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 stimulating electrodes. The device is designed in a manner that allows placing the electrodes on the linqual mucosa in the mandibular third molar region. Electrical stimulation is achieved by the delivery of low-power, low voltage, biphasic electrical pulses.

AI/ML Overview

This document, K232063 for the SaliPen device, is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a clinical study with detailed acceptance criteria and performance data for a new, AI-powered diagnostic device. Therefore, it does not contain the specific information required to complete all sections of your request regarding acceptance criteria and a study proving the device meets those criteria, especially in the context of AI performance.

The document describes the SaliPen as an electrical salivary stimulator system, not an AI-powered diagnostic device. The "performance data" section refers to nonclinical evaluations (electromagnetic compatibility, electrical safety, biocompatibility, and risk analysis) and comparative testing of electrical output to the predicate device, not a human reader or standalone algorithm performance study.

Here's what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (as implied by the document's purpose): The primary acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to the predicate devices (SaliPen K180838 and K220618). This means showing that the device is as safe and effective as, and does not raise new questions of safety and effectiveness than, the legally marketed predicate.
- Specific performance criteria mentioned relating to equivalence:
  - Mechanism of action is the same.
  - Placement of electrodes is the same.
  - Electronics are the same.
  - Anatomical adaptation is the same.
  - Frequency of use is the same.
  - External control is the same.
  - Electrical output is identical to the predicate (despite shortened electrodes).
  - Biocompatibility of shortened electrodes is demonstrated via cytotoxicity testing.
  - Risk assessment confirms no new/increased risks due to shortened electrodes.
Reported Device Performance:
- Nonclinical performance: "Testing (including electromagnetic compatibility, electrical safety, biocompatibility assessment, and risk analysis) was performed and found to be in compliance with the standards..." (listed standards such as ISO 10993-5, ISO 10993-12, EN ISO 14971:2012, EN 60601-1:2005, etc.)
- Comparative Electrical Output: "comparative testing of the electrical output of the subject device was conducted to demonstrate that the output is identical to the predicate."
- Biocompatibility: "Cytotoxicity testing per ISO 10993-5 was conducted on the shortened electrodes to demonstrate biocompatibility."
- Risk Analysis: "a risk assessment of the brass was performance. A contraindication has been added to the labeling for persons who are allergic to brass."
Note: Since this is not an AI diagnostic, there are no metrics like sensitivity, specificity, AUC, or reader improvement to report.

2. Sample size used for the test set and the data provenance:

Not applicable for this document. The document describes nonclinical testing and comparative electrical output verification, not a clinical study on a test set of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No expert review for ground truth associated with an AI algorithm's performance is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication is mentioned.

5. 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 algorithm that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This document describes a medical device, not a standalone AI algorithm. The performance evaluation focuses on the physical and electrical characteristics of the device itself and its biocompatibility, not its diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Implied "ground truth" for this device: The performance is benchmarked against established safety standards (e.g., ISO, EN standards for electrical safety, biocompatibility) and the electrical output of the predicate device. The "truth" is compliance with these standards and equivalence to the predicate.

8. The sample size for the training set:

Not applicable. There is no training set mentioned as this is not an AI/ML device.

9. How the ground truth for the training set was established:

Not applicable. There is no training set mentioned.

Summary

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December 13, 2023

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

Re: K232063

Trade/Device Name: SaliPen Regulation Number: 21 CFR 872.5560 Regulation Name: Electrical salivary stimulatory system Regulatory Class: Class II Product Code: QTT Dated: November 13, 2023 Received: November 14, 2023

Dear Dr. 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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Bobak Shirmohammadi -S

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

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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)

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/4/Picture/0 description: The image shows the logo for "SALIWELL LTD. MEDICAL SYSTEMS". The logo features a blue triangle shape with a stylized "S" formed by a series of blue circles inside the triangle. The text "SALIWELL LTD." is in a blue sans-serif font, and "MEDICAL SYSTEMS" is in a smaller, black sans-serif font.

510(k) Summary K232063

I. 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: December 12, 2023

II. DEVICE

Name of device: SaliPen

Common name: Electrical salivary stimulator system

Classification name: Electrical salivary stimulator system

Regulatory Class: II

Product Code: QTT

PREDICATE DEVICE III.

The predicate devices are SaliPen K180838 and K220618.

IV. DEVICE DESCRIPTION

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 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

Saliwell Ltd., 3A Hatamar St., 6091700 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 consists of a blue triangle with a stylized "S" inside, made up of a series of blue circles. The text "SALIWELL LTD. MEDICAL SYSTEMS" is written in blue and black to the right of the triangle.

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 saliya production.

INDICATIONS FOR USE V.

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

Feature being compared	SUBMISSION DEVICE	PREDICATE DEVICES
	SaliPen device withshortened electrodes	SaliPen devices (K180838and K220618)
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 device flexibility.
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 electrodes of both devices are made of brass plated with gold. The electrodes of the predicate device are fully gold plated. The electrodes of the submission device are shortened exposing the brass at the tip of the electrodes, an area of less than 1mm². The change is intended to make the device more comfortable to use, but does not affect its effectiveness. In addition, based on cytotoxicity testing and a risk analysis, we concluded that the difference between the submission device and the predicate device does not raise new risks or increase existing risks vs. the predicated device.

VII. PERFORMANCE DATA

Nonclinical performance evaluation:

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Image /page/6/Picture/0 description: The image shows the logo for Saliwell LTD. The logo features a blue triangle with a stylized "S" formed by a series of circles inside. To the right of the logo is the text "SALIWELL LTD. MEDICAL SYSTEMS" in a blue sans-serif font. The text is aligned horizontally with the logo.

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.

To demonstrate that the shorter electrodes does not affect the performance and the electrical stimulation, comparative testing of the electrical output of the subject device was conducted to demonstrate that the output is identical to the predicate.

Cytotoxicity testing per ISO 10993-5 was conducted on the shortened electrodes to demonstrate biocompatibility. In addition, a risk assessment of the brass was performance. A contraindication has been added to the labeling for persons who are allergic to brass.

VIII. CONCLUSIONS

Based on intended use, technological characteristics, and performance testing, we conclude that the submission device, the SaliPen, with shortened electrodes is substantially equivalent to the SaliPen predicate devices.

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.