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Chrome is intended for use in aesthetic, cosmetic and surgical applications requiring incision, ablation, vaporization and coagulation of body soft tissues in the medical specialties of dermatology, general, plastic and oral surgery as follows.

Indications for use

1064 & 532 nm (Q-Switched, nanosecond mode)

Chrome is intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to treatment of:

532 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos

Treatment of benign vascular lesions including, but not limited to:

• port wine birthmarks
• telangiectasias
• spider angioma
• Cherry angioma
• Spider nevi

Treatment of benign pigmented lesions including, but not limited to:

• cafe-au-Iait birthmarks
• Ephalides, solar lentigines
• senile lentigines
• Becker's nevi
• freckles
• common nevi
• nevus spilus
• Ota Nevus

Treatment of seborrheic keratosis

Treatment of post inflammatory hyperpigmentation

Skin resurfacing procedures for the treatment of acne scars and wrinkles.

1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces: Removal of dark ink (black, blue and brown) tattoos

Removal of benign pigmented lesions including;

• nevus of Ota
• Café au lait spot
• Ephalides, solar lentigo (lentigines)
• Becker Nevus
• Nevus spilus

Treatment of common nevi

Removal or lightening of unwanted hair

Skin resurfacing procedures for the treatment of acne scars and wrinkles

1064 nm (pulsed)

Dermatology/Plastic Surgery:

Intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangectasia, rosacea, venus lake, leg veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis.

The laser is also intended for the treatment of benign pigmented lessons such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques.

The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. The laser is also indicated for the treatment of facial wrinkles.

Additionally, the laser is indicated for the treatment of pseudofolliculitis barbae (PFB) and for stable long-term, or permanent hair reduction. Permanent hair reduction is defined as 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.

It is indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The laser is also indicated for benign pigmented lesion size, for patients with benign lesions that would potentiallybenefit from aggressive treatment, and for patients with benign that have not responded to other laser treatments.

It is indicated for use on all skin types (Fitzpatrick I-VI) including tanned skin, and the removal and permanent reduction of unwanted hair in Fitzpatrick I-VI, including suntanned skin types.

IPL 590-1200nm; 625-1200nm; 650-1200nm

Indicated for permanent hair removal.

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

IPL 550-1200nm; 570-1200nm

Indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.

IPL 400-1200nm

Indicated for inflammatory acne (mild to moderate acne vulgaris).

Integrated Skin Cooler

The intended use of the integrated cooling system in the laser hand piece is to provide cooling of the skin prior to laser treatment, for the reduction of pain during laser treatment, to allow for the use of higher fluencies for laser treatments such as hair removal and benign vascular lesion, and to reduce the potential side effects of laser treatments. Any other different use is considered incorrect.

Chrome is a laser family that includes Q-Switched and/or Pulsed laser sources, emitting at 532 nm and 1064 nm (Nd:YAG laser).

Chrome, through the special universal Twain connector, can be equipped with intense pulsed light handpieces (Twain IPL) emitting at the following wavelengths: 650-1200nm, 625-1200nm, 590-1200nm, 570-1200nm, 550-1200nm, 400-1200nm.

It can also be connected to Er:YAG handpieces cleared under K173002.

Chrome, when operating with Pulsed laser sources and IPL, can be used in combination with optional contact, or air, cooling systems.

The optical delivery system is an articulated arm with fixed or variable handpieces. The optical delivery system for the IPL system is a handpiece (Twain IPL) with fixed or interchangeable light filters at different wavelengths.

Chrome is controlled via a touch screen display housed in the front of the device.

Emission is triggered by means of a footswitch.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not contain information about acceptance criteria for performance, device performance metrics, or any clinical study details (sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, or training set details).

The document focuses on regulatory approval (510(k) premarket notification) for a laser device called "Chrome." It establishes "substantial equivalence" to predicate devices, primarily based on technological characteristics and safety standards.

