(131 days)
Not Found
No
The device description details a combination of a TENS unit and a motor-driven sponge stick, controlled by firmware. There is no mention of AI, ML, or any learning or adaptive capabilities based on data. The operation is fixed for 25 seconds.
Yes.
The device is intended to reduce pain and is classified as a Transcutaneous electrical nerve stimulator for pain relief, which is a therapeutic function.
No
The device is intended to reduce the pain of hypodermic injections by numbing the skin using a combination of TENS and mechanical tapping, and it disinfects the injection site. It does not diagnose any condition or disease.
No
The device description explicitly states it is a "battery-operated handheld device that includes a TENS unit and a motor operated by a 9V commercial battery." It also mentions a PCB and hydrogels, all of which are hardware components.
Based on the provided information, the Noodle device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Noodle's Function: The Noodle device is a physical device that applies electrical stimulation (TENS) and mechanical tapping to the skin on the body to reduce pain associated with injections. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for reducing pain of hypodermic injections into specific body areas. This is a direct interaction with the patient's body, not an analysis of a sample.
- Device Description: The description details a battery-operated handheld device with a TENS unit and a motor, designed to be applied to the skin.
- Classification Product Code: The classification product code is for a "Transcutaneous electrical nerve stimulator for pain relief," which is a device applied to the skin for therapeutic purposes, not for analyzing samples.
Therefore, the Noodle device falls under the category of a therapeutic or pain management device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Noodle is intended to reduce the pain of hypodermic injections into the upper extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.
The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers.
Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such as the upper and lower extremities (arms and legs), buttocks, abdomen, and deltoid and is not intended to be used on smaller body parts such as the hands, feet, head (including ears, nose and around the eyes), the neck, and the abdominal area in pregnant women.
Product codes
NUH
Device Description
Noodle is a battery-operated handheld device that includes a TENS unit and a motor operated by a 9V commercial battery. Once it is activated, it operates for 25 seconds and shuts off automatically.
Noodle consists of a TENS unit and a small motor that causes a polyurethane sponge stick to rotate and tap the skin. The combination of the TENS application and tapping on the skin for 25 seconds numbs the skin temporarily for a subsequent injection. The sponge stick is impregnated in 70% isopropanol and disinfects the injection site at the same time it taps it.
The device body has 5 pieces, the enclosure, the bottom, the battery door, and the receptacle. Noodle further includes a PCB that is controlled by a firmware. The PCB supplies TENS stimulation that is transferred to the skin by a pair of hydrogels that come in electrical contact with the skin around the injection site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper extremities (leg), buttocks, abdomen, and deltoid areas
Indicated Patient Age Range
18 to 70 years of age.
Intended User / Care Setting
Used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers.
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
The clinical performance data supporting the safety and effectiveness of the Noodle device for reducing the pain of hypodermic injections into the extremities, buttocks, abdomen, and deltoid (as described in the Indications for Use statement) was based on a multi-site sham-controlled double-blind causal-comparative trial using the Noodle device in 18 patients at 3 sites (one doctor's office and two pharmacies). The sham device was identical to the Noodle but did not deliver stimulation.
The 18 patients were divided into two groups: 9 who received treatment with the Noodle device first and 9 getting the sham first. Each subject gave themselves two needle sticks. Prior to each needle stick, they preconditioned the needle stick site either by the Noodle or a sham. The VAS pain scale was used to assess the level of pain. The sponsor assessed the improvement in acute pain from baseline before the needlestick to after, in comparison to the sham using two metrics: the peak pain score (peak VAS) and average pain score (average VAS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical performance data supporting the safety and effectiveness of the Noodle device for reducing the pain of hypodermic injections into the extremities, buttocks, abdomen, and deltoid (as described in the Indications for Use statement) was based on a multi-site sham-controlled double-blind causal-comparative trial using the Noodle device in 18 patients at 3 sites (one doctor's office and two pharmacies). The sham device was identical to the Noodle but did not deliver stimulation.
