(90 days)
No
The summary describes a laser system for surgical procedures and does not mention any AI or ML components.
Yes
The device is intended for the surgical treatment of soft tissue in various medical applications, which clearly indicates its use in the diagnosis, cure, mitigation, treatment, or prevention of disease, fitting the definition of a therapeutic device.
No
The device is described as being for "surgical treatment (i.e., incision, excision, ablation, coagulation, vaporization, debulking or hemostasis) of soft tissue," which indicates therapeutic rather than diagnostic use.
No
The device description explicitly states "Prima KTP Laser System," which is a hardware device used for surgical procedures. The intended use also describes surgical treatments performed with a laser, indicating a physical device is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's body (incision, excision, ablation, coagulation, vaporization, debulking, hemostasis of soft tissue). IVD devices are used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a person's health.
- Device Description: The device is described as a "Prima KTP Laser System," which is a surgical tool, not a diagnostic test kit or instrument for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as analyzing biological specimens, providing diagnostic information based on those analyses, or being used in a laboratory setting.
The device is a surgical laser intended for direct treatment of various tissues within the body.
N/A
Intended Use / Indications for Use
Nideks Prima KTP Laser System is intended for all clearedLaserscope AURA KTP applications.
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.
Product codes
GEX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Head and Neck (ENT), General Surgery, Plastic Surgery, Thoracic Surgery, Urology, Cutaneous, Esophageal, Colorectal, Hemorrhoidal, Colon, Gastric, Cervical, Vulvar, Vaginal, Intrauterine, Neurological (intracranial), Retina, Lumbar disk
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
SUMMARY OF SAFETY AND EFFECTIVENESS NIDEK PRIMA KTP SURGICAL LASER SYSTEM
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: (510) 226-5700 Fax: (510) 226-5750
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.
1
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.
2
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
3
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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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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Page 1 of 1
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