(957 days)
Not Found
No
The summary describes a vibration device used for pain relief and does not mention any AI or ML components or functionalities.
Yes.
The device is intended to control pain, provide temporary relief for minor injuries, and treat myofascial pain, all of which are therapeutic purposes.
No
The device is intended to control pain and provide temporary relief for minor injuries, not to diagnose medical conditions or diseases. Its function is to alleviate symptoms, not to identify their cause.
No
The device description explicitly states that Buzzy® and VibraCool® devices are "external use, skin contacting vibration devices" and mentions different "shapes of vibrating devices using the same motor," indicating a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Buzzy and VibraCool are for controlling pain associated with needle procedures, temporary relief of minor injuries, and treatment of myofascial pain. These are all related to treating or alleviating symptoms in a living patient, not analyzing samples taken from the body (which is the core of IVD).
- Device Description: The description states they are "external use, skin contacting vibration devices." This further reinforces their use on the body, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the device's function and intended use are focused on providing physical relief and pain management directly to the patient, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PHW, IME
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Buzzy: Patients 1 year and older when used with cold pack.
VibraCool (cold pack): Patients 4 years and older when used with cold pack.
VibraCool (hot pack): Patients 12 and older with hot pack.
Intended User / Care Setting
Not Found
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)
Study Type: Prospective, randomized study evaluating the effect of Buzzy on the pain of infants receiving MMR vaccine
Sample Size: N = 60
Key Results: The pulse was lower after injection for Buzzy (p=.037). Average pain rated with 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)
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
§ 890.5975 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.
0
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.
1
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
2
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)
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.
| 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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Image /page/4/Picture/0 description: The image shows the logo for PainCareLabs. The logo consists of a circular design with interconnected shapes in shades of blue and gold on the left. To the right of the design is the text "PainCareLabs" in a sans-serif font, with "PainCare" in a darker shade and "Labs" in a lighter shade.
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.
INDICATIONS FOR USE
Buzzy:
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:
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.
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. ●
5
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® Mini | |||||||||
| Healthcare | Buzzy XL | |||||||||
| Healthcare | Buzzy® Mini | |||||||||
| Personal | Buzzy® XL | |||||||||
| Personal | Buzzy Mini | |||||||||
| Healthcare | Buzzy XL | |||||||||
| Healthcare | Buzzy® Mini | |||||||||
| Personal | Buzzy® XL | |||||||||
| Personal | Buzzy® Pro | |||||||||
| Indications for | ||||||||||
| Use | Control pain associated with injections, venipuncture, IV starts, cosmetic | |||||||||
| injections and the temporary relief of minor injuries (muscle or tendon | ||||||||||
| aches, splinters and bee stings). Also intended to treat myofascial pain | ||||||||||
| caused 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 the | ||||||||||
| temporary 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 of | ||||||||||
| Action | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy1 | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy1 | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy1 | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy1 | Mechanical | |||||||||
| vibration with | ||||||||||
| cold therapy1 | ||||||||||
| Vibration | ||||||||||
