(121 days)
Not Found
No
The device description focuses on mechanical components (pumps, electronics, plumbing) for irrigation and suction. There is no mention of AI/ML terms, image processing, or data sets for training/testing algorithms. The performance studies evaluate mechanical effectiveness, not algorithmic performance.
Yes
The device is described as an "Ear Cleaning System" indicated to "remove earwax from the external ear canal," which is a therapeutic action aimed at treating or alleviating a condition (earwax buildup).
No
The device is an ear cleaning system designed to remove earwax. Its function is interventional (cleaning), not to provide a diagnosis of a condition.
No
The device description explicitly lists hardware components such as pumps, batteries, and printed circuit boards, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the OtoSet - Ear Cleaning System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body (in vitro).
- OtoSet's Function: The OtoSet is a device used to physically remove earwax from the external ear canal. It uses irrigation and suction to achieve this. It does not perform any tests on samples taken from the body.
- Intended Use: The intended use clearly states "to remove earwax from the external ear canal". This is a physical intervention, not a diagnostic test.
- Device Description: The description details the mechanical components and how the device works to physically remove earwax. There is no mention of analyzing samples or performing diagnostic tests.
Therefore, the OtoSet falls under the category of a medical device used for treatment or physical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OtoSet – Ear Cleaning System (OtoSet) is indicated to remove earwax from the external ear canal with irrigation and suction in adults.
Product codes
KYZ
Device Description
The OtoSet – Ear Cleaning System (OtoSet) is an automated ear irrigation device used to remove earwax, or cerumen, from the external ear canal of adults. The OtoSet consists of an adjustable head strap, two ear units, two single-patient-use disposable ear tips, and two singlepatient-use disposable waste containers.
In addition to the disposable ear tips and waste containers, each ear unit houses a solution container, liquid pump, vacuum pump, printed circuit board electronics, rechargeable batteries, and electrical and plumbing elements to connect these items together. The device can be used to clean the left, right, or both external ear canals at the same time.
The OtoSet includes components that come in contact with the patient during use. The singlepatient-use disposable ear tips, ear pads and head strap pad (all made of silicone rubber) are surface contacting components having limited contact duration (
§ 880.6960 Irrigating syringe.
(a)
Identification. An irrigating syringe is a device intended for medical purposes that consists of a bulb or a piston syringe with an integral or a detachable tube. The device is used to irrigate, withdraw fluid from, or instill fluid into, a body cavity or wound.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. If the device is not labeled or otherwise represented as sterile, it is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
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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 with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".
November 5, 2020
SafKan, Inc. Allison Komiyama Principal Consultant Acknowledge Regulatory Strategies, LLC 2251 San Diego Avenue Ste B-257 San Diego, California 92110
Re: K201877
Trade/Device Name: OtoSet - Ear Cleaning System Regulation Number: 21 CFR 880.6960 Regulation Name: Irrigating syringe Regulatory Class: Class I Product Code: KYZ Dated: October 2, 2020 Received: October 5, 2020
Dear Allison Komiyama:
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.
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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 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 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.
for Malvina Eydelman, M.D. Director 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) K201877
Device Name OtoSet - Ear Cleaning System
Indications for Use (Describe)
The OtoSet - Ear Cleaning System (OtoSet) is indicated to remove earwax from the external ear canal with irrigation and suction in adults.
Type of Use (Select one or both, as applicable)
X 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 SafKan Ear Care. The logo features a stylized "S" inside a circle on the left, followed by the text "SafKan" in a sans-serif font. Below "SafKan" is the text "EAR CARE" in smaller letters. The color scheme is a combination of gold and teal.
510(k) Summary K201877
DATE PREPARED
November 3, 2020
MANUFACTURER AND 510(k) OWNER
SafKan, Inc. 1665 E 18th Street #205, Tucson, AZ 85719, USA Telephone: Official Contact: Sahil Diwan, Co-Founder & CEO
REPRESENTATIVE/CONSULTANT
Allison C. Komiyama, Ph.D., R.A.C. Erin A. Gontang, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 akomiyama@acknowledge-rs.com, egontang@acknowledge-rs.com Email: Website: www.AcKnowledge-RS.com
DEVICE INFORMATION
Proprietary Name/Trade Name: OtoSet – Ear Cleaning System Common Name: Irrigating Syringe Regulation Number: 21 CFR 880.6960 Class: I Product Code: KYZ
PREDICATE DEVICE IDENTIFICATION
The OtoSet – Ear Cleaning System is substantially equivalent to the following devices:
| 510(k) Number | Predicate Device Name / Manufacturer | Primary Predicate |
|---|---|---|
| Class I Exempt | Welch Allyn Ear Wash System/ Welch Allyn, Inc. | ✓ |
| Class I Exempt | Bionix OtoClear/Bionix Development Corp. | Reference Device |
The predicate and reference devices have not been subject to a design related recall.
DEVICE DESCRIPTION
The OtoSet – Ear Cleaning System (OtoSet) is an automated ear irrigation device used to remove earwax, or cerumen, from the external ear canal of adults. The OtoSet consists of an adjustable head strap, two ear units, two single-patient-use disposable ear tips, and two singlepatient-use disposable waste containers.
In addition to the disposable ear tips and waste containers, each ear unit houses a solution
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Image /page/4/Picture/0 description: The image is a logo for SafKan Ear Care. The logo features a stylized "S" inside a circle on the left, followed by the text "SafKan" in a clean, sans-serif font. Below "SafKan" is the text "EAR CARE" in a smaller font size.
510(k) Summary
container, liquid pump, vacuum pump, printed circuit board electronics, rechargeable batteries, and electrical and plumbing elements to connect these items together. The device can be used to clean the left, right, or both external ear canals at the same time.
The OtoSet includes components that come in contact with the patient during use. The singlepatient-use disposable ear tips, ear pads and head strap pad (all made of silicone rubber) are surface contacting components having limited contact duration (