(208 days)
This device is intended to transmit light for illumination purposes from the light source to endoscopes.
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.
The provided document is a 510(k) premarket notification for a medical device called "Endo-Cord," which is a surgical lamp (fiber-optic light transmission cable). The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices.
The document describes non-clinical testing performed to establish the device's substantial equivalence, focusing on light transmission properties, cleaning validation, and sterilization validation. It does not describe a study involving human subjects, AI assistance, or expert readers, which would be relevant for devices that perform diagnostic interpretations or require human-in-the-loop performance studies (e.g., AI algorithms for medical image analysis).
Therefore, I can only provide information based on the presented non-clinical "study" for this specific device. Many of your requested points relate to studies involving human expertise and AI, which are not applicable to the information given for the Endo-Cord.
Here's the information parsed from the document:
1. A table of acceptance criteria and the reported device performance:
| Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (Endo-Cord) | Predicate Device (Sunoptics) Performance | Result |
|---|---|---|---|---|
| Light Transmission - High | Within reasonably close proximity to predicate (quantitative criteria not explicitly stated but implied by comparison) | Average: 650 | Average: 618 | 5.0% difference from Sunoptics. Concluded as substantially equivalent. |
| Light Transmission - Medium | Within reasonably close proximity to predicate | Average: 314 | Average: 305 | 2.8% difference from Sunoptics. Concluded as substantially equivalent. |
| Light Transmission - Low | Within reasonably close proximity to predicate | Average: 28 | Average: 27 | 3.6% difference from Sunoptics. Concluded as substantially equivalent. |
| Cleaning Validation | Meets AAMI TIR30 Cleaning of Reusable Medical Devices standard | Meets AAMI TIR30 | N/A (implicit that predicate similarly cleans) | Meets standard. |
| Steam Sterilization Validation | Supports a sterility assurance level (SAL) of 10-6 | Supports a cycle of Prevacuum, 130° C, 4 min exposure, 20 min drying cycle with SAL 10-6 | N/A (implicit that predicate similarly sterilizes) | Supports specified cycle and SAL. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size:
- For the light transmission testing, the ranges (e.g., "639-658") suggest multiple measurements were taken for both the Endo-Cord and Sunoptics cords, but the exact number of cords tested or measurements taken per cord is not specified.
- For cleaning and sterilization validation, specific sample sizes are not provided, only that the validation "meets" the standard.
- Data Provenance: Not specified, but generally, such tests for FDA submissions are conducted domestically (USA) in a controlled laboratory setting. It is not a retrospective or prospective clinical study.
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)
- Not applicable. This study is a non-clinical, bench-top performance and validation study of a physical device (light cable). It does not involve human interpretation or subjective assessment that would require expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. As a non-clinical performance study, there is no need for adjudication of human interpretation.
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
- No. An MRMC comparative effectiveness study was not done. This device is a fiber-optic light cable for illumination, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing was based on objective physical measurements (e.g., light intensity output) compared against a predicate device and adherence to recognized industry standards (AAMI TIR30 for cleaning, and ISO/AAMI standards for sterilization, implied by the SAL of 10-6).
8. The sample size for the training set
- Not applicable. This is a hardware device, not a machine learning algorithm. Therefore, there is no training set.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, no ground truth was established for it.
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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
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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-clinicalTesting | A cleaning validation performed meets AAMI TIR30 Cleaning ofReusable Medical Devices standard.Steam sterilization validation supports a cycle of a Prevacuum, 130° C,4 minute exposure, 20 minute drying cycle. Sterilization and SterilityAssurance 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 |
| DifferencefromSunoptics | 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 theCuda Products Co. Fiber Optic Cable (K901035)based onintended 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 lighttransmission | Glass fibers | Glass fibers |
| Length | 90 inches | 95.5 inches |
| Fiber-optic corereplacement | Field replaceable by user | Factory replaceable only |
| End coupling | • Universal configuration• Adapters commerciallyavailable | • Universal configuration• Adapters available frommanufacturer |
| Sterilization Method | Steam autoclave | Steam autoclaveCold soak |
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§ 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.