PRIMA KTP LASER SYSTEM

K973828 · Nidek, Inc. · GEX · Jan 5, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K973828
• Device Name: PRIMA KTP LASER SYSTEM
• Applicant: Nidek, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 5, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, ablation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes: Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology. Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, telangiectasia. Benign pigmented lesions: Nevi, Lentigines, chloasma, café-au-lait, Tattoos. Other Cutaneous Lesions. Verrucae, Skin Tags, Keratoses, Plaques, Cutaneous Lesion Treatment Goals Include; Hemostasis, Color Lightening, Blanching, Flattening, Reduction of Lesion Size. Gastroenterology: Ablation of esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma. Ablation and excision of obstructive colorectal carcinoma. Hemorrhoidectomy. Ablation of villous adenoma in non-operative patients. Ablation of familial polyposis of the colon. Excision of gastric cancer. Ablation of sessile polyps of the colon. Gynecology: Vaporizing, incising or coagulating tissue associated with treatments for conditions such as; Endometriosis, Cervical, vulvar and vaginal intraepithael neoplasia. Condyloma acuminata. Interuterine septum. Intrauterine adhesions. Submucosal fibroids. Neurosurgery: Vaporizing, coagulating, incising, excising, debulking, and ablating neurological tissue in both open and endoscopic intracranial procedures such as: Third ventriculostomy, transseptal fenestration, intraventricular cysts fenestration, ventriculocystostomy, tumor biopsy and excision, removal of proximal shunts occluded by choriod plexus. Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Spinal Surgery: Percutaneous lumbar diskectomy.

Device Story

Prima KTP Laser System; surgical laser for soft tissue treatment. Device delivers laser energy to target tissue for incision, excision, ablation, coagulation, vaporization, debulking, or hemostasis. Operated by physicians in clinical/surgical settings. Output allows precise tissue interaction to achieve clinical goals like hemostasis or lesion removal. Benefits include minimally invasive surgical capabilities across multiple specialties.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological and intended use comparison to predicate.

Technological Characteristics

KTP (Potassium Titanyl Phosphate) surgical laser system. Complies with 21 CFR 1040.10 and 1040.11. Class II device.

Indications for Use

Indicated for surgical treatment (incision, excision, ablation, coagulation, vaporization, debulking, hemostasis) of soft tissue in ENT, general, plastic, thoracic, urological, dermatological, gastroenterological, gynecological, neurosurgical, ophthalmological, and spinal procedures.

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

• Laserscope Aura KTP laser system

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK PRIMA KTP SURGICAL LASER SYSTEM

K973828

### REGULATORY AUTHORITY:

JAN - 5 1998

Safe Medical Devices Act of 1990, 21 CFR 807.92

# COMPANY NAME/CONTACT:

Ken Kato Vice President 47651 Westinghouse Drive Fremont, CA 94539 Phone: [phone] Fax: [phone]

DEVICE TRADE NAME:

Prima KTP Laser System

DEVICE COMMON NAME:

KTP Surgical Laser System

DEVICE CLASSIFICATION:

KTP laser systems are classified as Class II.

PERFORMANCE STANDARDS:

The laser systems manufactured by Nidek Inc. comply with 21 CFR 1040.10 and 1040.11, FDA regulations for medical laser products, as applicable.

INDICATIONS FOR USE STATEMENT:

Nideks Prima KTP Laser System is intended for all clearedLaserscope AURA KTP applications.

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#### COMPARISON WITH PREDICATE DEVICE:

The Nidek KTP system is substantially equivalent to Laserscope's Aura KTP laser system.

The risks and benefits of the Nidek Prima KTP are comparable to the predicate device when used for similar clinical applications.

Since the Nidek Prima KTP laser system is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirement for substantial equivalence according to 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 1998

Mr. Ken Kato Vice President Nidek, Incorporated 47651 Westinghouse Drive Fremont, California 94539

Re: K973828 Trade Name: Prima KTP Laser System Regulatory Class: II Product Code: GEX Dated: October 1, 1997 Received: October 7, 1997

Dear Mr. Kato:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for

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Page 2 - Mr. Kato

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Acoolez

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known): K973828 Device Name: Nidek Prima KTP Laser System

Indications for Use: The Prima KTP lasers are intended for the surgical treatment (i.e., incision, excision, ablation, coagulation, vaporization, debulking or hemostasis) of soft tissue in all surgical applications. This includes:

Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery and Urology.

Dermatology: Photocoagulation of cutaneous lesions, including the following general categories of lesions: Vascular lesions; Angiomas, telangiectasia. Benign pigmented lesions: Nevi, Lentigines, chloasma, café-au-lait, Tattoos. Other Cutaneous Lesions. Verrucae, Skin Tags, Keratoses, Plaques, Cutaneous Lesion Treatment Goals Include; Hemostasis, Color Lightening, Blanching, Flattening, Reduction of Lesion Size. Gastroenterology: Ablation of esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma. Ablation and excision of obstructive colorectal carcinoma. Hemorrhoidectomy. Ablation of villous adenoma in non-operative patients. Ablation of familial polyposis of the colon. Excision of gastric cancer. Ablation of sessile polyps of the colon.

Gynecology: Vaporizing, incising or coagulating tissue associated with treatments for conditions such as; Endometriosis, Cervical, vulvar and vaginal intraepithael neoplasia. Condyloma acuminata. Interuterine septum. Intrauterine adhesions. Submucosal fibroids. Neurosurgery: Vaporizing, coagulating, incising, excising, debulking, and ablating neurological tissue in both open and endoscopic intracranial procedures such as: Third ventriculostomy, transseptal fenestration, intraventricular cysts fenestration, ventriculocystostomy, tumor biopsy and excision, removal of proximal shunts occluded by

choriod plexus.

Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Spinal Surgery: Percutaneous lumbar diskectomy.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number. K973820

Prescription Use (Per 21 CFR 801 109)

OR

Over the Counter Use