SPHINX LASER SYSTEMS
Device Facts
| Record ID | K033437 |
|---|---|
| Device Name | SPHINX LASER SYSTEMS |
| Applicant | Allmed Systems, Inc. |
| Product Code | GEX · General, Plastic Surgery |
| Decision Date | Jan 20, 2004 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4810 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Sphinx 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 specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery.
Device Story
Sphinx is a 2.1-micron surgical laser system for soft tissue ablation, coagulation, dissection, and resection. System comprises laser console with internal computer control, fiber optic delivery system, and footswitch. Laser energy is delivered via silica fibers guided by handpieces or endoscopic instruments. Used in OR or clinical settings by physicians for open, laparoscopic, and endoscopic procedures. Output allows precise tissue interaction; enables minimally invasive surgical techniques; benefits patients through reduced trauma and improved hemostasis compared to traditional methods.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and intended use compared to legally marketed predicate devices.
Technological Characteristics
2.1-micron wavelength surgical laser system. Components: laser console, internal computer control, fiber optic delivery system (silica fibers), footswitch. Energy source: laser. Form factor: console-based. Connectivity: not specified. Sterilization: not specified. Software: internal computer control.
Indications for Use
Indicated for surgical incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue, cartilage, and bone across multiple specialties including urology (e.g., BPH, tumors, lithotripsy), gastroenterology, arthroscopy (joints/spine), pulmonary, gynecology, ENT, dermatology, plastic surgery, and general surgery. Prescription use only.
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
- Lumenis - Holmium VersaPulse Power Suite Holmium Laser
- Trimedyne - OmniPulse Max 80 Watt Holmium Laser System
Submission Summary (Full Text)
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JAN 2 0 2004
K033437
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# Attachment V
# 510(k) Summary
# 1.General Information
| Submitter: | AllMed Systems Inc.<br>9232 Klemetson Drive<br>Pleasanton CA 94588 |
|----------------|--------------------------------------------------------------------|
| Phone: | 925-468-0433 |
| Fax: | 925-399-5984 |
| Contact Person | Peter Allen |
Date Prepared 27th October 2003
- 2. Names
| Device Name | Sphinx |
|---------------------|-------------------------------------------|
| Common Name | 2.1micron Laser System |
| Classification Name | Laser Surgical Instrument and accessories |
# 3. Predicate Device
Lumenis - Holmium VersaPulse Power Suite Holmiun Laser Trimedyne - OmniPulse Max 80 Watt Holmium Laser System
### 4. Product Description
The Sphinx system is a surgical laser system operating at a wavelength of 2.1 micron. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument.
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K033437
205
It consists of:
Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch
### 5. Indications for Use
The Sphinx 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 specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, 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) Ablation and resection of Bladder Tumors, Uretheral Turnors and Ureteral Turnors. 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) Condviomas
Lesions of external genitalia
Lithotripsy and Percutaneous Urinary Lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
Endoscopic fragmentation of kidney calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
### Gasteroenterlogy
Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy
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Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
K033437
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#### Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
Ligament and tendon Release Countouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
Percutaneous Laser Disc Decompression/Discectorny of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy
#### Pulmonary
Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue)
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Image /page/3/Picture/0 description: The image shows a series of handwritten digits and letters. The first row contains the characters 'KO33437'. The second row contains the numbers '4', '8', and '5'.
### Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue
### ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including:
- Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomv 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 Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas
#### 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 Bioosv
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K033437
50g5
# 6. Rationale for Substantial Equivalence
The Sphinx laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are substantially equivalent to the Lumenis VersaPulse 100 watt Holmium Laser, and the Trimedyne OmniMax 80 watt Holmium Laser.
#### 7. Conclusion
The Sphinx Laser System with fiber optic delivery devices were found to be substantially equivalent to similar currently marketed and predicate surgical laser systems and delivery devices.
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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 0 2004
Mr. Peter Allen AllMed Systems, Inc. 9232 Klemetson Drive Pleasanton, California 94588
Re: K033437 Trade/Device Name: Sphinx Regulation Number: 21 CFR 878.4810 Regulation Name: 21 OFF CF 8781 1877
Regulation Name: Laser surgical instrument for use in general and plastic surgery and dermatology Regulatory Class: II Product Code: GEX Dated: October 26, 2003 Received: October 30, 2003
Dear Mr. Allen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreations of the enactment date of the Medical Device Amendments. Or to econner or rial a rialy as in accordance with the provisions of the Federal Food, Drug, de MCCs mat nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, decreter, mans of the Act include requirements for annual registration, listing of general controll proving 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 rr your artist to such additional controls. Existing major regulations affecting your device can may or sabject to and 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 dctermination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or my 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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# 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 cquivalence 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,
Muriam C Provost
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
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510(k) Number: K033437
Device Name: Sphinx
Indications For Use:
The Sphinx 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 specialties including: Urology, Uninary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy Pulmonary, 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) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Turnors. 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) Condviomas Lesions of external genitalia
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 1 of 6
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510(k) Number: K033437
Device Name: Sphinx
Indications For Use:
Lithotripsy and Percutaneous Urinary Lithotripsy
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.
Endoscopic fragmentation of kidney calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.
# Gasteroenterlogy
Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including:
- Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorthoids Cholecystectomy Benign and Malignant Neoplasm
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)
Page 2 of 6
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510(k) Number: K033437
Device Name: Sphinx
Indications For Use;
Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions
#### Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including:
Ligament and tendon Release Countouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears
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)
Page 3 of 6
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510(k) Number: K033437
Device Name: Sphinx
Indications For Use:
Plica Removal Meniscectomy Loose Body Debridement Lateral retinecular release
Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including
Percutaneous Laser Disc Decompression/Discectorny of the L4-5 and L5-51 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy
### 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) of soft tissue
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 4 of 6
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510(k) Number: K033437
Sphinx Device Name:
Indications For Use:
ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) 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 indision, excludin, roostlon, admous tissue, in therapeutic plastic, dematologic and aesthetic surgical procedures including:
Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue
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 5 of 6
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510(k) Number: K033437
Device Name: Sphinx
Indications For Use:
Port Wine Stains Papillomas
### 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 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)
| | <i>Miriam C Provost</i> |
|--|-----------------------------------------|
| | <i>(Signing Off)</i> |
| | <i>Division of General, Restorative</i> |
| | <i>and Neurological Devices</i> |
| | K033437 |
Page 6 of 6
