(124 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on optical measurements and processing electronics without mentioning AI/ML algorithms.
No
The device is described as an oximeter, which is a diagnostic tool used to estimate oxygen saturation in tissue. Its intended use is for monitoring patients during circulatory or perfusion examinations, indicating its role in diagnosis and monitoring, not treatment.
Yes
Explanation: The device is intended to non-invasively estimate oxygen saturation (StO2) in tissue and is indicated for use in monitoring patients during circulatory or perfusion examinations, which are diagnostic purposes to assess a patient's physiological state.
No
The device description explicitly states it includes hardware components such as a Main Unit with light sources, detectors, and processing electronics, a Sheath, and a Battery Pack. It also performs measurements through direct physical contact with the patient's tissue.
Based on the provided information, the Intra. Ox™ 2.0 Handheld Tissue Oximeter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro - "in glass"). This device directly measures oxygen saturation in the tissue (in vivo - "in the living").
- The device description clearly states it performs measurements on the patient by direct physical contact to the patient's tissue. This is characteristic of an in vivo device.
- The intended use is to non-invasively estimate oxygen saturation in a volume of tissue. This is a measurement taken directly from the living body.
Therefore, the Intra. Ox™ 2.0 Handheld Tissue Oximeter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
Product codes
MUD
Device Description
The ViOptix Intra.Ox" 2.0 Handheld Tissue Oximeter (device) is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: · Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;
• Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provide in the Disposable Kit); and · Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the Main Unit to provide power.
The device uses spatially resolved optical measurements. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tissue, including bowel tissue.
Indicated Patient Age Range
adult patients
Intended User / Care Setting
physicians, surgeons, nurses, or other skilled users in a medical environment.
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 animal study demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter responds appropriately to the presence of transient ischemia induced by arterial occlusion and satisfies simila to the prior clinical validation fingertip study, which was previously presented in K191676. This was the initial 510(k) that was submitted for the Intra.Ox™ 2.0 Handheld Tissue Oximeter.
The human study, Gonzalez-Jacobo et al., demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia across multiple surgical providing comparable information to the existing standard of care.
An animal study was conducted and human clinical data from published scientific literature was included to demonstrate that the Intra.Ox™ 2.0 Handheld Tissue Oximeter demonstrates clinically relevant differentiation in the cases of oxygenated tissue. Therefore, the proposed and cleared devices are substantially equivalent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(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.
February 28, 2024
ViOptix, Inc. % Valerie Defiesta-Ng Regulatory Consultant for ViOptix, Inc. / Vice President, Regulatory Affairs, Veranex, Inc. Veranex, Inc. 224 Airport Parkway Suite 250 San Jose, California 95110
Re: K233488
Trade/Device Name: Intra.OxTM 2.0 Handheld Tissue Oximeter Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: MUD Dated: January 26, 2024 Received: January 29, 2024
Dear Valerie Defiesta-Ng:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Tanisha L. Tanisha L. Hithe -S 2024.02.28 Hithe -S 18:23:01 -05'00'
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233488
Device Name Intra.Ox™ 2.0 Handheld Tissue Oximeter
Indications for Use (Describe)
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring patients during circulatory or perfusion examinations.
The Intra. Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
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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4
| 510(k) #: | K233488 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2024-02-28 |
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | ViOptix, Inc. |
|---|---|
| Applicant Address | 39655 Eureka Drive Newark CA 94560 United States |
| Applicant Contact Telephone | (510) 226-5860 |
| Applicant Contact | Mr. Scott Coleridge |
| Applicant Contact Email | secoleridge@vioptix.com |
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | Intra.Ox™ 2.0 Handheld Tissue Oximeter |
|---|---|
| Common Name | Oximeter |
| Classification Name | Oximeter, Tissue Saturation |
| Regulation Number | 870.2700 |
| Product Code | MUD |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221010 | Intra.Ox™ 2.0 Handheld Tissue Oximeter | MUD |
Device Description Summary
21 CFR 807.92(a)(4)The ViOptix Intra.Ox" 2.0 Handheld Tissue Oximeter (device) is a sterile, cordless, battery-powered device that non-invasively estimates the percent oxygen saturation (StO2) in a volume of tissue. The device includes three components and an accessory: · Main Unit: a re-usable module consists of light sources, detectors, and processing electronics to convert measurements of reflected light into an estimate of StO2;
• Sheath: a single-use, sterile Sheath placed around the Main Unit during device use (provide in the Disposable Kit); and · Battery Pack: a single-use battery (provided in the Disposable Kit) that is paired with the Main Unit to provide power.
The device uses spatially resolved optical measurements. The device performs measurements on the patient by direct physical contact to the patient's tissue and displays the StO2 estimate on the Intra.Ox 2.0 Handheld Tissue Oximeter is a single-use disposable constructed from biocompatible materials that and other liquids such as disinfectants and marking materials. The device shares the same technological characteristics as the predicate device (K221010), including principle of operation, StO2 measured parameters, accuracy and range, energy delivered and power source.
Intended Use/Indications for Use
The Intra.Ox™ 2.0 Handheld Tissue Oximeter is intended to non-invasively estimate the percent oxygen saturation (StO2) in a volume of tissue, including bowel tissue.
The Intra.Ox™ 2.0 Handheld Tissue Oximeter is indicated for use in monitoring circulatory or perfusion examinations. The Intra.Ox™ 2.0 Handheld Tissue Oximeter is intended to be used by physicians, surgeons, nurses, or other skilled users in a medical environment.
The Intra.Ox™ 2.0 Handheld Tissue Oximeter should only be used on adult patients.
Indications for Use Comparison
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
5
The proposed Intra.Ox™ 2.0 Handheld Tissue Oximeter and the cleared Intra.Ox™ 2.0 Handheld Tissue Oximeter (K221010) have the same intended use and share the same technological characteristics. ViOptix, Inc. is proposing modifications to the predicate Intra.Ox" 2.0 Handheld Tissue Oximeter (K221010) Indications for Use statement. The differences outlined in this Traditional 510k) premarket notification do not affect the intended use or alter the fundamental scientific technology of the device. The modification to the Indications for Use statement (including bowel tissue) is particular tissue which already falls under the general tissue indication of the modification to the Precautions statement language (stool-filled tissue) provides an added condition to avoid improper device placement.
Technological Comparison
21 CFR 807.92(a)(6)
The proposed Intra.Ox™ 2.0 Handheld Tissue Oximeter and the cleared Intra.Ox™ 2.0 Handheld Tissue Oximeter (K221010) share the same technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The animal study demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter responds appropriately to the presence of transient ischemia induced by arterial occlusion and satisfies simila to the prior clinical validation fingertip study, which was previously presented in K191676. This was the initial 510(k) that was submitted for the Intra.Ox™ 2.0 Handheld Tissue Oximeter.
The human study, Gonzalez-Jacobo et al., demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia across multiple surgical providing comparable information to the existing standard of care.
An animal study was conducted and human clinical data from published scientific literature was included to demonstrate that the Intra.Ox™ 2.0 Handheld Tissue Oximeter demonstrates clinically relevant differentiation in the cases of oxygenated tissue. Therefore, the proposed and cleared devices are substantially equivalent.