The sections that might typically contain such information (like "Performance data" and "Technological Characteristics Comparison") focus on:

• Performance data: Lists recognized consensus safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1) and states that "Software Verification and Validation Testing" was conducted. It also mentions biocompatibility was established by comparison to a predicate. This refers to safety and electrical performance standards, not clinical efficacy or diagnostic accuracy.
• Technological Characteristics Comparison: Compares specific technical parameters (laser wavelengths, pulse width, max fluence, spot size, repetition rate, microbeam handpiece details, IPL wavelengths) of the Chrome device to two predicate devices. This demonstrates that the device operates within similar technical specifications as already approved devices, not that it has met specific clinical performance criteria.

Therefore, I cannot populate the requested table and answer the detailed questions about the study that proves the device meets acceptance criteria, as that information is not present in the provided document.

The document primarily demonstrates:

1. Indications for Use: What conditions the device is intended to treat (various dermatological conditions, tattoo removal, hair reduction, etc.).
2. Technological Equivalence: That its technical specifications (laser types, wavelengths, power, etc.) are comparable to previously cleared devices.
3. Safety & Standards Compliance: That it complies with general safety and electrical standards for medical devices and lasers.

This type of 510(k) submission often does not require new clinical studies if substantial equivalence can be established based on technological characteristics and intended use compared to legally marketed predicate devices.

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The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.

The Chromsystems MassCheck Immunosuppressant Controls are Ivophilized, multi-analyte human whole blood based products containing the analytes Ciclosporin A, Rapamycin (Sirolimus) and Tacrolimus. The Controls are available as four levels + blank. Prior to use the different lyophilized controls need to be reconstituted by adding the corresponding amount of water as indicated on the respective packing leaflet. Each donor was tested and found negative for Human immunodeficiency virus (HIV) 1 and 2, Hepatitis B virus (HBV), Hepatitis C virus (HCV) in European blood banks. The tests used were cleared for in vitro diagnostic use in the EU (in compliance with the European Directive 98/79/EC on in vitro Diagnostic Medical Devices as Annex II, List A products) and are also approved by the Paul-Ehrlich-Institute in Germany.

The document provided is a 510(k) summary for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls. This type of device is a control material used to verify the performance of laboratory assay systems that measure concentrations of immunosuppressant drugs.

Based on the information provided in the document, here's a breakdown regarding acceptance criteria, study details, and related aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical thresholds (e.g., ±X% accuracy, Y% precision).
It also does not report specific performance data for the Chromsystems MassCheck Immunosuppressants Whole Blood Controls.

Instead, the submission primarily focuses on demonstrating substantial equivalence to predicate devices. The claim of substantial equivalence is based on the following similarities:

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a specific "test set" in the context of a performance study with a defined sample size for the proposed device itself, nor does it specify data provenance (country of origin, retrospective/prospective).

The submission relies on a comparison to predicate devices, implying that the performance of the proposed device is expected to be similar to that of the already legally marketed predicates. The comparison focuses on the characteristics and intended use rather than new clinical performance data from a specific test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable or provided in the 510(k) summary. Given that the device is a control material and the submission aims for substantial equivalence based on product characteristics rather than a diagnostic performance claim, there is no mention of an expert panel establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for the same reasons as above. No adjudication method is described.

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 or described. This type of study is typically performed for diagnostic imaging or screening devices to assess human reader performance with and without AI assistance. The MassCheck Immunosuppressants Whole Blood Controls are laboratory control materials, not diagnostic AI systems for human interpretation.

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

No, a standalone (algorithm only) performance study was not described. The device is a physical control material, not an algorithm. Its "performance" is in its stability, accuracy of stated concentrations, and ability to challenge an assay system appropriately. These characteristics are typically validated through analytical studies, not an algorithm-only performance study.

7. The Type of Ground Truth Used:

For the purpose of this 510(k) (seeking substantial equivalence for a control material):

• The "ground truth" for the analytes (Ciclosporin A, Rapamycin (Sirolimus), and Tacrolimus) in the control material would be their known, precisely manufactured concentrations.
• The "ground truth" for the safety of the human whole blood matrix is based on testing for specific pathogens (HIV 1 and 2, HBV, HCV) using cleared in vitro diagnostic tests in EU blood banks.

However, the document does not elaborate on how the precise concentrations of the analytes within the controls were verified or how the controls were analytically characterized. The focus is on the device's intended use as a control, not on its own diagnostic accuracy against a gold standard in patient samples.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The device is a manufactured control product, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable or provided for the same reason as above.

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