SaliPen

K220618 · Saliwell , Ltd. · QTT · Aug 30, 2022 · Dental

Device Facts

• Record ID: K220618
• Device Name: SaliPen
• Applicant: Saliwell , Ltd.
• Product Code: QTT · Dental
• Decision Date: Aug 30, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5560
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

SaliPen is an electrical salivary stimulator system, and is identified as an intraoral device intended to electrically stimulate a relative increase in saliva production.

Device Story

SaliPen is an electrical salivary stimulator system for xerostomia. Device consists of an intraoral stimulating unit and an extra-oral command unit. Intraoral unit, made of silicone rubber, features a stem for lip-holding and two flexible arms with gold-plated electrodes. Electrodes are placed on the lingual mucosa in the mandibular third molar region to stimulate the lingual nerve, triggering the salivary reflex. Command unit contains an electronic circuit, 3V coin battery, and an On/Off switch. User activates device, places it in mouth for up to 5 minutes, then removes and deactivates. Maximum usage is 5 times per day. Device delivers low-power, low-voltage, biphasic electrical pulses below sensation and pain thresholds. Intended for over-the-counter use by patients to increase saliva production.

Clinical Evidence

Human Factors validation trial conducted per FDA guidance. Study confirmed that subjects with and without xerostomia could correctly determine eligibility for device use based on labeling. Subjects were able to successfully follow OTC labeling instructions for device operation.

Technological Characteristics

Silicone rubber intraoral unit; gold-plated electrodes. Microprocessor-based digital electronics. Powered by 3V coin battery. Biphasic electrical pulse stimulation. Standards: ISO 10993-5/12 (biocompatibility), EN ISO 14971:2012 (risk), EN 60601-1:2005/IEC 60601-1-11:2010 (electrical safety), EN 60601-1-2:2007 (EMC), IEC 62304 (software), EN ISO 13485:2003 (quality), UL 1642 (battery).

Indications for Use

Indicated for use in patients with xerostomia (dry mouth).

Regulatory Classification

Identification

An electrical salivary stimulatory system is a prescription intraoral device that is intended to electrically stimulate a relative increase in saliva production.

Special Controls

*Classification* —Class II (special controls). The special controls for this device are:(1) The design characteristics of the device must ensure that the device design, material composition, and electrical output characteristics are consistent with the intended use; (2) Any element of the device that contacts the patient must be demonstrated to be biocompatible; (3) Appropriate analysis and/or testing must validate electromagnetic compatibility and electrical safety, including the safety of any battery used in the device; (4) Software validation, verification, and hazard testing must be performed; and (5) Documented clinical experience must demonstrate safe and effective use for stimulating saliva production by addressing the risks of damage to intraoral tissue and of ineffective treatment and must capture any adverse events observed during clinical use.

Predicate Devices

• SaliPen (K180838)

Submission Summary (Full Text)

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August 30, 2022

Saliwell Ltd. Andy Wolff President 3A Hatamar St. Harutzim, Israel 6091700 ISRAEL

Re: K220618

Trade/Device Name: SaliPen Regulation Number: 21 CFR 872.5560 Regulation Name: Electrical salivary stimulatory system Regulatory Class: Class II Product Code: OTT Dated: May 19, 2022 Received: May 25, 2022

Dear Andy Wolff:

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

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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 (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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K220618

Device Name SaliPen

Indications for Use (Describe)

SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

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

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 contains a logo for a company called SALIWELL LTD. MEDICAL SYSTEMS. The logo consists of a blue abstract shape resembling a stylized letter S, with a series of blue dots running through it. Below the company name is the identifier "K220618".

# 510(k) Summary

#### I. SUBMITTER

Saliwell Ltd., 65 Hatamar St., Harutzim 6091700, Israel

Phone: [phone]

Fax: [phone]

# Contact person:

Ben Z. Beiski, MSc.

Phone: [phone]

Mobile: [phone]

e-mail: [e-mail]

Fax: [phone]

Date of Summary preparation: February 2, 2022

#### II. DEVICE

Name of device: SaliPen

Common name: Electrical salivary stimulator system

Classification name: Electrical salivary stimulator system

Regulatory Class: II

Product Code: QTT

#### III. PREDICATE DEVICE

The predicate device is SaliPen, K180838.

