(185 days)
Not Found
No
The 510(k) summary describes a laser fiber and its physical properties and testing, with no mention of AI or ML.
Yes
The device is described as being used for "incision/excision, ablation, and coagulation (hemostasis)", which are therapeutic actions performed on a patient.
No
Explanation: The device is described as being for "incision/excision, ablation, and coagulation (hemostasis)," which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it is a "Cook Holmium Laser Fiber," which is a physical component intended to be attached to a laser system. The performance studies also describe physical tests like tensile testing and bend radius testing, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used for "incision/excision, ablation, and coagulation (hemostasis)" when attached to a laser system. These are surgical procedures performed directly on the patient's tissue.
- Device Description: The description reinforces its use in surgical procedures, mentioning "incision, ablation, and coagulation."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a tool used for direct surgical intervention on the body.
N/A
Intended Use / Indications for Use
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Cook Holmium Laser Fiber is intended for incision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared. The devices are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in six sizes, and will be sold in boxes of three.
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
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 proposed Cook Holmium Laser Fiber was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Tensile Testing
- Bend Radius Testing
- Energy Loss Testing
- Accelerated Aged Testing
- Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use.
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).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are 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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K124030 Page 1 of 2
510(k) SUMMARY
Submitted By:
David Chadwick, Ph.D., RAC, FRAPS Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812)339-2235 Ex. 2330 Fax: (812)332-0281
Device:
Trade Name: Common Name: Classification Name: Cook Holmium Laser Fiber Laser Fiber Laser Instrument, Surgical, Powered GEX (21 CFR §878.4810)
Indications for Use: .
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.
Predicate Device:
The Cook Holmium Laser Fiber is similar to the predicate device (OptiLite™ Holmium Laser Fibers; K073496) in terms of intended use, principles of operation, materials of construction, and technological characteristics.
Comparison to Predicate Device:
Cook Incorporated (formally Cook Urological, Inc.) currently markets the predicate OptiLite™ Holmium Laser Fiber cleared for marketing on January 23, 2008 (K073496). The similar indications for use, principles of operation, and technological characteristics of the Cook Holmium Laser Fibers as compared to the predicate device support a determination of substantial equivalence.
Device Description:
The Cook Holmium Laser Fiber is intended for incision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared. The devices are supplied sterile in peel-open packages. The multi-use fibers have a color coded connector to identify the four different fiber sizes, and will be sold individually. The single-use fibers have a red connector and come in six sizes, and will be sold in boxes of three.
1
K124030 Page 2 of 2
Test Data:
The proposed Cook Holmium Laser Fiber was subjected to the following tests to assure reliable design and performance under the specified testing parameters.
- Tensile Testing .
- Bend Radius Testing .
- Energy Loss Testing .
- . Accelerated Aged Testing
- . Biocompatibility Testing
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use. .
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes above three wave-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
July 1, 2013
Cook Incorporated % Ms. Connie Rice, RAC Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K124030
Trade/Device Name: Cook Holmium Laser Fiber Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and plastic surgery and in dermatology
Regulatory Class: Class II Product Code: GEX Dated: June 11, 2013 Received: June 12, 2013
Dear Ms. Rice:
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
3
Page 2 - Ms. Connie Rice, RAC
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/ResourcesforYou/Industry/default.htm.
For
Sincerely yours,
Do
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K.124030
Device Name: Cook Holmium Laser Fiber
Indications for Use for the Cook Holmium Laser Fiber:
The Cook Holmium Laser Fiber is intended for incision/excision, ablation, and coagulation (hemostasis) when attached to the cleared H-30 Holmium Laser System for the indications for which the system has been cleared.
Prescription Use XX
OR
Over-the-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
"
Neil R Ogden
2013.07.01 14:51:48 -04'00'
(Division Sign-Off) for MXM
Division of Surgical Devices
510(k) Number K 124030