COOK HOLMIUM LASER FIBER

K124030 · Cook Incorporated · GEX · Jul 1, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K124030
• Device Name: COOK HOLMIUM LASER FIBER
• Applicant: Cook Incorporated
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 1, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Cook Holmium Laser Fiber is a surgical accessory designed for attachment to the H-30 Holmium Laser System. It functions as a delivery conduit for laser energy to perform incision, excision, ablation, and coagulation (hemostasis) in surgical procedures. The device features color-coded connectors for fiber size identification; multi-use and single-use configurations are available. It is supplied sterile for clinical use. By transmitting laser energy to target tissue, the fiber enables precise surgical cutting and hemostasis, benefiting patients by facilitating minimally invasive surgical interventions. The device is operated by trained clinicians in a surgical setting.

Clinical Evidence

No clinical data. Bench testing only: tensile testing, bend radius testing, energy loss testing, accelerated aging, and biocompatibility testing.

Technological Characteristics

Fiber-optic laser delivery system; multi-use (color-coded connector) and single-use (red connector) variants; supplied sterile. Operates as a passive accessory to the H-30 Holmium Laser System. No software or electronic components.

Indications for Use

Indicated for incision, excision, ablation, and coagulation (hemostasis) when used with the H-30 Holmium Laser System. Patient population defined by the cleared indications of the H-30 Holmium Laser System.

Regulatory Classification

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.

Predicate Devices

• OptiLite™ Holmium Laser Fibers (K073496)

Submission Summary (Full Text)

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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: [phone] Ex. 2330 Fax: [phone]

### 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.

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## 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. .

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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

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### 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 [phone] or [phone] 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

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### 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