The Sphinx Jr. laser system is 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 Jr. 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 and non aqueous medium. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece endoscopic surgical instrument or similar approved device. It consists of: Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for the Sphinx Jr Laser system. This type of submission in the US regulatory process for medical devices asserts substantial equivalence to a previously legally marketed device (predicate device), rather than directly demonstrating safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.

Therefore, the document does not contain a table of acceptance criteria nor a study proving the device meets said criteria in the traditional sense of a clinical trial. Instead, the core argument is that the Sphinx Jr Laser is substantially equivalent to existing predicate devices (Sphinx Family of Lasers K033437 and Lumenis - Versapulse K011703) because it shares the same intended use, indications for use, similar design features, and functional features.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is absent due to the nature of a 510(k) submission based on substantial equivalence:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated or defined in the document. For a 510(k) submission, acceptance is based on demonstrating substantial equivalence to a predicate device, not on meeting predefined performance thresholds in de novo clinical studies.
Reported Device Performance: The document states, "Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required." This implies that the performance is considered to be equivalent to the predicate devices, rather than providing new, original performance data against specific criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. No "test set" in the context of a clinical performance study is described. The demonstration of equivalence relies on comparing the device's design, intended use, and functional specifications to those of the predicate devices.
Data Provenance: Not applicable. No clinical data or performance data from human or animal subjects is described as being used to establish equivalence in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a "test set" requiring ground truth establishment by experts in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "test set" and thus no adjudication method for it is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a surgical laser system, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is not an algorithm-only device. It is a physical surgical laser system operated by medical professionals.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth is established in the context of a performance study for the Sphinx Jr Laser. Its safety and effectiveness are inferred by its substantial equivalence to previously cleared devices.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that would require a "training set."

9. How the ground truth for the training set was established

Not applicable. As above, no training set or ground truth for such a set is relevant to this device.

Summary of the Study and "Acceptance" for the Sphinx Jr Laser:

The "study" in this context is the 510(k) Premarket Notification (K132975) process itself, which aims to demonstrate substantial equivalence (SE) to predicate devices. The "acceptance criteria" are effectively the FDA's requirements for establishing SE.

The document states:

"The Sphinx Jr systems 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 Sphinx Family of Lasers K033437 and Versapulse K011703."
"All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to support a determination of safety to the predicate devices." (This refers to non-clinical, engineering-level testing, not clinical performance).
"Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required."
Conclusion: "The Sphinx Jr Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices."

The FDA's letter on March 18, 2014, confirms that they have "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This letter constitutes the "acceptance" that the device meets the regulatory requirements for market clearance via the 510(k) pathway, based on the argument of substantial equivalence.

Summary

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Attachment V

510(k) Summary K132 975

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	17th September 2013
2. Names
Device Name	Sphinx Jr Laser
Common Name	laser surgical instrument
Classification Name	79GEX
CFR Reference	21 CFR 878.4810 Laser surgical instrument for use ingeneral, plastic and dermatological surgery
3. Predicate Device

Sphinx Family of lasers, and Lumenis - Versapulse

4. Product Description

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It consists of:

Laser Console with Internal Computer Control Panel and Display Operating Software Fiber port Footswitch

5. Indications for Use

The Sphinx Jr laser system is 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 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)

Condvlomas

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 kidnev 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 Hemorrhoids 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

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 includina:

Ligament and tendon Release Contouring 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/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty

3 Lumbar discs, including Foraminoplasty
Percutaneous Cervical Disc Decompression/Disce

Percutaneous Cervical Disc Decompression/Discectomy

Percutaneous Thoracic Disc Decompression/Discectomy

Thoracic and Pulmonary

Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue)

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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 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 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: Appendectomv Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsy

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Safety and Effectiveness of the Sphinx Jr.

Rationale for Substantial Equivalence

The Sphinx Jr systems 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 Sphinx Family of Lasers K033437 and Versapulse K011703.

Non Clinical Testing

All necessary Software and EMC testing was conducted on the proposed Sphinx Jr to support a determination of safety to the predicate devices.

Performance

Since the specification and performance of the Sphinx laser system and the predicate devices are the same, it is suggested that preclinical performance data is not required

Conclusion

The Sphinx Jr Systems with fiber optic delivery devices was found to be safe and effective and therefore substantially equivalent to the predicate surgical laser systems and delivery devices.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 18, 2014

AllMed Systems, Inc. Peter N. Allen 9232 Klemetson Drive Pleasanton, California 94588

Re: K132975 Trade/Device Name: Sphinx Jr. Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: February 10, 2014 Received: February 25, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Peter N. Allen

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aguel

Binita Ashar, MD, MBA, FACS for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known) K132975

Device Name Sphinx Jr Laser System

Indications for Use (Describe)

The Sphinx Jr. laser system is intended for use in surgical procedures using open, laparoscopic incision, excision, resection, ablation, vaporization and hemostasis of soft and hard tissue in use in medical specialties including:

Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discectory, Pulmonary, Cynecology, Plastic Surgery and General Surgery

Urology

Open and endoscopic surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP) Resection of the Prostrate Condylomas Lesions of external genitalia

Lithouripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi Endoscopic fragmentation of kidney calculi Treatment of steinstrasse when guide wire cannot be passed

Gasteroenterlogy

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, cought:ation and hemostasis) including

Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Uicers Gastric ulcers Duodenal ulcers Pancreatitas Hemorrhouds Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia

FORM FDA 3881 (1/14)

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Colorectal cancer Telangicctasias Vascular Malformation Gastritis Esophagitis

Arthroscopy

Arthroscopy/Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) excluding the spinc but including:

Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including

Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty

Pulmonary

Open and endoscopic surgery (incision, escision, resection, coagulation, coagulation and hemostasis)

Gynecology

Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) including: Outer female genitals Ablation of condilomata and genital warts Inner genitalia Endometrium ablation Treatment of Uterine polyps Treatment of endometriosis

ENT

Endoscopic endonasal surgery (incision, excision, ablation, vaporization, coagulation and hemostasis of soli tissue) including:

Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Ethmoidectomy

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Dermatology and Plastic Surgery

Incision, excision, resection, ablation, coagulation and hemostasis of soft,mucosal, fatty and carilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including:

Basal Cell Carcinomas Lesions of skin and subcutancous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue

General Surgery

Open laparoscopic and cndoscopic surgery (incision, resection, ablation, vaportization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, turnors and lesions Biopsv

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.03.18 13:44:01 -04'00' For BSA

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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.