| Settings | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz1 | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz1 | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz1 | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz1 | A: 0.1 m/s2 | |||||||||
| F: 200±10 Hz1 | ||||||||||
| Vibration | ||||||||||
| Mode | Continuous or | |||||||||
| intermittent | ||||||||||
| vibration | Continuous | |||||||||
| vibration | Continuous | |||||||||
| vibration | Continuous | |||||||||
| vibration | Continuous or | |||||||||
| intermittent | ||||||||||
| vibration1 | Continuous | |||||||||
| vibration1 | Continuous | |||||||||
| vibration1 | Continuous | |||||||||
| vibration1 | Continuous | |||||||||
| vibration1 | ||||||||||
| Power On/Off | Automatic | |||||||||
| shut-off after | ||||||||||
| 3 min. | Manual power | |||||||||
| switch | Automatic | |||||||||
| shut-off after 3 | ||||||||||
| min. | Manual power | |||||||||
| switch | Automatic | |||||||||
| shut-off after | ||||||||||
| 3 min.1 | Manual toggle | |||||||||
| power switch1 | Automatic | |||||||||
| shut-off after | ||||||||||
| 3 min.1 | Manual toggle | |||||||||
| power switch1 | Manual toggle | |||||||||
| power switch1 | ||||||||||
| Patient Use | Multi-patient | Multi-patient | Single patient | Single patient | Multi-patient | Multi-patient | Single patient | Single patient | Multi-patient | |
| Accessories | ||||||||||
| Included | Ice packs | |||||||||
| Hands-free | ||||||||||
| strap | Ice packs | |||||||||
| Hands-free | ||||||||||
| strap | Ice packs | Ice packs | ||||||||
| Hands-free strap | Ice packs | |||||||||
| Hands-free | ||||||||||
| strap2 | Ice packs | |||||||||
| Hands-free | ||||||||||
| strap2 | Ice packs1 | Ice packs | ||||||||
| Hands-free | ||||||||||
| strap1 | Ice packs | |||||||||
| Hands-free | ||||||||||
| strap2 | ||||||||||
| 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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Image /page/6/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 interlocking shapes in blue and gold.
510(k) Summary
| Table 2. Comparison of the subject (VibraCool) and predicate (Buzzy®) devices | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Predicate Device (K130631) | Subject Device (K202993) - VibraCool | ||||||||
| Model | |||||||||
| names | Buzzy® Mini | ||||||||
| Healthcare | Buzzy® XL | ||||||||
| Healthcare | Buzzy® Mini | ||||||||
| Personal | Buzzy® XL | ||||||||
| Personal | VibraCool Easy Fit | VibraCool Extended | VibraCool Plantar | VibraCool Flex | |||||
| Indications | |||||||||
| for Use | Control pain associated with injections, venipuncture, IV starts, cosmetic | ||||||||
| injections and the temporary relief of minor injuries (muscle or tendon | |||||||||
| aches, splinters and bee stings). Also intended to treat myofascial pain | |||||||||
| caused by trigger points, restricted motion and muscle tension | 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. | |||||||||
| 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" | |
| Mechanism | |||||||||
| of Action | Mechanical | ||||||||
| vibration with | |||||||||
| cold therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| heat or cold | |||||||||
| therapy3 | |||||||||
| Vibration | |||||||||
| Settings | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | |||||||||
| Vibration | |||||||||
| Mode | Continuous or | ||||||||
| intermittent | |||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | |||||||||
| Power | |||||||||
| On/Off | Automatic shut- | ||||||||
| off after 3 min. | Manual power | ||||||||
| switch | Automatic shut- | ||||||||
| off after 3 min. | Manual power | ||||||||
| switch | Automatic shut-off | ||||||||
| after 10 min.2 | Manual toggle power | ||||||||
| switch1 | Manual toggle power | ||||||||
| switch1 | Manual toggle power | ||||||||
| switch1 | |||||||||
| Patient Use | Multi-patient | Multi-patient | Single patient | Single patient | Single patient1 | Single patient1 | Single patient1 | Single patient1 | |
| Accessories | |||||||||
| Included | Ice packs | ||||||||
| Hands-free | |||||||||
| strap | Ice packs | ||||||||
| Hands-free | |||||||||
| strap | Ice packs | Ice packs | |||||||
| Hands-free strap | Two-chamber ice | ||||||||
| pack | |||||||||