77% of subjects (14 of 18) reported a reduction in pain scores of at least 3 or greater on the VAS scale, about 30% pain reduction, when the injection site was preconditioned with Noodle. No adverse events were reported in the 18 subjects. Average VAS was lower with Noodle than with the sham device by 35%. The difference seen in the clinical results was considered to provide clinical benefit to patients given that a sham-controlled, double-blind trial and the study results did not indicate any significant adverse effects or safety risks for this device. Hence, the results were considered to provide clinical benefit in reducing the pain of hypodermic injections into the extremities, buttocks, abdomen, and deltoid.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
77% of subjects (14 of 18) reported a reduction in pain scores of at least 3 or greater on the VAS scale, about 30% pain reduction, when the injection site was preconditioned with Noodle. Average VAS was lower with Noodle than with the sham device by 35%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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.
July 9, 2022
Pourang Bral, DDS, LLC President 155 Albion Street Passaic. New Jersey 07055
Re: K220573
Trade/Device Name: Noodle Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: February 15, 2022 Received: February 28, 2022
Dear Dr. Bral:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Pamela Scott 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
Enclosure
2
Indications for Use
510(k) Number (if known) K220573
Device Name Noodle
Indications for Use (Describe)
Noodle is intended to reduce the pain of hypodermic injections into the upper extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.
The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers.
Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such as the upper and lower extremities (arms and legs), buttocks, abdomen, and deltoid and is not intended to be used on smaller body parts such as the hands, feet, head (including ears, nose and around the eyes), the neck, and the abdominal area in pregnant women.
Type of Use (Select one or both, as applicable)
| Residential Use (Per 24 CFR 982.1 Subpart E) | ☒ |
|---|---|
| Homeownership Option (Per 24 CFR 982.625-641) | ☐ |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
Type of submission: Traditional 510(k)
Date: July 9, 2022 Submitter: Pourang Bral, DDS, LLC Address 155 Albion Street, Passaic, NJ 07055 Phone: 201 264-4862 Contact: Pourang Bral Email: Pourangb@gmail.com
Identification of the Subject Device
| Device name | Noodle |
|---|---|
| Common or usual name | Electrical and mechanical stimulator for injection site pain reduction |
| Classification product code | NUH |
| Device classification | II |
| Regulation number | 882.5890 |
| Regulation description | Transcutaneous electrical nerve stimulator for pain relief. |
| Review panel | Neurology |
This is an application for a 510K approval of a device called Noodle that uses electrical and physical stimulation on the skin to temporarily anesthetize an injection to reduce the pain of the injection without the use of chemicals.
Noodle is a battery-operated handheld device that includes a TENS unit and a motor operated by a 9V commercial battery. The classification product code for Noodle is a Class II Device: § 882.5890 - Transcutaneous electrical nerve stimulator for pain relief. Once it is activated, it operates for 25 seconds and shuts off automatically.
ldentification of the predicate device
Predicate Device K130802
| Device name | OTC Electrical Stimulator LT3060 |
|---|---|
| Common or usual name | Transcutaneous Electrical Nerve Stimulator |
| Classification product code | NUH, NGX |
| Device classification | II |
4
| Regulation number | 21 CFR 882.5890 |
|---|---|
| Regulation description | Transcutaneous Electrical Nerve Stimulator for Pain Relief |
| Review panel | Neurology |
The predicate device is the OTC Electrical Stimulator LT3060, with the stated indication for use of Temporary relief of pain associated with sore and aching muscles in the shoulder, waist, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. It has a 510(K) number of K130802, a Product Code NUH, and a Classification Name of Stimulator, Nerve, Transcutaneous, over the counter.
Indications for use of the subject device
Noodle is intended to reduce injection-site pain of hypodermic injections into the upper extremities (arms), lower extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.
The Noodle device may be used in the home by patients who self-administer injections or in a medical setting by professional healthcare providers.
Body parts intended to be conditioned by the Noodle device are sites that are commonly the target of injections such as the upper and lower extremities (arms and legs), buttocks, abdomen, and deltoid and is not intended to be used on smaller body parts such as the hands, feet, head (including ears, nose and around the eyes), the neck, and the abdominal area in pregnant women.
