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 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. It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch

AI/ML Overview

This submission focuses on establishing substantial equivalence for a surgical laser system (Sphinx) to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI performance is not applicable or cannot be extracted from this document.

Here's what can be inferred and stated based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The document does not explicitly state acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for a new device's function. Instead, the "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to existing predicate devices. This means proving that the Sphinx laser system has the same intended use, indications for use, and similar design/functional features as the predicate devices.
Reported Device Performance: The document does not provide quantitative performance metrics for the Sphinx laser system such as power output accuracy, beam stability, or tissue ablation rates against specific benchmarks. It describes the device's capabilities (ablation, coagulation, dissection, resection of soft tissue) and its intended applications across various medical specialties.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence)	Reported Device Performance (as described in the document)
Same Intended Use as Predicate Devices	Surgical laser system for ablation, coagulation, dissection, and resection of soft tissue.
Same Indications for Use as Predicate Devices	Broad range of surgical procedures in Urology, Lithotripsy, Gastroenterology, Arthroscopy, Discectomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, and General Surgery.
Similar Design Features as Predicate Devices	Surgical laser system operating at 2.1 micron, delivery via standard silica laser fibers, handpiece or endoscopic instrument guidance.
Similar Functional Features as Predicate Devices	Provides laser power for soft tissue modification.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. This submission is not based on a clinical performance study using a test set of patient data to evaluate an AI/CAD device's diagnostic or predictive performance. It's a regulatory submission affirming substantial equivalence based on technical specifications and intended use.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. As there is no "test set" in the context of an AI/CAD device's performance, there were no experts used to establish ground truth for such a set. The "ground truth" here would be the established safety and efficacy of the predicate devices.

4. Adjudication Method for the Test Set:

Not Applicable. No test set or adjudication process for AI/CAD performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This document does not mention an MRMC study. It is a submission for a surgical laser device, not a diagnostic imaging AI.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware device (laser system), not an algorithm.

7. The Type of Ground Truth Used:

Not Applicable / Implied Equivalence: The "ground truth" for this 510(k) submission is the pre-existing regulatory approval and established safety and efficacy of the predicate devices (Lumenis - Holmium VersaPulse Power Suite Holmium Laser and Trimedyne - OmniPulse Max 80 Watt Holmium Laser System). The "proof" for the Sphinx system is its demonstration of substantial equivalence to these legally marketed devices, implying that if it is sufficiently similar, it can be considered safe and effective for the stated indications.

8. The Sample Size for the Training Set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. See point 8.

Summary

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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.9232 Klemetson DrivePleasanton CA 94588
Phone:	925-468-0433
Fax:	925-399-5984
Contact Person	Peter Allen

Date Prepared 27th October 2003

1. 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

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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

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

3 7 5

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:

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)

	Miriam C Provost
	(Signing Off)
	Division of General, Restorative
	and Neurological Devices
	K033437

Page 6 of 6

Regulation Number and Section

§ 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.