(90 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and function of a fiber optic light cable, with no mention of AI or ML technologies.
No.
The device provides surgical site illumination and is designed to be compatible with light sources, not to treat a disease or condition itself.
No
Explanation: The TruView Light Cable is described as a surgical light cable intended to provide illumination. Its performance tests focus on compatibility, heating, and light intensity to ensure safety and functionality during surgery, not on diagnosing medical conditions. There is no mention of identifying, classifying, or predicting disease or health conditions.
No
The device description explicitly states it is a "fiber optic surgical light designed to be compatible with a variety of fiber optic light sources," indicating it is a hardware component (a light cable) and not software.
Based on the provided information, the TruView Light Cable is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to "provide surgical site illumination from a fiber optic light source." This describes a device used during a surgical procedure to illuminate the surgical field, not a device used to examine specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its function as a "fiber optic surgical light."
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information about a patient's health status
The performance studies described also focus on the physical performance of the light cable in a surgical setting (fit, heating, intensity), not on the accuracy or reliability of diagnostic results from analyzing samples.
N/A
Intended Use / Indications for Use
The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
Product codes
FST
Device Description
The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources. The TruView Light Guide contains borosilicate glass optical fibers wrapped in a silicone sheath and has surgical stainless-steel couplings per ASTM F899.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
(Non-clinical)—The TruView Light Cable was subjected to three (3) performance tests that indicated it performs in accordance with its intended use. Testing included a Fit Test to show that it is compatible with the retractor; a Collateral Heating Test to show that the cable, when used with the identified light source, does not pose a risk to the surgeon or operating room users (burn/injury to user); and an Intensity Test to show that the cable, when used with the identified light source and the worst-case retractor blade configuration, does not pose a risk to the patient (burn/patient injury).
The subject TruView Light Cable met the acceptance criteria for the testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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June 30, 2020
Image /page/0/Picture/1 description: The image shows 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.
Innovasis, Inc. Marshall Mccarty Director QA/RA 614 East 3900 South Salt Lake City, Utah 84107
Re: K200874
Trade/Device Name: TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: FST Dated: March 31, 2020 Received: April 1, 2020
Dear Marshall Mccarty:
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 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 (OS) 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/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,
Colin Kejing Chen Acting 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)
Device Name TruView™ Light Cable
Indications for Use (Describe)
The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
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/1 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font.
510(k)
5.0 510(k) Summary Report:
TruView™ Lateral Retractor Light Cable
| Company: | Innovasis, Inc. |
|---|---|
| 614 E. 3900 South | |
| Salt Lake City, UT 84107 |
- Contact: Marshall C. McCarty Phone: (801) 261-2236 x8012 mmccarty@innovasis.com
- Trade Name: TruView Light Cable
- Common Name: Fiber Optic Light Cable
- Classification: Requlation No.: 21 CFR 878.4580 Class 2 Product Code: FST Review Panel: General & Plastic Surgery
- Primary Predicate: K042034 NuVasive, Inc. MaXcess Light Guide This predicate has not been subject to a design-related recall.
Additional Predicate:
Cuda Products Co./Sunoptic Technologies Fiberoptic Light Cable
- Device Description: The TruView Light Cable is a fiber optic surgical light designed to be compatible with a variety of fiber optic light sources.
- Performance Data: (Non-clinical)—The TruView Light Cable was subjected to three (3) performance tests that indicated it performs in accordance with its intended use. Testing included a Fit Test to show that it is compatible with the retractor; a Collateral Heating Test to show that the cable, when used with the identified light source, does not pose a risk to the surgeon or operating room users (burn/injury to user); and an Intensity Test to show that the cable, when used with the identified light source and the worst-case retractor blade configuration, does not pose a risk to the patient (burn/patient injury).
The subject TruView Light Cable met the acceptance criteria for the testing performed.
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Image /page/4/Picture/0 description: The image shows the logo for Innovasis. The logo is black and features the word "INNOVASIS" in all caps. Below the word is the phrase "INNOVATE / INVOLVE / INVENT" in a smaller font. The logo is simple and modern.
Materials: The TruView Light Guide contains borosilicate glass optical fibers wrapped in a silicone sheath and has surgical stainless-steel couplings per ASTM F899.
The TruView sterilization trays are comprised of Anodized 5052 Aluminum and have components made of Nylon, Stainless Steel, Polypropylene, and RADEL per ASTM D6394 SP031.
- Indications for Use: The TruView Light Cable is intended to provide surgical site illumination from a fiber optic light source.
Comparison of Technological Characteristics with the Predicate Devices:
The TruView Light Cable has been subjected to risk analysis, engineering analysis and testing to recognized standards and has been shown to be substantially equivalent to the predicate devices, NuVasive MaXcess Light Guide (K042034) and Sunoptic Fiberoptic Light Cable (K901035).
- Technology is substantially equivalent. -
- Design is substantially equivalent. —
- -Size is substantially equivalent.
- Indications for use (intended use) are substantially ー equivalent.
- Materials (biocompatibility profile) are substantially equivalent.
- Conclusion: The overall technology characteristics and mechanical performance data lead to the conclusion that the subject device is substantially equivalent to legally marketed predicate devices.