(31 days)
No
The 510(k) summary describes a laser system for surgical procedures and lithotripsy. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML functionality. The description focuses on the physical characteristics and operation of the laser.
Yes
The device is indicated for various medical procedures such as incision, excision, ablation, and hemostasis across multiple surgical specialties, which are all therapeutic interventions designed to treat medical conditions.
No
The "Intended Use / Indications for Use" section describes various surgical procedures like incision, excision, ablation, and coagulation. These are therapeutic actions, not diagnostic ones. A diagnostic device would be used to identify a disease or condition.
No
The device description explicitly states it is a "compact, portable, self-contained system that produces a beam of infrared radiation" and includes a "laser console, unit fiber-optic delivery system, and a footswitch," indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description and intended use clearly indicate that the New Star Lasers, Inc. Model 100 Holmium Laser System is a surgical laser used for direct treatment of tissues within the body (incision, excision, ablation, etc.) across various anatomical sites. It is a therapeutic device, not a diagnostic one that analyzes samples.
The device's function is to interact directly with the patient's body for surgical procedures, which is the opposite of how an IVD operates.
N/A
Intended Use / Indications for Use
The New Star Lasers, Inc. Model 100 Holmium Laser System is indicated for the following:
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including:
Cholecystectomy, lysis og adhesions, appendectomy, biopsy, pylrosternotomy (sp?), benign and malignant lestions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
Incision, excision, resection, ablation, coabulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.
General Surgery of soft tissues, including:
skin incision, tissue dissection, excision or external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablation.
Genitourinary Surgery, including:
superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including:
knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinecular release, and debridement of the degenerative knees.
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The New Star Model 1000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible Helium Neon (HeNe) laser beam at 632.8 nm for aiming. The system emits a pulsed laser beam, which is delivered to the treatment site using a fiber-optic delivery system.
The system consists of a laser console, unit fiber-optic delivery system, and a footswitch The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Gastroenterological/Gastrointestinal, Dermatologic, Plastic, General Surgery (soft tissues), Genitourinary, Gynecological, Orthopedic (small and large joints, cartilaginous tissue), Otorhinolaryngology (ENT) (soft, mucosal, cartilaginous and bony tissue), Lumbar (soft and cartilaginous tissue)
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): 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.
K912879, K920248, K921724, K933007, K942542, K945156
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.
0
| K994273 | |
|---|---|
| JAN 20 2000 | Summary of Safety and Effectiveness |
| Company Name: | New Star Lasers, Inc. |
| 11802 Kemper Road | |
| Auburn, California 95603 | |
| (916) 823-1434 | |
| Company Contact: | Donald V. Johnson |
| Director, Regulatory & Quality Affairs | |
| Date Prepared: | December 14, 1999 |
| Device Name: | |
| Trade Name: | New Star Lasers Model 1000 Holmium Laser System |
| Common Name: | Surgical Laser System |
| Classification Name: | Instrument, Surgical, Powered Laser |
| 21 CFR § 878.4810 | |
| Predicate Device: | Omni Pulse™ Holmium Laser System, Model 1210 |
| Trimedyne, Inc. | |
| Irvine, California | |
| K992574 |
Device Description:
The New Star Model 1000 is a compact, portable, self-contained system that produces a beam of infrared radiation at 2,100 nm wavelength for treatment, and a visible Helium Neon (HeNe) laser beam at 632.8 nm for aiming. The system emits a pulsed laser beam, which is delivered to the treatment site using a fiber-optic delivery system.
The system consists of a laser console, unit fiber-optic delivery system, and a footswitch The system provides safety features that are designed to protect the user and patient from high voltages and laser emissions.
1
Intended Use/Indications:
Incision, excision, resection, ablation, vaporization, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including:
Cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylrosternotomy (sp?), benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
Incision, excision, resection, ablation, coagulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), coms, papillomas, and basal cell carcinomas.
General Surgery of soft tissues, including:
skin incision, tissue dissection, excision of external turnors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablation.
Genitourinary Surgery, including:
superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including:
fragmentation of urinary calculi, fragmentation of ureteral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints. including:
knee meniscectomy, knee synovectorny, chondromalacia and tears, loose body debridement, lateral retinecular release, and debridement of the degenerative knees.
- Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocvstorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.
Comparison with Predicate Device:
See following table.
