(105 days)
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.
The device is not intended to be used to illuminate the surgical field.
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
There are three separate models made for the three types of light cables: WLF, STZ, ACM.
Here's an analysis of the provided text regarding the CableCap™ device, focusing on the acceptance criteria and the study performed:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text only details one explicit performance criterion related to temperature.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maximum device temperature below a "standard" | Maximum temperature was 101 °F |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The text mentions "test runs" and "bench-top physical testing," implying multiple tests were done, but the exact number of units tested or runs performed is not provided.
- Data Provenance: The testing was conducted by Materials, Engineering, and Testing Corp. in Oak Ridge, TN. This indicates the testing was likely performed in the USA. The text does not specify if the tests were performed on retrospective or prospective data/scenarios; it describes simulating "an extreme scenario" for prospective product safety.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the type of testing described. The performance testing for the CableCap™ device was a physical bench-top test measuring temperature, not a diagnostic or interpretive task that would require expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. Since the testing involved physical measurements (temperature), there was no need for expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. The CableCap™ is a physical accessory designed to prevent burns and ignition, not a diagnostic or interpretive tool that would involve human readers or AI assistance in decision-making. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable. The CableCap™ is a passive mechanical device, not an algorithm or software. Its performance is inherent in its physical properties and design, not in an algorithmic output.
7. Type of Ground Truth Used
The ground truth used for the performance testing was a physical measurement benchmark (a "standard" for safe temperature) against which the device's measured temperature was compared.
8. Sample Size for the Training Set
This information is not applicable. The CableCap™ is a hardware device; it does not involve machine learning or AI, and therefore does not have a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
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510(k) Summary SensorMed CableCap™ 510(k) Number K101496
Manufacturer Identification Submitted by:
SensorMed, Inc. 2450 EJ Chapman Dr., Suite 104 Knoxville, TN 37996 865-216-6307
Contact Information: William Milam
VP of Engineering SensorMed, Inc. 2450 EJ Chapman Dr., Suite 104 Knoxville, TN 37996 865-216-6307 wmilam@sensormed.com
Date Prepared: May 25, 2010 Device Identification Proprietary Name CableCap™ Common Name Light Cable Burn and Fire Prevention Device Classification Name Accessory to Fiberoptic Surgical Light Device Classification 21 CFR 878.4580 Proposed Regulatory Class Class II Device Product Code FST
Device Description
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite.
There are three separate models made for the three types of light cables:
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Intended Use of the Device
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. The device is not intended to illuminate the surgical field.
Predicate Device
Axxion Light Guide from Spinal Elements, Inc. (K082992)
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SEP 1 4 2010
FDA CDRJI DMC
AUG 2 4 2010
Received
{1}------------------------------------------------
Technology Comparison
Both devices are constructed from biocompatible steel and plastics. Both are accessories to high intensity light cables. Both devices attach to the distal end of light cables and modify the outgoing light stream to benefit minimally invasive surgical procedures. Please see the table below for a device comparison table.
| Axxion | CableCap | |
|---|---|---|
| Attenuates light from a medical light box | X | X |
| Diffuses light in multiple directions | X | X |
| Is manufactured from a combination of biocompatible steel and plastic | X | X |
| Is autoclave-able | X | X |
| Improves surgical procedure for patient | X | X |
| Does not directly treat or diagnose patient | X | X |
| Works with multiple light sources and different intensities | X | X |
Performance Testing
Bench-top physical testing was performed by Materials, Engineering, and Testing Corp. located in Oak Ridge, TN. Their Accreditation number is 59214 and they are ISO/IEC 17025:2005 compliant. As an extreme scenario, we assumed that the device might remain in contact with a patient's skin for 30 minutes. As an extra precaution, we doubled this time to 60 minutes for test runs. As indicated in the report included in the testing section, the maximum temperature was only 101 °F, which is still well below the standard.
Therefore, SensorMed is confident that the device temperature will not be a concern even if used for extended periods of time.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 4 2010
SensorMed, Inc. % Mr. William Milam Vice President of Engineering 2450 EJ Chapman Drive, Suite 104 Knoxville, Tennessee 37996
Re: K101496
Trade/Device Name: CableCap™ Model: WLF, STZ, ACM Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: .FST Dated: May 25, 2010 Received: August 24, 2010
Dear Mr. Milam:
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
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Page 2 - Mr. William Milam
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 vours.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
| 510(k) Number (if known): | K101496 |
|---|---|
| Device Name: | CableCap |
| Indications For Use: |
The CableCap device attaches to the distal end of high intensity light cables. The device absorbs and diffuses the light transmitted through the cable in order to prevent patient burns and igniting flammable items in the surgical suite. It is necessary to check each light cable to determine which CableCap model (STZ, ACM, WLF) to use. See product instructions for cleaning and sterilization protocols.
The device is not intended to be used to illuminate the surgical field.
Prescription Use x AND/OR Over - The - Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) led al Orde - MXA
:
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) (Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101496
§ 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.