Description of the Device
Noodle consists of a TENS unit and a small motor that causes a polyurethane sponge stick to rotate and tap the skin. The combination of the TENS application and tapping on the skin for 25 seconds numbs the skin temporarily for a subsequent injection. The sponge stick is impregnated in 70% isopropanol and disinfects the injection site at the same time it taps it.
The device body has 5 pieces, the enclosure, the bottom, the battery door, and the receptacle. Noodle further includes a PCB that is controlled by a firmware. The PCB supplies TENS stimulation that is transferred to the skin by a pair of hydrogels that come in electrical contact with the skin around the injection site.
Statement of Conformity
List of FDA recognized voluntary consensus standards cited in this submission.
| IEC 60601-1 |
|---|
| IEC 60601-1-2 |
| IEC 60601-2-10 |
5
IEC 60601-1-11
Discussion of non-clinical tests
- ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009((R)2012 And A2:2010/(R)2012 (Consolidated i. Text) Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, MOD)
- ii. ANSI AAMI IEC 60601-1-2:2014, Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance -- Collateral Standard: Disturbances -- Requirements and Test
- iii. IEC 60601-2-10 Edition 2.1 2016-04, Medical Electrical Equipment Part 2-10: Particular Requirements for The Basic Safety and Essential Performance of Nerve and Muscle Stimulators
- iv. IEC 60601-1-11 Edition 2.0 2015-01. Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment (General II (ES/EMC))
Noodle has passed all these non-clinical tests.
Discussion of clinical tests
The clinical performance data supporting the safety and effectiveness of the Noodle device for reducing the pain of hypodermic injections into the extremities, buttocks, abdomen, and deltoid (as described in the Indications for Use statement) was based on a multi-site sham-controlled double-blind causal-comparative trial using the Noodle device in 18 patients at 3 sites (one doctor's office and two pharmacies). The sham device was identical to the Noodle but did not deliver stimulation.
The 18 patients were divided into two groups: 9 who received treatment with the Noodle device first and 9 getting the sham first. Each subject gave themselves two needle sticks. Prior to each needle stick, they preconditioned the needle stick site either by the Noodle or a sham. The VAS pain scale was used to assess the level of pain. The sponsor assessed the improvement in acute pain from baseline before the needlestick to after, in comparison to the sham using two metrics: the peak pain score (peak VAS) and average pain score (average VAS).
77% of subjects (14 of 18) reported a reduction in pain scores of at least 3 or greater on the VAS scale, about 30% pain reduction, when the injection site was preconditioned with Noodle. No adverse events were reported in the 18 subjects. Average VAS was lower with Noodle than with the sham device by 35%. The difference seen in the clinical results was considered to provide clinical benefit to patients given that a sham-controlled, double-blind trial and the study results did not indicate any significant adverse effects or safety risks for this device. Hence, the results were considered to provide clinical benefit in reducing the pain of hypodermic injections into the extremities, buttocks, abdomen, and deltoid.
Substantial Equivalence Determination
Both Noodle and the predicate device use TENS stimulation to achieve their desired effects.
6
A side-by-side comparison of the technological characteristics of Noodle and the cited predicate device is included in the table below.
