(124 days)
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.
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.
The provided text does not contain detailed information regarding the acceptance criteria of a device for regulatory approval or a specific study proving it meets these criteria with the level of detail requested in the prompt.
The document is an FDA 510(k) clearance letter for the ViOptix Intra.OxTM 2.0 Handheld Tissue Oximeter. It states that the device is substantially equivalent to a previously marketed predicate device (K221010). The information provided is primarily about the regulatory basis for clearance, the device's intended use, and a high-level summary of studies performed.
Here's an analysis of what information is available and what is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- Missing. The document does not specify quantitative acceptance criteria (e.g., accuracy, precision targets) for the device's performance, nor does it present a table of reported device performance against such criteria. It generally states that the device "responds appropriately" and "provides clinically relevant information."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions an "animal study" and "human clinical data from published scientific literature (Gonzalez-Jacobo et al.)".
- Sample Size: The exact sample sizes for both the animal study and the human clinical data are not provided.
- Data Provenance:
- Animal study: No details on country of origin or whether it was retrospective/prospective.
- Human clinical data (Gonzalez-Jacobo et al.): No details on country of origin or whether it was retrospective/prospective from the provided text. It merely states it included "multiple surgical" settings.
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. The document does not specify how ground truth was established, nor does it mention the number or qualifications of experts involved in any ground truth determination.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information on adjudication methods is present.
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
- Not applicable / Missing. This device is an oximeter, not an AI-assisted diagnostic imaging device that requires human readers to interpret results. Therefore, an MRMC study related to human readers improving with AI assistance is not relevant to this type of device. The document mentions the device provides "comparable information to the existing standard of care" but doesn't quantify improvement in human performance with the device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The Intra.Ox™ 2.0 Handheld Tissue Oximeter is a standalone device that measures StO2. Its performance as a measurement device is inherent. The studies mentioned (animal and human clinical data) would assess the device's ability to accurately measure oxygen saturation. So, in essence, the "standalone performance" of the device is what these studies would have evaluated.
- Stated from text: "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 the human study "demonstrates that the Intra.Ox™ 2.0 Handheld Tissue Oximeter provides clinically relevant information regarding bowel ischemia". This describes its standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the animal study: The ground truth was likely induced "transient ischemia induced by arterial occlusion" which is a physiological challenge.
- For the human study: The "existing standard of care" is mentioned, implying that the device's measurements were compared against established clinical methods for assessing bowel ischemia. The specific nature of this "standard of care" (e.g., pathology, clinical observation, other monitoring devices) is not detailed.
8. The sample size for the training set
- Not applicable / Missing. This is not an AI/ML device that typically has a separate "training set" in the common understanding of machine learning. It's a measurement device. It was likely "calibrated" or developed using internal data, but the document doesn't provide details on sample sizes for such development or calibration processes.
9. How the ground truth for the training set was established
- Not applicable / Missing. See point 8.
In summary: The provided document is a regulatory clearance letter, not a detailed clinical study report. It confirms the device's substantial equivalence based on summaries of testing, but it does not contain the granular detail on acceptance criteria, sample sizes, expert involvement, or ground truth establishment that you are requesting. Such details would typically be found in the full 510(k) submission, specifically the non-clinical and clinical test reports, which are not part of this public clearance letter.
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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.
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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).
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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
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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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| 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)
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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.
§ 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).