =1.53)) in the Buzzy group than control(9.07 (SD = 1.2)), (4.2 (SD = 1.24)),respectively (p=.001)	Siktas, O. Uysal, G. "The Effect ofBuzzy Application on Pain LevelDuring Vaccine Injection in Infants. JNurs Care Qual (2023) 38(1):E9-E15DOI: 10.1097/NCQ.0000000000000656

CONCLUSION

Based on the testing performed to confirm electromagnetic compatibility and electrical safety, and the clinical evidence described in published clinical studies, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate devices. The similar indications for use, technological characteristics, and performance characteristics for the proposed Buzzy, Buzzy Pro, VibraCool, and VibraCool Pro devices are assessed to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 890.5975 Therapeutic vibrator.

(a)
Identification. A therapeutic vibrator is an electrically powered device intended for medical purposes that incorporates various kinds of pads and that is held in the hand or attached to the hand or to a table. It is intended for various uses, such as relaxing muscles and relieving minor 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.