| Compression strap2 | Four-chamber ice | ||||||||
| pack | |||||||||
| Compression strap2 | Single-chamber ice | ||||||||
| pack | |||||||||
| D-ring strap2 | Two-chamber ice pack | ||||||||
| Heat pack | |||||||||
| Neoprene 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 | ||||||||
| Model | |||||||||
| Names | Buzzy® Mini | ||||||||
| Healthcare | Buzzy® XL | ||||||||
| Healthcare | Buzzy® Mini | ||||||||
| Personal | Buzzy® XL | ||||||||
| Personal | VibraCool Pro DME | ||||||||
| (Durable Medical | |||||||||
| Equipment) | VibraCool Pro UE | ||||||||
| (Upper Extremity) | VibraCool Pro LE | ||||||||
| (Lower Extremity) | VibraCool Pro | ||||||||
| Healthcare | |||||||||
| VibraCool Pro | |||||||||
| Healthcare | |||||||||
| Indications | |||||||||
| for Use | Control pain associated with injections, venipuncture, IV starts, cosmetic | ||||||||
| injections and the temporary relief of minor injuries (muscle or tendon | |||||||||
| aches, splinters and bee stings). Also intended to treat myofascial pain | |||||||||
| caused by trigger points, restricted motion and muscle tension | 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. | |||||||||
| 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" | |
| Mechanism | |||||||||
| of Action | Mechanical | ||||||||
| vibration | |||||||||
| with cold | |||||||||
| therapy | Mechanical | ||||||||
| vibration | |||||||||
| with cold | |||||||||
| therapy | Mechanical | ||||||||
| vibration | |||||||||
| with cold | |||||||||
| therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold therapy | Mechanical | ||||||||
| vibration with | |||||||||
| cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| heat and cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| heat and cold | |||||||||
| therapy3 | Mechanical | ||||||||
| vibration with | |||||||||
| cold | |||||||||
| therapy3 | |||||||||
| Vibration | |||||||||
| Settings | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz1 | A: 0.1 m/s² | ||||||||
| F: 200±10 Hz or | |||||||||
| 100±10 Hz1, 2 | |||||||||
| Vibration | |||||||||
| Mode | Continuous or | ||||||||
| intermittent | |||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | Continuous | ||||||||
| vibration1 | |||||||||
| Power | |||||||||
| On/Off | Automatic shut- | ||||||||
| off after 3 min. | Manual power | ||||||||
| switch | Automatic shut- | ||||||||
| off after 3 min. | Manual power | ||||||||
| switch | Manual toggle power | ||||||||
| switch1 | Manual toggle | ||||||||
| power switch1 | Manual toggle | ||||||||
| power switch1 | Manual toggle power | ||||||||
| switch1 | |||||||||
| Patient Use | Multi-patient | Multi-patient | Single patient | Single patient | Multi-patient1 | Single patient1 | Single patient1 | Multi-patient1 | |
| Accessories | |||||||||
| Included | Ice packs | ||||||||
| Hands-free® | |||||||||
| strap | Ice packs | ||||||||
| Hands-free® | |||||||||
| strap | Ice packs | Ice packs | |||||||
| Hands-free strap | Ice pack2 | Ice pack | |||||||
| Heat pack | |||||||||
| D-ring strap2 | Ice pack | ||||||||
| Heat pack | |||||||||
| Compression strap2 | Ice packs | ||||||||
| Straps2 | |||||||||
| 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.
7
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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Image /page/10/Picture/0 description: The image contains the logo for PainCareLabs. The logo consists of a circular design with interwoven blue and gold lines on the left. To the right of the design is the text "PainCareLabs" in a simple, sans-serif font, with the word "PainCare" in a slightly larger font size than "Labs".
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 study | ||
| evaluating the effect of Buzzy | ||
| on the pain of infants receiving | ||
| MMR vaccine using the total | ||
| "facial expression, leg | ||
| movements, activity, cry, | ||
| and consolability" (FLACC) | ||
| scale rated by nurses and | ||
| parents. |
Study Subjects: 12-month olds
N = 60 | The pulse was lower after injection for
Buzzy (p=.037). Average pain rated
with 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 of
Buzzy Application on Pain Level
During Vaccine Injection in Infants. J
Nurs Care Qual (2023) 38(1):E9-E15
DOI: 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.