(196 days)
Not Found
No
The device description and intended use are purely mechanical/optical, and there is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device transmits light for illumination of body cavities, but it does not directly treat or diagnose any medical condition.
No
Explanation: The device transmits light for illumination during examinations or surgical procedures. It does not collect or analyze data to diagnose a condition.
No
The device description explicitly states it is a physical cable made of glass fibers with ferrules and silicone sheathing, designed to transmit light. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit light for illumination during examinations or surgical procedures within body cavities. This is a therapeutic or procedural function, not a diagnostic one performed in vitro (outside the body).
- Device Description: The description details a physical cable for light transmission, not a reagent, instrument, or system used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on in vitro testing.
Therefore, the Schott Light Guide Cable, as described, falls under the category of a medical device used for illumination during procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
Product codes
HBI
Device Description
The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body cavities
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)
The Light Guide Cable performance testing includes electrical safety testing and sterilization validation to the appropriate FDA Recognized Consensus Standards The results of this performance testing conclude that the technological characteristics have not diminished the safety and effectiveness of the Light Guide Cable when compared to the predicate device.
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.
0
510(K) SUMMARY
NOV 2 5 2011
Schott North America Light Guide Cable (per 21CFR 807.92)
K111342
1/2
1. SUBMITTER/510(K) HOLDER
Schott North America 122 Charlton Street Southbridge, MA 01550
| Contact Person: | Nilesh Samant |
|---|---|
| Telephone: | 1-508-765-9744 |
Date Prepared: May 11, 2011
2. DEVICE NAME
Proprietary Name: Common/Usual Name: Classification Name:
Light Guide Cable Fiberoptic Cable Surgical Lamp
3. PREDICATE DEVICE
Endoscopic Fiber Optic Cable marketed by Isolux America, K991208
4. DEVICE DESCRIPTION
The Light guide cable consists of glass fibers which are glued or fused into ferrules on both ends. The ends are polished to effectively transmit light and are equipped with standard endoscope connectors to transmit visible light from the light source to the intended instrument. The fibers are covered by Silicone sheathing for ease of handling and protecting the fibers from damage. The device is intended to be Ethylene Oxide (EtO) sterilized by the user. Sterilization information is contained in section 14.
5. INTENDED USE
The Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
1
K 111342 2/2
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The characteristics of the Light Guide Cable are substantially equivalent to the following current legally marketed predicate devices based on intended use, typical o linical use, and operational and fundamental technological characteristics.
Endoscopic Fiber Optic Cable marketed by Isolux America, K991208
A detailed side-by-side comparison of the Light Guide Cable with the identified predicate device is provided in the substantial equivalence discussion in this premarket notficulon.
7. PERFORMANCE TESTING
The Light Guide Cable performance testing includes electrical safety testing and sterilization validation to the appropriate FDA Recognized Consensus Stardands The results of this performance testing conclude that the technological characteristics have not diminished the safety and effectiveness of the Light Guide Cable when compared to the predicate device.
8. CONCLUSION
Based on the similarities in indication for use, design, functional, and operational features the Light Guide Cable has demonstrated substantial equivalence to the listed legally marketed predicate device and any differences do not affect the product's safety or effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the wings and a snake-like form at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV 25 2011
Schott North America % Medical Device Consultants, Inc. Mr. Jeffrey Roberts 40 Plain Street North Attleboro, Massachusetts 02760
Re: K111342
Trade/Device Name: Light Guide Cable Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: HBI Dated: November 09, 2011 Received: November 10, 2011
Dear Mr. Roberts:
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
3
Page 2 – Mr. Jeffrey Roberts
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Erich Keith
So Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE 4.
510(k) Number (if known): Not yet assigned
Device Name:
Light Guide Cable
Indications for Use:
The Schott Light Guide Cable is indicated for use in transmitting light for illumination purposes from an illuminator to various instruments such as headlights, microscopes and endoscopes, providing illumination in body cavities during examinations or surgical procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Keith
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K111342 510(k) Number
May 11, 2011