(87 days)
The Profile 2000 Laser System, and Delivery Devices and Accessories, is indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery, Gastroenterological/Gastrointestinal Surgery, General Surgery, Genitourinary Surgery/Urology, Gynecological Surgery, Lithotripsy and Percutaneous Urinary Lithotripsy, Lumbar Discectomy, Orthopedic Surgery, Otorhinolaryrigological (ENT) Surgery, Pulmonary Surgery.
The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthetic Surgery, Dermatology & Plastic Surgery, Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial, Otorhinolaryrigological (ENT) Surgery, Podiatry, Pulmonary Surgery, Thoracic Surgery.
The Profile 2000 and Profile 3000 emits laser energy with wavelength of 2.01 µm and 2.94 µm respectively. The laser consists of a system console, internal computer, control panel and display, and a fiber optic delivery system and footswitch.
1. Acceptance Criteria and Reported Device Performance:
The document does not explicitly state numerical "acceptance criteria" or specific "reported device performance" in the way one might find for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices.
2. Sample Size and Data Provenance for Test Set:
Not applicable. This device is a laser system, not a diagnostic algorithm that would typically use a test set of data for performance evaluation in the context of the requested questions. The equivalence is based on design features, intended use, and functional features.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. Ground truth for a test set of data is not relevant for this type of device submission.
4. Adjudication Method:
Not applicable. Adjudication methods are typically used in studies involving expert review of diagnostic outputs, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses how AI might improve human reader performance, which is not relevant for a laser surgical instrument.
6. Standalone (Algorithm Only) Performance:
Not applicable. This device is a physical laser system, not a standalone algorithm.
7. Type of Ground Truth Used:
Not applicable. The ground truth concept, as it pertains to AI/algorithm development, is not applicable to the substantial equivalence determination for this laser system. The "truth" in this context is the safety and effectiveness profile of the predicate devices.
8. Sample Size for Training Set:
Not applicable. This device does not involve a training set for an AI algorithm.
9. How Ground Truth for Training Set Was Established:
Not applicable. This device does not involve a training set for an AI algorithm.
Summary of the Study for Device Acceptance:
The acceptance of the Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices and Accessories, is based on a substantial equivalence determination to legally marketed predicate devices. This is a common pathway for medical device clearance (510(k)) in the U.S.
The study, or rather, the justification for acceptance, presented in the 510(k) summary (sections {0}-{4} of the provided text) highlights the following:
-
Rationale for Substantial Equivalence: The key argument is that the Profile 2000 and Profile 3000 Laser Systems share:
- Intended Use: They are both laser surgical instruments.
- Indications for Use: The current devices are indicated for a broad range of surgical applications, which are outlined in detail for both Profile 2000 and Profile 3000 systems. These indications are explicitly stated to be "based upon the indications for use for predicate systems."
- Similar Design Features: This includes wavelength (2.01 µm for Profile 2000 and 2.94 µm for Profile 3000), power supply, cooling system, and control system.
- Functional Features: This includes power output, repetition rate, and pulse duration.
-
Predicate Devices: A comprehensive list of legally marketed predicate devices (both for Profile 2000 and Profile 3000 equivalents) is provided. These predicate devices serve as the benchmark against which the new device is compared.
-
Safety and Effectiveness Information: The document states that because the new devices are "technologically substantially equivalent to the listed predicate devices," their "risks and benefits... are comparable to the predicate devices." This implies that the safety and effectiveness of the predicate devices, established through their marketing history, implicitly serve as the "acceptance criteria" which the new device meets by virtue of its equivalence.
In essence, the "study" proving the device met acceptance criteria was a regulatory comparison demonstrating that the new laser systems are sufficiently similar in design, function, and intended use to already cleared devices, and therefore share a comparable safety and effectiveness profile. There are no explicit performance metrics in this document because the regulatory pathway is based on equivalence rather than de novo performance benchmarks against a "ground truth" data set in the way an AI algorithm might be evaluated.
{0}------------------------------------------------
MAR 2 9 2004
.
