(208 days)
Not Found
No
The device description and performance studies focus on the physical properties and sterilization of a fiber-optic light cable, with no mention of AI or ML.
No
Explanation: The device is intended to transmit light for illumination purposes to endoscopes and is compared to a predicate fiber optic cable, indicating it is an accessory for visualization rather than a device with a direct therapeutic effect.
No
The device is described as a fiber-optic light transmitting cord for illumination during endoscopic procedures. Its intended use is to transmit light, not to diagnose medical conditions or analyze patient data.
No
The device description clearly outlines physical components like a fiber-optic core, protective sleeve, stainless steel couplings, and a silicone rubber sheath. It is a hardware device for transmitting light.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to transmit light for illumination purposes from the light source to endoscopes." This is a function related to medical imaging and visualization within the body, not the analysis of samples outside the body.
- Device Description: The description details a fiber-optic cable for light transmission, which aligns with the intended use and not with typical IVD components (like reagents, test strips, or analyzers for biological samples).
- Lack of IVD-related information: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is purely for illumination during an endoscopic procedure.
N/A
Intended Use / Indications for Use
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
Product codes (comma separated list FDA assigned to the subject device)
FST
Device Description
A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet. Field replaceable fiber-optic core.
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)
Light Transmission Properties of the Endo-Cord is substantially equivalent to the predicate Sunoptics cord.
Results Table:
| High | Medium | Low | ||||
|---|---|---|---|---|---|---|
| Endo-Cord | Sunoptics | Endo-Cord | Sunoptics | Endo-Cord | Sunoptics | |
| Range | 639-658 | 614-621 | 311-316 | 303-306 | 28-28 | 27-27 |
| Average | 650 | 618 | 314 | 305 | 28 | 27 |
| Difference from Sunoptics | 5.0% | 2.8% | 3.6% |
The Endo-Cord intensity is substantially equivalent to the Sunoptics predicate fiber-optic cord. The average high intensity of the Endo-Cord is within 5% of the predicate Sunoptics cord. The average medium intensity is within 2.8% difference from the Sunoptics cord intensity. The average low intensity is within 3.6% of the Sunoptics.
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
§ 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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 15, 2014
Enroxtech Incorporated Mr. Lewis Ward L.W. Ward and Associates Incorporated 4655 Kirkwood Court Boulder, Colorado 80301
Re: K141330
Trade/Device Name: Endo-Cord Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FST Dated: October 31, 2014 Received: November 5, 2014
Dear Mr. Ward:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141330
Device Name Endo-Cord
Indications for Use (Describe)
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
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, Section 807.92(a)(2)
| Submitted by | Enroxtech, Inc. |
|---|---|
| 4605 S. Denice Drive | |
| Englewood, CO 80111 |
| Contact Person | Lewis Ward |
|---|---|
| L.W. Ward and Associates, Inc. | |
| 4655 Kirkwood Court | |
| Boulder, CO 80301 | |
| 303-530-3279 | |
| 303-530-4774 Fax | |
| lwward@qwest.net |
| Date Prepared | April 30, 2014 |
|---|---|
| --------------- | ---------------- |
| Product Name | Endo-Cord |
|---|---|
| -------------- | ----------- |
| Classification | 21 CFR 878.4580, Class II |
|---|---|
| Light, Surgical, Fiberoptic | |
| Product Code: FST | |
| General and Plastic Surgery Panel |
| Intended Use | This device is intended to transmit light for illumination purposes from the light source to endoscopes. |
|---|---|
| -------------- | ---------------------------------------------------------------------------------------------------------- |
| Technological Characteristics | A 5mm fiber-optic light transmitting core with durable protective sleeve and stainless steel couplings at each end. One coupling is for the light source and the opposite end for connection to an endoscope. The core is inserted into a durable and reusable silicone rubber sheath. One length is available: 7.5 Feet |
|---|---|
| Field replaceable fiber-optic core. |
| Non-clinical
Testing | A cleaning validation performed meets AAMI TIR30 Cleaning of
Reusable Medical Devices standard.
Steam sterilization validation supports a cycle of a Prevacuum, 130° C,
4 minute exposure, 20 minute drying cycle. Sterilization and Sterility
Assurance 10-6. |
| ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
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Light Transmission Properties of the Endo-Cord is substantially equivalent to the predicate Sunoptics cord.
Results Table:
| High | Medium | Low | ||||
|---|---|---|---|---|---|---|
| Endo- | ||||||
| Cord | Sunoptics | Endo- | ||||
| Cord | Sunoptics | Endo- | ||||
| Cord | Sunoptics | |||||
| Range | 639- | |||||
| 658 | 614-621 | 311- | ||||
| 316 | 303-306 | 28-28 | 27-27 | |||
| Average | 650 | 618 | 314 | 305 | 28 | 27 |
| Difference | ||||||
| from | ||||||
| Sunoptics | 5.0% | 2.8% | 3.6% |
Conclusion:
The Endo-Cord intensity is substantially equivalent to the Sunoptics predicate fiber-optic cord. The average high intensity of the Endo-Cord is within 5% of the predicate Sunoptics cord. The average medium intensity is within 2.8% difference from the Sunoptics cord intensity. The average low intensity is within 3.6% of the Sunoptics
| Substantial Equivalence | The Endroxtech Endo-Cord is substantially equivalent to the
Cuda Products Co. Fiber Optic Cable (K901035)based on
intended use, technology, materials, and light transmission. |
| ------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Key Features Comparison
| Feature | Enroxtech Inc.
Endo-Cord | Cuda Products Co.
Fiber-Optic Cable, K901035
(predicate) |
|-----------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------|
| Size | 5 mm | 3.0 and 5.0 mm |
| Sheathing | Silicone, reusable | Silicone, reusable |
| Fiber-optic light
transmission | Glass fibers | Glass fibers |
| Length | 90 inches | 95.5 inches |
| Fiber-optic core
replacement | Field replaceable by user | Factory replaceable only |
| End coupling | • Universal configuration
• Adapters commercially
available | • Universal configuration
• Adapters available from
manufacturer |
| Sterilization Method | Steam autoclave | Steam autoclave
Cold soak |
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