(281 days)
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No
The summary describes a simple surgical suction tube with integrated lighting, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device provides illumination and aspiration during surgery but does not treat a medical condition.
No
Explanation: The device is intended to provide surgical site illumination and suction, not to diagnose a condition.
No
The device description clearly states it is a "disposable Kogent™ Spetzler Lighted Suction Tubes" and requires connection to a suction system and illumination machine, indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide surgical site illumination from a high intensity light source" and "aspirate the surgical site." This describes a device used during a surgical procedure on a patient's body, not a device used to examine specimens outside of the body to diagnose a condition.
- Device Description: The description reinforces its use in surgical procedures, connecting to a suction system and an illumination machine.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers of disease, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on facilitating the surgical procedure itself.
N/A
Intended Use / Indications for Use
The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
Product codes (comma separated list FDA assigned to the subject device)
HBI, FST
Device Description
This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.
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
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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)
Bench testing demonstrates that Kogent™ Spetzler Lighted Suction Tubes are validated for their Indications for Use.
Non-Clinical Testing: The Kogent™ Spetzler Lighted Suction Tubes were tested in accordance with IEC 60601-1 and satisfy testing requirements. It is believed that the predicate device also claims compliance with IEC 60601-1. Bench testing was performed on the Kogent™ Spetzler Lighted Suction Tubes to verify the design inputs. The measured values and visual evidence confirmed that the Kogent™ Spetzler Lighted Suction Tubes conform to design dimensions and characteristics. Biocompatibility testing was performed on the materials present within the Kogent™ Spetzler Lighted Suction Tubes. All biocompatibility testing results satisfied the corresponding ISO 10993 specific requirements.
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).
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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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three human profiles nested within it, suggesting a sense of care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem, emphasizing the organization's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2015
Katalyst Surgical, LLC Ms. Meryl Koch Quality Assurance and Regulatory Affairs Manager 754 Goddard Avenue Chesterfield, MO 63005
Re: K141781
Trade/Device Name: The Kogent™ Spetzler Lighted Suction Tubes Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: HBI, FST Dated: February 23, 2015 Received: March 20, 2015
Dear Ms. Koch:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/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.
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4 Indications for Use
K141781 510(k) Number (if known):
The Kogent™ Spetzler Lighted Suction Tubes Device Name: Indications for Use: The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
V Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (OD
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5 510(k) Summary
| Manufacturer: | Katalyst Surgical, LLC
754 Goddard Avenue
Chesterfield, MO 63005
636-536-5950 (phone)
636-787-0603 (fax) |
|------------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Meryl Koch
Katalyst Surgical, LLC
636-536-5950 (phone)
636-787-0603(fax)
M.koch@katalystsurgical.com |
| Date Prepared: | June 25th, 2014 |
| Device Trade Name: | Kogent™ Spetzler Lighted Suction Tubes |
| Common Name: | Lighted Suction Tubes |
| Device Classification: | 21 CFR 878.4580: Surgical Lamp |
| Classification Name: | General and Plastic Surgery |
| Class: | II |
| Product Code: | HBI EST |
Indications for Use:
The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
Device Description:
This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.
Predicate Device:
The Kogent™ Spetzler Lighted Suction Tube was shown to be substantially equivalent to the previously cleared devices: Invuity® Eigr™ Surgical Illumination System, K113697.
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Substantial Equivalence:
SUMMARY OF EVALUATION
Bench testing demonstrates that Kogent™ Spetzler Lighted Suction Tubes are validated for their Indications for Use.
| FDA File Reference No. | 510(k) No. K113697 |
|---|---|
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison Result |
| Indications for Use | Equivalent |
| Target Population | Equivalent |
| Design | Similar |
| Materials | Equivalent |
| Performance | Equivalent |
| Sterility | Equivalent |
| Biocompatibility | Equivalent |
| Maximum Power Input | Equivalent |
| Energy Used and/or Delivered | Equivalent |
| Compatibility with Environment | |
| and Other Devices | Similar |
| Where Used | Equivalent |
| Illumination Pattern | Equivalent |
| Illumination Intensity | Similar |
| Max. Tip Temperature | Similar |
SUMMARY OF EQUIVALENCE
Design: The tip configuration for the predicate device is either a Yankauer suction tip or a Frazier suction tip. The tip configuration of the subject device is a cone shaped tip. The difference in design between the cone shaped tip of the Kogent™ Spetzler Lighted Suction Tubes and the suction tips of the predicate device does not affect the safety or effectiveness of the Lighted Suction Tubes when used as indicated. The handle configuration for the predicate device is a vertical "pistol" grip designed to be held in one hand. The handle configuration of the subject device is a horizontal handle designed to be held in one hand between the thumb and fingers. The differences in design between the vertical "pistol" handle of the predicate device and the horizontal handle of the subject device does not affect the safety or effectiveness of the Lighted Suction Tubes when used as indicated.
Compatibility with Environment and Other Devices: The connector of the predicate device is an ACMI connector and the connector of the subject device is a Storz style connector. The difference in connector types does not affect the safety or effectiveness of the Lighted Suction Tubes when used as indicated.
Illumination Intensity: The illumination intensity of the Kogent Spetzler Lighted Suction Tubes is similar to the Invuity Eigr Surgical Illumination System. The intensity of the illumination is slightly higher for the subject device. This difference does not impact the safety or the effectiveness of the Kogent Lighted Suction Tube as the outcome is additional light to illuminate the surgical site.
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Maximum Tip Temperature: The maximum tip temperature of the Kogent Spetzler Lighted Suction Tubes is similar to the Invuity Eigr Surgical Illumination System. The temperature is slightly lower for the subject device. This difference does not impact the safety or the effectiveness of the Kogent Lighted Suction Tube as the outcome is a cooler tip and less risk of overheating.
Non-Clinical Testing: The Kogent™ Spetzler Lighted Suction Tubes were tested in accordance with IEC 60601-1 and satisfy testing requirements. It is believed that the predicate device also claims compliance with IEC 60601-1. Bench testing was performed on the Kogent™ Spetzler Lighted Suction Tubes to verify the design inputs. The measured values and visual evidence confirmed that the Kogent™ Spetzler Lighted Suction Tubes conform to design dimensions and characteristics. Biocompatibility testing was performed on the materials present within the Kogent™ Spetzler Lighted Suction Tubes. All biocompatibility testing results satisfied the corresponding ISO 10993 specific requirements.
Conclusion
The Kogent™ Spetzler Lighted Suction Tubes were shown to be substantially equivalent to the previously cleared device with respect to intended use, indications for use, technological characteristics, performance characteristics, and biocompatibility.