K 040005
Attachment IV
510(k) Summary
| Submitter: | Sciton, Inc. |
|---|---|
| Address: | 845 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, Director of Regulatory Affairs |
| Date Prepared: | March 23, 2003 |
| Device Trade Name: | Profile 2000 and Profile 3000 Laser Systems, and DeliveryDevices and Accessories |
| Common Name: | Laser Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally MarketedPredicate Device: | Profile 2000 EquivalentTrimedyne Holmium Laser SystemSurgical Laser Technologies LaserPro CTH HolmiumLaser SystemLumenis VersaPulse Holmium and Dual WavelengthSurgical Lasers & Delivery Devices with AccessoriesNew Star Holmium Laser System |
| Profile 3000 EquivalentErbium 2000 Laser FamilyFutureLase 3000/3002 Erbium Laser SystemSchwartz Electro-Optics CLR 2940 Erbium CrystaLaseLaserscope VELA Erbium:YAG Laser System andAccessories | |
| Description ofProfile EV Laser System: | The Profile 2000 and Profile 3000 emits laser energy withwavelength of 2.01 µm and 2.94 µm respectively.The laser consists of a system console, internal computer,control panel and display, and a fiber optic delivery systemand footswitch. |
| Intended Use: | The Profile 2000 Laser System, and Delivery Devices andAccessories, is indicated for incision, excision, resection,ablation, vaporization, coagulation and hemostasis, with orwithout an endoscope, in contact and non-contact with |
{1}------------------------------------------------
tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization.
Gastroenterological/Gastrointestinal Surgery
Gastroenterologic surgery of soft tissue, including: cholecystectomy, lysis of adhesions, appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benion and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophaqitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions. colorectal cancer, qastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease.
General Surgery
General surgery of soft tissues, including; skin incision. tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablations; removal of benign and malignant lesions; mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectory.
Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and
{2}------------------------------------------------
resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Gynecological surgery of soft tissue, including condyloma acuminata.
Lithotripsy and Percutaneous Urinary Lithotripsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectomy
Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery
Orthopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spine), including: knee meniscectomy, knee synovectomy, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation.
Otorhinolaryrigological (ENT) Surgery
Otorhinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectorny, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty.
Pulmonary Surgery Open and endoscopic pulmonary surgery.
The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or
{3}------------------------------------------------
fragments, mucous membrane, lymph vessels and nodes, organs and glands.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology & Plastic Surgery
Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers.
Gastroenterology
General Surgery
The Erbium:YAG laser is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation.
Genitourinary/Urology
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Otorhinolaryrigological (ENT) Surgery
Podiatry
Indications include warts, plantar verruae, large mosaic verrucae and matrixectomy.
Pulmonary Surgery
Thoracic Surgery
Rationale for Substantial Equivalence:
The Profile 2000 and Profile 3000 Laser Systems and Delivery Devices and Accessories share intended use, indications for use, similar design features (including wavelength, power supply, cooling and control system). functional features (including power output, repetition rate
{4}------------------------------------------------
| and pulse duration), and is therefore substantiallyequivalent to above legally marketed predicate devices. | ||
|---|---|---|
| Safety and EffectivenessInformation | The indications for use are based upon the indications foruse for predicate systems. Technologically, the Profile2000 and Profile 3000 Laser Systems, and DeliveryDevices and Accessories are substantially equivalent tothe listed predicate devices. Therefore, the risks andbenefits for the Profile 2000 and Profile 3000 LaserSystems, and Delivery Devices and Accessories arecomparable to the predicate devices. | |
| Conclusion | The Profile 2000 and Profile 3000 Laser Systems, andDelivery Devices and Accessories, share similarindications for use, design features, and similar functionalfeatures as, and therefore are substantially equivalent to,the currently marketed predicate surgical lasers, deliverydevices and accessories. |
1000 - 1000
{5}------------------------------------------------
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human figures, possibly representing health, family, and community. The emblem is designed with flowing lines to create a sense of movement and unity.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 9 2004
Mr. Jay M. Patel Director of Regulatory Affairs Sciton, Inc. 845 Commercial Street Palo Alto. California 94303
Re: K040005 Trade/Device Name: Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices and Accessories 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: December 30, 2003 Received: January 7, 2004
Dear Mr. Patel:
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.
{6}------------------------------------------------
Page 2 - Mr. Jay M. Patel
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/cdrb/dsma/dsmamain.html
Sincerely yours.
Miriam 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
{7}------------------------------------------------
Attachment III
Statement of Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Profile 2000 and Profile 3000 Laser Systems, and Delivery Devices Device Name: _________________________________________________________________________________________________________________________________________________________________ and Accessories
Indications for Use:
The Profile 2000 Laser System, and Delivery Devices and Accessories, is incieated for incision, excision, The Profite 2000 Laser System, and Delivery Delivery Devece without an endoscope, in contact and room ontact with tissue, with or without a hand piece, in the following indications:
Dermatology and Plastic Surgery
Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in thereoutic plastic Dermatological and Plastic Surgely of Sol, macosal, including scars, tettoo removal, vascular
therapeutic dermatological and aesthetic surgical procedures, including seconomi therapedite dermatological and aestrests surgious proceeding (facial, leg] and rosacea), coms.
lesions (including port wine stains, hemangioma, telangiectasias (facial, cont lesions (ficiouning por wire stams, nemongloma, thengrounds tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization.
