The Simple One Lung Ventilation for Everyone (sOLVe) Tube is a single use dual lumen endobronchial tube (DLT) intended for lung isolation and for lung ventilation by healthcare professionals (HCP) in hospitals. The sOLVe Tube can function as both a left-sided and a rightsided DLT. The distal tip of the tube will fit in either the left or right mainstem bronchus. The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components: 1. sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet 2. Dual Bronchoscopy Swivel adapter with integrated safety clamp 3. Haider TubeGuard endotracheal tube holder/bite block with strap 4. Soft suction catheters 5. Two syringes (3 mL and 10 mL)

AI/ML Overview

The provided text is a 510(k) summary for the sOLVe Tube™, a medical device intended for lung isolation and ventilation. The document describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, details about sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, or results from MRMC or standalone studies.

Therefore, I cannot fully answer your request with the information provided. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench and animal testing, rather than reporting quantitative performance metrics against pre-defined acceptance criteria.

Based on the available information, here is what can be extracted and what is missing:

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

Information Provided: The document lists several performance tests conducted (e.g., Determination of Cuff Diameter, Resistance to Cuff Tube Collapse, Cuff Compliance Leak Test, Bronchoscope Insertion Test, Ease of Insertion in animal model, Performance of tracheal/bronchial balloon, Success of lung isolation and one lung ventilation).
Missing: Specific quantitative acceptance criteria for each of these tests are not provided. The document only states that "The results of these tests support the substantial equivalence of the sOLVe Tube to the predicate device," implying that the device met some internal or industry-standard criteria, but these criteria and the exact results are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Provided: The document mentions "Cadaver Trial to test the Universal Design" and "Performance Testing (Animal)."
Missing: The specific sample sizes for these tests (e.g., number of cadavers, number of animals) are not provided. Data provenance (country of origin, retrospective/prospective) is also not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing: This information is not provided as the studies appear to be primarily non-clinical (bench and animal testing). There is no mention of human experts establishing "ground truth" in the context of diagnostic performance.

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

Missing: This information is not provided as it relates to expert review of data, which is not described for the non-clinical tests.

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

Missing: This is inapplicable. The described device is an endobronchial tube, not an AI software/diagnostic tool that would involve human "readers" or an "AI assistance" component.

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

Missing: This is inapplicable. The described device is an endobronchial tube, not an algorithm.

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

Information Provided: For bench tests, the "ground truth" would be the direct measurement against the test standard (e.g., ISO specifications). For animal trials, it would be direct observation of "Ease of Insertion," "Performance of the Tracheal and Bronchial Balloon," and "Success of Lung Isolation and One Lung Ventilation."
Missing: Specific details on how success was quantified or measured consistently are not provided.

8. The sample size for the training set

Missing: Not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

Missing: Not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

HyTek Medical, Inc. % Allison Komiyama Principal Consultant AcKnowledge Regulatory Strategies LLC 2251 San Diego Ave Suite B-257 San Diego, California 92110

Re: K201026

Trade/Device Name: sOLVe Tube Regulation Number: 21 CFR 868.5740 Regulation Name: Tracheal/Bronchial Differential Ventilation Tube Regulatory Class: Class II Product Code: CBI Dated: July 13, 2021 Received: July 15, 2021

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.

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

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requirements, including, but not limited to: registration and listing (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 mediation-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/cdrl-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,

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices 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) K201026

Device Name sOLVe Tube™

Indications for Use (Describe)

The sOLVe Tube™ is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

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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510(k) Summary K201026

DATE PREPARED

August 5, 2021

MANUFACTURER AND 510(k) OWNER

HyTek Medical, Inc. 8741 Shirley Ave., Northridge, CA 91324, USA Telephone: Official Contact: Nir Hoftman, M.D., President

REPRESENTATIVE/CONSULTANT

Allison C. Komiyama, Ph.D., R.A.C. Michelle Rubin-Onur, Ph.D. Lucie Dalet, Ph.D. AcKnowledge Regulatory Strategies, LLC Telephone: +1 (619) 458-9547 Email: akomiyama@acknowledge-rs.com Website: www.AcKnowledge-RS.com

DEVICE INFORMATION

Proprietary Name/Trade Name:	sOLVe Tube™
Common Name:	Tube, Tracheal/Bronchial, Differential Ventilation (w/wo connecter)
Regulation Number:	21 CFR 868.5740
Class:	Class II
Product Code:	CBI
Premarket Review:	Anesthesiology
Review Panel:	ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Device (DHT1C)

PREDICATE DEVICE IDENTIFICATION

The sOLVe Tube" is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	Primary Predicate
K051522	Silbroncho® Tubes / Fuji Systems Corporation	✓

The predicate device has not been subject to a design related recall.

DEVICE DESCRIPTION

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510(k) Summary

The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components:

1. sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet
1. Dual Bronchoscopy Swivel adapter with integrated safety clamp
1. Haider TubeGuard endotracheal tube holder/bite block with strap
1. Soft suction catheters
1. Two syringes (3 mL and 10 mL)

The sOLVE tube is intended for an adult population only.

