(80 days)
The Revolix laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialities including: Urology, Gasteroenterlogy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
The RevoLix diode pump solid state is a surgical laser system operating at a wavelength of 2.0 micron. The purpose of the laser is the ablation, coagulation, and hemostasis of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via a fiber optic delivery system and this is guided by a handpiece or endoscopic surgical instrument. It consists of Laser Console with Internal Computer Control Panel and Display, A fiber optic delivery system, Footswitch.
The provided text is a 510(k) Summary for the RevoLix Family of Laser Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) submission process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the manner you've described for AI/diagnostic devices. For laser systems, substantial equivalence is typically established based on similar intended use, technological characteristics, and safety profiles.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this information is not present in the provided document.
The document states:
- Rationale for Substantial Equivalence: The RevoLix laser system shares "intended use, indications for use, similar design features and functional features" with the predicate devices.
- Conclusion: The RevoLix Laser System was found to be "substantially equivalent" to the predicate surgical laser systems.
This type of submission focuses on regulatory comparison, not on detailed performance validation with specific acceptance criteria and study designs as would be expected for a software-as-a-medical-device (SaMD) or AI-based diagnostic tool.
{0}------------------------------------------------
JAN 1 5 2004
K033423 1 of 4
Attachment V
510(k) Summary
1. General Information
| Submitter: | AllMed Systems Inc.9232 Klemetson DrivePleasanton CA 94588 |
|---|---|
| Phone: | 925-468-0433 |
| Fax: | 925-399-5984 |
| Contact Person: | Peter Allen |
| Date Prepared | 22nd October 2003 |
-
- Names
| Device Name | Revolix Family of Laser Systems |
|---|---|
| Common Name | 2.01micron Laser System |
| Classification Name | Laser Surgical Instrument and accessories |
3. Predicate Device
Lumenis – Holmium VersaPulse Power Suite Holmiun Laser Eaments - TomniPulse Max 80 Watt Holmium Laser System
4. Product Description
The RevoLix diode pump solid state is a surgical laser system operating at a The RevolElx diode purpose of the laser is the laser is the ablation, coagulation, wavelength of 2.0 milliording soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via arro surgical applications in aquebad this is guided by a handpiece or endoscopic surgical instrument.
{1}------------------------------------------------
K033423 2 of 4
It consists of
Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
5. Indications for Use
The Revolix laser system and its fiber optic delivery system are intended for use in The Revolix laser system and its liber optio dollively of oscision, excision, surgical procedures using open, laparosooplound onlostasis of soft tissue in use in use in use in resection, abiation, vaporization, congulation and normost, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Bladder Neck Includio (BN)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia
Gasteroenterlogy
Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including
- Appendectomy Polyps Biobsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm
{2}------------------------------------------------
K033423 3g
- Angiodysplasia Colorectal cancer Telangjectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
Pulmonary
Open and endoscopic pulmonary surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery
Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:
Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts
{3}------------------------------------------------
K033423 4084
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, resection, resection, resection, Open laparoscopic and endoscopis cargery (
ablation, vaporization, coagulation and hemostasis) including:
Appendectomy Skin incision Excision of external and internal lesions Excision of external and internal lesions
Complete of partial resection of internal organs, tumors and lesions Biopsy
6. Rationale for Substantial Equivalence
The Revolix laser system with fiber optic delivery devices share intended use,
the same in the find of the first and firstigated foatures and therefore are The Revolix laser system will hoer oplic ucures and therefore and therefore are are
indications for use, similar design features and functional features and therefore and indications for use, similar design leather and the loversuite 10 watt Holmium Laser,
substantially equivalent to the Lumenis VersaPulse 100 watt Holmium Laser substantially equivalent to the Luments versal uise Forrelession
the Trimedyne OmniMax 80 watt Holmium Laser and the Laserscope Green Laser
7. Conclusion
- Conclusion
The Revolix Laser System with fiber optic delivery devices were found to be substantially The Revolix Laser System with hiber optic delivery actives and the surgical laser systems and delivery devices.
{4}------------------------------------------------
Image /page/4/Picture/1 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 resembling an eagle or bird with three stylized wings or feathers.
Public Health Service
JAN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Peter Allen President Allmed Systems, Inc. 9232 Klemetson Drive Pleasanton, California 94588
Re: K033423 Tradc/Device Name: Revolix Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: October 22, 2003 Received: October 29, 2003
Dear Mr. Allen:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
{5}------------------------------------------------
Page 2 - Mr. Peter Allen
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
C.C.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
510(k) Number: K033423
Revolix Device Name:
Indications For Use:
The Revolix laser system and its fiber optic delivery system are intended for use in surgical The Revolix laser System and its ther optic and endoscopic incision, resection, ablation, procedures using open, laparuscopic and enosus in use in medical specialies including.
vaporization, coagulation and hemostasis of soft tissue in use in medical specializes f vaponzation, coagulation and hemostals of Sort tread in 2001 miles of the Surgery and General Surgery
Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:
Urethral Strictures Bladder Neck Incisions (BNI) Bladder Neck Inclisions (DNI)
Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia
Gasteroenterlogy
Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaponzation, coagulation and hemostasis ) including:
Prescription Use v (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use ............. (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Meriaw C. Provost
Division Sign-Off
Page 1 of 4
Vision Sign-Off) Civision of General, Restorative and Neurological Devices
Ko 33423
{7}------------------------------------------------
510(k) Number: K033423
Revolix Device Name:
Indications For Use:
Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophaqitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
V Prescription Use _ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 4
{8}------------------------------------------------
510(k) Number: K033423
Revolix Device Name:
Indications For Use:
Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis)
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including:
- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery
ما Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 3 of 4
{9}------------------------------------------------
510(k) Number: K033423
Revolix Device Name:
Indications For Use:
Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of including excludit, resection, abliation, vaponation, or stic, dermatologic and aesthetic surgical procedures including
Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts
General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including.
Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsy
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
....
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Suhpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 4 of 4
§ 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.