Gastroenterological/Gastrointestinal Surgery
Gastroenterologic surgery of soft tissue, including: cholecysted on of significansis appendectorny, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid color, gall bladder biopsy, pylorosteriotony, belligh and malignant neoplasm, polypes collits, ulcers, angiodysplassia.
calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyp carculi, billarylblie doct calcul, beingh and nealignally porporation in and and allest, ducer, ducer, ducer, ducer, and class and nemormolds, values, esophageal cancer, gastritis, bleeting gumrs, pancealitis, vascular
non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleebing turnsesse molleding uncer, gastro erodono, establish Judinestas of the Osler-Weber-Rendu disease.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21CFR801) | OR Over-The-Counter Use |
|---|---|
| ------------------------------------ | ------------------------- |
Miriam C. Provont
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
Page 1 of 3
| 510(k) Number | K040005 |
|---|---|
| --------------- | --------- |
{8}------------------------------------------------
General Surgery
General surgery of soft tissues, including; skin incision, tissue dissection, excision of exemal turnors and firens and firens and firens and firens and firens a General surgely of son ilssues, including, akki meason, associations, and tissue ablations, and tissue ableting and lealons, complete of patilar reseason or member of pepatectorny, pancreationy, spienectomy, particl removal of beth and mongham lobemiormaphy, tonsillectorny, lymphadenectorny, patial thyroldectorny, parathyroldectorly, nemothlaphy, tonsmectory, the program of decubitus nephectority, pilonidal cystexonly, rooosler or spair, debridement of statis ulcer, biopsy, bicer, nemormolas, phornations, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectorny.
Genitourinary Surgery/Urology
Genitourinary surgery of soft tissue, including; treatment of bladder, und und secule heaveniems Genitountary bladder turnors; invasive bladder carcinomas; urethral and penile hennangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder nectors; lease plant urelifal strictures, lesions of the external generalia, or the prostate, laser able for Efficultures in and resection of prostate, biadel mobilities and excision for treatment of benign prostatic hypertrophy.
Gynecological Surgery
Gynecological surgery of soft tissue, including condyloma acuminata.
Lithotripsy and Percutaneous Urinary Lithotripsy
Lithotripsy and perculaneous urinary lithotripsy, including; fragmentation of kirker of kirker on Cithollipsy and percularieous unlary illusting, fraguitis, fragmentation of kidney calculi, tragmentation of calculi in the dreler and dicital impacted fragments of steinstrasse when guide wires cannot be passed.
Lumbar Discectomy
Lumbar discectorny in soft, cartilaginous and bony tissue, including: vaporization of the advances Eurnbar disocctorry in Gott Garalagine open, percutaneous and endoscopic spine procedures; foraminotomy.
Orthopedic Surgery
Othopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spire). Officipedic surgery in son canaginous in still and tears, loose body debridement.
including: knee meniscectorny, knee synovectomy, chondromalacia and tearing of Including. Kree menisceclonity, knee synoven and tendon release, contouring and sculpting of lateral relifacular release, plica removal, ligatheri, and tendon rolouse, considerative, in the knee, chondroplasty in the knee, chondromalacia ablation.
Otorhinolaryrigological (ENT) Surgery
Otominolaryngological (ENT) surgery in soft, mucosal, cartilaginous and borny tissue, including, Olominolarynguogical (ENT) surgery in son, moosed, dertingmosphy, from the procedures (e.g. turningplash, endosinos surgery, funkalonal ondosophe simal birgory, polypectomy, maxiltary antrotomy, tarbinectority), but your routinationy, hereditary hemorrhagic telangectasia, septoplasty.
Pulmonary Surgery
Open and endoscopic pulmonary surgery.
The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated for use in aurgical The Fronte Jour Laser System, and Delivery De need and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, not deads resultacing. Sont insue muddes min, coosetancede liberty vessels and nodes, organs and glands.
Aesthetic Surgery
Skin resurfacing and treatment of wrinkles.
Dermatology & Plastic Surgery
Uermatology & Elashc Suggel
Indications include, epidermal nevi, telangietasia, spider veilini, keloids, verrucae, skin the transmont and the revision, debulking benign tumors, decubitis ulcers,
{9}------------------------------------------------
Gastroenterology
General Surgery
General Surgery
The Erbium,YAG laser is intended for the surgical incision, vaportization argicion of soft The Erbitin', FAG laser is internet for surger resion existed dissection, excision, excision of external tissue dunny any general strigery application where bail industry, issue ablation and/or vessel coagulation.
Genitourinary/Urology
Gynecology
Gynecology
Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma.
Ophthalmology
Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy.
Oral/Maxillofacial
Otorhinolaryrigological (ENT) Surgery
Podiatry
Indications include warts, plantar verruae, large mosaic verrucae and matrixectorny.
Pulmonary Surgery
Thoracic Surgery
§ 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.