(82 days)
1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to-telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.
1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use; Skin resurfacing and treatment of wrinkles.
Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter) Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
The Profile Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.
This submission (K070388) is for the Sciton Profile Multi-Platform System, a modular, multi-wavelength laser/light system. It is a 510(k) submission, meaning the device is seeking clearance based on substantial equivalence to existing legally marketed predicate devices, rather than requiring new clinical studies to prove safety and effectiveness from scratch.
Therefore, the document does not contain explicit acceptance criteria and a study demonstrating the device meets those criteria in the way one might expect for a novel device or a device claiming superior performance. Instead, the "acceptance criteria" are implied by the substantial equivalence determination process, where the device must demonstrate comparable performance and safety characteristics to established predicates.
Here's an analysis of the provided information in the context of a substantial equivalence submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, there are no explicit "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy that a diagnostic AI device would typically have. The "performance" is demonstrated by asserting that the device shares the same intended use, similar design features, and functional features as the predicate devices.
| Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (as stated in the submission) |
|---|---|
| Intended Use Equivalence: Device's intended uses are substantially the same as predicate devices. | 1064 nm Indications: Coagulation and hemostasis of benign vascular lesions; hair removal for all skin types (Fitzpatrick I-VI), including tanned skin, and treatment for pseudofolliculitis barbae (PFB); treatment of facial wrinkles; incision/excision, cutting, vaporization, ablation, coagulation/hemostasis of soft tissue; laser assisted lipolysis. 1320 nm Indications: Treatment of fine lines and wrinkles; back acne, atrophic acne scars, and mild to moderate inflammatory acne vulgaris; treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for incompetence and reflux of superficial veins in the lower extremity. 2940 nm Indications: Skin resurfacing and treatment of wrinkles. Pulsed Light (300-1400 nm) Indications: Surgical, aesthetic, and cosmetic applications requiring selective photothermolysis and hemostasis of soft tissue for: benign pigmented lesions; benign cutaneous vascular lesions; removal of unwanted hair from all skin types for stable long-term or permanent hair reduction; treatment of facial wrinkles, fine lines and wrinkles; topical heating for temporary relief of minor muscle/joint pain and stiffness, minor joint pain associated with arthritis, temporary increase in local circulation, muscle relaxation, muscle spasms, minor sprains/strains, and minor muscular back pain. |
| Technological Characteristics Equivalence: Device design and functional features are similar to predicate devices. | The Profile Multi-Platform System shares "similar design features (including wavelength, laser/light medium and delivery systems, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence)" with its predicate devices. |
| Safety and Effectiveness Equivalence: Risks and benefits are comparable to predicate devices. | "The indications for use are based upon the indications for use for predicate systems. Technologically, the Profile Multi-Platform System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the Profile Multi-Platform System are comparable to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
This is a physical medical device submission (laser/light system), not an AI/software device that requires a test set of data for performance evaluation. Therefore, there is no "test set" in the context of an algorithm's performance on a dataset. The device's performance is established through equivalence to predicate devices, which implies that the predicate devices have already demonstrated safety and effectiveness through their own clinical use and/or studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As described in point 2, there is no "test set" or ground truth establishment in the context of evaluating an algorithm's performance.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of evaluating an algorithm's performance.
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. The Sciton Profile Multi-Platform System is a laser/light system, not an AI software intended to assist human readers (e.g., radiologists interpreting images). Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical laser/light system, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no "ground truth" in the context of evaluating an AI algorithm's performance. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which would have had their own evidence for safety and effectiveness, potentially including clinical outcomes data.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical medical device.
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Attachment IV
510(k) Summary
MAY - 2 2007
:
.
