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 (< 24 hours) with intact skin.

AI/ML Overview

The provided text describes the submission of the SafKan OtoSet Ear Cleaning System for 510(k) clearance. The focus of the clinical testing was to demonstrate the effectiveness of earwax removal and equivalence to a predicate device, rather than strictly defining acceptance criteria with specific thresholds for performance metrics.

However, based on the information provided, we can infer some "acceptance criteria" through the objective of the clinical studies and the results presented.

Here's an attempt to structure the information based on your request, acknowledging that explicit numerical acceptance criteria are not detailed in this FDA document for this Class I device.

Implied Acceptance Criteria and Reported Device Performance for the OtoSet Ear Cleaning System

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

Performance Metric	Implied Acceptance Criteria (Objective)	Reported Device Performance
Effectiveness of Earwax Removal (Occlusion Scale)	To demonstrate effective earwax removal using a 0-3 Degree of Occlusion Scale.	The second study (n=23 subjects, 31 ears) "evaluated the subject device's ability to effectively remove earwax (also using a 0-3 Degree of Occlusion Scale)." The results "support the proposed intended use of the OtoSet." (Exact effectiveness percentage or change in occlusion score not provided).
Equivalence to Predicate Device	To demonstrate equivalence in earwax removal effectiveness compared to the primary predicate, the Welch Allyn Ear Wash System.	The first study (n=31 subjects, 62 ears) "evaluated the OtoSet against the device's primary predicate, the Class I Welch Allyn Ear Wash System." "The data in these studies show that the OtoSet is equivalent to the predicate device in terms of removing earwax from the external ear canal."
Safety	To ensure the device does not raise new issues of safety compared to the predicate device.	Non-clinical testing (biocompatibility, software validation, electromagnetic compatibility and electrical safety, and usability testing) and clinical testing were performed. "It can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device."
Usability	Intended users can successfully perform simulated scenarios and sub-tasks and provide feedback.	Usability testing was assessed by 15 individuals representative of the intended user population. "All participants successfully performed simulated scenarios and sub-tasks, and provided feedback on the use of the subject device."

2. Sample Sizes and Data Provenance for the Test Set

Study 1 (Equivalence):
- Sample Size: 31 subjects, 62 ears.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Given that it's clinical testing for a 510(k) submission, it's highly likely to be prospective data collected specifically for this purpose.
Study 2 (Effectiveness):
- Sample Size: 23 subjects, 31 ears.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Likely prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts used to establish ground truth or their qualifications.
The studies used a "0-3 Degree of Occlusion Scale" to assess earwax removal. This scale likely involves a clinical assessment by a trained medical professional (e.g., an ENT specialist, nurse, or physician) examining the ear canal, but the specific individuals establishing this "ground truth" for the study are not detailed.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method (e.g., 2+1, 3+1) for the ground truth assessment in the clinical studies. Since the "ground truth" here is a clinical assessment of earwax obstruction rather than, for example, image interpretation, a multi-reader adjudication method might not have been applicable in the traditional sense. It's more likely a single trained clinician made the assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not explicitly done. The clinical studies focused on comparing the device's performance to a predicate device and evaluating its standalone effectiveness in earwax removal. This is a Class I device, and the type of comparative effectiveness study typically seen with AI algorithms reading medical images (i.e., human readers with/without AI assistance) is not relevant here.

6. Standalone (Algorithm Only) Performance

This concept is not applicable here. The OtoSet is a physical medical device, not an AI algorithm. Its "standalone performance" refers to its direct application in earwax removal by a user (clinical staff or patient, depending on prescription status). The clinical studies evaluated the performance of the device itself (though operated by a user), not an algorithm's performance independent of human interaction.

7. Type of Ground Truth Used

The ground truth used was based on a "0-3 Degree of Occlusion Scale" which represents a clinical assessment of earwax removal. This is a form of clinical assessment/outcome data related to the device's intended use.

8. Sample Size for the Training Set

Not applicable / Not disclosed. This device is a physical medical device. It does not use machine learning algorithms that require "training sets" in the conventional sense. The "training" for this device would refer to its design and engineering iterations, followed by verification and validation testing (non-clinical and clinical), but not a data-driven "training set" for an algorithm.

9. How Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no "training set" in the context of machine learning for this device.

Summary

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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

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.

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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

SafKan believes that the OtoSet is substantially equivalent to the predicate device based on the information summarized here:

The intended use and indications for use of the OtoSet are the same as the primary predicate device, the Welch Allyn Ear Wash System. Both devices are irrigation devices used to remove earwax from the external ear canal, and control irrigation pressure via a pump. The OtoSet and the Welch Allyn Ear Wash System also control suction pressure via vacuum.

The OtoSet and the predicate device use non-sterile single-patient-use disposable ear tips.

The technological characteristics of the OtoSet are very similar to the predicate device, in its function, principle of operation, performance, and biocompatibility. These technological characteristics have undergone testing to ensure the device is as safe and effective as the primary predicate.

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the OtoSet. The following tests were performed to demonstrate safety based on current industry standards:

Cleaning validation: Device cleaning was validated using ANSI/AAMI TIR 12 and ISO 10993-5.

Biocompatibility: Patient contacting material met the requirements outlined in ISO 10993-1.

Software Verification: The software development and testing were executed in compliance to IEC 62304.

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510(k) Summary

Image /page/5/Picture/1 description: The image is a logo for SafKan Ear Care. The logo consists of a circular icon with the letter "S" inside, followed by the words "SafKan" and "EAR CARE" stacked on top of each other. The icon and the words are in a light brown color. The logo is simple and modern, and it is likely used to represent a business that provides ear care services.

Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, IEC 60601-1-2, FCC 47 CFR 15 Subpart B and ANSI C63.4, and IEC 62133-2.

Usability testing: The usability of the subject device was assessed by 15 individuals who adequately represented the intended user population. All participants successfully performed simulated scenarios and sub-tasks, and provided feedback on the use of the subject device.

SUMMARY OF CLINICAL TESTING

Clinical testing of the OtoSet included two studies. The first study (n=31 subjects, 62 ears) evaluated the OtoSet against the device's primary predicate, the Class I Welch Allyn Ear Wash System. The objective of the study was to evaluate the effectiveness of earwax removal (using a 0-3 Degree of Occlusion Scale) of the OtoSet compared to the Welch Allyn Ear Wash System. The second study (n=23 subjects, 31 ears) evaluated the subject device's ability to effectively remove earwax (also using a 0-3 Degree of Occlusion Scale).

The data in these studies show that the OtoSet is equivalent to the predicate device in terms of removing earwax from the external ear canal. The results also support the proposed intended use of the OtoSet.

CONCLUSION

Based on the testing performed, non-clinical (biocompatibility, software validation, electromagnetic compatibility and electrical safety, and usability testing), and clinical testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The similar indications for use, technological characteristics, and performance characteristics for the proposed OtoSet – Ear Cleaning System are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.