| | New Device | Predicate Device | Substantial Equivalence
Determination |
|---------------------------------------|-------------------------|------------------------------------------|-----------------------------------------------------------|
| 1. 510(k) Number | | K130802 | |
| 2. Device Name,
Model | Noodle | OTC Electrical Stimulator
LT3060 | |
| 3. Manufacturer | Painless World | Shenzhen Dongdixin
Technology Co. Ltd | |
| 4. Power Source(s)
Battery | (9V - user replaceable) | 9V Battery | Same |
| - Method of Line Current
Isolation | N/A | N/A | Same |
| - Patient Leakage Current | N/A | | |
| - Normal condition | N/A | 0.61uA | This parameter is not
applicable to the new
device. |
| - Single fault condition | N/A | 0.68uA | This parameter is not
applicable to the new
device. |
| 5. Number of Output
Modes | 1 | 1 | Same |
| 6. Number of Output
Channels | 1 | Alternating | Different but does not
adversely impact safety
and effectiveness of the
new device. |
|---------------------------------|-----|-------------|----------------------------------------------------------------------------------------------|
| Synchronous or
Alternating? | N/A | Alternating | This parameter is not
applicable to the new
device. |
7
| - Method of Channel
Isolation | N/A | By electrical circuit and
software | This parameter is not
applicable to the new
device. |
|-------------------------------------------------|-------------------|---------------------------------------|----------------------------------------------------------------------------------------------|
| 7. Regulated Current or
Regulated Voltage? | Regulated Voltage | Regulated Current | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 8.Software/Firmware/
Microprocessor Control? | Yes | Yes | Same |
| 9. Automatic Overload
Trip? | Yes | Yes | Same |
| 10. Automatic
No-Load Trip? | No | Yes | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 11. Automatic Shut
Off? | Yes | Yes | Same |
| 12. Patient Override
Control? | No | Yes | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 13. Indicator Display: | | | |
| - On/Off Status? | Yes | Yes | Same |
| - Low Battery? | No | Yes | Different but does not
adversely impact safety
and effectiveness of the
new device. |
8
| 14. Timer Range | 25 seconds | 1-60 minutes | New device is several
times safer than the
predicate because of the
short usage time. |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| 15. Compliance with
Voluntary Standards? (If
yes, specify) | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
IEC 60601-1-11 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-10
ISO 10993-5/10 | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 16. Compliance* with 21
CFR 898? Yes /
No | Yes | Yes | Same |
| 17. Weight | 119 grams, including a
9V battery | 128 grams
(including
batteries) | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 18. Dimensions (in.)
[W x H x D] | 120 x 45 x 47 | 117 x 60 x 34 mm | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| 19. Housing Materials
and Construction | Polypropylene | ABS | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Waveform (e.g.,
pulsed monophasic,
biphasic) | Monophasic | Biphasic | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Shape (e.g.,
rectangular, spike,
rectified sinusoidal) | Rectangular | Square | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Voltage@ 500Ω | 28.6V | 96+-20%
(48+-20% (Vp)) | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Voltage @ 2kΩ | 94.3V | 228+-20%
(114+-20% (Vp)) | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Voltage @ 10kΩ | 125.7V | 230+-20%
(115+-20% (Vp)) | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Current @ 500Ω | 58mA | 96+-20% | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Current @ 2kΩ | 50mA | 57+-20% | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Output
Current @ 10kΩ | 14mA | 11.5 +-20% | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Pulse Width | 9us - 113us | 50 - 300uS | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Frequency | 150Hz | 1-150Hz | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Net Charge (mC per
pulse) @ 500Ω | 7uC | 0uC@500Ω | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Phase
Charge, (mC) @
500Ω | 7uC | 0.0288@500Ω | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Current
Density, (mA/cm²) @
500Ω | 4.23mA/cm2 | 1.15@500Ω | Different but does not
adversely impact safety
and effectiveness of the
new device. |
| Maximum Power
Density, (mW/cm²) @
500Ω | 120mW/cm2 | Unavailable | |
| Max. Average Power
Density, mW/cm²
(using smaller
electrode conductive
surface area | 2.03 | 0.373@500Ω | |
9
10
The electronic characteristics listed in the table above were designed to those of the predicate. They were then measured and confirmed in the lab. The power source in Noodle and predicate are the same. In lines 5 and 6, the output modes and output channels in the predicate are more numerous. The predicate offers more output modes, and the user opts for one of them. Noodle offers only one output mode and one output channel that are offered by the predicate.
In line 14, the time range for Noodle is significantly less than the predicate.
Similarly in lines 15 and 16, the predicate offers more choices in waveform and in pulse width range than Noodle. Noodle is preset to offer only one of those options offered by the predicate. Line 22 shows what the Noodle enclosure is made of. This material meets all applicable industrial standards. Conclusion
11
All nonclinical tests recommended by the FDA were performed and found Noodle to meet all the requirements of the stated standards. In addition, Noodle was tested clinically and was shown to effectively and safely reduce pain of hypodermic injections into the upper extremities (arms), lower extremities (leg), buttocks, abdomen, and deltoid areas in patients 18 to 70 years of age.