(176 days)
Not Found
No
The document describes a surgical laser system with internal computer control and operating software, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes.
The device is intended for use in various surgical procedures involving the "ablation, coagulation, dissection and resection of soft tissue," which are direct therapeutic interventions.
No
This device is a surgical laser system intended for use in various surgical procedures, primarily for the ablation, coagulation, dissection, and resection of soft tissue. Its functions are therapeutic, not diagnostic.
No
The device description explicitly states it is a "surgical laser system" and lists hardware components such as a "Laser Console," "Fiber port," and "Footswitch." While it includes "Operating Software," it is clearly part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical procedures involving the incision, excision, resection, ablation, vaporization, coagulation, and hemostasis of soft tissue. These are all procedures performed directly on the patient's body.
- Device Description: The device description details a surgical laser system used for ablating, coagulating, dissecting, and resecting soft tissue. It describes how the laser energy is delivered via fibers and guided by surgical instruments. This is consistent with a surgical device, not a diagnostic one.
- Anatomical Site: The listed anatomical sites are all locations within or on the human body where surgical procedures are performed.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition or provide information about a patient's health status.
IVD devices are designed to perform tests on samples taken from the body to provide diagnostic information. This device is designed to perform therapeutic and surgical interventions directly on the body.
N/A
Intended Use / 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.
Product codes
GEX
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, hard tissue, cartilaginous tissue, mucosal tissue, fatty tissue, bony tissue, in various organs and body parts, including but not limited to: Urethra, Bladder, Ureter, Prostate, External genitalia, Kidneys, Appendix, Colon, Gall Bladder, Biliary/Bile duct, Stomach, Duodenum, Pancreas, Rectum, Joints (small and large, excluding spine), Ligaments, Tendons, Articular surfaces, Synovial tissue, Menisci, Lumbar discs, Cervical discs, Thoracic discs, Chest, Lungs, Female external genitals, Uterus, Endometrium, Nasal cavity, Sinuses, Turbinates, Polyps, Lacrimal sac, Ethmoid bone, Maxillary antrum, Skin, Subcutaneous 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)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Attachment V
510(k) Summary K132 975
| 1.General Information | |
|---|---|
| Submitter: | AllMed Systems Inc. |
| 9232 Klemetson Drive | |
| Pleasanton 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 in |
| general, plastic and dermatological surgery | |
| 3. Predicate Device |
Sphinx Family of lasers, and Lumenis - Versapulse
4. Product 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
1
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
2
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)
3
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
4
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.
5
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
6
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
7
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)
8
Colorectal cancer Telangicctasias Vascular Malformation Gastritis Esophagitis
Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation of soft and cartilaginous tissue) excluding the spinc but including:
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
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
9
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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