| Submitter | Sciton, Inc. |
|---|---|
| Address: | 925 Commercial Street, Palo Alto, CA 94303 |
| Phone: | (650) 493-9155 |
| Fax : | (650) 493-9146 |
| Contact Person: | Jay M. Patel, VP of Regulatory Affairs |
| Date Prepared: | April 10, 2007 |
| Device Trade Name: | Profile Multi-Platform System |
| Common Name: | Laser/Light Powered Surgical Device (and Accessories) |
| Classification Name: | Laser Surgical Instrument, 21 CFR 878.4810. |
| Legally MarketedPredicate Device: | K060033: Profile Multi-Platform Laser System and AccessoriesK062321: Cynosure SmartLipo Nd:YAG Laser SystemK062822, K051287: Vascular Solutions Vari-Lase LasersK062210, K061618: CoolTouch CTEV Nd:YAG Laser SystemsK023954: Altus Medical CoolGlide Aesthetic LasersK003715: CoolTouch Nd:YAG Laser SystemK050673, K043251, K033461, K033331: Candela Pulsed Dye Laser SystemsK053616, K031671: Polaris WR, ST ApplicatorK0041242: Candela Smoothbeam LaserK051255: Opusmed LumiPhase-RK031425: Light BioScience GentleWaves LED Photomodulation DeviceK042165: Cutera Titan Tabletop ProductK042630: RevLight Skin Care System |
| Description ofProfile Multi-PlatformSystem | The Profile Multi-Platform System is a modular, multi-wavelength laser/light system.The system uses scanning and focusing optics to deliver a pattern of thermalenergy to the treatment site. The system consists of control console which houses thepower supply, cooling system, fiber optic delivery system and/or articulated armdelivery system with handpiece and/or scanner. |
| Intended Use: | 1064 nm Indications for Use: |
| Coagulation and hemostasis of benign vascular lesions such as, but not limitedto-telangiectasia and rosacea.Removal of unwanted hair, for the stable long term, or permanent hairreduction through selective targeting of melanin in hair follicles, and forthe treatment for pseudofolliculitis barbae (PFB). The Profile 1064 LaserSystems and Accessories are indicated for use on all skin types(Fitzpatrick I-VI), including tanned skin.The Profile 1064 Laser Systems and Accessories are indicated for thetreatment of facial wrinkles.Incision/excision and cutting, vaporization, ablation,coagulation/hemostasis of soft tissue in the performance of surgicalapplications. All soft tissue is included, such as skin, cutaneous tissue,subcutaneous tissue, striated and smooth tissue, muscle, cartilagemeniscus, mucous membrane, lymph vessels and nodes, organs andglands. It is further indicated for laser assisted lipolysis. |
:
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1320 nm Indications for Use:
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use;
Skin resurfacing and treatment of wrinkles.
Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for.
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter)
- · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiornas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction: (590nm LP filter, 640nm LP filter, 695nm LP filter)
- · Treatment of facial wrinkles, treatment of fine lines and wrinkles; and (590nm LP filter, 640nm LP filter, 695nm LP filter, 800nm LP filter)
- · Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
| TechnologicalCharacteristics | The Profile Multi-Platform System shares the same indications for use, similar designfeatures (including wavelength, laser/light medium and delivery systems, powersupply, cooling and control system), functional features (including power output,repetition rate, energy, spot size and fluence), and is therefore substantiallyequivalent to the above legally marketed predicate devices. |
|---|---|
| Safety andEffectiveness | The indications for use are based upon the indications for use for predicate systems.Technologically, the Profile Multi-Platform System is substantially equivalent to thelisted predicate devices. Therefore, the risks and benefits for the Profile Multi-PlatformSystem are comparable to the predicate devices. |
| Conclusion | The Profile Multi-Platform System shares similar indications for use, design features,and similar functional features as, and therefore is substantially equivalent to, thecurrently marketed predicate devices. |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 6 2008
Sciton, Inc % Mr. Jav M. Patel 925 Commercial Street Palo Alto, California 94303
Re: K070388
Trade/Device Name: Profile Multi-Platform System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery in dermatology Regulatory Class: II Product Code: GEX Dated: February 8, 2007 Received: February 13, 2007
Dear Mr. Patel:
This letter corrects our substantially equivalent letter of May 2, 2007.
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 (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 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.
{3}------------------------------------------------
Page 2 - Mr. Jay M. Patel
This letter will allow you to continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Neil R.E. Ogden
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Attachment III
Statement of Indications for Use
| 510(k) Number (if known): | K070388 |
|---|---|
| --------------------------- | --------- |
Profile Multi-Platform System Device Name:
Indications for Use:
1064 nm Indications for Use:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to telangiectasia and rosacea.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial winkles.
Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.
1320 nm Indications for Use:
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.
Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
2940 nm Indications for Use:
Skin resurfacing and treatment of wrinkles.
| Prescription Use(Per 21CFR801) | X |
|---|---|
| OR Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
Page 1 of 2
1 of 2
510(k) Number K070388
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Pulsed Light (300-1400 nm) Indications for Use:
The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for:
- · The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter)
- · The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
- (560nm LP filter, 590nm LP filter)
- · The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and
- (590nm LP filter, 640nm LP filter, 695nm LP filter)
- · Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter)
Nil R.P. Ogle
(Division Sign-Off) for mxm
Division of General, Restorative, and Neurological Devices
510(k) Number K070388
§ 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.