(477 days)
Not Found
No
The device description and performance studies focus on the mechanical and functional aspects of a dual lumen endobronchial tube and its accessories. There is no mention of AI, ML, image processing, or data-driven algorithms.
No
The device is used for lung isolation and ventilation during surgery, not for treating a disease or condition.
No
The device is used to isolate and ventilate the lungs during surgery or anesthesia, not to diagnose a condition.
No
The device description clearly outlines a physical medical device (dual lumen endobronchial tube) and a kit containing various hardware components. The performance studies also focus on bench and animal testing of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The sOLVe Tube is used to physically isolate a lung for surgical procedures or ventilation. This is a direct intervention on the patient's body.
- Device Description: The device is a physical tube with balloons and accessories designed for insertion into the airway.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for health issues.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic purposes. The sOLVe Tube operates in vivo (inside the body) and is a therapeutic/interventional device, not a diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBI
Device Description
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 right-sided 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:
-
- sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet
-
- Dual Bronchoscopy Swivel adapter with integrated safety clamp
-
- Haider TubeGuard endotracheal tube holder/bite block with strap
-
- Soft suction catheters
-
- Two syringes (3 mL and 10 mL)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
adult population only
Intended User / Care Setting
healthcare professionals (HCP) in hospitals
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)
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
- 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.
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
§ 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).
0
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
1
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
2
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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3
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
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.
4
510(k) Summary
The sOLVe Tube is packaged and provided to the HCP as a kit. The kit includes the following components:
-
- sOLVe Tube with pre-installed pliable aluminum 10Fr intubation stylet
-
- Dual Bronchoscopy Swivel adapter with integrated safety clamp
-
- Haider TubeGuard endotracheal tube holder/bite block with strap
-
- Soft suction catheters
-
- 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 isolate | |
| the left or the right lung of a patient | ||
| for surgery, one lung ventilation or | ||
| one lung anesthesia | The Silbroncho® is used to isolate the | |
| left or the right lung of a patient for | ||
| surgery, one lung ventilation or one | ||
| lung anesthesia | ||
| Product Code | CBI | CBI |
| Regulation | ||
| Number | 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 Y | ||
| adapter | • Double lumen shaft with stylet | |
| • Tracheal cuff | ||
| • Endobronchial cuff | ||
| • Swivel connector with Carlens Y | ||
| adapter |
5
| Subject Device | Predicate Device | |
|---|---|---|
| sOLVe Tube™ | ||
| K201026 | Silbroncho° Tubes | |
| K051522 | ||
| 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 mm |
| 35Fr: 10.0 – 13.3 mm | ||
| 37Fr: 10.5 – 14.3 mm | ||
| 39Fr: 11.0 – 15.3 mm | ||
| Recommended | ||
| bronchoscope O.D. | Tracheal lumen: ≤ 6.0 mm | |
| Bronchial lumen: ≤ 5.0 mm | Sizes 33 and 35Fr: ≤ 3.1 mm | |
| Sizes 37 and 39Fr: ≤ 4.0 mm | ||
| Maximum Inflation | ||
| Volumes | Endobronchial balloon: |