(155 days)
Not Found
No
The device description and performance studies focus on electrical stimulation and safety testing, with no mention of AI or ML algorithms for data processing, decision-making, or personalized stimulation. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is indicated for use in patients with xerostomia (dry mouth) and aims to treat this condition through electrical stimulation, which qualifies it as a therapeutic device.
No
The device is described as an electrical salivary stimulator system, indicated for the treatment of xerostomia (dry mouth) through electrical stimulation. It does not mention any function for diagnosing or detecting a disease or condition.
No
The device description explicitly details physical hardware components, including an intraoral stimulating unit made of silicone rubber with electrodes, and an extra-oral command unit containing an electronic circuit, battery compartment, and switch. The performance studies also include testing related to hardware, such as electromagnetic compatibility, electrical safety, and biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to stimulate saliva production in patients with dry mouth (xerostomia) using electrical stimulation. This is a therapeutic intervention applied directly to the patient's body.
- Device Description: The device is an electrical stimulator with intraoral and extra-oral components. It delivers electrical pulses to the linqual mucosa. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, saliva, etc.) or providing diagnostic information about a patient's condition based on such analysis. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, SaliPen is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
SaliPen is an electrical salivary stimulator system, indicated for use in patients with xerostomia (dry mouth).
Product codes (comma separated list FDA assigned to the subject device)
QTT
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 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 not more than 5 times per day. The device and replacement devices are allowed for a cumulative use of up to 50 months.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral device intended to electrically stimulate a relative increase in saliya production.
Positioned on the lingual mucosa in the mandibular third molar area in vicinity of the lingual nerve.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical performance evaluation:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".
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).
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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
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. 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 with | ||
| shortened electrodes | SaliPen devices (K180838 | |
| and K220618) | ||
| Mechanism of action | Promote salivary function by | |
| mechanical and electrical | ||
| stimulation of nerves that | ||
| are involved in the salivary | ||
| reflex. | Promote salivary function by | |
| mechanical and electrical | ||
| stimulation of nerves that | ||
| are involved in the salivary | ||
| reflex. | ||
| Placement of electrodes | Positioned on the lingual | |
| mucosa in the mandibular | ||
| third molar area in vicinity of | ||
| the lingual nerve. | Positioned on the lingual | |
| mucosa in the mandibular | ||
| third molar area in vicinity of | ||
| the lingual nerve. | ||
| Electronics | Digital. | Digital. |
| Anatomical adaptation to the | ||
| oral cavity | Yes, due to device flexibility. | Yes, due to device flexibility. |
| Frequency of use | Up to 5 times per day, 5 | |
| minutes at a time. | Up to 5 times per day, 5 | |
| minutes 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.