(221 days)
No
The description focuses on electrical stimulation and mechanical design, with no mention of AI or ML algorithms for data processing, decision-making, or adaptive stimulation.
Yes
The device is indicated for use in patients with xerostomia (dry mouth) and its mechanism of action involves increasing relative saliva production, resulting in more oral lubrication, which directly addresses the symptoms of a medical condition.
No
The device is an electrical salivary stimulator system used for treatment of xerostomia (dry mouth) by increasing saliva production, not for diagnosing a condition.
No
The device description clearly outlines two hardware units: an intraoral stimulating unit and an extra-oral command unit, which includes an electronic circuit and battery. This indicates it is a hardware device with electrical components, not software only.
Based on the provided information, the SaliPen device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to stimulate saliva production in patients with dry mouth (xerostomia). This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an electrical stimulator that is placed in the mouth to directly interact with the lingual nerve. It does not analyze biological samples like blood, urine, or saliva itself for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes related to collecting, preparing, or analyzing biological samples for the purpose of diagnosing a condition or monitoring a treatment.
In summary, SaliPen is a therapeutic device designed to treat a symptom (dry mouth) through electrical stimulation, not a diagnostic device that analyzes samples to identify a condition.
N/A
Intended Use / 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.
Product codes
LTF
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.
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 saliva production.
Placement of electrodes: 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
prescription of a dental practitioner or physician.
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, 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 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.
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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
1
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
2
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
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
4
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.
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).
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 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 customization. |
| 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 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.