#### IV. DEVICE DESCRIPTION

SaliPen is an electrical salivary stimulatory system device. It is comprised of two units: an intraoral stimulating unit and an extra-oral command unit. The latter includes an electronic circuit, a compartment containing a 3V coin battery, and a bottom for switching the stimulation "On" and "Off".

The stimulating unit is made of silicone rubber and includes a stem and two flexible arms. The stem is used to hold SaliPen between the lips. The flexible arms are shaped to the inner contour of the lower dental arch. Each arm carries one pair of gold-plated stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the lingual mucosa in the mandibular third molar region. The lingual nerve, which runs closely to this location, is the target of the stimulation due to its crucial role in the salivary reflex.

Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses. The selected stimulating parameters provide effective stimulation, yet are well below the sensation thresholds, and definitely below the pain threshold.

The user turns the device "On" and afterwards places the device in his/her mouth. After up to five minutes of use, the user removes the device from his/her mouth and deactivates the

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Image /page/4/Picture/0 description: The image shows the logo for Saliwell LTD Medical Systems. The logo consists of a blue triangle with a stylized "S" shape inside, made up of a series of circles. The text "Saliwell LTD Medical Systems" is written in blue, with "LTD" in a smaller font size.

stimulation. The device is used not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.

### Intended use:

SaliPen is an electrical salivary stimulator system, and is identified as an intraoral device intended to electrically stimulate a relative increase in saliva production.

#### V. INDICATIONS FOR USE

SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).

| Feature being compared | SUBMISSION DEVICE | PREDICATE DEVICE |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| | SaliPen OTC device<br>(K220618) | SaliPen prescription<br>device (K180838) |
| Mechanism of action | Promote salivary function by<br>mechanical and electrical<br>stimulation of nerves that<br>are involved in the salivary<br>reflex. | Promote salivary function by<br>mechanical and electrical<br>stimulation of nerves that<br>are involved in the salivary<br>reflex. |
| Placement of electrodes | Positioned on the lingual<br>mucosa in the mandibular<br>third molar area in vicinity of<br>the lingual nerve. | Positioned on the lingual<br>mucosa in the mandibular<br>third molar area in vicinity of<br>the lingual nerve. |
| Electronics | Digital. | Digital. |
| Anatomical adaptation to the<br>oral cavity | Yes, due to device flexibility. | Yes, due to device flexibility. |
| Frequency of use | Up to 5 times per day, 5<br>minutes at a time. | Up to 5 times per day, 5<br>minutes at a time. |
| External control | Microprocessor-based. | Microprocessor-based. |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Summarizing, the similarities of the technological characteristics between the submission device and the predicate device include mechanism of action, placement of electrodes, electronics, frequency of use and external control. The difference between the submission device and the predicate device as to their availability (over-the-counter or prescription) does not raise concerns of safety and effectiveness in the OTC device.

#### VII. PERFORMANCE DATA

### Nonclinical performance evaluation:

Testing (including electromaqnetic compatibility, electrical safety, biocompatibility assessment, and risk analysis) was performed and found to be in compliance with the standards, such as ISO 10993-5, ISO 10993-12, EN ISO 14971:2012, EN 60601-1:2005, EN 60601-1-2:2007, IEC 60601-1-11:2010, ISO 15223-1:2016, EN 60529:1992+A2:2013, IEC 62304 1st edition 2006-05, EN ISO 13485:2003, and UL 1642.

Saliwell Ltd., 3A Hatamar St., 6091700 Harutzim, Israel. Ph: [phone], Fax: [phone]. www.saliwell.com

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ELL LTDo MEDICAL SYSTEMS

Image /page/5/Picture/1 description: The image shows the logo for Saliwell LTD. The logo features a blue triangle with a white "S" shape inside, made up of small circles. To the right of the triangle is the text "Saliwell LTD." in a blue, sans-serif font, followed by the word "MEDI" in a smaller, gray font.

## Clinical performance evaluation:

A Human Factors validation trial was conducted in accordance with the FDA Guidance Document "Applying Human Factors and Usability Enqineering to Medical Devices" from February 3, 2016. This trial showed that, based on the external label of the product, both study subjects with xerostomia (dry mouth) and subjects without this condition were able to decide correctly whether they are eligible or not, respectively, to using the device. Furthermore, the study results showed that study subjects who participated in using the device were able to follow the over-the-counter labeling instructions for use.

# VIII. CONCLUSIONS

Based on intended use, technological characteristics, and performance testing, we conclude that the SaliPen OTC device is substantially equivalent to the SaliPen prescription device.