INDICATIONS FOR USE

The sOLVe Tube™ is used to isolate the left or the right lung of a patient for surgery, one lung ventilation or one lung anesthesia.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

HyTek believes that the sOLVe Tube is substantially equivalent to the predicate devices based on the information summarized here:

The subject device has a similar design and dimensions and uses similar or identical materials as the device cleared in K051522. The subject device is uniquely designed so that it can function as both a left-sided and a right-sided DLT and includes additional safety features (i.e., ridges on the balloons to prevent balloon slippage that can lead to DLT dislodgement). The subject device has the same intended use and similar technological characteristics (maximum inflation volumes, suction catheter diameters, and design features) to the device cleared in K051522. These technological characteristics have undergone testing to ensure the device is as safe and effective as the predicate.

The technological characteristics of the subject device and the predicate device are summarized in the table below.

	Subject Device	Predicate Device
	sOLVe Tube™	Silbroncho® Tubes
	K201026	K051522
Indications for Use	The sOLVe Tube™ is used to isolatethe left or the right lung of a patientfor surgery, one lung ventilation orone lung anesthesia	The Silbroncho® is used to isolate theleft or the right lung of a patient forsurgery, one lung ventilation or onelung anesthesia
Product Code	CBI	CBI
RegulationNumber	21 CFR 868.5740	21 CFR 868.5740
Technological characteristics
Design Features	• Double lumen shaft with stylet• Tracheal balloon• Endobronchial balloon• Swivel connector with Carlens Yadapter	• Double lumen shaft with stylet• Tracheal cuff• Endobronchial cuff• Swivel connector with Carlens Yadapter

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	Subject Device	Predicate Device
	sOLVe Tube™K201026	Silbroncho° TubesK051522
Sizes	Device available in 1 size: 35Fr	Device available in 4 distinct sizes: 33Fr,35Fr, 37Fr, and 39Fr
Tube O.D.	13 mm	33Fr: 9.5 – 12.3 mm35Fr: 10.0 – 13.3 mm37Fr: 10.5 – 14.3 mm39Fr: 11.0 – 15.3 mm
Recommendedbronchoscope O.D.	Tracheal lumen: ≤ 6.0 mmBronchial lumen: ≤ 5.0 mm	Sizes 33 and 35Fr: ≤ 3.1 mmSizes 37 and 39Fr: ≤ 4.0 mm
Maximum InflationVolumes	Endobronchial balloon: < 5 mLTracheal balloon: < 10 mL	Endobronchial cuff: 4.5 – 7 mLTracheal cuff: < 10 mL
Suction CatheterDiameter	10Fr	8Fr, 12Fr
Main Materials ofComposition	silicone, polypropylene	silicone, polyethylene
Sterilization	Sterile	Sterile
Sterilizationmethod	Ethylene Oxide	Ethylene Oxide

SUMMARY OF NON-CLINICAL TESTING

No FDA performance standards have been established for the sOLVe Tube.

The sOLVe Tube includes components that come in contact with the patient during use. The dual lumen component and the T-type suction catheters were evaluated as external communicating devices with limited duration (≤ 24 hours) with mucosal membrane. Biocompatibility testing included cytotoxicity testing per ISO 10993-5, irritation testing per ISO 10993-10, sensitization testing per ISO 10993-10, acute systemic toxicity testing per ISO 10993-11, VOC emissions and toxicity per ISO 18562-3, particulate matter analysis per ISO 18562-2, and bacterial endotoxin testing per ANSI/AAMI ST72.

The following tests were performed to demonstrate equivalence to the predicate device:

. Performance testing (Bench)
- Determination of Cuff Diameter (per ISO 5361) O
- Resistance to Cuff Tube Collapse (per ISO 5361) O
- Resistance to Cuff Herniation (per ISO 5361) O
- Cuff Tracheal Seal (per ISO 5361) O
- Resistance to Kinking of Main Shaft and Distal Bronchial Shaft (per ISO 5361) O
- Cuff Compliance Leak Test (per ISO 5361) O
- Determination of Dual Lumen Tube Lumen Internal Diameter (per ISO 16628) O
- O Radio-opacity Test (ASTM F640)
- Balloon Bench Testing O
- Membrane Durability Test O

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Bronchoscope Insertion Test O
о Double Clamp Operation
O Cadaver Trial to test the Universal Design
Performance Testing (Animal) ●
- Ease of Insertion O
- O Performance of the Tracheal and Bronchial Balloon
- Success of Lung Isolation and One Lung Ventilation o

The results of these tests support the substantial equivalence of the sOLVe Tube to the predicate device.

CONCLUSION

The subject device and the predicate device have the same intended use, and based on the testing performed, including non-clinical performance testing (bench and animal), it can be concluded that the differences in technological features do not raise different questions of safety and effectiveness. The similar indications for use, technological characteristics, and performance characteristics for the proposed sOLVe Tube are assessed to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 868.5740 Tracheal/bronchial differential ventilation tube.

(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).