ENDO-CORD

K141330 · Enroxtech, Inc. · FST · Dec 15, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141330
• Device Name: ENDO-CORD
• Applicant: Enroxtech, Inc.
• Product Code: FST · General, Plastic Surgery
• Decision Date: Dec 15, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

This device is intended to transmit light for illumination purposes from the light source to endoscopes.

Device Story

Endo-Cord is a fiber-optic light transmission cable used to connect a surgical light source to an endoscope. It consists of a 5mm glass fiber-optic core housed within a reusable silicone rubber sheath, with stainless steel couplings at both ends for universal connection. The device is operated by clinical staff in surgical or diagnostic environments. It functions as a passive conduit for light; it does not process data or provide automated analysis. The device is designed for steam sterilization and features a field-replaceable fiber-optic core, allowing for maintenance by the user. By providing consistent illumination, it enables visualization of internal anatomy during endoscopic procedures, supporting clinical decision-making and surgical accuracy.

Clinical Evidence

Bench testing only. Light transmission intensity was measured across high, medium, and low settings, showing differences of 5.0%, 2.8%, and 3.6% respectively compared to the Sunoptics reference device. Cleaning validation performed per AAMI TIR30. Steam sterilization validation (Prevacuum, 130°C, 4-minute exposure, 20-minute dry) confirmed sterility assurance level of 10^-6.

Technological Characteristics

5mm glass fiber-optic core; reusable silicone rubber sheath; stainless steel couplings. Length: 7.5 feet (90 inches). Passive light transmission. Sterilization: Steam autoclave. Field-replaceable core design.

Indications for Use

Indicated for use in clinical settings to provide illumination for endoscopes during surgical or diagnostic procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cuda Products Co. Fiber Optic Cable (K901035)

Reference Devices

• Sunoptics cord

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 |
| | [e-mail] |

| 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<br>Testing | A cleaning validation performed meets AAMI TIR30 Cleaning of<br>Reusable Medical Devices standard.<br><br>Steam sterilization validation supports a cycle of a Prevacuum, 130° C,<br>4 minute exposure, 20 minute drying cycle. Sterilization and Sterility<br>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-<br>Cord | Sunoptics | Endo-<br>Cord | Sunoptics | Endo-<br>Cord | Sunoptics |
| Range | 639-<br>658 | 614-621 | 311-<br>316 | 303-306 | 28-28 | 27-27 |
| Average | 650 | 618 | 314 | 305 | 28 | 27 |
| Difference<br>from<br>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<br>Cuda Products Co. Fiber Optic Cable (K901035)based on<br>intended use, technology, materials, and light transmission. |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

### Key Features Comparison

| Feature | Enroxtech Inc.<br>Endo-Cord | Cuda Products Co.<br>Fiber-Optic Cable, K901035<br>(predicate) |
|-----------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------|
| Size | 5 mm | 3.0 and 5.0 mm |
| Sheathing | Silicone, reusable | Silicone, reusable |
| Fiber-optic light<br>transmission | Glass fibers | Glass fibers |
| Length | 90 inches | 95.5 inches |
| Fiber-optic core<br>replacement | Field replaceable by user | Factory replaceable only |
| End coupling | • Universal configuration<br>• Adapters commercially<br>available | • Universal configuration<br>• Adapters available from<br>manufacturer |
| Sterilization Method | Steam autoclave | Steam autoclave<br>Cold soak |

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