2
| Specification | New Star Model 1000 10 Watt
Holmium Laser System | Trimedyne 40 Watt OmniPulse
Holmium Laser System |
|------------------------|------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser source | Pulsed, solid-state Ho:YAG | Pulsed, solid-state Ho:YAG |
| Wavelength | 2.1 microns | 2.1 microns |
| Pulse width | 350 microseconds nominal | 350 microseconds nominal |
| Pulse repetition rate | 5-12 Hz | 5-25 Hz |
| Power output | 10 watts | 40 watts |
| Energy range per Pulse | 0.5-1.25 Joules | 0.5-3.5 Joules |
| Electrical service | 115 VAC ± 10%, 10 amps, single
phase, 50-60 Hz | 220 VAC ± 10%, 30 amps, single
phase, 50-60 Hz |
| Cooling | Self-contained air/water | Self-contained air/water |
| Aiming beam | 1.5 mW red HeNe | 5mW red HeNe |
| Dimensions | 21"L x 14"W x 31"H | 39"L x 26"W x 47"H |
| Weight | 115 lbs. | 600 lbs. |
| Indications | General/Orthopedic Surgery,
PLDD, Sclerostomy, Endosinus
(ENT), Soft Tissue (Urology),
Lithotripsy (Ureteral) | General/Orthopedic/
Gastroenterological/
Gastrointestinal/ Dermatologic/
Genitourinary/ Gynecological/
Otorhinolaryngological (ENT)
Surgery, PLDD, Lithotripsy
(urinary, urethral, kidney, gall
bladder, and biliary/bile duct
calculi) |
| K Numbers | K912879, K920248, K921724,
K933007, K942542, K945156 | K992574 |
Technical Specifications Comparison
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 20 2000
Mr. Donald V. Johnson Director Regulatory & Quality Affairs New Star Lasers, Inc. 11802 Kemper Road Auburn, California 95603
K994273 Re:
Trade Name: Model 1000 Holmium Laser System Regulatory Class: II Product Code: GEX Dated: December 14, 1999 Received: December 20, 1999
Dear Mr. Johnson:
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 requirement, 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 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
4
Page 2 - Mr. Donald V. Johnson
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,
Hypt Charles
L. James E. Dillard III
for
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATION FOR USE STATEMENT
K994273 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: New Star Lasers, Inc. Model 1000 Holmium Laser System
Indications for Use:
The New Star Lasers, Inc. Model 100 Holmium Laser System is indicated for the following:
Incision, excision, resection, ablation, vaporization, coagulation, and hemostasis, with or without an endoscope, in Gastroenterological/Gastrointestinal Surgery, including:
Cholecystectomy, lysis og adhesions, appendectomy, biopsy, pylrosternotomy (sp?), benign and malignant lestions, rectal polyps of sigmoid colon, gall blader calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
Incision, excision, resection, ablation, coabulation, hemostasis, and vaporization, with or without an endoscope, in the following indications:
Dermatology and Plastic Surgery of soft, mucosal, fatty, and cartilaginous tissues, with or without an endoscope, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasia [facial, leg], and rosacea), corns, papillomas, and basal cell carcinomas.
General Surgery of soft tissues, including:
skin incision, tissue dissection, excision or external turnors and lesions, complete or partial resection of internal organs, turnors and lesions, and tissue ablation.
(Continued on following page)
(Please do not write below this line- Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of General Restorative Devices (994273 510(k) Number
| Prescription Use | ☑ |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-the Counter Use _
6
Indications for Use New Star Lasers, Inc. Model 1000 Holmium Laser System Page 2 of 2
Genitourinary Surgery, including:
superficial urinary bladder tumors, invasive bladder carcinoma, urethral strictures, and lesions of the external genitalia.
Gynecological Surgery during open and endoscopic procedures.
Lithotripsy and Percutaneous Urinary Lithotripsy, including: fragmentation of urinary calculi, fragmentation of urethral calculi, and fragmentation of kidney calculi.
Orthopedic Surgery in pathological soft and cartilaginous tissue in small and large joints, including:
knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinecular release, and debridement of the degenerative knees.
Otorhinolaryngology (ENT) Surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinectomy), and dacryocystorhinostomy (DCR).
Percutaneous Lumbar Discectomy, soft and cartilagineous tissue.