SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.

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 linqual mucosa in the mandibular third molar region. The linqual 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 stimulation. The device is used on "as need" base (i.e., when the users feels oral dryness) but not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.

Clinical trials showed that electrical stimulation to the lingual mucosa in the mandibular third molar region increases relative saliva production, resulting in more oral lubrication, due to the mechanical and electrical stimulation (both well-known techniques to increase salivary secretion and to relieve symptoms of dry mouth).

AI/ML Overview

The provided text is a 510(k) summary for the SaliPen device, an electrical salivary stimulator. It focuses on demonstrating substantial equivalence to a predicate device (GenNarino, K160799) through comparison of technological characteristics and performance data.

However, the document does not contain the kind of detailed information typically found in a clinical study report that would allow for a precise filling out of the requested table and sections regarding acceptance criteria and a study proving those criteria.

Specifically, it lacks:

A defined set of acceptance criteria for "device performance."
Reported numerical performance metrics directly linked to specific acceptance criteria.
Details about sample size, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any clinical performance study.
Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.

The "Clinical performance evaluation" section only mentions "Usability testing was conducted in accordance to the standard IEC 60601-1-6:2013," which is about user interface and design, not clinical effectiveness in terms of salivary stimulation. The statement "Clinical trials showed that electrical stimulation to the lingual mucosa...increases relative saliva production..." is a general claim and not a detailed report of a specific study to prove acceptance criteria.

Therefore, I cannot fully complete the requested information based solely on the provided text.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from document)	Reported Device Performance (from document)
Clinical Performance: Increase relative saliva production	"Clinical trials showed that electrical stimulation to the lingual mucosa in the mandibular third molar region increases relative saliva production, resulting in more oral lubrication, due to the mechanical and electrical stimulation (both well-known techniques to increase salivary secretion and to relieve symptoms of dry mouth)." (Note: This is a general statement, not specific numerical performance data against a defined criterion in this submission document.)
Usability: In accordance with IEC 60601-1-6:2013	"Usability testing was conducted in accordance to the standard IEC 60601-1-6:2013." (Implies compliance, but no specific performance metrics like task completion rates or error rates are provided).
Nonclinical Performance (Safety & EMC): Compliance with standards	"Testing (including electromagnetic 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." (Implies compliance, but no specific test results or metrics are provided).
Technological Characteristics' Equivalence to Predicate Device	The submission device (SaliPen) has similar mechanism of action, electrode placement, electronics, frequency of use, and external control as the predicate device (GenNarino). The difference in anatomical adaptation (flexibility vs. customization) does not raise safety/effectiveness concerns.

Missing Information (Not Available in the Provided Text):

Sample size used for the test set and the data provenance: Not specified for any clinical performance or efficacy studies. The general reference to "Clinical trials" does not provide these details.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified, as no rigorous "ground truth" establishment for assessing device performance is detailed in this summary.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrical stimulator, not an AI diagnostic/imaging device that would involve human readers or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined for any performance claims regarding increased saliva. It seems to rely on the general physiological understanding of salivary stimulation.
The sample size for the training set: Not applicable, as this is a physical medical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Saliwell Ltd. Ben Beiski CEO 65 Hatamar St. Harutzim, 6091700 Israel

Re: K180838

Trade/Device Name: SaliPen Regulation Number: 21 CFR 872.5560 Regulation Name: Electrical Salivary Stimulator Regulatory Class: Class II Product Code: LTF Dated: October 4, 2018 Received: October 9, 2018

Dear Ben Beiski:

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

November 6, 2018

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mar Mary S. S Runner - 53 Runner -S33 - 09:39:01 -05:00 For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180838

Device Name SaliPen

Indications for Use (Describe)

SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth), under prescription of a dental practitioner or physician.

Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ 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 Saliwell LTD. The logo consists of a blue triangle with a stylized "S" inside, followed by the text "SALIWELL LTD." in blue. To the right of "SALIWELL LTD." is the text "MEDICAL SYSTEMS" in a smaller, gray font.

510(k) Summary – K180838

. SUBMITTER

Saliwell Ltd., 65 Hatamar St., Harutzim 6091700, Israel Phone: +972-3-534-7592 Fax: +972-77-353-4338 Contact person:

Ben Z. Beiski, MSc.

Phone: +972-3-534-7592

Mobile: +972-50-725-6338

e-mail: bbeiski@saliwell.com

Fax: +972-77-353-4338

Date of Summary preparation: September 25th, 2018

== DEVICE

Name of device: SaliPen

Common name: Electrical salivary stimulator system

Classification name: Electrical salivary stimulator system

Regulatory Class: II

Product Code: LTF

.............................................................................................................................................................................. PREDICATE DEVICE

The predicate device is GenNarino, K160799.

IV. DEVICE DESCRIPTION

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ELL LTD. MEDICAL SYSTEMS

Image /page/4/Picture/1 description: The image shows the logo for Saliwell LTD. The logo consists of a blue triangle with a stylized "S" formed by a series of circles inside. To the right of the triangle is the text "SALIWELL LTD. MEDICAL SYSTEMS" in a blue sans-serif font. The text is horizontally aligned with the triangle logo.

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 a prescription 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), under prescription of a dental practitioner or physician.

Comparison of Indications for Use: Both, the submission and the predicate devices have the same intended use for electrically stimulate a relative increase in saliva production.

Feature being compared	SUBMISSION DEVICE	PREDICATE DEVICE
	SaliPen	GenNarino (K160799)
Mechanism of action	Promote salivary function bymechanical and electricalstimulation of nerves thatare involved in the salivaryreflex.	Promote salivary function bymechanical and electricalstimulation of nerves thatare involved in the salivaryreflex.
Placement of electrodes	Positioned on the lingualmucosa in the mandibularthird molar area in vicinity ofthe lingual nerve.	Positioned on the lingualmucosa in the mandibularthird molar area in vicinity ofthe lingual nerve.
Electronics	Digital.	Digital.
Anatomical adaptation to theoral cavity	Yes, due to device flexibility.	Yes, due to customization.
Frequency of use	Up to 5 times per day, 5minutes at a time.	Up to 5 times per day, 5minutes at a time.
External control	Microprocessor-based.	Microprocessor-based.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE 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 the way anatomical adaptation to the oral cavity is achieved (by flexibility in the submission device vs. by customization in the predicate device) does not raise concerns of safety and effectiveness, since in both devices anatomical adaptation is accomplished.

Saliwell Ltd., 65 Hatamar St., 60917 Harutzim, Israel. Ph: +972-3-534-7592, Fax: +972-77-353.4338. www.saliwell.com

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Image /page/5/Picture/0 description: The image shows the logo for "SALIWELL LTD. MEDICAL SYSTEMS". The logo features a blue triangle with a stylized "S" formed by a series of blue circles inside. The text "SALIWELL LTD." is in blue, with "MEDICAL SYSTEMS" in a smaller, lighter font to the right.

PERFORMANCE DATA VII.

Nonclinical performance evaluation:

Testing (including electromagnetic compatibility, electrical safety, biocompatibilty 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.

Clinical performance evaluation:

Usability testing was conducted in accordance to the standard IEC 60601-1-6:2013.

VIII. CONCLUSIONS

Based on intended use, technological characteristics, and performance testing, we conclude that SaliPen is substantially equivalent to GenNarino.

Regulation Number and Section

§ 872.5560 Electrical salivary stimulatory system.

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