(131 days)
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.
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.
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.
Here's a summary of the acceptance criteria and study findings for the Noodle device based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a quantitative manner as is typical for AI/ML performance. Instead, it describes clinical benefit based on pain reduction. I will interpret the reported clinical results as the "reported device performance."
| Acceptance Criteria (Inferred from Clinical Study Goal) | Reported Device Performance |
|---|---|
| Reduction in pain scores (VAS scale) for hypodermic injections | - 77% of subjects (14 of 18) reported a reduction in pain scores of at least 3 or greater on the VAS scale when preconditioned with Noodle. - This is approximately a 30% pain reduction. - Average VAS was lower with Noodle than with the sham device by 35%. - The difference seen was considered to provide clinical benefit to patients. |
| No significant adverse effects or safety risks | - No adverse events were reported in the 18 subjects. |
| Compliance with non-clinical test standards (electrical safety, EMC, nerve stimulation) | - Noodle passed all non-clinical tests (ANSI AAMI ES60601-1, ANSI AAMI IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 18 patients.
- Data Provenance: The study was a multi-site causal-comparative trial conducted at 3 sites (one doctor's office and two pharmacies). It was a prospective clinical study designed to test the device's efficacy.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
The concept of "ground truth" as typically defined for AI/ML (e.g., expert consensus on image labels) is not directly applicable here. The study measures a subjective patient outcome (pain perception via VAS scale) during a medical procedure.
- Ground Truth Establishment: The ground truth for pain reduction was established by the patients themselves using the VAS pain scale. Healthcare professionals administered the injections and collected the VAS scores. The document does not specify the qualifications of the healthcare providers who administered the injections or collected the data, beyond stating the study took place in a "doctor's office" and "pharmacies."
4. Adjudication Method for the Test Set
Not applicable in the AI/ML sense. Patient-reported outcomes (VAS scores) were directly collected. The study was described as "sham-controlled double-blind," meaning neither the patient nor the person administering the treatment (presumably the healthcare provider) knew whether the active Noodle device or a sham device was used. This blinding helps minimize bias in outcome reporting.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance?
Not applicable. This device is a transcutaneous electrical nerve stimulator for pain relief, not an AI-powered diagnostic or assistive tool for human readers/clinicians. Therefore, an MRMC study comparing human performance with and without AI assistance was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done?
Not applicable. This is a medical device, not an algorithm. The device provides the therapy (electrical and mechanical stimulation) directly to the patient. It requires human-in-the-loop for application and administration of the injection. The study evaluates the device's effect on patient pain, not the performance of an algorithm.
7. The Type of Ground Truth Used
The ground truth used was patient-reported outcomes (pain perception), measured using the Visual Analog Scale (VAS).
8. The Sample Size for the Training Set
Not applicable. This document is a 510(k) summary for a physical medical device, not an AI/ML algorithm. There is no "training set" in the context of device development described here. The clinical study described served as a clinical validation (test set) to demonstrate safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML algorithm.
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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.
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
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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
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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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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 |
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| 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 |
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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.
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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 EquivalenceDetermination | |
|---|---|---|---|
| 1. 510(k) Number | K130802 | ||
| 2. Device Name,Model | Noodle | OTC Electrical StimulatorLT3060 | |
| 3. Manufacturer | Painless World | Shenzhen DongdixinTechnology Co. Ltd | |
| 4. Power Source(s)Battery | (9V - user replaceable) | 9V Battery | Same |
| - Method of Line CurrentIsolation | N/A | N/A | Same |
| - Patient Leakage Current | N/A | ||
| - Normal condition | N/A | 0.61uA | This parameter is notapplicable to the newdevice. |
| - Single fault condition | N/A | 0.68uA | This parameter is notapplicable to the newdevice. |
| 5. Number of OutputModes | 1 | 1 | Same |
| 6. Number of OutputChannels | 1 | Alternating | Different but does notadversely impact safetyand effectiveness of thenew device. |
|---|---|---|---|
| Synchronous orAlternating? | N/A | Alternating | This parameter is notapplicable to the newdevice. |
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| - Method of ChannelIsolation | N/A | By electrical circuit andsoftware | This parameter is notapplicable to the newdevice. |
|---|---|---|---|
| 7. Regulated Current orRegulated Voltage? | Regulated Voltage | Regulated Current | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 8.Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| 9. Automatic OverloadTrip? | Yes | Yes | Same |
| 10. AutomaticNo-Load Trip? | No | Yes | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 11. Automatic ShutOff? | Yes | Yes | Same |
| 12. Patient OverrideControl? | No | Yes | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 13. Indicator Display: | |||
| - On/Off Status? | Yes | Yes | Same |
| - Low Battery? | No | Yes | Different but does notadversely impact safetyand effectiveness of thenew device. |
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| 14. Timer Range | 25 seconds | 1-60 minutes | New device is severaltimes safer than thepredicate because of theshort usage time. |
|---|---|---|---|
| 15. Compliance withVoluntary Standards? (Ifyes, specify) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10IEC 60601-1-11 | IEC 60601-1IEC 60601-1-2IEC 60601-2-10ISO 10993-5/10 | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 16. Compliance* with 21CFR 898? Yes /No | Yes | Yes | Same |
| 17. Weight | 119 grams, including a9V battery | 128 grams(includingbatteries) | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 18. Dimensions (in.)[W x H x D] | 120 x 45 x 47 | 117 x 60 x 34 mm | Different but does notadversely impact safetyand effectiveness of thenew device. |
| 19. Housing Materialsand Construction | Polypropylene | ABS | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Waveform (e.g.,pulsed monophasic,biphasic) | Monophasic | Biphasic | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Shape (e.g.,rectangular, spike,rectified sinusoidal) | Rectangular | Square | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputVoltage@ 500Ω | 28.6V | 96+-20%(48+-20% (Vp)) | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputVoltage @ 2kΩ | 94.3V | 228+-20%(114+-20% (Vp)) | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputVoltage @ 10kΩ | 125.7V | 230+-20%(115+-20% (Vp)) | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputCurrent @ 500Ω | 58mA | 96+-20% | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputCurrent @ 2kΩ | 50mA | 57+-20% | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum OutputCurrent @ 10kΩ | 14mA | 11.5 +-20% | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Pulse Width | 9us - 113us | 50 - 300uS | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Frequency | 150Hz | 1-150Hz | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Net Charge (mC perpulse) @ 500Ω | 7uC | 0uC@500Ω | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum PhaseCharge, (mC) @500Ω | 7uC | 0.0288@500Ω | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum CurrentDensity, (mA/cm²) @500Ω | 4.23mA/cm2 | 1.15@500Ω | Different but does notadversely impact safetyand effectiveness of thenew device. |
| Maximum PowerDensity, (mW/cm²) @500Ω | 120mW/cm2 | Unavailable | |
| Max. Average PowerDensity, mW/cm²(using smallerelectrode conductivesurface area | 2.03 | 0.373@500Ω |
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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
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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.
§ 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).