(300 days)
The JOULE 810/940/980 Multi-Platform System (and delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue.
The device is specifically indicated for use as follows:
810nm and 980nm
Dermatology/Aesthetics:
- Photocoagulation of vascular & dermatological lesions of the face and extremities
- Photocoagulation of telangiectasia, veinulectasia of the legs and face
- Treatment of reticular veins and branch varicosities
- Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
- Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi.
- Dermatological surgery: Condyloma acuminate, warts, small non malignant skin tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
- Seborrheic keratosis
- Mixoid cyst
- Papillary varix
- Acne treatment
- Hair removal of unwanted hair from skin type I-V
Plastic Surgery:
- Cut, coagulation & vaporization
- Resurfacing
- Blepharoplasty
Vascular Surgery:
- Endoluminal or endovenous laser surgery for saphenous incompetent veins
810nm
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.
The JOULE Multi-Platform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. It is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
940nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
980nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted lipolysis.
The device is specifically indicated for use as follows:
Dermatology, Plastic Surgery and Podiatry:
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include:
- Matrixectomy
- Excision of neuromas
- Excision of periungual and subungual warts
- Excision of plantar warts
- Excision of keloids
- Excision of cutaneous lesions
- Dermabrasion
- Vaporization and hemostasis of capillary hemangioma
- Debridement of wounds
- Photocoagulation of teleangectasia of the legs and face
- Photocoagulation of vascular lesions of the face and extremities
- Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
- Treatment of reticular veins and branch varicosities
Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.
The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.
The provided document is a 510(k) Summary for the JOULE 810/940/980 Multi-Platform System. This type of document establishes substantial equivalence to legally marketed predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical study or performance study for a novel device would.
Therefore, the Acceptance Criteria in this context are primarily based on demonstrating that the JOULE system's technological characteristics and intended uses are substantially equivalent to those of existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Devices) | Reported Device Performance (JOULE 810/940/980 Multi-Platform System) | Met? |
|---|---|---|
| Indications for Use: General surgical applications; hair removal; treatment for benign pigmented and vascular lesions; temporary relief of muscle & joint pain due to elevated tissue temperature. | General surgical applications (vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue); hair removal; permanent hair reduction; treatment of benign pigmented and vascular lesions; temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature. | Yes |
| Wavelength: Similar to predicate devices (e.g., 810 nm, 940 nm, 980 nm, 1064 nm) | 810, 940 & 980 nm | Yes |
| Fluence: Comparable to predicate devices (e.g., ≤ 120 J/cm2) | ≤ 120 J/cm2 | Yes |
| Max Power: Comparable to predicate devices (e.g., ≤ 100 W, ≤ 15 W, ≤ 30 W, 1600 W peak power) | ≤ 100 W | Yes |
| Pulse Duration: Comparable to predicate devices (e.g., ≤ 1350 msec, ≤ 2500 msec, 5 - 400 msec) | ≤ 2500 msec | Yes |
| Spot Size: Comparable to predicate devices (e.g., 1.2 cm2, 0.6 - 2.4 mm Ø, 22x35mm) | 0.6mm Ø to 7.7 cm2 | Yes |
| Output Mode: CW & pulsed mode | CW & pulsed mode | Yes |
| Repetition Rate: Comparable to predicate devices (e.g., ≤ 10 Hz, ≤ 200 Hz, 2.5 - 20,000 Hz, ≤ 3 Hz) | ≤ 200 Hz | Yes |
| Laser Type: Diode | Diode | Yes |
| Electrical Requirements: Comparable to predicate devices (e.g., 230 VAC, 50/60 Hz, 1Φ) | 230 VAC, 50/60 Hz, 1Φ | Yes |
| Console Dimensions: Comparable to predicate devices | 16" x 30" x 43" high | Yes |
| Delivery System: Fiber optic with handpiece | Fiber optic with handpiece | Yes |
| User Interface: LCD touchscreen | LCD touchscreen | Yes |
Study Proving Acceptance Criteria:
The "study" proving the device meets the acceptance criteria is a Substantial Equivalence (SE) determination based on a comparison to legally marketed predicate devices. This is not a traditional clinical trial or performance study in the sense of collecting new patient data. Instead, it's an analytical comparison.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of a 510(k) submission focused on substantial equivalence through comparison of technical specifications and intended uses. No an independent "test set" of patient data was used for this submission. The comparison is made against the established characteristics of already approved predicate devices.
- Data Provenance: The data provenance is from the technical specifications and intended use statements of previously cleared 510(k) devices (K112031, K102036, K100558, K100143, K053628). This is retrospective in nature, as it relies on existing regulatory clearances and documented device designs. The country of origin of the data is implicitly the USA (FDA regulatory filings).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not applicable. Ground truth for a clinical "test set" is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by the FDA in their original clearances. FDA reviewers (experts in medical devices) assess the substantial equivalence.
- Qualifications of Experts: The experts would be the FDA reviewers from the Center for Devices and Radiological Health (CDRH)'s Office of Device Evaluation, specifically the Division of Surgical Devices, who are responsible for assessing 510(k) submissions. Their qualifications include expertise in medical device regulations, engineering, and medical science.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used. The adjudication process is the formal FDA review process to determine substantial equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed in imaging diagnostics to compare human reader performance with and without AI assistance. The JOULE system is a surgical laser, not an imaging diagnostic device that would involve human readers interpreting images.
- Effect Size of Human Readers with vs. without AI: Not applicable for this device type and submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. The JOULE system is a physical laser device operated by a human, not an algorithm or AI system that would operate in a standalone manner without human intervention.
7. The Type of Ground Truth Used:
- The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices, as acknowledged by their prior FDA clearances. The applicant is demonstrating that their new device is fundamentally similar in terms of technology and intended use, thus inheriting the "ground truth" of the predicates.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. This submission does not involve machine learning or AI models that would require a training set. The device's design and performance are compared directly to predicate devices.
9. How the Ground Truth for the Training Set was Established:
- Not applicable as there is no training set for this type of medical device submission.
§ 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.